MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) today announced that it has submitted a clinical trial application (CTA) to initiate a phase 1 trial using the HuCAL-derived antibody MOR103 for the treatment of Rheumatoid Arthritis. MorphoSys plans to reveal the target molecule of its lead antibody program MOR103 and additional information on the design of the phase 1 clinical study on January 16, 2008.
"The initiation of clinical development of our lead proprietary drug candidate MOR103 is a significant milestone for MorphoSys and we achieved it as planned by the end of 2007. We look forward to providing an in-depth update on MOR103 in January," commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG.
MorphoSys will hold a public conference call and live audio webcast on January 16, 2008 to provide detailed information on its lead compound MOR103. Additional information will be provided on the Company's website: morphosys/conferencecalls
About MorphoSys
MorphoSys is a publicly traded biotechnology company focused on the generation of fully human antibodies as a means to discover and develop innovative antibody-based drugs against life-threatening diseases. MorphoSys's goal is to establish HuCAL as the technology of choice for antibody generation in research, diagnostics and therapeutic applications. The Company currently has therapeutic and research alliances with the majority of the world largest pharmaceutical companies including Bayer-Schering, Boehringer Ingelheim, Centocor/Johnson & Johnson, Novartis, Pfizer and Roche. Within these partnerships, more than 40 therapeutic antibody programs are ongoing in which MorphoSys participates through exclusive license and milestones payments as well as royalties on any end products. Additionally, MorphoSys is active in the antibody research market through its AbD Serotec business unit. The business unit has operations in Germany (Munich), the U.S. (Raleigh, NC) and U.K. (Oxford). For further information please visit morphosys
HuCAL(R) and HuCAL GOLD(R) are registered trademarks of MorphoSys AG
This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve risks and uncertainties. Should actual conditions differ from the Company's assumptions, actual results and actions may differ from those anticipated. MorphoSys does not intend to update any of these forward-looking statements as far as the wording of the relevant press release is concerned.
вторник, 31 мая 2011 г.
понедельник, 30 мая 2011 г.
Diagnostic "Guidelines" A Barrier To Prompt Relief For Some Back Pain
Slavishly following long-held guidelines for diagnosing the cause of arthritis-related back pain is resulting in excessive tests, delays in pain relief and wasteful spending of as much as $10,000 per patient, new Johns Hopkins-led research suggests.
Arthritis is a common cause of back pain, though difficult to precisely diagnose, experts say, because of the poor correlation between a finding of arthritis on an X-ray or MRI and the degree of a patient's back pain. That has routinely led to a series of temporary diagnostic nerve blocks to prove the arthritis connection before doctors will recommend radiofrequency denervation, a relatively safe, noninvasive procedure that interrupts nerve-pain signals from arthritic joints.
The new study, published in the August issue of the journal Anesthesiology, says the wiser course is to skip the diagnostic nerve blocks altogether and move straight to treatment when arthritis is the suspected cause of back pain.
"The whole way we're doing this is wrong," says study leader Steven P. Cohen, M.D., an associate professor of anesthesiology and critical care medicine at the Johns Hopkins University School of Medicine. "If we just do the radiofrequency procedure first, we're going to help more people and we're going to save a lot of money."
In Cohen's study, 151 patients at several hospitals whose back pain fit the criteria for arthritic back pain were randomized to one of three groups: Group 0 received radiofrequency denervation based on clinical findings without nerve blocks; group 1 underwent the radiofrequency treatment only after a positive response to a single diagnostic block; and group 2 only got the treatment if they had positive responses to two diagnostic blocks.
One-third of the patients in group 0 experienced significant pain relief lasting at least three months, while just 16 percent of group 1 and 22 percent of group 2 improved. Those in group 0 were treated immediately, visited a clinic just once and lost no extra days of work to undergo repeated diagnostic tests, Cohen says. The costs per successful treatment in groups 0, 1 and 2 were $6,286, $17,142 and $15,241, respectively.
Notably, among those who had radiofrequency treatment, success rates were higher in those who had the diagnostic blocks first because they were more likely to actually have arthritis. Still, Cohen says, those patients endured long delays and multiple procedures before finally getting lasting pain relief, and some may have not gotten needed radiofrequency treatment because of the false-negative results associated with diagnostic blocks.
"Our goal is to get people feeling better," he says. "When you do two blocks, you may be wrongly weeding out many people who would actually benefit from radiofrequency denervation."
Cohen notes that radiofrequency denervation is as safe as giving a diagnostic block and need only be done once for relief of symptoms. "The proof is in the treatment," he says. Radiofrequency denervation is unlikely to help patients whose back pain is not caused by arthritis. However, the procedure is not considered dangerous for those without arthritis.
Radiofrequency denervation is the second most common procedure in pain clinics across the United States. The relief can last many months and sometimes years, but often must be repeated when pain returns.
Cohen, who is also a colonel in the U.S. Army Reserves and director of chronic pain research at Walter Reed Army Medical Center, says the idea to do without diagnostic blocks came from his experience treating active-duty soldiers who complain of debilitating back pain. Deployed military doctors are under time pressure because soldiers who can't be sent back to their posts quickly are likely to be evacuated out of the war zone with the likelihood that they will not return.
In the civilian world, he says, patients also should be treated as quickly and safely as possible. Going straight to treatment typically means that those patients can also return to work and their normal lives in a shorter period of time.
Until recently, the big debate in the pain management community was whether to do one or two diagnostic blocks before the radiofrequency nerve-burning procedure. The rationale behind using two blocks is that some people without arthritic back pain can get pain relief from a single block, which is called a "false-positive" test. But Cohen and colleagues believe that making diagnostic accuracy a higher priority than pain relief may be misguided.
"If you ask patients what their main goal of treatment is, the answer is typically that they want to be able to pick up their grandkids or play golf,'" he says. "It's not, 'I want to know if it's my arthritic joints or my discs.'"
Cohen cautions that diagnostic nerve blocks are called for in some cases. For example, they should be used to determine whether surgery is the right option for relieving certain kinds of back pain in people without a clear-cut anatomical problem in order to avoid an unnecessary, risky operation.
The research was supported by a grant from the John P. Murtha Neuroscience and Pain Institute, the U.S. Army and the Army Regional Anesthesia and Pain Medicine Institute.
Kayode A. Williams, M.D., M.B.A., of Johns Hopkins, Connie Kurihara, R.N., of Walter Reed, and Scott Strassels, Pharm.D., Ph.D., of the University of Texas, also participated in the study.
Source: Johns Hopkins Medicine
Arthritis is a common cause of back pain, though difficult to precisely diagnose, experts say, because of the poor correlation between a finding of arthritis on an X-ray or MRI and the degree of a patient's back pain. That has routinely led to a series of temporary diagnostic nerve blocks to prove the arthritis connection before doctors will recommend radiofrequency denervation, a relatively safe, noninvasive procedure that interrupts nerve-pain signals from arthritic joints.
The new study, published in the August issue of the journal Anesthesiology, says the wiser course is to skip the diagnostic nerve blocks altogether and move straight to treatment when arthritis is the suspected cause of back pain.
"The whole way we're doing this is wrong," says study leader Steven P. Cohen, M.D., an associate professor of anesthesiology and critical care medicine at the Johns Hopkins University School of Medicine. "If we just do the radiofrequency procedure first, we're going to help more people and we're going to save a lot of money."
In Cohen's study, 151 patients at several hospitals whose back pain fit the criteria for arthritic back pain were randomized to one of three groups: Group 0 received radiofrequency denervation based on clinical findings without nerve blocks; group 1 underwent the radiofrequency treatment only after a positive response to a single diagnostic block; and group 2 only got the treatment if they had positive responses to two diagnostic blocks.
One-third of the patients in group 0 experienced significant pain relief lasting at least three months, while just 16 percent of group 1 and 22 percent of group 2 improved. Those in group 0 were treated immediately, visited a clinic just once and lost no extra days of work to undergo repeated diagnostic tests, Cohen says. The costs per successful treatment in groups 0, 1 and 2 were $6,286, $17,142 and $15,241, respectively.
Notably, among those who had radiofrequency treatment, success rates were higher in those who had the diagnostic blocks first because they were more likely to actually have arthritis. Still, Cohen says, those patients endured long delays and multiple procedures before finally getting lasting pain relief, and some may have not gotten needed radiofrequency treatment because of the false-negative results associated with diagnostic blocks.
"Our goal is to get people feeling better," he says. "When you do two blocks, you may be wrongly weeding out many people who would actually benefit from radiofrequency denervation."
Cohen notes that radiofrequency denervation is as safe as giving a diagnostic block and need only be done once for relief of symptoms. "The proof is in the treatment," he says. Radiofrequency denervation is unlikely to help patients whose back pain is not caused by arthritis. However, the procedure is not considered dangerous for those without arthritis.
Radiofrequency denervation is the second most common procedure in pain clinics across the United States. The relief can last many months and sometimes years, but often must be repeated when pain returns.
Cohen, who is also a colonel in the U.S. Army Reserves and director of chronic pain research at Walter Reed Army Medical Center, says the idea to do without diagnostic blocks came from his experience treating active-duty soldiers who complain of debilitating back pain. Deployed military doctors are under time pressure because soldiers who can't be sent back to their posts quickly are likely to be evacuated out of the war zone with the likelihood that they will not return.
In the civilian world, he says, patients also should be treated as quickly and safely as possible. Going straight to treatment typically means that those patients can also return to work and their normal lives in a shorter period of time.
Until recently, the big debate in the pain management community was whether to do one or two diagnostic blocks before the radiofrequency nerve-burning procedure. The rationale behind using two blocks is that some people without arthritic back pain can get pain relief from a single block, which is called a "false-positive" test. But Cohen and colleagues believe that making diagnostic accuracy a higher priority than pain relief may be misguided.
"If you ask patients what their main goal of treatment is, the answer is typically that they want to be able to pick up their grandkids or play golf,'" he says. "It's not, 'I want to know if it's my arthritic joints or my discs.'"
Cohen cautions that diagnostic nerve blocks are called for in some cases. For example, they should be used to determine whether surgery is the right option for relieving certain kinds of back pain in people without a clear-cut anatomical problem in order to avoid an unnecessary, risky operation.
The research was supported by a grant from the John P. Murtha Neuroscience and Pain Institute, the U.S. Army and the Army Regional Anesthesia and Pain Medicine Institute.
Kayode A. Williams, M.D., M.B.A., of Johns Hopkins, Connie Kurihara, R.N., of Walter Reed, and Scott Strassels, Pharm.D., Ph.D., of the University of Texas, also participated in the study.
Source: Johns Hopkins Medicine
воскресенье, 29 мая 2011 г.
New Data Reinforce One In Three Rheumatoid Arthritis (RA) Patients Achieve Clinical Remission With Tocilizumab
Exciting new data from the TOWARD study, at the American College of Rheumatology (ACR) Annual Scientific Meeting in Boston, show that around one in three patients achieved clinical remission in the tocilizumab (Actemra) group, as assessed using DAS28
At 24 weeks significantly more patients achieved a 20%, 50% and 70% (ACR20, ACR50 and ACR70) reduction of symptoms with Actemra plus DMARDs compared to the control group. The ACR20, ACR50 and ACR70 was achieved in 61%, 38% and 21%, respectively, of Actemra plus DMARDs patients versus 25%, 9% and 3%, respectively, in the placebo plus DMARDs arm. Disease remission was demonstrated in 30% of Actemra patients (DAS28
At 24 weeks significantly more patients achieved a 20%, 50% and 70% (ACR20, ACR50 and ACR70) reduction of symptoms with Actemra plus DMARDs compared to the control group. The ACR20, ACR50 and ACR70 was achieved in 61%, 38% and 21%, respectively, of Actemra plus DMARDs patients versus 25%, 9% and 3%, respectively, in the placebo plus DMARDs arm. Disease remission was demonstrated in 30% of Actemra patients (DAS28
суббота, 28 мая 2011 г.
Osteologix Initiates Phase II Clinical Trial Of Investigational Drug For Osteoporosis
Osteologix Inc. (OTC
Bulletin Board: OLGX) announced today that it has initiated a randomized,
double-blind, placebo-controlled phase II clinical trial of NB S101, its
investigational drug for osteoporosis. The primary endpoint of the study is
the change in patients' bone resorption. Osteologix plans to enroll
approximately 275 postmenopausal women with low bone mineral density and
treat them for 12 weeks in the clinical trial, which is being conducted at
investigator sites located throughout the UK and Denmark.
"I am very pleased to be initiating this phase II study within only
three years of the creation of Osteologix and initiation of NB S101
development. Our goal is to build further evidence of the efficacy and
safety of NB S101 as a primary treatment for osteoporosis," stated Charles
J. Casamento, CEO and President. "There is a significant need for improved
osteoporosis treatments. We believe NB S101 may have the ability to both
increase bone formation and decrease bone resorption, while also reducing
the side effects most common in osteoporosis drugs available today,
providing a tremendous potential opportunity for Osteologix."
The clinical trial being initiated by Osteologix, "A dose-response
study with strontium malonate in healthy post-menopausal women," is
designed with five randomized arms. The company plans to enroll
approximately 55 patients in each arm. Four arms of the trial will be
double-blind, including three different doses of NB S101 (750 mg, 1000 mg
and 2000 mg) and placebo. The primary endpoint will be the effect of NB
S101 on CTX-1, a biochemical marker of bone resorption. NB S101 is the
Osteologix investigational drug containing strontium malonate as its active
ingredient. In addition to the four double- blind arms, there will be an
open-label arm containing Protelos (strontium ranelate, approved in Europe
for the treatment of Osteoporosis). The Protelos arm is open-label because
Protelos is only available in a sachet and must be mixed with water prior
to ingestion. NB S101 is a once-daily tablet available with increased
bioavailability of free strontium when compared to Protelos (strontium
ranelate).
In addition to the primary endpoint of quantifying bone resorption,
Osteologix plans to evaluate the effect of NB S101 on bone formation by
measuring markers specific for this process. Other secondary endpoints
being evaluated include the effects of NB S101 on bone mineral density,
strontium levels and markers of cartilage degradation. Side effects will
also be assessed.
About Osteologix
Osteologix develops proprietary therapeutics for the treatment of
important unmet medical needs in bone disease and women's health. The
Company's lead product, NB S101, has entered phase II clinical trials for
the treatment of osteoporosis. Based on the Company's own data as well as
data from phase III clinical trials conducted on another salt of strontium
that is approved for sale in Europe, Osteologix believes that NB S101
increases new bone formation and decreases bone resorption. Osteologix
further believes that NB S101 will provide patients with greater
convenience and fewer side effects than drugs currently approved for
osteoporosis in the United States, Europe and elsewhere, thereby addressing
the need for an osteoporosis drug with higher compliance rates and better
long term efficacy. The Company is not aware of any osteoporosis drug
currently approved for sale in the United States that simultaneously
increases bone formation and decreases bone resorption. Osteologix is
committed to creating value by building a world- class team, accelerating
the development of lead product candidates, expanding its pipeline by being
the alliance partner of choice, and nurturing a unique company culture.
Additional information on Osteologix can be obtained on the Company's
website, osteologix.
FORWARD-LOOKING STATEMENTS:
Certain of the statements set forth in this press release constitute
"Forward looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include, without
limitation, any statement that may predict, forecast, indicate, or imply
future results, performance or achievements, and may contain the words
"estimate," "project," "intend," "forecast," "anticipate," "plan,"
"planning," "expect," "believe," "will," "will likely," "should," "could,"
"would," "may" or words or expressions of similar meaning. All such forward
looking statements involve risks and uncertainties, including, but not
limited to: statements regarding Osteologix's research and development
programs; proposed marketing and sales; patents and regulatory approvals;
the effect of competition and proprietary rights of third parties; the need
for and availability of additional financing and access to capital; and the
seeking of joint development, licensing or distribution and collaboration
and marketing arrangements with pharmaceutical companies. There can be no
assurance that such forward-looking statements will prove to be accurate
and Osteologix undertakes no obligation to update any forward-looking
statements or to announce revisions to any of the forward-looking
statements.
Osteologix Inc.
osteologix
Bulletin Board: OLGX) announced today that it has initiated a randomized,
double-blind, placebo-controlled phase II clinical trial of NB S101, its
investigational drug for osteoporosis. The primary endpoint of the study is
the change in patients' bone resorption. Osteologix plans to enroll
approximately 275 postmenopausal women with low bone mineral density and
treat them for 12 weeks in the clinical trial, which is being conducted at
investigator sites located throughout the UK and Denmark.
"I am very pleased to be initiating this phase II study within only
three years of the creation of Osteologix and initiation of NB S101
development. Our goal is to build further evidence of the efficacy and
safety of NB S101 as a primary treatment for osteoporosis," stated Charles
J. Casamento, CEO and President. "There is a significant need for improved
osteoporosis treatments. We believe NB S101 may have the ability to both
increase bone formation and decrease bone resorption, while also reducing
the side effects most common in osteoporosis drugs available today,
providing a tremendous potential opportunity for Osteologix."
The clinical trial being initiated by Osteologix, "A dose-response
study with strontium malonate in healthy post-menopausal women," is
designed with five randomized arms. The company plans to enroll
approximately 55 patients in each arm. Four arms of the trial will be
double-blind, including three different doses of NB S101 (750 mg, 1000 mg
and 2000 mg) and placebo. The primary endpoint will be the effect of NB
S101 on CTX-1, a biochemical marker of bone resorption. NB S101 is the
Osteologix investigational drug containing strontium malonate as its active
ingredient. In addition to the four double- blind arms, there will be an
open-label arm containing Protelos (strontium ranelate, approved in Europe
for the treatment of Osteoporosis). The Protelos arm is open-label because
Protelos is only available in a sachet and must be mixed with water prior
to ingestion. NB S101 is a once-daily tablet available with increased
bioavailability of free strontium when compared to Protelos (strontium
ranelate).
In addition to the primary endpoint of quantifying bone resorption,
Osteologix plans to evaluate the effect of NB S101 on bone formation by
measuring markers specific for this process. Other secondary endpoints
being evaluated include the effects of NB S101 on bone mineral density,
strontium levels and markers of cartilage degradation. Side effects will
also be assessed.
About Osteologix
Osteologix develops proprietary therapeutics for the treatment of
important unmet medical needs in bone disease and women's health. The
Company's lead product, NB S101, has entered phase II clinical trials for
the treatment of osteoporosis. Based on the Company's own data as well as
data from phase III clinical trials conducted on another salt of strontium
that is approved for sale in Europe, Osteologix believes that NB S101
increases new bone formation and decreases bone resorption. Osteologix
further believes that NB S101 will provide patients with greater
convenience and fewer side effects than drugs currently approved for
osteoporosis in the United States, Europe and elsewhere, thereby addressing
the need for an osteoporosis drug with higher compliance rates and better
long term efficacy. The Company is not aware of any osteoporosis drug
currently approved for sale in the United States that simultaneously
increases bone formation and decreases bone resorption. Osteologix is
committed to creating value by building a world- class team, accelerating
the development of lead product candidates, expanding its pipeline by being
the alliance partner of choice, and nurturing a unique company culture.
Additional information on Osteologix can be obtained on the Company's
website, osteologix.
FORWARD-LOOKING STATEMENTS:
Certain of the statements set forth in this press release constitute
"Forward looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include, without
limitation, any statement that may predict, forecast, indicate, or imply
future results, performance or achievements, and may contain the words
"estimate," "project," "intend," "forecast," "anticipate," "plan,"
"planning," "expect," "believe," "will," "will likely," "should," "could,"
"would," "may" or words or expressions of similar meaning. All such forward
looking statements involve risks and uncertainties, including, but not
limited to: statements regarding Osteologix's research and development
programs; proposed marketing and sales; patents and regulatory approvals;
the effect of competition and proprietary rights of third parties; the need
for and availability of additional financing and access to capital; and the
seeking of joint development, licensing or distribution and collaboration
and marketing arrangements with pharmaceutical companies. There can be no
assurance that such forward-looking statements will prove to be accurate
and Osteologix undertakes no obligation to update any forward-looking
statements or to announce revisions to any of the forward-looking
statements.
Osteologix Inc.
osteologix
пятница, 27 мая 2011 г.
Women Who Exercise Into Their 70's Can Delay The Onset Of Arthritis Symptoms
Women in their 70s who keep active could be dodging painful arthritis symptoms, according to research published recently in Arthritis Research & Therapy. The study is the first to show that the more you exercise, the better your chances of preventing the onset of stiff and painful joints.
Kristiann Heesch and colleagues at the University of Queensland, Australia examined data on middle-aged (48-55) and older (72-79) women collected using surveys over three years as part of the Australian Longitudinal Study on Women's Health. Excluding women who reported arthritis symptoms at the beginning of the study, the authors looked at those who began reporting stiff or painful joints 'often' and how much exercise they undertook.
The results suggest that for women in the older age bracket, doing a little over an hour of moderate physical activity each week will lessen your chances of developing frequent arthritis symptoms in the next three years. Pushing that up to 2 ?? hours per week is even more likely to prevent arthritis symptoms appearing. These results were not seen for the middle-aged group.
A debilitating health problem which is more likely to strike as we get older and affects more women than men, arthritis is almost as common as cardiovascular disease in Australia, affecting 17% of the population. By 2020 this figure is set to approach US levels, where arthritis is the most prevalent chronic condition for middle aged and older people, affecting over a fifth of the population. Exercising into old age could ensure movement without stiffness and pain for longer, and could reduce the burden of arthritis on the healthcare system.
Article:
Relationship between physical activity and stiff or painful joints in mid-aged and older women: a 3 year prospective study
Kristiann C Heesch, Yvette D Miller and Wendy J Brown
Arthritis Research & Therapy (In press)
Contact: Martyn Thomas
BioMed Central
Kristiann Heesch and colleagues at the University of Queensland, Australia examined data on middle-aged (48-55) and older (72-79) women collected using surveys over three years as part of the Australian Longitudinal Study on Women's Health. Excluding women who reported arthritis symptoms at the beginning of the study, the authors looked at those who began reporting stiff or painful joints 'often' and how much exercise they undertook.
The results suggest that for women in the older age bracket, doing a little over an hour of moderate physical activity each week will lessen your chances of developing frequent arthritis symptoms in the next three years. Pushing that up to 2 ?? hours per week is even more likely to prevent arthritis symptoms appearing. These results were not seen for the middle-aged group.
A debilitating health problem which is more likely to strike as we get older and affects more women than men, arthritis is almost as common as cardiovascular disease in Australia, affecting 17% of the population. By 2020 this figure is set to approach US levels, where arthritis is the most prevalent chronic condition for middle aged and older people, affecting over a fifth of the population. Exercising into old age could ensure movement without stiffness and pain for longer, and could reduce the burden of arthritis on the healthcare system.
Article:
Relationship between physical activity and stiff or painful joints in mid-aged and older women: a 3 year prospective study
Kristiann C Heesch, Yvette D Miller and Wendy J Brown
Arthritis Research & Therapy (In press)
Contact: Martyn Thomas
BioMed Central
четверг, 26 мая 2011 г.
NICE Gives Backing For The Use Of Advanced Biological Therapies To Treat Severe Psoriasis
Top experts, however, worry that many patients across Europe may still be denied access to these breakthrough therapies due to lack of funding
The UK National Institute for Health and Clinical Excellence (NICE) has today issued guidance for the use of the targeted biological therapies, Enbrel (etanercept) and Raptiva (efalizumab), to treat adult patients with severe plaque psoriasis. However, top experts have expressed their concerns that many patients across Europe could still be denied treatment with this newest class of drugs due to funding issues.
NICE's announcement comes as welcome relief to the thousands of UK patients who have exhausted current available treatment options and failed to sustain a long-term benefit. It is a positive sign for patients throughout Europe, whose healthcare systems are influenced by NICE decisions. Leeroy Blake in England was fortunate enough to be offered treatment with a biological therapy, after years of trying every other available psoriasis treatment: "For many years, I tried every suitable treatment but nothing seemed to relieve the painful itching. As the itching got worse, I would get more stressed and this only made my condition worse. Following a treatment review with my doctor, I was prescribed a biological therapy and for the first time since developing psoriasis, my skin started to clear and my confidence came back. This treatment might not be suitable for everyone with severe psoriasis, but I think that it's important that patients at least discuss this option with their doctor".
Latest research has dismissed the preconception that psoriasis is merely a skin complaint, with recent data showing that severe psoriasis can affect a patient's quality of life to a similar extent as other prevalent chronic diseases such as diabetes and even heart diseases.
In addition to the impact on a patient's appearance, up to 30% of patients with psoriasis have been reported to have psoriatic arthritis, which causes pain, stiffness and swelling in and around the joints. Coinciding with its decision on the use of biological therapies in moderate to severe psoriasis, NICE has also given its backing for the NHS to use Enbrel and Remicade (infliximab) to treat patients with severe, active psoriatic arthritis. Professor Robert Moots, Professor of Rheumatology at the University of Liverpool, UK welcomes this guidance commenting, "the NICE guidance is a positive step forward for those patients whose condition is severe enough to warrant treatment with biologic therapies" adding that "the onus is now on NHS trusts to take note of this recent recommendation and ensure that the necessary funding is in place to allow patients access to these much-needed therapies."
This latest NICE guidance should now ensure that for adult patients with severe plaque psoriasis, who have failed on standard therapies, these new treatment options can now be made available. Lars Ettarp, President of the International Federation of Psoriasis Associations (IFPA) underlines that "psoriasis is a systemic disease and that IFPA welcomes the new therapies in the treatment of severe psoriasis/psoriatic arthritis. The national healthcare providers must now make funding for these new drugs available in order to help these really sick persons."
Professor Knud Kragballe, Department of Dermatology, ???rhus University Hospital in Denmark, has echoed this call: "Health care providers throughout Europe should take note of these recommendations and ensure that necessary funding is in place to allow access to biological therapies. Psoriasis can be highly debilitating and painful condition. If patients fulfill the criteria for a biological therapy then, I believe, it is important that treatment is started with minimal delay.5"
Stevo Knezevic, MD, PhD, chief medical officer of Wyeth Europa commented: "This endorsement of biological therapies is excellent news for psoriatic patients across Europe and the healthcare professionals who care for them. It is now vital that healthcare providers take note of the positive NICE decision, the opinion of dermatologists and the needs of psoriatic patients, and make funding for these therapies available as quickly as possible."
Patients who would like to find out more about biological therapy are advised to talk to their dermatologist.
In the European Union, Enbrel is approved for the treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA (Psoralen (a light-sensitizing medication) combined with exposure to ultraviolet light A (UVA).2 Enbrel is also approved for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate.2
Physicians in Europe have become familiar with the benefits and long-term tolerability profile of ENBREL since it became commercially available over six years ago. More than 400,000 patients have been treated worldwide across indications. Enbrel is a recombinant human tumour necrosis factor (TNF) receptor fusion protein that inhibits the activity of TNF. TNF is a cytokine that is released from T lymphocytes; it mediates inflammation and modulates the cellular immune response2. Enbrel is also indicated for treatment of the following: 2
Severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Active Juvenile Idiopathic Arthritis in children aged 4 to 17 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Enbrel has not been studied in children aged less than 4 years.
Severe active ankylosing spondylitis in adults who have had an inadequate response to conventional therapy.
Since the product was first introduced, serious infections, some involving death, have been reported in patients using ENBREL. Patients should tell their doctor if they currently have an infection or are prone to getting infections. Patients should not start ENBREL if they have an infection of any type or an allergy to ENBREL or its components. ENBREL should be used with caution in patients prone to infection.
There have been reports of serious nervous-system disorders such as multiple sclerosis and/or inflammation of the nerves of the eyes. Patients should inform their doctor if they have ever had any of these disorders or if they develop them after starting ENBREL9. Patients should also tell their doctor if they have ever been treated for heart failure. There also have been rare reports of serious blood disorders, some involving death.
Patients should contact their doctor immediately if they develop symptoms such as persistent fever, bruising, bleeding, or paleness. It is unclear if ENBREL has caused these nervous-system or blood disorders. If a patient's doctor confirms serious blood problems, patients may need to stop using ENBREL.
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ketchum
View drug information on Enbrel; Remicade.
The UK National Institute for Health and Clinical Excellence (NICE) has today issued guidance for the use of the targeted biological therapies, Enbrel (etanercept) and Raptiva (efalizumab), to treat adult patients with severe plaque psoriasis. However, top experts have expressed their concerns that many patients across Europe could still be denied treatment with this newest class of drugs due to funding issues.
NICE's announcement comes as welcome relief to the thousands of UK patients who have exhausted current available treatment options and failed to sustain a long-term benefit. It is a positive sign for patients throughout Europe, whose healthcare systems are influenced by NICE decisions. Leeroy Blake in England was fortunate enough to be offered treatment with a biological therapy, after years of trying every other available psoriasis treatment: "For many years, I tried every suitable treatment but nothing seemed to relieve the painful itching. As the itching got worse, I would get more stressed and this only made my condition worse. Following a treatment review with my doctor, I was prescribed a biological therapy and for the first time since developing psoriasis, my skin started to clear and my confidence came back. This treatment might not be suitable for everyone with severe psoriasis, but I think that it's important that patients at least discuss this option with their doctor".
Latest research has dismissed the preconception that psoriasis is merely a skin complaint, with recent data showing that severe psoriasis can affect a patient's quality of life to a similar extent as other prevalent chronic diseases such as diabetes and even heart diseases.
In addition to the impact on a patient's appearance, up to 30% of patients with psoriasis have been reported to have psoriatic arthritis, which causes pain, stiffness and swelling in and around the joints. Coinciding with its decision on the use of biological therapies in moderate to severe psoriasis, NICE has also given its backing for the NHS to use Enbrel and Remicade (infliximab) to treat patients with severe, active psoriatic arthritis. Professor Robert Moots, Professor of Rheumatology at the University of Liverpool, UK welcomes this guidance commenting, "the NICE guidance is a positive step forward for those patients whose condition is severe enough to warrant treatment with biologic therapies" adding that "the onus is now on NHS trusts to take note of this recent recommendation and ensure that the necessary funding is in place to allow patients access to these much-needed therapies."
This latest NICE guidance should now ensure that for adult patients with severe plaque psoriasis, who have failed on standard therapies, these new treatment options can now be made available. Lars Ettarp, President of the International Federation of Psoriasis Associations (IFPA) underlines that "psoriasis is a systemic disease and that IFPA welcomes the new therapies in the treatment of severe psoriasis/psoriatic arthritis. The national healthcare providers must now make funding for these new drugs available in order to help these really sick persons."
Professor Knud Kragballe, Department of Dermatology, ???rhus University Hospital in Denmark, has echoed this call: "Health care providers throughout Europe should take note of these recommendations and ensure that necessary funding is in place to allow access to biological therapies. Psoriasis can be highly debilitating and painful condition. If patients fulfill the criteria for a biological therapy then, I believe, it is important that treatment is started with minimal delay.5"
Stevo Knezevic, MD, PhD, chief medical officer of Wyeth Europa commented: "This endorsement of biological therapies is excellent news for psoriatic patients across Europe and the healthcare professionals who care for them. It is now vital that healthcare providers take note of the positive NICE decision, the opinion of dermatologists and the needs of psoriatic patients, and make funding for these therapies available as quickly as possible."
Patients who would like to find out more about biological therapy are advised to talk to their dermatologist.
In the European Union, Enbrel is approved for the treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA (Psoralen (a light-sensitizing medication) combined with exposure to ultraviolet light A (UVA).2 Enbrel is also approved for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate.2
Physicians in Europe have become familiar with the benefits and long-term tolerability profile of ENBREL since it became commercially available over six years ago. More than 400,000 patients have been treated worldwide across indications. Enbrel is a recombinant human tumour necrosis factor (TNF) receptor fusion protein that inhibits the activity of TNF. TNF is a cytokine that is released from T lymphocytes; it mediates inflammation and modulates the cellular immune response2. Enbrel is also indicated for treatment of the following: 2
Severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Active Juvenile Idiopathic Arthritis in children aged 4 to 17 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Enbrel has not been studied in children aged less than 4 years.
Severe active ankylosing spondylitis in adults who have had an inadequate response to conventional therapy.
Since the product was first introduced, serious infections, some involving death, have been reported in patients using ENBREL. Patients should tell their doctor if they currently have an infection or are prone to getting infections. Patients should not start ENBREL if they have an infection of any type or an allergy to ENBREL or its components. ENBREL should be used with caution in patients prone to infection.
There have been reports of serious nervous-system disorders such as multiple sclerosis and/or inflammation of the nerves of the eyes. Patients should inform their doctor if they have ever had any of these disorders or if they develop them after starting ENBREL9. Patients should also tell their doctor if they have ever been treated for heart failure. There also have been rare reports of serious blood disorders, some involving death.
Patients should contact their doctor immediately if they develop symptoms such as persistent fever, bruising, bleeding, or paleness. It is unclear if ENBREL has caused these nervous-system or blood disorders. If a patient's doctor confirms serious blood problems, patients may need to stop using ENBREL.
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среда, 25 мая 2011 г.
Need For Inpatient Rehabilitation Reduced By Exercise Prior To Hip And Knee Replacement
Osteoarthritis is increasingly common among aging Americans and is the leading cause of disability in the U.S. Exercise is often used in treating osteoarthritis and is an important part in rehabilitation following joint replacement. The level of function prior to knee and hip replacement has been shown to be strongly related to function after surgery, yet little is known about the effects of exercise on patients with end-stage osteoarthritis. A study published in the October 2006 issue of Arthritis Care & Research (interscience.wiley/journal/arthritiscare) examined whether an exercise program prior to hip or knee replacement would benefit patients in terms of function, pain, and muscle strength before or after surgery.
Led by Daniel S. Rooks, ScD of New England Baptist Hospital, Beth Israel Deaconess Medical Center and Harvard Medical School in Boston, MA, the study included 108 patients scheduled to undergo hip or knee replacement between November 2001 and November 2003. The patients were divided into two groups: 54 patients participated in water and land-based exercise three times a week for the six-week period immediately before surgery and 54 controls received educational materials. Prior to surgery all patients were questioned about their level of function and were evaluated in terms of lower-extremity strength, balance, and mobility. The exercisers participated in strength training, aerobic and flexibility exercises that were individually tailored to each person's fitness level, performed in a group and supervised by a physical therapist.
The results showed that patients who exercised reduced their odds of discharge to an inpatient rehabilitation facility by 73 percent. "The potential economic implication of this finding is noteworthy and should be examined in future studies, particularly with the rise in inpatient rehabilitation use," the authors note. The exercisers were also more likely to walk more than 50 feet at the time of hospital discharge. Those who exercised responded differently before surgery and immediately following surgery depending upon the joint replaced: although patients who exercised increased lower-extremity muscle strength, only those undergoing hip replacements showed improved function before surgery.
"Our findings show that an appropriately designed program of water and land-based exercise involving cardiovascular, strength training, and flexibility activities can be a safe, well tolerated, and effective approach to improving function and muscle strength in middle-aged and older adults with severe osteoarthritis of the hip and knee," the authors state. They point out that patients participated in strength training for only 3 weeks (9 sessions), which is well below the recommended duration required to bring about significant strength gains. They suggest that the increase in strength was due to a combination of increased neuromuscular coordination and a reduction of fear about anticipated pain associated with increased muscular effort. They note that knee replacement patients would probably need to participate in strength training for a longer period of time in order to experience increased function prior to surgery.
The fact that the patients responded differently depending upon what joint was being replaced suggests the need for different approaches for people with osteoarthritis of the hip and knee. Also, because several participants who dropped out of the study did so because of the travel required to get to the group exercise location, the authors suggest that future studies should consider the location and convenience of the exercise sessions. They conclude: "Additional attention should be placed on testing postoperative interventions for building on preoperative gains in function and fitness, adapting the intervention more successfully for the TKA [knee replacement] population, and examining the cost effectiveness of exercise for patients undergoing total joint replacement."
Article: "Effect of Preoperative Exercise on Measures of Functional Status in Men and Women Undergoing Total Hip and Knee Arthroplasty," Daniel S. Rooks, Jie Huang, Benjamin E. Bierbaum, Sarah A. Bolus, James Rubano, Christine E. Connolly, Sandra Alpert, Maura D. Iverson, Jeffrey N. Katz, Arthritis Care & Research, October 2006; (DOI: 10.1002/art.22223).
Contact: Amy Molnar
John Wiley & Sons, Inc.
Led by Daniel S. Rooks, ScD of New England Baptist Hospital, Beth Israel Deaconess Medical Center and Harvard Medical School in Boston, MA, the study included 108 patients scheduled to undergo hip or knee replacement between November 2001 and November 2003. The patients were divided into two groups: 54 patients participated in water and land-based exercise three times a week for the six-week period immediately before surgery and 54 controls received educational materials. Prior to surgery all patients were questioned about their level of function and were evaluated in terms of lower-extremity strength, balance, and mobility. The exercisers participated in strength training, aerobic and flexibility exercises that were individually tailored to each person's fitness level, performed in a group and supervised by a physical therapist.
The results showed that patients who exercised reduced their odds of discharge to an inpatient rehabilitation facility by 73 percent. "The potential economic implication of this finding is noteworthy and should be examined in future studies, particularly with the rise in inpatient rehabilitation use," the authors note. The exercisers were also more likely to walk more than 50 feet at the time of hospital discharge. Those who exercised responded differently before surgery and immediately following surgery depending upon the joint replaced: although patients who exercised increased lower-extremity muscle strength, only those undergoing hip replacements showed improved function before surgery.
"Our findings show that an appropriately designed program of water and land-based exercise involving cardiovascular, strength training, and flexibility activities can be a safe, well tolerated, and effective approach to improving function and muscle strength in middle-aged and older adults with severe osteoarthritis of the hip and knee," the authors state. They point out that patients participated in strength training for only 3 weeks (9 sessions), which is well below the recommended duration required to bring about significant strength gains. They suggest that the increase in strength was due to a combination of increased neuromuscular coordination and a reduction of fear about anticipated pain associated with increased muscular effort. They note that knee replacement patients would probably need to participate in strength training for a longer period of time in order to experience increased function prior to surgery.
The fact that the patients responded differently depending upon what joint was being replaced suggests the need for different approaches for people with osteoarthritis of the hip and knee. Also, because several participants who dropped out of the study did so because of the travel required to get to the group exercise location, the authors suggest that future studies should consider the location and convenience of the exercise sessions. They conclude: "Additional attention should be placed on testing postoperative interventions for building on preoperative gains in function and fitness, adapting the intervention more successfully for the TKA [knee replacement] population, and examining the cost effectiveness of exercise for patients undergoing total joint replacement."
Article: "Effect of Preoperative Exercise on Measures of Functional Status in Men and Women Undergoing Total Hip and Knee Arthroplasty," Daniel S. Rooks, Jie Huang, Benjamin E. Bierbaum, Sarah A. Bolus, James Rubano, Christine E. Connolly, Sandra Alpert, Maura D. Iverson, Jeffrey N. Katz, Arthritis Care & Research, October 2006; (DOI: 10.1002/art.22223).
Contact: Amy Molnar
John Wiley & Sons, Inc.
вторник, 24 мая 2011 г.
Trubion Announces Initiation Of Phase 2b Study Of TRU 015 For The Treatment Of Rheumatoid Arthritis
Trubion Pharmaceuticals Inc.
(Nasdaq: TRBN) announced that its partner, Wyeth Pharmaceuticals, a
division of Wyeth (NYSE: WYE), has commenced patient dosing in the next
Phase 2b clinical trial of TRU-015 in patients with rheumatoid arthritis
(RA). In collaboration with Trubion, Wyeth Pharmaceuticals is developing
TRU-015, SBI-087 and other CD20-directed products.
The randomized, parallel, double-blind, placebo-controlled, dose
regimen-finding study will evaluate the safety and efficacy of two dosing
regimens administered to approximately 216 patients with active,
seropositive RA on a background of methotrexate. The primary outcome
measurement for the TRU-015 Phase 2b study will be the American College of
Rheumatology (ACR) 50 response measured at 24 weeks. Secondary outcome
measurements will be ACR 20 and 70 and DAS-28 responses.
"Data reported previously demonstrates TRU-015's ability to
significantly improve RA signs and symptoms, and maintain response rates
with repeat administration of single doses given every six months," said
Peter Thompson, M.D., FACP, president, CEO and chairman of Trubion. "This
study is designed to help us identify an induction, or initial, dosing
regimen and allow us to further establish the most effective treatment
regimen for TRU-015. We believe this study has been designed in a way that
could support a registration package, and we look forward to the results of
this evaluation."
With the addition of SBI-087 -- Trubion's next-generation, fully
humanized CD20-directed SMIPTM -- Trubion's pipeline now includes two
compounds under development for the treatment of autoimmune and
inflammatory diseases. Trubion and Wyeth are leveraging Trubion's SMIPTM
technology to create a portfolio of product candidates with customized
mechanisms of action in an effort to optimize patient safety, efficacy and
convenience.
About Trubion
Trubion is a biopharmaceutical company that is creating a pipeline of
novel protein therapeutic product candidates to treat autoimmune and
inflammatory diseases and cancer. The company's mission is to develop a
variety of first-in-class and best-in-class product candidates, customized
for optimal safety, efficacy, and convenience that it believes may offer
improved patient experiences. Trubion's current product candidates are
novel single-chain protein, or SMIP(TM), therapeutics, and are designed
using its custom drug assembly technology. Trubion's product pipeline
includes CD20-directed candidates such as TRU-015 and SBI-087 for
autoimmune and inflammatory diseases, developed under the company's Wyeth
collaboration. Trubion's product pipeline also includes Trubion's
proprietary product candidate, TRU-016, a novel CD37-targeted therapy for
the treatment of B-cell malignancies that is currently in Phase 1/2
clinical evaluation. In addition to Trubion's current product candidates,
the company is also developing additional alliance and proprietary product
candidates that build on its product development experience. More
information is available in the investors section of Trubion's website:
investors.trubion.
Forward-Looking Statements
Certain statements in this release may constitute "forward-looking
statements" within the meaning of Section 21E of the Securities Exchange
Act of 1934 and Section 27A of the Securities Act of 1933. These statements
include, but are not limited to, those related to the company's future
clinical development programs and the timing thereof, the company's
expected financial and operating results, future clinical development
plans, the details of the clinical trials and the results and timing
thereof, and the timing of regulatory applications and action. These
statements are based on current expectations and assumptions regarding
future events and business performance and involve certain risks and
uncertainties that could cause actual results to differ materially. These
risks include, but are not limited to, risks associated with the company's
Wyeth collaboration, including Wyeth's control over development timelines
and the risk that the current Phase 2b study of TRU-015 does not help the
Company and Wyeth identify a TRU-015 induction dosing regimen or further
establish the most effective treatment regimen for TRU-015, the risks that
the Company is unable to advance its clinical development programs and
regulatory applications and action at the rate it expects, the risk that
the Company does not achieve the financial and operating results it expects
and such other risks as identified in the company's quarterly report on
Form 10-K for the period ended Dec. 31, 2007, and from time to time in
other reports filed by Trubion with the U.S. Securities and Exchange
Commission. These reports are available on the Investors page of the
company's corporate Web site at trubion. Trubion undertakes
no duty to update any forward-looking statement to conform the statement to
actual results or changes in the company's expectations.
Trubion Pharmaceuticals Inc.
trubion
(Nasdaq: TRBN) announced that its partner, Wyeth Pharmaceuticals, a
division of Wyeth (NYSE: WYE), has commenced patient dosing in the next
Phase 2b clinical trial of TRU-015 in patients with rheumatoid arthritis
(RA). In collaboration with Trubion, Wyeth Pharmaceuticals is developing
TRU-015, SBI-087 and other CD20-directed products.
The randomized, parallel, double-blind, placebo-controlled, dose
regimen-finding study will evaluate the safety and efficacy of two dosing
regimens administered to approximately 216 patients with active,
seropositive RA on a background of methotrexate. The primary outcome
measurement for the TRU-015 Phase 2b study will be the American College of
Rheumatology (ACR) 50 response measured at 24 weeks. Secondary outcome
measurements will be ACR 20 and 70 and DAS-28 responses.
"Data reported previously demonstrates TRU-015's ability to
significantly improve RA signs and symptoms, and maintain response rates
with repeat administration of single doses given every six months," said
Peter Thompson, M.D., FACP, president, CEO and chairman of Trubion. "This
study is designed to help us identify an induction, or initial, dosing
regimen and allow us to further establish the most effective treatment
regimen for TRU-015. We believe this study has been designed in a way that
could support a registration package, and we look forward to the results of
this evaluation."
With the addition of SBI-087 -- Trubion's next-generation, fully
humanized CD20-directed SMIPTM -- Trubion's pipeline now includes two
compounds under development for the treatment of autoimmune and
inflammatory diseases. Trubion and Wyeth are leveraging Trubion's SMIPTM
technology to create a portfolio of product candidates with customized
mechanisms of action in an effort to optimize patient safety, efficacy and
convenience.
About Trubion
Trubion is a biopharmaceutical company that is creating a pipeline of
novel protein therapeutic product candidates to treat autoimmune and
inflammatory diseases and cancer. The company's mission is to develop a
variety of first-in-class and best-in-class product candidates, customized
for optimal safety, efficacy, and convenience that it believes may offer
improved patient experiences. Trubion's current product candidates are
novel single-chain protein, or SMIP(TM), therapeutics, and are designed
using its custom drug assembly technology. Trubion's product pipeline
includes CD20-directed candidates such as TRU-015 and SBI-087 for
autoimmune and inflammatory diseases, developed under the company's Wyeth
collaboration. Trubion's product pipeline also includes Trubion's
proprietary product candidate, TRU-016, a novel CD37-targeted therapy for
the treatment of B-cell malignancies that is currently in Phase 1/2
clinical evaluation. In addition to Trubion's current product candidates,
the company is also developing additional alliance and proprietary product
candidates that build on its product development experience. More
information is available in the investors section of Trubion's website:
investors.trubion.
Forward-Looking Statements
Certain statements in this release may constitute "forward-looking
statements" within the meaning of Section 21E of the Securities Exchange
Act of 1934 and Section 27A of the Securities Act of 1933. These statements
include, but are not limited to, those related to the company's future
clinical development programs and the timing thereof, the company's
expected financial and operating results, future clinical development
plans, the details of the clinical trials and the results and timing
thereof, and the timing of regulatory applications and action. These
statements are based on current expectations and assumptions regarding
future events and business performance and involve certain risks and
uncertainties that could cause actual results to differ materially. These
risks include, but are not limited to, risks associated with the company's
Wyeth collaboration, including Wyeth's control over development timelines
and the risk that the current Phase 2b study of TRU-015 does not help the
Company and Wyeth identify a TRU-015 induction dosing regimen or further
establish the most effective treatment regimen for TRU-015, the risks that
the Company is unable to advance its clinical development programs and
regulatory applications and action at the rate it expects, the risk that
the Company does not achieve the financial and operating results it expects
and such other risks as identified in the company's quarterly report on
Form 10-K for the period ended Dec. 31, 2007, and from time to time in
other reports filed by Trubion with the U.S. Securities and Exchange
Commission. These reports are available on the Investors page of the
company's corporate Web site at trubion. Trubion undertakes
no duty to update any forward-looking statement to conform the statement to
actual results or changes in the company's expectations.
Trubion Pharmaceuticals Inc.
trubion
понедельник, 23 мая 2011 г.
Anti-TNF Therapy Increases The Occurrence Of Shingles And Chicken Pox In People With Rheumatoid Arthritis
Anti tumor necrosis factor therapy increases the risk of developing varicella zoster virus infections, including shingles and chicken pox, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta.
Rheumatoid arthritis is a chronic disease that causes pain, stiffness, swelling, and limitation in the motion and function of multiple joints. Though joints are the principal body parts affected by RA, inflammation can develop in other organs as well. An estimated 1.3 million Americans have RA, and the disease typically affects women twice as often as men..
Varicella zoster virus is a common viral infection. The initial infection typically occurs in childhood, causing chicken pox, and reactivation later in life results in herpes zoster (shingles). The body's immune defense against both chicken pox and herpes zoster relies on immune pathways that may be impaired by anti-TNF therapy theoretically predisposing people who take anti-TNF therapy to varicella zoster-associated infection..
Using the British Society for Rheumatology Biologics Register a registry that tracks the progress of patients with severe rheumatoid arthritis and other rheumatic conditions who are taking anti-TNF therapy researchers recently looked at the association between anti-TNF therapy and varicella zoster infections..
They studied 11,864 people with RA who were undergoing anti-TNF therapy and compared them to 3,666 patients who were undergoing treatment with disease-modifying antirheumatic drugs (commonly called DMARDs). They began recruiting patients in October 2001 and continued to monitor them until the first episode of herpes zoster infection (which is caused by varicella zoster virus), death, or the end of 2009, whichever came first. A patient's health was monitored through questionnaires filled out by the patients and their physicians, and a varicella zoster infection was attributed to anti-TNF therapy if diagnosed while a patient was actively receiving the drug (up to the date of the first missed dose)..
During the study, 322 herpes zoster infections occurred in the patients taking anti-TNF therapy and 46 infections occurred in the DMARD group. A greater proportion of the cases in the anti-TNF group were severe (defined as herpes zoster being a primary reason for hospitalization, requiring intravenous anti-viral medication, or being multi-dermatomal). Furthermore, 12 cases of chicken pox, presumably initial infection with the varicella zoster virus, were reported in the anti-TNF group and none in the DMARD group. These results suggest that anti-TNF therapy may be associated with both primary and recurrent infections with the varicella zoster virus..
"Anti-TNF therapy conferred more than a twofold increase in the risk of developing shingles in our dataset when compared to traditional DMARD therapy," explains James Galloway, MD, MBChB, MRCP, MSc; clinical research fellow; BSR Biologics Register; ARC unit; University of Manchester, Manchester, United Kingdom, and lead investigator in the study."Chicken pox was also observed more frequently in the anti-TNF cohort, although absolute numbers were small. This supports a recent similar observation from the Spanish Registry BIOBADASER." Dr. Galloway adds. "The clinical message from this study is to be vigilant for shingles with anti-TNF therapy.".
Dr. Galloway also suggests that the study's findings raise two important questions that warrant further research: Is there any value in screening people for immunity to the varicella zoster virus, and what role does vaccination have in preventing the VZV-associated infections?.
TNF-antagonists (anti-TNF therapy; among drugs called biologics) are a class of drugs that have been used since 1998. Overall, they have been given to more than 600,000 people worldwide. These drugs are given to lessen inflammation by interfering with biologic substances that cause or worsen inflammation..
Source: American College of Rheumatology (ACR)
Rheumatoid arthritis is a chronic disease that causes pain, stiffness, swelling, and limitation in the motion and function of multiple joints. Though joints are the principal body parts affected by RA, inflammation can develop in other organs as well. An estimated 1.3 million Americans have RA, and the disease typically affects women twice as often as men..
Varicella zoster virus is a common viral infection. The initial infection typically occurs in childhood, causing chicken pox, and reactivation later in life results in herpes zoster (shingles). The body's immune defense against both chicken pox and herpes zoster relies on immune pathways that may be impaired by anti-TNF therapy theoretically predisposing people who take anti-TNF therapy to varicella zoster-associated infection..
Using the British Society for Rheumatology Biologics Register a registry that tracks the progress of patients with severe rheumatoid arthritis and other rheumatic conditions who are taking anti-TNF therapy researchers recently looked at the association between anti-TNF therapy and varicella zoster infections..
They studied 11,864 people with RA who were undergoing anti-TNF therapy and compared them to 3,666 patients who were undergoing treatment with disease-modifying antirheumatic drugs (commonly called DMARDs). They began recruiting patients in October 2001 and continued to monitor them until the first episode of herpes zoster infection (which is caused by varicella zoster virus), death, or the end of 2009, whichever came first. A patient's health was monitored through questionnaires filled out by the patients and their physicians, and a varicella zoster infection was attributed to anti-TNF therapy if diagnosed while a patient was actively receiving the drug (up to the date of the first missed dose)..
During the study, 322 herpes zoster infections occurred in the patients taking anti-TNF therapy and 46 infections occurred in the DMARD group. A greater proportion of the cases in the anti-TNF group were severe (defined as herpes zoster being a primary reason for hospitalization, requiring intravenous anti-viral medication, or being multi-dermatomal). Furthermore, 12 cases of chicken pox, presumably initial infection with the varicella zoster virus, were reported in the anti-TNF group and none in the DMARD group. These results suggest that anti-TNF therapy may be associated with both primary and recurrent infections with the varicella zoster virus..
"Anti-TNF therapy conferred more than a twofold increase in the risk of developing shingles in our dataset when compared to traditional DMARD therapy," explains James Galloway, MD, MBChB, MRCP, MSc; clinical research fellow; BSR Biologics Register; ARC unit; University of Manchester, Manchester, United Kingdom, and lead investigator in the study."Chicken pox was also observed more frequently in the anti-TNF cohort, although absolute numbers were small. This supports a recent similar observation from the Spanish Registry BIOBADASER." Dr. Galloway adds. "The clinical message from this study is to be vigilant for shingles with anti-TNF therapy.".
Dr. Galloway also suggests that the study's findings raise two important questions that warrant further research: Is there any value in screening people for immunity to the varicella zoster virus, and what role does vaccination have in preventing the VZV-associated infections?.
TNF-antagonists (anti-TNF therapy; among drugs called biologics) are a class of drugs that have been used since 1998. Overall, they have been given to more than 600,000 people worldwide. These drugs are given to lessen inflammation by interfering with biologic substances that cause or worsen inflammation..
Source: American College of Rheumatology (ACR)
воскресенье, 22 мая 2011 г.
Vitamin D May Not Benefit Knee Osteoarthritis Sufferers
Adding vitamin D as a supplement does not appear to lessen the symptoms, or slow the progression, of knee osteoarthritis, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta.
Osteoarthritis, or OA as it is commonly called, is the most common joint disease affecting middle-age and older people. It is characterized by progressive damage to the joint cartilage the cushioning material at the end of long bones and causes changes in the structures around the joint. These changes can include fluid accumulation, bony overgrowth, and loosening and weakness of muscles and tendons, all of which may limit movement and cause pain and swelling.
Vitamin D promotes the absorption of calcium and phosphorus needed for bone mineralization, growth and repair. Sources of vitamin D are available to a lesser extent from dietary sources typically found in fortified margarine, oily fish, liver, fortified breakfast cereals and dairy products. Sun exposure helps vitamin D to become active.
Previous studies have suggested that vitamin D may reduce the structural progression of knee OA, and researchers recently studied 146 people who showed symptoms of knee OA to determine if taking vitamin D would be an effective way of treating the disease. The participants were predominately Caucasian women with an average age of just over 62 years. Their average body mass index was 30.7, their average vitamin D level was 22.3 ng/ml-1, and their average femoral neck bone mineral density was .92 gcm-2. Additionally, 56 percent of the participants were taking supplements.
The researchers divided participants evenly into two groups. The first group was assigned to take placebo, and the second group was assigned to take vitamin D throughout the course of the study. Participants were not told which group they had been placed in. Those in the vitamin D group started by taking 2,000 IU of vitamin D daily, and this was raised as necessary over the course of the study in 2,000 IU increments to help each participant achieve a vitamin D level higher than 30 ng/ml.
The researchers also performed physical function tests and X-rays on each participant at the beginning of the study and again at 12 months. And, they computed the knee cartilage volume and thickness, bone marrow lesion volume from the MRIs taken at the beginning of the study and again at 12 months to determine if any changes had occurred.
At the end of the study, the participants in the vitamin D group had an average vitamin D level increase of 15 ng/ml (compared to only 1.8 ng/ml in the placebo group), but researchers found no substantial differences between the two groups in the areas studied leading them to believe that those taking vitamin D did not benefit more than those who were not.
"This study tested whether vitamin D supplementation, given over a two-year period, could influence the rate of progression of joint damage in people with knee osteoarthritis," explains Timothy McAlindon, MD, MPH; associate professor of medicine, division of rheumatology, Tufts New England Medical Center and lead investigator in the study. "The vitamin D doses were increased as necessary to elevate participants' serum levels to over 30 ng/ml. The study found no difference compared to a placebo (inert) treatment."
Patients should talk to their rheumatologists to determine their best course of treatment.
Source: American College of Rheumatology (ACR)
Osteoarthritis, or OA as it is commonly called, is the most common joint disease affecting middle-age and older people. It is characterized by progressive damage to the joint cartilage the cushioning material at the end of long bones and causes changes in the structures around the joint. These changes can include fluid accumulation, bony overgrowth, and loosening and weakness of muscles and tendons, all of which may limit movement and cause pain and swelling.
Vitamin D promotes the absorption of calcium and phosphorus needed for bone mineralization, growth and repair. Sources of vitamin D are available to a lesser extent from dietary sources typically found in fortified margarine, oily fish, liver, fortified breakfast cereals and dairy products. Sun exposure helps vitamin D to become active.
Previous studies have suggested that vitamin D may reduce the structural progression of knee OA, and researchers recently studied 146 people who showed symptoms of knee OA to determine if taking vitamin D would be an effective way of treating the disease. The participants were predominately Caucasian women with an average age of just over 62 years. Their average body mass index was 30.7, their average vitamin D level was 22.3 ng/ml-1, and their average femoral neck bone mineral density was .92 gcm-2. Additionally, 56 percent of the participants were taking supplements.
The researchers divided participants evenly into two groups. The first group was assigned to take placebo, and the second group was assigned to take vitamin D throughout the course of the study. Participants were not told which group they had been placed in. Those in the vitamin D group started by taking 2,000 IU of vitamin D daily, and this was raised as necessary over the course of the study in 2,000 IU increments to help each participant achieve a vitamin D level higher than 30 ng/ml.
The researchers also performed physical function tests and X-rays on each participant at the beginning of the study and again at 12 months. And, they computed the knee cartilage volume and thickness, bone marrow lesion volume from the MRIs taken at the beginning of the study and again at 12 months to determine if any changes had occurred.
At the end of the study, the participants in the vitamin D group had an average vitamin D level increase of 15 ng/ml (compared to only 1.8 ng/ml in the placebo group), but researchers found no substantial differences between the two groups in the areas studied leading them to believe that those taking vitamin D did not benefit more than those who were not.
"This study tested whether vitamin D supplementation, given over a two-year period, could influence the rate of progression of joint damage in people with knee osteoarthritis," explains Timothy McAlindon, MD, MPH; associate professor of medicine, division of rheumatology, Tufts New England Medical Center and lead investigator in the study. "The vitamin D doses were increased as necessary to elevate participants' serum levels to over 30 ng/ml. The study found no difference compared to a placebo (inert) treatment."
Patients should talk to their rheumatologists to determine their best course of treatment.
Source: American College of Rheumatology (ACR)
суббота, 21 мая 2011 г.
Scientists Shine New Light On Inflammatory Diseases
Investigators at Hospital for Special Surgery have identified a new mechanism involved in the pathogenesis of inflammatory diseases such as rheumatoid arthritis. The mechanism may also shed some light on why gene therapy experiments that use adenoviruses to deliver genes to humans have run into problems. The study will appear online on March 16 in the journal Nature Immunology.
Tumor necrosis factor (TNF) is known to play a role in several important inflammatory diseases including rheumatoid arthritis. While much is known about early signaling pathways activated by TNF, little is known about delayed and chronic TNF responses. In addition, cells called macrophages produce TNF, but little is known about the effects of TNF on the macrophages themselves.
In studies using human blood cells and mice, scientists examined the responses of macrophages during a two-day period after being stimulated with TNF. They found that macrophages secreted TNF and that then the TNF activated surface receptors on the macrophages themselves, spurring the cells into a low and sustained production of a protein called interferon-beta. This protein acted synergistically with TNF signals to induce 1) sustained expression of genes encoding inflammatory molecules and 2) delayed expression of genes encoding interferon-response molecules.
"The striking thing about many of these genes that came to our attention first was that there were these classic interferon response genes which had previously not been associated with TNF," said Lionel Ivashkiv, M.D., director of Basic Research at Hospital for Special Surgery, who led the study. "It suggests a new mechanism by which TNF can drive and sustain inflammation."
Experiments also revealed that the so-called autocrine loop was dependant on so-called interferon-response factor 1. "This was the first implication that IRF1 was linked to TNF inflammatory pathways," said Dr. Ivashkiv.
The researchers say that these findings could lead scientists to ways of preventing the bone destruction that is associated with some diseases. "There is the potential to control inflammation and also to control bone destruction. This interferon response is very effective at preventing the destruction of bones, which is one of the major issues with rheumatoid arthritis," said Dr. Ivashkiv. "So, what it does is sets up the next series of studies, in animal models, to try to determine whether this induction of interferon is beneficial or not."
The new research could also help explain how a patient involved in a University of Pennsylvania gene therapy experiment that used an adenovirus to deliver the gene died. Host response to adenoviral vectors is dependant on both IRF1 and TNF.
"What we have described is that TNF has both pathogenic affects it helps to sustain some of these inflammatory chemokines, but it also has a potential protective effect, because some of these interferon responses limit the amount of cell proliferation and they can also help to limit inflammation."
In addition to HSS researchers, investigators from the Weill Graduate School of Medical Sciences of Cornell University contributed to the study. The National Institutes of Health supported the work.
About Hospital for Special Surgery
Founded in 1863, Hospital for Special Surgery (HSS) is a world leader in orthopedics, rheumatology and rehabilitation. HSS is nationally ranked as No. 1 in orthopedics, No. 3 in rheumatology by U.S.News & World Report, and has received Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center. In the 2006 edition of HealthGrades' Hospital Quality in America Study, HSS received five-star ratings for clinical excellence in its specialties. A member of the NewYork-Presbyterian Healthcare System and an affiliate of Weill Cornell Medical College, HSS provides orthopedic and rheumatologic patient care at NewYork-Presbyterian Hospital at New York Weill Cornell Medical Center. All Hospital for Special Surgery medical staff are on the faculty of Weil Cornell Medical College. The hospital's research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. Hospital for Special Surgery is located in New York City and online at hss.
Hospital for Special Surgery
535 E. 70th St.
New York, NY 10021
United States
hss
Tumor necrosis factor (TNF) is known to play a role in several important inflammatory diseases including rheumatoid arthritis. While much is known about early signaling pathways activated by TNF, little is known about delayed and chronic TNF responses. In addition, cells called macrophages produce TNF, but little is known about the effects of TNF on the macrophages themselves.
In studies using human blood cells and mice, scientists examined the responses of macrophages during a two-day period after being stimulated with TNF. They found that macrophages secreted TNF and that then the TNF activated surface receptors on the macrophages themselves, spurring the cells into a low and sustained production of a protein called interferon-beta. This protein acted synergistically with TNF signals to induce 1) sustained expression of genes encoding inflammatory molecules and 2) delayed expression of genes encoding interferon-response molecules.
"The striking thing about many of these genes that came to our attention first was that there were these classic interferon response genes which had previously not been associated with TNF," said Lionel Ivashkiv, M.D., director of Basic Research at Hospital for Special Surgery, who led the study. "It suggests a new mechanism by which TNF can drive and sustain inflammation."
Experiments also revealed that the so-called autocrine loop was dependant on so-called interferon-response factor 1. "This was the first implication that IRF1 was linked to TNF inflammatory pathways," said Dr. Ivashkiv.
The researchers say that these findings could lead scientists to ways of preventing the bone destruction that is associated with some diseases. "There is the potential to control inflammation and also to control bone destruction. This interferon response is very effective at preventing the destruction of bones, which is one of the major issues with rheumatoid arthritis," said Dr. Ivashkiv. "So, what it does is sets up the next series of studies, in animal models, to try to determine whether this induction of interferon is beneficial or not."
The new research could also help explain how a patient involved in a University of Pennsylvania gene therapy experiment that used an adenovirus to deliver the gene died. Host response to adenoviral vectors is dependant on both IRF1 and TNF.
"What we have described is that TNF has both pathogenic affects it helps to sustain some of these inflammatory chemokines, but it also has a potential protective effect, because some of these interferon responses limit the amount of cell proliferation and they can also help to limit inflammation."
In addition to HSS researchers, investigators from the Weill Graduate School of Medical Sciences of Cornell University contributed to the study. The National Institutes of Health supported the work.
About Hospital for Special Surgery
Founded in 1863, Hospital for Special Surgery (HSS) is a world leader in orthopedics, rheumatology and rehabilitation. HSS is nationally ranked as No. 1 in orthopedics, No. 3 in rheumatology by U.S.News & World Report, and has received Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center. In the 2006 edition of HealthGrades' Hospital Quality in America Study, HSS received five-star ratings for clinical excellence in its specialties. A member of the NewYork-Presbyterian Healthcare System and an affiliate of Weill Cornell Medical College, HSS provides orthopedic and rheumatologic patient care at NewYork-Presbyterian Hospital at New York Weill Cornell Medical Center. All Hospital for Special Surgery medical staff are on the faculty of Weil Cornell Medical College. The hospital's research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. Hospital for Special Surgery is located in New York City and online at hss.
Hospital for Special Surgery
535 E. 70th St.
New York, NY 10021
United States
hss
пятница, 20 мая 2011 г.
New Two-Year Orencia(R) (abatacept) Aim Data Presented At Annual Eular Congress
Data presented at the 2006 European League Against Rheumatism (EULAR) annual congress looked at the Bristol-Myers Squibb Company (NYSE: BMY) rheumatoid arthritis (RA) treatment ORENCIA(R) (abatacept) and evaluated clinical benefits, including patient-reported outcomes, through two years of treatment in RA patients who had an inadequate response to methotrexate (MTX). 1
These data are part of a Phase III trial known as AIM (Abatacept in Inadequate responders to Methotrexate), which included an initial one-year, double-blind phase and a subsequent open-label extension phase. 2 Radiographic results (Genant, et al) were presented separately. 3
Details from the Long-Term Extension of the AIM Trial
In an analysis of the AIM Long-Term Extension (LTE) (Kremer, et al) clinical outcomes were based on the percent of people achieving ACR 20, 50 and 70 scores (indicating a 20 percent, 50 percent and 70 percent improvement in signs and symptoms of rheumatoid arthritis, respectively) and the Disease Activity Score 28 (DAS28) based on C-Reactive Protein (CRP). Patient-reported outcomes using the Health Assessment Questionnaire Disability Index (HAQDI) and the Short-Form (SF-36) were also measured. The HAQ-DI was used to assess physical function. The SF-36, which measured health-related quality of life and the physical and mental component summary scores (PCS and MCS, respectively), were reported.
In the group treated with ORENCIA (R) (abatacept) plus MTX through two years, approximately 82 percent of patients achieved ACR 20 responses in Year 1 and 80 percent achieved ACR 20 responses in Year 2; 54 percent of patients achieved ACR 50 responses in Year 1 and 56 percent achieved ACR 50 responses in Year 2; 32 percent of patients achieved ACR 70 responses in Year 1 and 34 percent achieved ACR 70 responses in Year 2.
Those who switched from placebo plus MTX to ORENCIA plus MTX at the start of the extension phase achieved similar ACR responses following one year of treatment compared with those receiving ORENCIA plus MTX for two years (ACR 20: 78 percent vs. 80 percent; ACR 50: 58 percent vs. 56 percent; and, ACR 70: 32 percent vs. 34 percent, for the 1-year of treatment vs 2-years of treatment, respectively).
Rates of DAS28 scores of less than 2.6 were similar at two years, regardless of initial randomization. At Year 1, 25.4 percent of patients in the ORENCIA plus MTX group achieved DAS28 scores of less than 2.6 compared to 2.5 percent in the placebo plus MTX group. By Year 2, 30.9 percent of those continuing to receive ORENCIA plus MTX achieved DAS28 scores of less than 2.6 versus 32.6 percent of patients who had been in the placebo group and then received ORENCIA plus MTX in the LTE.
Patient-reported outcomes were measured using the SF-36. At Year 1 for PCS, patients in the ORENCIA plus MTX group had a mean change from baseline of 9.7 compared to 6.6 in the placebo plus MTX group. At Year 2 for PCS, patients in the ORENCIA plus MTX group had a mean change from baseline of 10.6 compared to 10.5 who had been in the placebo plus MTX group and then received ORENCIA plus MTX in the LTE.
At Year 1 for MCS, patients in the ORENCIA plus MTX group had a mean change from baseline of 7.3 compared to 6.4 in the placebo plus MTX group. At Year 2 for MCS, patients in the ORENCIA plus MTX group had a mean change from baseline of 7.2 compared to 8.3 who had been in the placebo plus MTX group and then received ORENCIA plus MTX in the LTE.
Improvements in physical function of greater than or equal to 0.3 units using HAQ-DI were maintained through two years in the LTE.
Patients in the initial double-blind phase of the trial received a fixed dose of ORENCIA (R) (abatacept) (based on weight range approximating 10mg/kg; n=433) or placebo (n=219) on Days 1, 15 and 29, and every 4 weeks thereafter, in addition to MTX, for one year. Of these enrollees, 539 individuals from both the group treated with ORENCIA and the group treated with placebo entered the open-label extension phase of the trial and were treated with a fixed dose of ORENCIA (based on weight range approximating 10 mg/kg every 4 weeks) while continuing treatment with MTX [after six months during the double-blind phase and in the longterm extension phase, adjustment of disease-modifying rheumatic drugs (DMARDs) and doses of DMARDs were allowed at the discretion of the investigator].
Important Safety Information about ORENCIA
Before receiving treatment with ORENCIA, individuals should notify their healthcare providers if they currently are receiving treatment with a TNF antagonist (e.g., Enbrel (R), Humira (R), Remicade(R)) or Kineret(R) to treat rheumatoid arthritis (RA). These individuals may have a higher risk of experiencing serious infections if they receive treatment with ORENCIA together with other biologic medications for RA. People receiving treatment with ORENCIA also should notify their healthcare providers if they are taking any other medications including hormones, over-the-counter medicines, vitamins, supplements or herbal products.
Individuals should discuss their risks of infection with their healthcare providers. People should inform their healthcare providers of any infections that they may have, including infections in a specific location in or on the body (such as an open cut or sore), or an infection that involves the whole body (such as the flu), as these types of infection could put individuals at risk for serious side effects from ORENCIA. Additionally, individuals should alert their healthcare providers if they have infections that won't heal or have histories of recurring infections.
People who have had tuberculosis (TB), have had a positive skin test for TB, or who recently have been in close contact with someone who has had TB should inform their healthcare providers. If these individuals develop any of the symptoms of TB (i.e., a dry cough that doesn't improve, weight loss, fever, night sweats, etc.), they should notify their healthcare providers immediately. Before initiating treatment with ORENCIA, healthcare providers may examine individuals for TB or perform a skin test to determine the presence of TB.
Additionally, individuals should inform their healthcare providers if they are scheduled to have surgery, or if they recently received a vaccination or are scheduled to receive any vaccinations. Before receiving ORENCIA (R) (abatacept), people should alert their healthcare providers if they have a history of chronic obstructive pulmonary (lung) disease (COPD), as taking ORENCIA may cause their COPD symptoms to worsen.
Pregnant women, women planning to get pregnant or women thinking about becoming pregnant should inform their healthcare providers prior to starting treatment with ORENCIA. It is not known if exposure to ORENCIA poses risks to unborn infants. Women should alert their healthcare providers if they are breastfeeding, as these individuals will need to decide either to breastfeed or to receive treatment with ORENCIA, but not both.
Like all medicines that affect the immune system, ORENCIA can cause serious side effects, including serious infections, allergic reactions and malignancies. Individuals receiving treatment with ORENCIA are at increased risk for developing infections including pneumonia and other infections caused by viruses, bacteria or fungi. Individuals should immediately contact their healthcare providers if they feel sick or experience any infection during treatment with ORENCIA. Allergic reactions to ORENCIA therapy may also occur.
These reactions are usually mild or moderate, generally occur within the first 24 hours of an infusion and can include hives, swollen face, eyelids, lips, tongue, throat or difficulty breathing.
There have been two serious allergic reactions reported in individuals following ORENCIA infusion. There have also been cases of certain kinds of cancer in individuals receiving ORENCIA. The role of ORENCIA in the development of cancer is not known.
The more common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat and nausea.
For full prescribing information, please visit ORENCIA or bms
Dosing and Administration
ORENCIA (a fully human soluble fusion protein) is administered as a 30-minute intravenous infusion at a fixed dose based on weight range approximating 10 mg/kg at day 0, 2 weeks, 4 weeks, and every 4 weeks thereafter. Infusion reactions were experienced in nine percent of people treated with ORENCIA (R) (abatacept) and in six percent of people treated with placebo. The most frequently reported infusion-related adverse events (1 percent to 2 percent) were dizziness, headache, and hypertension. In clinical trials, premedications were not required. However, appropriate medical support measures for the treatment of hypersensitivity reactions should be available for immediate use in the event of a reaction.
About ORENCIA
ORENCIA, approved by the U.S. Food and Drug Administration (FDA) on December 23, 2005, is indicated for reducing signs and symptoms, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs, such as MTX or TNF antagonists. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. ORENCIA should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with anakinra.
ORENCIA, a selective modulator of a co-stimulatory signal required for full T-cell activation, was discovered and developed by Bristol-Myers Squibb Company.
About Rheumatoid Arthritis
Rheumatoid arthritis is a systemic, chronic, autoimmune disease characterized by inflammation in the lining of joints (or synovium), causing joint damage with chronic pain, stiffness and swelling. 4 RA causes limited range of motion and decreased function as a result of affected joints losing their shape and alignment. 4
RA affects about 1 percent of the world's population, including more than two million people in the United States. 6
The condition is more common in women, who account for 75 percent of patients diagnosed with RA. 6
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
References
1 Kremer JM, Emery P, Becker JP, Aranda R, Teng J, Li T, Westhovens R. Abatacept provides significant and sustained benefits in clinical and patient-reported outcomes through 2 years in patients with rheumatoid arthritis and an inadequate response to methotrexate: the long-term extension of the AIM trial. Poster presentation FRI0134, Abstract 705 at: 2006 European League Against Rheumatism (EULAR) annual congress. congress. Amsterdam, Netherlands, June 21-24, 2006.
2 Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, Szechinski K, Li T, Zhiyu G, Becker JP, Westhovens R. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis. Annals of Internal Medicine 2006;144:865-876.
3 Genant HK, Peterfy C, Westhovens R, Becker JP, Aranda R, Teng J, Kremer JM. Abatacept sustains inhibition of radiographic progression over 2 years in rheumatoid arthritis (RA) patients with an inadequate response to methotrexate (MTX): results from the long-term extension (LTE) of the AIM trial. Oral presentation OP0015, Abstract 1566 at: 2006 European League Against Rheumatism (EULAR) annual congress. Amsterdam, Netherlands, June 21-24, 2006.
4 Guidelines for the management of rheumatoid arthritis; 2002 update. Arthritis & Rheumatism. 2002;46(2):328-346.
5 Lee DM and Weinblatt ME. Rheumatoid arthritis. Lancet. 2001;358:903-911.
6 American College of Rheumatology Web site. Rheumatoid arthritis. rheumatology/public/factsheets/ra_new.asp?aud=pat#3 Accessed December 20, 2005.
bms
View drug information on Enbrel; Humira; Orencia.
These data are part of a Phase III trial known as AIM (Abatacept in Inadequate responders to Methotrexate), which included an initial one-year, double-blind phase and a subsequent open-label extension phase. 2 Radiographic results (Genant, et al) were presented separately. 3
Details from the Long-Term Extension of the AIM Trial
In an analysis of the AIM Long-Term Extension (LTE) (Kremer, et al) clinical outcomes were based on the percent of people achieving ACR 20, 50 and 70 scores (indicating a 20 percent, 50 percent and 70 percent improvement in signs and symptoms of rheumatoid arthritis, respectively) and the Disease Activity Score 28 (DAS28) based on C-Reactive Protein (CRP). Patient-reported outcomes using the Health Assessment Questionnaire Disability Index (HAQDI) and the Short-Form (SF-36) were also measured. The HAQ-DI was used to assess physical function. The SF-36, which measured health-related quality of life and the physical and mental component summary scores (PCS and MCS, respectively), were reported.
In the group treated with ORENCIA (R) (abatacept) plus MTX through two years, approximately 82 percent of patients achieved ACR 20 responses in Year 1 and 80 percent achieved ACR 20 responses in Year 2; 54 percent of patients achieved ACR 50 responses in Year 1 and 56 percent achieved ACR 50 responses in Year 2; 32 percent of patients achieved ACR 70 responses in Year 1 and 34 percent achieved ACR 70 responses in Year 2.
Those who switched from placebo plus MTX to ORENCIA plus MTX at the start of the extension phase achieved similar ACR responses following one year of treatment compared with those receiving ORENCIA plus MTX for two years (ACR 20: 78 percent vs. 80 percent; ACR 50: 58 percent vs. 56 percent; and, ACR 70: 32 percent vs. 34 percent, for the 1-year of treatment vs 2-years of treatment, respectively).
Rates of DAS28 scores of less than 2.6 were similar at two years, regardless of initial randomization. At Year 1, 25.4 percent of patients in the ORENCIA plus MTX group achieved DAS28 scores of less than 2.6 compared to 2.5 percent in the placebo plus MTX group. By Year 2, 30.9 percent of those continuing to receive ORENCIA plus MTX achieved DAS28 scores of less than 2.6 versus 32.6 percent of patients who had been in the placebo group and then received ORENCIA plus MTX in the LTE.
Patient-reported outcomes were measured using the SF-36. At Year 1 for PCS, patients in the ORENCIA plus MTX group had a mean change from baseline of 9.7 compared to 6.6 in the placebo plus MTX group. At Year 2 for PCS, patients in the ORENCIA plus MTX group had a mean change from baseline of 10.6 compared to 10.5 who had been in the placebo plus MTX group and then received ORENCIA plus MTX in the LTE.
At Year 1 for MCS, patients in the ORENCIA plus MTX group had a mean change from baseline of 7.3 compared to 6.4 in the placebo plus MTX group. At Year 2 for MCS, patients in the ORENCIA plus MTX group had a mean change from baseline of 7.2 compared to 8.3 who had been in the placebo plus MTX group and then received ORENCIA plus MTX in the LTE.
Improvements in physical function of greater than or equal to 0.3 units using HAQ-DI were maintained through two years in the LTE.
Patients in the initial double-blind phase of the trial received a fixed dose of ORENCIA (R) (abatacept) (based on weight range approximating 10mg/kg; n=433) or placebo (n=219) on Days 1, 15 and 29, and every 4 weeks thereafter, in addition to MTX, for one year. Of these enrollees, 539 individuals from both the group treated with ORENCIA and the group treated with placebo entered the open-label extension phase of the trial and were treated with a fixed dose of ORENCIA (based on weight range approximating 10 mg/kg every 4 weeks) while continuing treatment with MTX [after six months during the double-blind phase and in the longterm extension phase, adjustment of disease-modifying rheumatic drugs (DMARDs) and doses of DMARDs were allowed at the discretion of the investigator].
Important Safety Information about ORENCIA
Before receiving treatment with ORENCIA, individuals should notify their healthcare providers if they currently are receiving treatment with a TNF antagonist (e.g., Enbrel (R), Humira (R), Remicade(R)) or Kineret(R) to treat rheumatoid arthritis (RA). These individuals may have a higher risk of experiencing serious infections if they receive treatment with ORENCIA together with other biologic medications for RA. People receiving treatment with ORENCIA also should notify their healthcare providers if they are taking any other medications including hormones, over-the-counter medicines, vitamins, supplements or herbal products.
Individuals should discuss their risks of infection with their healthcare providers. People should inform their healthcare providers of any infections that they may have, including infections in a specific location in or on the body (such as an open cut or sore), or an infection that involves the whole body (such as the flu), as these types of infection could put individuals at risk for serious side effects from ORENCIA. Additionally, individuals should alert their healthcare providers if they have infections that won't heal or have histories of recurring infections.
People who have had tuberculosis (TB), have had a positive skin test for TB, or who recently have been in close contact with someone who has had TB should inform their healthcare providers. If these individuals develop any of the symptoms of TB (i.e., a dry cough that doesn't improve, weight loss, fever, night sweats, etc.), they should notify their healthcare providers immediately. Before initiating treatment with ORENCIA, healthcare providers may examine individuals for TB or perform a skin test to determine the presence of TB.
Additionally, individuals should inform their healthcare providers if they are scheduled to have surgery, or if they recently received a vaccination or are scheduled to receive any vaccinations. Before receiving ORENCIA (R) (abatacept), people should alert their healthcare providers if they have a history of chronic obstructive pulmonary (lung) disease (COPD), as taking ORENCIA may cause their COPD symptoms to worsen.
Pregnant women, women planning to get pregnant or women thinking about becoming pregnant should inform their healthcare providers prior to starting treatment with ORENCIA. It is not known if exposure to ORENCIA poses risks to unborn infants. Women should alert their healthcare providers if they are breastfeeding, as these individuals will need to decide either to breastfeed or to receive treatment with ORENCIA, but not both.
Like all medicines that affect the immune system, ORENCIA can cause serious side effects, including serious infections, allergic reactions and malignancies. Individuals receiving treatment with ORENCIA are at increased risk for developing infections including pneumonia and other infections caused by viruses, bacteria or fungi. Individuals should immediately contact their healthcare providers if they feel sick or experience any infection during treatment with ORENCIA. Allergic reactions to ORENCIA therapy may also occur.
These reactions are usually mild or moderate, generally occur within the first 24 hours of an infusion and can include hives, swollen face, eyelids, lips, tongue, throat or difficulty breathing.
There have been two serious allergic reactions reported in individuals following ORENCIA infusion. There have also been cases of certain kinds of cancer in individuals receiving ORENCIA. The role of ORENCIA in the development of cancer is not known.
The more common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat and nausea.
For full prescribing information, please visit ORENCIA or bms
Dosing and Administration
ORENCIA (a fully human soluble fusion protein) is administered as a 30-minute intravenous infusion at a fixed dose based on weight range approximating 10 mg/kg at day 0, 2 weeks, 4 weeks, and every 4 weeks thereafter. Infusion reactions were experienced in nine percent of people treated with ORENCIA (R) (abatacept) and in six percent of people treated with placebo. The most frequently reported infusion-related adverse events (1 percent to 2 percent) were dizziness, headache, and hypertension. In clinical trials, premedications were not required. However, appropriate medical support measures for the treatment of hypersensitivity reactions should be available for immediate use in the event of a reaction.
About ORENCIA
ORENCIA, approved by the U.S. Food and Drug Administration (FDA) on December 23, 2005, is indicated for reducing signs and symptoms, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs, such as MTX or TNF antagonists. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. ORENCIA should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with anakinra.
ORENCIA, a selective modulator of a co-stimulatory signal required for full T-cell activation, was discovered and developed by Bristol-Myers Squibb Company.
About Rheumatoid Arthritis
Rheumatoid arthritis is a systemic, chronic, autoimmune disease characterized by inflammation in the lining of joints (or synovium), causing joint damage with chronic pain, stiffness and swelling. 4 RA causes limited range of motion and decreased function as a result of affected joints losing their shape and alignment. 4
RA affects about 1 percent of the world's population, including more than two million people in the United States. 6
The condition is more common in women, who account for 75 percent of patients diagnosed with RA. 6
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
References
1 Kremer JM, Emery P, Becker JP, Aranda R, Teng J, Li T, Westhovens R. Abatacept provides significant and sustained benefits in clinical and patient-reported outcomes through 2 years in patients with rheumatoid arthritis and an inadequate response to methotrexate: the long-term extension of the AIM trial. Poster presentation FRI0134, Abstract 705 at: 2006 European League Against Rheumatism (EULAR) annual congress. congress. Amsterdam, Netherlands, June 21-24, 2006.
2 Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, Szechinski K, Li T, Zhiyu G, Becker JP, Westhovens R. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis. Annals of Internal Medicine 2006;144:865-876.
3 Genant HK, Peterfy C, Westhovens R, Becker JP, Aranda R, Teng J, Kremer JM. Abatacept sustains inhibition of radiographic progression over 2 years in rheumatoid arthritis (RA) patients with an inadequate response to methotrexate (MTX): results from the long-term extension (LTE) of the AIM trial. Oral presentation OP0015, Abstract 1566 at: 2006 European League Against Rheumatism (EULAR) annual congress. Amsterdam, Netherlands, June 21-24, 2006.
4 Guidelines for the management of rheumatoid arthritis; 2002 update. Arthritis & Rheumatism. 2002;46(2):328-346.
5 Lee DM and Weinblatt ME. Rheumatoid arthritis. Lancet. 2001;358:903-911.
6 American College of Rheumatology Web site. Rheumatoid arthritis. rheumatology/public/factsheets/ra_new.asp?aud=pat#3 Accessed December 20, 2005.
bms
View drug information on Enbrel; Humira; Orencia.
четверг, 19 мая 2011 г.
Addition Of A TNF Antagonist Better Option For Patients With Early Rheumatoid Arthritis Who Have Poor Response To Methotrexate
Treating all patients with early rheumatoid arthritis (RA) with methotrexate monotherapy for a short period, followed by the addition of a tumour necrosis factor (TNF) antagonist such as infliximab in patients with inadequate response to methotrexate, is the best treatment option and could prevent overtreatment, as well as reducing the side-effects and costs associated with aggressive combination therapy. The findings are in an Article published in this week's edition of The Lancet.
Given in combination with methotrexate, both TNF antagonists such as infliximab and conventional disease-modifying antirheumatic drugs (DMARDs) such as sulfasalazine and hydroxychloroquine are better than methotrexate alone at reducing the signs and symptoms of RA. However, previous trials have shown that between 20-40% of patients have a good response to methotrexate monotherapy and do not need a more intensive combination treatment. But it is not known which of these aggressive combination treatment options is more effective in patients who do not respond well to methotrexate.
To resolve this uncertainty, Ronald van Vollenhoven from the Karolinska University Hospital and the Karolinska Institute, Sweden, and colleagues undertook the Swedish Pharmacotherapy (Swefot) trial and recruited 487 patients with early RA (less than 1 year's duration) from 15 rheumatology units in Sweden between October 2002 and December 2005. All patients were initially treated with methotrexate. After 3-4 months patients with an inadequate response were randomised to receive addition of either infliximab (128) or sulfasalazine and hydroxychloroquine (130). Clinical response was assessed by criteria of the European League Against Rheumatism (EULAR).
After 12 months, patients given infliximab achieved better outcomes than those given sulfasalazine and hydroxychloroquine. 32 of 130 (25%) of patients given sulfasalazine and hydroxychloroquine and 50 of 128 (39%) of patients given infliximab achieved a good response according to EULAR scores. Similar numbers of adverse events were recorded in both groups and all had previously been reported with the drugs used.
The authors conclude: "We believe that by treating all patients with methotrexate for 3-4 months, we screened out a sizeable proportion (30% in this trial) who would have been overtreated if aggressive combination therapy was used for all, an approach that could have increased the risk of side-effects and potentially entailed high costs."
In an accompanying Comment, Tuulikki Sokka from Jyv?¤skyl?¤ Central Hospital, Finland and Theodore Pincus from New York University Hospital for Joint Diseases, USA, say that the results highlight that the treatment strategy is more important than the agent in treating RA: "The Swefot trialists ask (properly) whether a 3-month delay of optimum therapy is ethical to offset the risks and costs of biological agents versus methotrexate and DMARD therapy. The data suggest that this delay is acceptable, because most patients with rheumatoid arthritis have an adequate response without biological agents, and 3 months of methotrexate followed by 3 months of triple therapy might be a reasonable standard."
Source
The Lancet
Given in combination with methotrexate, both TNF antagonists such as infliximab and conventional disease-modifying antirheumatic drugs (DMARDs) such as sulfasalazine and hydroxychloroquine are better than methotrexate alone at reducing the signs and symptoms of RA. However, previous trials have shown that between 20-40% of patients have a good response to methotrexate monotherapy and do not need a more intensive combination treatment. But it is not known which of these aggressive combination treatment options is more effective in patients who do not respond well to methotrexate.
To resolve this uncertainty, Ronald van Vollenhoven from the Karolinska University Hospital and the Karolinska Institute, Sweden, and colleagues undertook the Swedish Pharmacotherapy (Swefot) trial and recruited 487 patients with early RA (less than 1 year's duration) from 15 rheumatology units in Sweden between October 2002 and December 2005. All patients were initially treated with methotrexate. After 3-4 months patients with an inadequate response were randomised to receive addition of either infliximab (128) or sulfasalazine and hydroxychloroquine (130). Clinical response was assessed by criteria of the European League Against Rheumatism (EULAR).
After 12 months, patients given infliximab achieved better outcomes than those given sulfasalazine and hydroxychloroquine. 32 of 130 (25%) of patients given sulfasalazine and hydroxychloroquine and 50 of 128 (39%) of patients given infliximab achieved a good response according to EULAR scores. Similar numbers of adverse events were recorded in both groups and all had previously been reported with the drugs used.
The authors conclude: "We believe that by treating all patients with methotrexate for 3-4 months, we screened out a sizeable proportion (30% in this trial) who would have been overtreated if aggressive combination therapy was used for all, an approach that could have increased the risk of side-effects and potentially entailed high costs."
In an accompanying Comment, Tuulikki Sokka from Jyv?¤skyl?¤ Central Hospital, Finland and Theodore Pincus from New York University Hospital for Joint Diseases, USA, say that the results highlight that the treatment strategy is more important than the agent in treating RA: "The Swefot trialists ask (properly) whether a 3-month delay of optimum therapy is ethical to offset the risks and costs of biological agents versus methotrexate and DMARD therapy. The data suggest that this delay is acceptable, because most patients with rheumatoid arthritis have an adequate response without biological agents, and 3 months of methotrexate followed by 3 months of triple therapy might be a reasonable standard."
Source
The Lancet
среда, 18 мая 2011 г.
BUPA Launches Online Exercise Classes To Ease Arthritis Pain
Britain's nine million arthritis sufferers can now find relief from symptoms and boost their wellbeing by following free online exercise videos launched today by Bupa, the health and care company.
The videos represent a first on the web for arthritis treatment .They've been developed with Bupa doctors and physiotherapists to educate people with arthritis about the benefits of gentle exercise in helping to relieve symptoms. This is in response to fears held by many arthritis sufferers that exercise may aggravate their condition.
Dr Annabel Bentley, assistant medical director at Bupa said: "Gentle exercise can be enormously beneficial for people with arthritis, helping to ease symptoms, strengthen joints and increase mobility. Our online exercise videos are designed to make it easier to do the right exercises with someone to follow and guide you through."
There are five arthritis videos to choose from; one on general exercise and others looking at joint-specific exercises including knees, the back, shoulders and hands/wrists/forearms. Each video has a person demonstrating the exercises and a Bupa physiotherapist to guide you through.
The online arthritis exercise videos are the first in a series of free online videos from Bupa designed to provide users with practical hints, tips and advice on healthcare issues that matter today. Other videos will cover issues such as improving your health at work and give self-care advice, for example treating sprains and strains at home.
For more information or to view the videos visit hcd2.bupa/fact_sheets/html/arthritis.html or bupa/health
the videos are listed in the health factsheet section under rheumatoid arthritis.
The following videos can be viewed at
Should I exercise if I have arthritis?
What exercise can I do for arthritis in my hands, wrists and forearms?
What exercises can I do for arthritis in my shoulders?
What exercises can I do for arthritis in my back?
What exercises can I for do for arthritis in my knees?
Bupa is the UK market leader in health and care with a strong international presence. Established in 1947, it has around 10 million customers in almost 200 countries and more than 49,000 employees. Its main interests are health insurance, care homes for older people and young disabled, health assessments, workplace health and childcare services. Bupa Travel offers a bespoke travel insurance service. Sanitas in Spain, MBF, HBA, Mutual Community in Australia and DCA Agedcare in Australia and New Zealand, IHI in Denmark and Health Dialog in the US are all part of the Bupa Group which also has centres in Hong-Kong, Thailand and Saudi Arabia. Bupa is a company limited by guarantee and does not have a share capital. As a result, it can focus on its customers, helping them to live longer, healthier lives and can reinvest all of its profits to do this - this is the dividend that Bupa provides.
Source
Julie Urquhart
Bupa Corporate Communications
The videos represent a first on the web for arthritis treatment .They've been developed with Bupa doctors and physiotherapists to educate people with arthritis about the benefits of gentle exercise in helping to relieve symptoms. This is in response to fears held by many arthritis sufferers that exercise may aggravate their condition.
Dr Annabel Bentley, assistant medical director at Bupa said: "Gentle exercise can be enormously beneficial for people with arthritis, helping to ease symptoms, strengthen joints and increase mobility. Our online exercise videos are designed to make it easier to do the right exercises with someone to follow and guide you through."
There are five arthritis videos to choose from; one on general exercise and others looking at joint-specific exercises including knees, the back, shoulders and hands/wrists/forearms. Each video has a person demonstrating the exercises and a Bupa physiotherapist to guide you through.
The online arthritis exercise videos are the first in a series of free online videos from Bupa designed to provide users with practical hints, tips and advice on healthcare issues that matter today. Other videos will cover issues such as improving your health at work and give self-care advice, for example treating sprains and strains at home.
For more information or to view the videos visit hcd2.bupa/fact_sheets/html/arthritis.html or bupa/health
the videos are listed in the health factsheet section under rheumatoid arthritis.
The following videos can be viewed at
Should I exercise if I have arthritis?
What exercise can I do for arthritis in my hands, wrists and forearms?
What exercises can I do for arthritis in my shoulders?
What exercises can I do for arthritis in my back?
What exercises can I for do for arthritis in my knees?
Bupa is the UK market leader in health and care with a strong international presence. Established in 1947, it has around 10 million customers in almost 200 countries and more than 49,000 employees. Its main interests are health insurance, care homes for older people and young disabled, health assessments, workplace health and childcare services. Bupa Travel offers a bespoke travel insurance service. Sanitas in Spain, MBF, HBA, Mutual Community in Australia and DCA Agedcare in Australia and New Zealand, IHI in Denmark and Health Dialog in the US are all part of the Bupa Group which also has centres in Hong-Kong, Thailand and Saudi Arabia. Bupa is a company limited by guarantee and does not have a share capital. As a result, it can focus on its customers, helping them to live longer, healthier lives and can reinvest all of its profits to do this - this is the dividend that Bupa provides.
Source
Julie Urquhart
Bupa Corporate Communications
вторник, 17 мая 2011 г.
Phase III Study Showed Rituxan® Decreased The Progression Of Joint Damage In Patients With Early Rheumatoid Arthritis (RA)
Genentech, Inc. (NYSE: DNA) and Biogen Idec (Nasdaq: BIIB) announced that a Phase III clinical study of Rituxan® (rituximab) in patients with early rheumatoid arthritis (RA) who have not previously been treated with methotrexate (MTX) met its primary endpoint.
In this study, known as IMAGE, patients received two infusions of either 500 mg or 1000 mg of Rituxan or placebo for up to two treatment courses in combination with a stable dose of MTX. At week 52, only patients in the 1000 mg treatment group met the primary endpoint and showed significantly less progression of joint damage compared to patients who received placebo in combination with MTX. Joint damage was assessed by changes in X-ray images using the Genant-modified total Sharp score.
In both Rituxan treatment groups, secondary endpoints showed a significantly higher proportion of patients with a substantial improvement in RA signs and symptoms (including ACR scores and DAS remission) compared to patients receiving MTX alone. Further analyses of the data are ongoing and will be submitted for presentation at an upcoming medical meeting.
"The study results with Rituxan plus methotrexate in this early RA population are important because the majority of joint damage -- a leading cause of disability in patients with RA -- is believed to occur within the first two years of the disease, often before traditional disease-modifying drugs like methotrexate have been prescribed," said Hal Barron, M.D., Genentech's senior vice president, Development and chief medical officer. "The results from IMAGE reinforce our belief that B cells play an important role in the underlying disease process in RA."
"The IMAGE study results provide further support for initiating a B-cell targeted agent earlier in RA treatment," said Evan Beckman, M.D., Biogen Idec's senior vice president of Immunology Research and Development. "The study results also confirm Rituxan's positive impact on disease activity and physical function in RA patients. We look forward to sharing the full data set with the medical community and the FDA."
The safety profile of Rituxan was consistent with our previous experience and a preliminary analysis did not reveal any new or unexpected safety signals. The incidence of adverse events and serious adverse events including infections and serious infections were comparable between Rituxan and placebo treatment groups. The companies continue to monitor the long-term safety of Rituxan treatment.
About the IMAGE Study
IMAGE is a multi-year, Phase III, randomized, double-blind, placebo-controlled, parallel group, multicenter international study designed to evaluate the safety and efficacy profile of Rituxan in combination with a stable dose of MTX compared to MTX alone, in methotrexate-naive patients with active rheumatoid arthritis. Methotrexate is a commonly used disease-modifying, anti-rheumatic drug (DMARD). The primary objective of the study was to determine the efficacy of Rituxan in the prevention of progression of structural joint damage and to evaluate the safety of Rituxan in patients with active, early rheumatoid arthritis initiating treatment with MTX.
A total of 755 MTX-na??ve patients with active RA from 168 study sites across 27 countries were randomized to receive either Rituxan (500 mg or 1000 mg) or placebo by intravenous infusion on days 1 and 15, in addition to therapy with MTX. Eligible patients who were not in DAS28-ESR remission 24 weeks following their previous course received a further course of RTX with the same dose as the first course. The primary endpoint evaluating change in total Genant-modified total Sharp scores was measured at week 52.
About Rheumatoid Arthritis (RA)
RA is a debilitating autoimmune disease that affects an estimated 1.3 million Americans and hinders daily activities. The damage that occurs in RA is a result of the immune system attacking joint tissue, causing painful chronic inflammation and irreversible destruction of cartilage, tendons and bones, which often results in disability. Common RA symptoms include inflammation of the joints, swelling, fatigue, stiffness and pain. Additionally, since RA is a systemic disease, it can affect other tissues such as the lungs and eyes.
About Rituxan®
Rituxan, discovered by Biogen Idec, is a therapeutic antibody that first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B cell non-Hodgkin's lymphoma. It was also approved in the European Union under the trade name MabThera® in June 1998. Rituxan received FDA approval in February 2006 for the treatment of diffuse large B-cell lymphoma (DLBCL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens in previously untreated patients.
In February 2006, Rituxan also received FDA approval in combination with MTX to reduce signs and symptoms in adult patients with moderately-to-severely active RA who have had an inadequate response to one or more TNF antagonist therapies. In January 2008, Rituxan was approved to slow the progression of structural damage in adult patients with moderately-to-severely active RA who have had an inadequate response to one or more TNF-antagonist therapies. Rituxan is the first treatment for RA that selectively targets immune cells known as CD20-positive B cells. Rituxan does not target the entire immune system.
CD20 is not found on stem cells, pro-B cells (B cell precursors), normal plasma cells, or other normal tissues. Rituxan does not target plasma cells. These cells make antibodies that help fight infections.
Rituxan does not target stem cells in the bone marrow, and B cells can usually regenerate and gradually return to normal levels after retreatment with Rituxan in about 12 months for most patients.
In addition, Rituxan received FDA approval in September 2006 for first-line treatment of previously-untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine, and prednisolone) chemotherapy and also for the treatment of low-grade NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy.
Over the past ten years, there have been more than 1 million patient exposures to Rituxan.
Rituxan is also being studied in other autoimmune diseases with significant unmet medical needs, including lupus nephritis and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
Rituxan Safety
Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (PML).
Hepatitis B reactivation with fulminant hepatitis, other viral infections, cardiovascular events, renal toxicity, and bowel obstruction and perforation have also been observed. Patients should be closely observed for signs of infection if biologic agents and/or disease modifying anti-rheumatic drugs (DMARDs) other than methotrexate are used concomitantly.
The most common adverse reactions in Rituxan-treated RA patients are hypertension, nausea, upper respiratory tract infection, arthralgia, pruritus, and pyrexia.
The most common adverse reactions (incidence ?‰? 25 %) in Rituxan-treated NHL patients are infusion reactions, fevers, chills, infection, asthenia, and lymphopenia.
About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines for patients with significant unmet medical needs. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit gene.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit biogenidec.
View drug information on Rituxan.
In this study, known as IMAGE, patients received two infusions of either 500 mg or 1000 mg of Rituxan or placebo for up to two treatment courses in combination with a stable dose of MTX. At week 52, only patients in the 1000 mg treatment group met the primary endpoint and showed significantly less progression of joint damage compared to patients who received placebo in combination with MTX. Joint damage was assessed by changes in X-ray images using the Genant-modified total Sharp score.
In both Rituxan treatment groups, secondary endpoints showed a significantly higher proportion of patients with a substantial improvement in RA signs and symptoms (including ACR scores and DAS remission) compared to patients receiving MTX alone. Further analyses of the data are ongoing and will be submitted for presentation at an upcoming medical meeting.
"The study results with Rituxan plus methotrexate in this early RA population are important because the majority of joint damage -- a leading cause of disability in patients with RA -- is believed to occur within the first two years of the disease, often before traditional disease-modifying drugs like methotrexate have been prescribed," said Hal Barron, M.D., Genentech's senior vice president, Development and chief medical officer. "The results from IMAGE reinforce our belief that B cells play an important role in the underlying disease process in RA."
"The IMAGE study results provide further support for initiating a B-cell targeted agent earlier in RA treatment," said Evan Beckman, M.D., Biogen Idec's senior vice president of Immunology Research and Development. "The study results also confirm Rituxan's positive impact on disease activity and physical function in RA patients. We look forward to sharing the full data set with the medical community and the FDA."
The safety profile of Rituxan was consistent with our previous experience and a preliminary analysis did not reveal any new or unexpected safety signals. The incidence of adverse events and serious adverse events including infections and serious infections were comparable between Rituxan and placebo treatment groups. The companies continue to monitor the long-term safety of Rituxan treatment.
About the IMAGE Study
IMAGE is a multi-year, Phase III, randomized, double-blind, placebo-controlled, parallel group, multicenter international study designed to evaluate the safety and efficacy profile of Rituxan in combination with a stable dose of MTX compared to MTX alone, in methotrexate-naive patients with active rheumatoid arthritis. Methotrexate is a commonly used disease-modifying, anti-rheumatic drug (DMARD). The primary objective of the study was to determine the efficacy of Rituxan in the prevention of progression of structural joint damage and to evaluate the safety of Rituxan in patients with active, early rheumatoid arthritis initiating treatment with MTX.
A total of 755 MTX-na??ve patients with active RA from 168 study sites across 27 countries were randomized to receive either Rituxan (500 mg or 1000 mg) or placebo by intravenous infusion on days 1 and 15, in addition to therapy with MTX. Eligible patients who were not in DAS28-ESR remission 24 weeks following their previous course received a further course of RTX with the same dose as the first course. The primary endpoint evaluating change in total Genant-modified total Sharp scores was measured at week 52.
About Rheumatoid Arthritis (RA)
RA is a debilitating autoimmune disease that affects an estimated 1.3 million Americans and hinders daily activities. The damage that occurs in RA is a result of the immune system attacking joint tissue, causing painful chronic inflammation and irreversible destruction of cartilage, tendons and bones, which often results in disability. Common RA symptoms include inflammation of the joints, swelling, fatigue, stiffness and pain. Additionally, since RA is a systemic disease, it can affect other tissues such as the lungs and eyes.
About Rituxan®
Rituxan, discovered by Biogen Idec, is a therapeutic antibody that first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B cell non-Hodgkin's lymphoma. It was also approved in the European Union under the trade name MabThera® in June 1998. Rituxan received FDA approval in February 2006 for the treatment of diffuse large B-cell lymphoma (DLBCL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens in previously untreated patients.
In February 2006, Rituxan also received FDA approval in combination with MTX to reduce signs and symptoms in adult patients with moderately-to-severely active RA who have had an inadequate response to one or more TNF antagonist therapies. In January 2008, Rituxan was approved to slow the progression of structural damage in adult patients with moderately-to-severely active RA who have had an inadequate response to one or more TNF-antagonist therapies. Rituxan is the first treatment for RA that selectively targets immune cells known as CD20-positive B cells. Rituxan does not target the entire immune system.
CD20 is not found on stem cells, pro-B cells (B cell precursors), normal plasma cells, or other normal tissues. Rituxan does not target plasma cells. These cells make antibodies that help fight infections.
Rituxan does not target stem cells in the bone marrow, and B cells can usually regenerate and gradually return to normal levels after retreatment with Rituxan in about 12 months for most patients.
In addition, Rituxan received FDA approval in September 2006 for first-line treatment of previously-untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine, and prednisolone) chemotherapy and also for the treatment of low-grade NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy.
Over the past ten years, there have been more than 1 million patient exposures to Rituxan.
Rituxan is also being studied in other autoimmune diseases with significant unmet medical needs, including lupus nephritis and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
Rituxan Safety
Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (PML).
Hepatitis B reactivation with fulminant hepatitis, other viral infections, cardiovascular events, renal toxicity, and bowel obstruction and perforation have also been observed. Patients should be closely observed for signs of infection if biologic agents and/or disease modifying anti-rheumatic drugs (DMARDs) other than methotrexate are used concomitantly.
The most common adverse reactions in Rituxan-treated RA patients are hypertension, nausea, upper respiratory tract infection, arthralgia, pruritus, and pyrexia.
The most common adverse reactions (incidence ?‰? 25 %) in Rituxan-treated NHL patients are infusion reactions, fevers, chills, infection, asthenia, and lymphopenia.
About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines for patients with significant unmet medical needs. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit gene.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit biogenidec.
View drug information on Rituxan.
понедельник, 16 мая 2011 г.
New Treatment Approach For Inflammatory Conditions Suggested
Scientists at The Feinstein Institute for Medical Research have made a discovery that may change the way inflammatory conditions are treated. The researchers looked at certain nerve cell receptors in the brain and found they control inflammation in the body. The discovery presents a potential new approach for treating inflammatory conditions like rheumatoid arthritis and inflammatory bowel disease. The study, by Valentin Pavlov, PhD, Kevin Tracey, MD, and colleagues, was published in the March issue of Proceedings of the National Academy of Sciences.
The brain chemical acetylcholine binds to muscarinic receptors on nerve cells in the brain, causing the brain to send messages to the body that slow the inflammatory response. The receptors can be stimulated though a number of mechanisms, including by use of drugs that mimic the effect of acetylcholine, by blocking an enzyme that naturally destroys acetylcholine, or by provoking the nerve cells to release more acetylcholine. The researchers also tested muscarinic receptors in other parts of the body, but unlike the central receptors in the brain, they do not play an essential role in controlling the inflammatory response.
"Medications in a class of drugs called centrally acting cholinergic agents are already available on the U.S. market, approved by the Food and Drug Administration (FDA) for treating Alzheimer's disease," said Dr. Tracey, who is also Director and Chief Executive Officer of The Feinstein. "Our next step will be to conduct a clinical trial with one of these drugs as an anti-inflammatory agent to evaluate its effect on inflammatory measures in healthy people."
The research team plans to test galantamine, a drug whose active ingredient was first extracted from a plant and is now synthesized in the laboratory, which works primarily by blocking the enzyme that destroys acetylcholine. The drug allows the nerve cells in the brain to communicate their anti-inflammatory signals to the rest of the body. The FDA approved galantamine for mild to moderate Alzheimer's dementia in 2001. Galantamine was approved with the trade name Reminyl and is now known as Razadyne.
"In addition to stopping the natural breakdown of acetylcholine, galantamine stimulates nerve cells in the brain to release more of the chemical messenger," said Dr. Pavlov. "This secondary mechanism of action is unique in this class of drugs."
Before being approved in the United States, galantamine was commercially available in Europe under the trade name Nivalin and used for decades in the fields of anesthesiology, neurology, ophthalmology, gastroenterology, cardiology and others.
Contact: Christina Verni
cverninshs
North Shore-Long Island Jewish (LIJ) Health System
View drug information on Reminyl.
The brain chemical acetylcholine binds to muscarinic receptors on nerve cells in the brain, causing the brain to send messages to the body that slow the inflammatory response. The receptors can be stimulated though a number of mechanisms, including by use of drugs that mimic the effect of acetylcholine, by blocking an enzyme that naturally destroys acetylcholine, or by provoking the nerve cells to release more acetylcholine. The researchers also tested muscarinic receptors in other parts of the body, but unlike the central receptors in the brain, they do not play an essential role in controlling the inflammatory response.
"Medications in a class of drugs called centrally acting cholinergic agents are already available on the U.S. market, approved by the Food and Drug Administration (FDA) for treating Alzheimer's disease," said Dr. Tracey, who is also Director and Chief Executive Officer of The Feinstein. "Our next step will be to conduct a clinical trial with one of these drugs as an anti-inflammatory agent to evaluate its effect on inflammatory measures in healthy people."
The research team plans to test galantamine, a drug whose active ingredient was first extracted from a plant and is now synthesized in the laboratory, which works primarily by blocking the enzyme that destroys acetylcholine. The drug allows the nerve cells in the brain to communicate their anti-inflammatory signals to the rest of the body. The FDA approved galantamine for mild to moderate Alzheimer's dementia in 2001. Galantamine was approved with the trade name Reminyl and is now known as Razadyne.
"In addition to stopping the natural breakdown of acetylcholine, galantamine stimulates nerve cells in the brain to release more of the chemical messenger," said Dr. Pavlov. "This secondary mechanism of action is unique in this class of drugs."
Before being approved in the United States, galantamine was commercially available in Europe under the trade name Nivalin and used for decades in the fields of anesthesiology, neurology, ophthalmology, gastroenterology, cardiology and others.
Contact: Christina Verni
cverninshs
North Shore-Long Island Jewish (LIJ) Health System
View drug information on Reminyl.
воскресенье, 15 мая 2011 г.
Non-Invasive Imaging Method For Diagnosing Osteoarthritis
Researchers at New York University and Tel Aviv University have developed a non-invasive imaging method that can be used to diagnose and monitor a number of diseases, including osteoarthritis and inter-vertebral disc degeneration, in their early stages. Their work appears in the latest issue of the journal Proceedings of the National Academy of Sciences (PNAS).
The research team examined glycosaminogycans (GAGs), which are molecules that serve as the building blocks of cartilage and are involved in numerous vital functions in the human body. Mapping the GAG concentration in vivo, or in a living organism, is desirable for the diagnosis and monitoring of a number of diseases. It is also valuable in determining the efficacy of drug therapies. For instance, GAG loss in cartilage typically marks the onset of osteoarthritis and inter-vertebral disc degeneration.
However, the existing techniques for GAG monitoring - based on traditional magnetic resonance imaging (MRI) - have limitations: they cannot directly map GAG concentrations or they require the administration of contrast agents. The NYU-Tel Aviv research team sought a more direct measurement of GAGs. In this study, they employed the exchangeable protons of GAG to directly measure GAG concentration in vivo.
Knowing that GAG molecules have proton groups that are not tethered tightly, the researchers investigated whether proton exchange in GAGs could allow concentrations of the molecule to be measured by the MRI. By separating out the GAG protons from those of water, they can be used as a sort of inherent contrast agent. Testing the idea in tissue samples, the researchers found that the available GAG protons provided an effective type of contrast enhancement, allowing them to readily monitor GAGs through a clinical MRI scanner. The in vivo application of this method showed that this technique can be readily implemented in a clinical setting.
This chemical exchange saturation method (gagCEST) not only could provide a non-invasive way to diagnose osteoarthritis in its very early stages, but could also help to indicate early interventions for degenerative disc disease, which is responsible for lower back pain, and defects in heart valves and, potentially, the cornea.
The research was conducted by NYU Chemistry Professor Alexej Jerschow, Professor Ravinder Regatte of the Department of Radiology at NYU's School of Medicine, Professor Gil Navon, Tel Aviv University, and Wen Ling, who holds appointments in the chemistry departments at NYU and Tel Aviv University.
Source: James Devitt
New York University
The research team examined glycosaminogycans (GAGs), which are molecules that serve as the building blocks of cartilage and are involved in numerous vital functions in the human body. Mapping the GAG concentration in vivo, or in a living organism, is desirable for the diagnosis and monitoring of a number of diseases. It is also valuable in determining the efficacy of drug therapies. For instance, GAG loss in cartilage typically marks the onset of osteoarthritis and inter-vertebral disc degeneration.
However, the existing techniques for GAG monitoring - based on traditional magnetic resonance imaging (MRI) - have limitations: they cannot directly map GAG concentrations or they require the administration of contrast agents. The NYU-Tel Aviv research team sought a more direct measurement of GAGs. In this study, they employed the exchangeable protons of GAG to directly measure GAG concentration in vivo.
Knowing that GAG molecules have proton groups that are not tethered tightly, the researchers investigated whether proton exchange in GAGs could allow concentrations of the molecule to be measured by the MRI. By separating out the GAG protons from those of water, they can be used as a sort of inherent contrast agent. Testing the idea in tissue samples, the researchers found that the available GAG protons provided an effective type of contrast enhancement, allowing them to readily monitor GAGs through a clinical MRI scanner. The in vivo application of this method showed that this technique can be readily implemented in a clinical setting.
This chemical exchange saturation method (gagCEST) not only could provide a non-invasive way to diagnose osteoarthritis in its very early stages, but could also help to indicate early interventions for degenerative disc disease, which is responsible for lower back pain, and defects in heart valves and, potentially, the cornea.
The research was conducted by NYU Chemistry Professor Alexej Jerschow, Professor Ravinder Regatte of the Department of Radiology at NYU's School of Medicine, Professor Gil Navon, Tel Aviv University, and Wen Ling, who holds appointments in the chemistry departments at NYU and Tel Aviv University.
Source: James Devitt
New York University
суббота, 14 мая 2011 г.
Rheumatoid Arthritis Doesn't Hinder Computing Skills
A recent study by researchers from the University of Pittsburgh found that workers with rheumatoid arthritis (RA) were comparable to non-impaired individuals in keyboarding speed. Individuals who were trained in touch typing demonstrated faster typing speeds than those using a visually-guided ("hunt and peck") method, regardless of impairment. Researchers also noted slightly impaired mouse skills in workers with RA. Results of this study appear in the February issue of Arthritis Care & Research, a journal published by Wiley-Blackwell on behalf of the American College of Rheumatology.
According to the U.S. Census Bureau the number of workers using computers increased from 46% in 1993 to 56% in 2003 with figures expected to continue climbing higher. For workers with RA the capacity to use computers may be limited by impairment in hand range of motion (ROM) and strength caused by inflammation of their joints due to the disease. Prior studies have shown that workers with RA have higher rates of work disability, premature work cessation, and reduced hours on the job.
"With more arthritic workers using computers, understanding the associations between hand function impairment and peripheral device (keyboard and mouse) limitations is essential and the focus of our current study," said lead author Nancy Baker, Sc.D., MPH, OTR/L. Researchers recruited 45 participants from the University of Pittsburgh Medical Center (UPMC) Arthritis Network Registry for the study. Those subjects enrolled had an average age of 55, were primarily white females, and had RA for 17 years. Half of all participants worked full or part-time, with 100% of this group using computers at work.
Hand function was assessed using the Keitel Hand Function Index (KHFI) and the Arthritis Hand Function Test (AHFT). The KHFI included 11 performance test items to measure active ROM of the thumb, fingers, writs, forearms and elbows. The AHFT consisted of 10 test items to evaluate pure and applied strength and dexterity in a variety of hand tasks. Participants' abilities to use a standard keyboard and mouse were measured using the Assessment of Computer Task Performance (ACTP).
The research team found that 73% of participants were trained in touch typing and used the computer an average of 18 hours per week. Regression models suggested that keyboarding speed was significantly associated with touch typing training and age. Mouse speed was significantly associated with age only, with younger participants demonstrating faster speeds than older subjects. Impairments in hand function were associated with 2 of 7 keyboarding tasks and no mouse tasks. "Our research suggests that if individuals with motor impairments have the capacity to learn touch typing it may increase their overall speed," noted Dr. Baker.
Researchers further compared the current study group results with an impaired and non-impaired subject group from a normative study by Dumont et al to benchmark ACTP. "We found that our RA workers had similar keyboarding speed compared with the non-impaired sample," Dr. Baker stated. "However, we found that mouse speed was much slower in some participants in our RA sample." Task-specific training for mouse use is not available and the reduced productivity with this device has the potential to place computer using workers with RA at risk for work disability. "Further research is needed to identify effective strategies to maintain productivity in computer users with RA," concluded Dr. Baker.
Article: "Association Between Computer Use Speed and Age, Impairments in Function, and Touch Typing Training in People With Rheumatoid Arthritis." Nancy A. Baker and Joan C. Rogers. Arthritis Care and Research; Published Online: January 28, 2010 (DOI: 10.1002/acr.20074); Print Issue Date: February 2010.
Source:
Dawn Peters
Wiley-Blackwell
According to the U.S. Census Bureau the number of workers using computers increased from 46% in 1993 to 56% in 2003 with figures expected to continue climbing higher. For workers with RA the capacity to use computers may be limited by impairment in hand range of motion (ROM) and strength caused by inflammation of their joints due to the disease. Prior studies have shown that workers with RA have higher rates of work disability, premature work cessation, and reduced hours on the job.
"With more arthritic workers using computers, understanding the associations between hand function impairment and peripheral device (keyboard and mouse) limitations is essential and the focus of our current study," said lead author Nancy Baker, Sc.D., MPH, OTR/L. Researchers recruited 45 participants from the University of Pittsburgh Medical Center (UPMC) Arthritis Network Registry for the study. Those subjects enrolled had an average age of 55, were primarily white females, and had RA for 17 years. Half of all participants worked full or part-time, with 100% of this group using computers at work.
Hand function was assessed using the Keitel Hand Function Index (KHFI) and the Arthritis Hand Function Test (AHFT). The KHFI included 11 performance test items to measure active ROM of the thumb, fingers, writs, forearms and elbows. The AHFT consisted of 10 test items to evaluate pure and applied strength and dexterity in a variety of hand tasks. Participants' abilities to use a standard keyboard and mouse were measured using the Assessment of Computer Task Performance (ACTP).
The research team found that 73% of participants were trained in touch typing and used the computer an average of 18 hours per week. Regression models suggested that keyboarding speed was significantly associated with touch typing training and age. Mouse speed was significantly associated with age only, with younger participants demonstrating faster speeds than older subjects. Impairments in hand function were associated with 2 of 7 keyboarding tasks and no mouse tasks. "Our research suggests that if individuals with motor impairments have the capacity to learn touch typing it may increase their overall speed," noted Dr. Baker.
Researchers further compared the current study group results with an impaired and non-impaired subject group from a normative study by Dumont et al to benchmark ACTP. "We found that our RA workers had similar keyboarding speed compared with the non-impaired sample," Dr. Baker stated. "However, we found that mouse speed was much slower in some participants in our RA sample." Task-specific training for mouse use is not available and the reduced productivity with this device has the potential to place computer using workers with RA at risk for work disability. "Further research is needed to identify effective strategies to maintain productivity in computer users with RA," concluded Dr. Baker.
Article: "Association Between Computer Use Speed and Age, Impairments in Function, and Touch Typing Training in People With Rheumatoid Arthritis." Nancy A. Baker and Joan C. Rogers. Arthritis Care and Research; Published Online: January 28, 2010 (DOI: 10.1002/acr.20074); Print Issue Date: February 2010.
Source:
Dawn Peters
Wiley-Blackwell
пятница, 13 мая 2011 г.
Initiation Of Phase III Program Using Emisphere's Eligen(R) Technology For Oral Salmon Calcitonin
Emisphere
Technologies, Inc. ("Emisphere") (Nasdaq: EMIS) announced today that
Novartis Pharma AG and its development partner Nordic Bioscience have
notified Emisphere of the initiation of a Phase III clinical trial for the
treatment of osteoporosis with an oral form of salmon calcitonin (referred
to as SMC021), a new drug candidate, using Emisphere's eligen(R) delivery
technology. As a result of the initiation of the trial, Emisphere will
receive a milestone payment from Novartis. The use of Emisphere's novel
eligen(R) technology reflects the potential that for the first time salmon
calcitonin may also be available as a convenient oral medication, rather
than the currently available injectable or intranasal options. (1)
Osteoporosis is a disease that reduces the density and quality of bone
and worldwide affects an estimated 75 million people in Europe, the United
States and Japan. (2) The Phase III trial, which will include more than
4,500 osteoporosis patients in Europe, United States, China and Latin
America, is a three year, randomized, multi-center, placebo-controlled
study to evaluate the safety and efficacy of oral calcitonin.
"Oral calcitonin has potential to be a novel oral treatment option in
the fight against osteoporosis," said Lewis H. Bender, President and Chief
Executive Officer of Emisphere. "We are very excited about the opportunity
to be in Phase III with Novartis and their development partner Nordic
Bioscience. Emisphere has a long working relationship with Novartis on oral
calcitonin and we believe that this study is an important confirmation of
the Emisphere eligen(R) technology."
To reach this point, initiation of this Phase III study, Novartis has
conducted extensive safety testing on both the oral calcitonin product and
the Emisphere technology. There has been a Phase II study, several Phase I
clinical trials and extensive preclinical safety studies conducted. Carrier
and drug product materials (including the Phase III clinical trial
materials) have been produced at large scale and also tested in clinical
trials.
Novartis has received CHMP advice on the Phase III trial design and
clearance from FDA to proceed with Phase III study under a special protocol
assessment. The clinical trial is being conducted by Nordic Bioscience
following a development agreement with Novartis.
In 2000, Emisphere and Novartis Pharma AG entered into a license
agreement for the development of oral salmon calcitonin for the treatment
of osteoporosis. The two companies entered into additional license
agreements for the development of oral human growth hormone and an oral
form of parathyroid hormone (PTH) fragment 1-34 in 2004 and 2006,
respectively.
About Salmon Calcitonin
Calcitonin is a polypeptide hormone secreted by the parafollicular
cells of the thyroid gland. Calcitonin enables the bone to retain more of
its mass and functionality by inhibiting the bone-tissue resorbing activity
of specialized bone cells called osteoclasts. (3) Calcitonin is involved in
the regulation of calcium and the decrease of bone loss and fractures.
Calcitonin derived from salmon is estimated to be about 30 times more
potent than the human version. Synthetic salmon calcitonin, which is
identical to the natural salmon calcitonin, is currently available only as
nasal spray or as an injectable therapy.
About Osteoporosis
Osteoporosis is a progressive disease that causes bones to become thin
and brittle, making them more likely to break. The number of patients in
the United States, Europe and Japan with osteoporosis or low bone mineral
density is estimated at 75 million. (2) Osteoporosis may result in broken
bones and fractures in the spine and hip. Hip fractures often require
hospitalization, and fractures of the bones in the spine (vertebrae) can
cause loss of height and severe back pain. Both may lead to permanent
disability.
About the eligen(R) Technology
Emisphere's broad-based oral drug delivery technology platform, known
as the eligen(R) technology, is based on the use of proprietary, synthetic
chemical compounds, known as EMISPHERE(R) delivery agents, or "carriers".
These molecules facilitate or enable the transport of the therapeutic
macromolecules across biological membranes such as those of the
gastrointestinal tract, and exert their desired pharmacological effect.
Emisphere's eligen(R) technology makes it possible to orally deliver a
therapeutic molecule without altering its chemical form or biological
integrity.
About Emisphere Technologies, Inc.
Emisphere Technologies, Inc. is a biopharmaceutical company pioneering
the oral delivery of otherwise injectable drugs. Emisphere's business
strategy is to develop oral forms of injectable drugs, either alone or with
corporate partners, by applying its proprietary eligen(R) technology to
those drugs or licensing its eligen(R) technology to partners who typically
apply it directly to their marketed drugs. Emisphere's eligen(R) technology
has enabled the oral delivery of proteins, peptides, macromolecules and
charged organics. Emisphere and its partners have advanced oral
formulations or prototypes of salmon calcitonin, heparin, insulin,
parathyroid hormone, human growth hormone and cromolyn sodium into clinical
trials. Emisphere has strategic alliances with world-leading pharmaceutical
companies. For further information, please visit emisphere.
Safe Harbor Statement Regarding Forward-looking Statements
The statements in this release and oral statements made by
representatives of Emisphere relating to matters that are not historical
facts (including without limitation those regarding the timing or potential
outcomes of research collaborations or clinical trials, any market that
might develop for any of Emisphere's product candidates and the sufficiency
of Emisphere's cash and other capital resources) are forward-looking
statements that involve risks and uncertainties, including, but not limited
to, the likelihood that future research will prove successful, the
likelihood that any product in the research pipeline will receive
regulatory approval in the United States or abroad, the ability of
Emisphere and/or its partners to develop, manufacture and commercialize
products using Emisphere's drug delivery technology, Emisphere's ability to
fund such efforts with or without partners, and other risks and
uncertainties detailed in Emisphere's filings with the Securities and
Exchange Commission, including those factors discussed under the caption
"Risk Factors" in Emisphere's Annual Report on Form 10-K (file no. 1-10615)
filed on March 16, 2006 and our Quarterly Reports on Form 10-Q for the
quarters ended March 31, 2006, June 30, 2006 and September 30, 2006.
References
1. Emisphere Technologies, Inc. Available at:
emisphere/ot_tet.asp. Accessed January 29, 2007.
2. International Osteoporosis Foundation. "Facts and statistics about
osteoporosis and its impact." iofbonehealth/facts-and-statistics.html. Accessed December 18, 2006.
3. Azria M. The Calcitonins: Physiology and Pharmacology. Basel, Karger.
1989.
Emisphere Technologies, Inc.
emisphere/
Technologies, Inc. ("Emisphere") (Nasdaq: EMIS) announced today that
Novartis Pharma AG and its development partner Nordic Bioscience have
notified Emisphere of the initiation of a Phase III clinical trial for the
treatment of osteoporosis with an oral form of salmon calcitonin (referred
to as SMC021), a new drug candidate, using Emisphere's eligen(R) delivery
technology. As a result of the initiation of the trial, Emisphere will
receive a milestone payment from Novartis. The use of Emisphere's novel
eligen(R) technology reflects the potential that for the first time salmon
calcitonin may also be available as a convenient oral medication, rather
than the currently available injectable or intranasal options. (1)
Osteoporosis is a disease that reduces the density and quality of bone
and worldwide affects an estimated 75 million people in Europe, the United
States and Japan. (2) The Phase III trial, which will include more than
4,500 osteoporosis patients in Europe, United States, China and Latin
America, is a three year, randomized, multi-center, placebo-controlled
study to evaluate the safety and efficacy of oral calcitonin.
"Oral calcitonin has potential to be a novel oral treatment option in
the fight against osteoporosis," said Lewis H. Bender, President and Chief
Executive Officer of Emisphere. "We are very excited about the opportunity
to be in Phase III with Novartis and their development partner Nordic
Bioscience. Emisphere has a long working relationship with Novartis on oral
calcitonin and we believe that this study is an important confirmation of
the Emisphere eligen(R) technology."
To reach this point, initiation of this Phase III study, Novartis has
conducted extensive safety testing on both the oral calcitonin product and
the Emisphere technology. There has been a Phase II study, several Phase I
clinical trials and extensive preclinical safety studies conducted. Carrier
and drug product materials (including the Phase III clinical trial
materials) have been produced at large scale and also tested in clinical
trials.
Novartis has received CHMP advice on the Phase III trial design and
clearance from FDA to proceed with Phase III study under a special protocol
assessment. The clinical trial is being conducted by Nordic Bioscience
following a development agreement with Novartis.
In 2000, Emisphere and Novartis Pharma AG entered into a license
agreement for the development of oral salmon calcitonin for the treatment
of osteoporosis. The two companies entered into additional license
agreements for the development of oral human growth hormone and an oral
form of parathyroid hormone (PTH) fragment 1-34 in 2004 and 2006,
respectively.
About Salmon Calcitonin
Calcitonin is a polypeptide hormone secreted by the parafollicular
cells of the thyroid gland. Calcitonin enables the bone to retain more of
its mass and functionality by inhibiting the bone-tissue resorbing activity
of specialized bone cells called osteoclasts. (3) Calcitonin is involved in
the regulation of calcium and the decrease of bone loss and fractures.
Calcitonin derived from salmon is estimated to be about 30 times more
potent than the human version. Synthetic salmon calcitonin, which is
identical to the natural salmon calcitonin, is currently available only as
nasal spray or as an injectable therapy.
About Osteoporosis
Osteoporosis is a progressive disease that causes bones to become thin
and brittle, making them more likely to break. The number of patients in
the United States, Europe and Japan with osteoporosis or low bone mineral
density is estimated at 75 million. (2) Osteoporosis may result in broken
bones and fractures in the spine and hip. Hip fractures often require
hospitalization, and fractures of the bones in the spine (vertebrae) can
cause loss of height and severe back pain. Both may lead to permanent
disability.
About the eligen(R) Technology
Emisphere's broad-based oral drug delivery technology platform, known
as the eligen(R) technology, is based on the use of proprietary, synthetic
chemical compounds, known as EMISPHERE(R) delivery agents, or "carriers".
These molecules facilitate or enable the transport of the therapeutic
macromolecules across biological membranes such as those of the
gastrointestinal tract, and exert their desired pharmacological effect.
Emisphere's eligen(R) technology makes it possible to orally deliver a
therapeutic molecule without altering its chemical form or biological
integrity.
About Emisphere Technologies, Inc.
Emisphere Technologies, Inc. is a biopharmaceutical company pioneering
the oral delivery of otherwise injectable drugs. Emisphere's business
strategy is to develop oral forms of injectable drugs, either alone or with
corporate partners, by applying its proprietary eligen(R) technology to
those drugs or licensing its eligen(R) technology to partners who typically
apply it directly to their marketed drugs. Emisphere's eligen(R) technology
has enabled the oral delivery of proteins, peptides, macromolecules and
charged organics. Emisphere and its partners have advanced oral
formulations or prototypes of salmon calcitonin, heparin, insulin,
parathyroid hormone, human growth hormone and cromolyn sodium into clinical
trials. Emisphere has strategic alliances with world-leading pharmaceutical
companies. For further information, please visit emisphere.
Safe Harbor Statement Regarding Forward-looking Statements
The statements in this release and oral statements made by
representatives of Emisphere relating to matters that are not historical
facts (including without limitation those regarding the timing or potential
outcomes of research collaborations or clinical trials, any market that
might develop for any of Emisphere's product candidates and the sufficiency
of Emisphere's cash and other capital resources) are forward-looking
statements that involve risks and uncertainties, including, but not limited
to, the likelihood that future research will prove successful, the
likelihood that any product in the research pipeline will receive
regulatory approval in the United States or abroad, the ability of
Emisphere and/or its partners to develop, manufacture and commercialize
products using Emisphere's drug delivery technology, Emisphere's ability to
fund such efforts with or without partners, and other risks and
uncertainties detailed in Emisphere's filings with the Securities and
Exchange Commission, including those factors discussed under the caption
"Risk Factors" in Emisphere's Annual Report on Form 10-K (file no. 1-10615)
filed on March 16, 2006 and our Quarterly Reports on Form 10-Q for the
quarters ended March 31, 2006, June 30, 2006 and September 30, 2006.
References
1. Emisphere Technologies, Inc. Available at:
emisphere/ot_tet.asp. Accessed January 29, 2007.
2. International Osteoporosis Foundation. "Facts and statistics about
osteoporosis and its impact." iofbonehealth/facts-and-statistics.html. Accessed December 18, 2006.
3. Azria M. The Calcitonins: Physiology and Pharmacology. Basel, Karger.
1989.
Emisphere Technologies, Inc.
emisphere/
среда, 11 мая 2011 г.
Key To Cancer, Arthritis And Cardiac Treatments Could Be The ADAM-12 Gene
ADAM-12 is not only the name of a 1970's television police drama - it's also the gene that University of Missouri researchers believe could be an important element in the fight against cancer, arthritis, and cardiac hypertrophy, or thickening of the heart's walls.
Alpana Ray, research associate professor in the MU College of Veterinary Medicine, and a team of researchers including Bimal Ray, professor of Veterinary Pathobiology, have been studying the ADAM family of genes for several years. Alpana Ray's latest publication in the Proceedings of the National Academy of Sciences (PNAS) discusses one pathway by which the ADAM-12 gene could be regulated, a process that could eventually be used as part of a treatment plan.
Scientists know that ADAM-12 is normally found in very low levels in adults, but during cancer, arthritis and cardiac hypertrophy, ADAM-12 level goes up. The only time it is normal to find a high level of the gene is during pregnancy, when ADAM-12 can be found in the placenta.
At the molecular level, Ray's team found a Z-DNA-binding silencer element that keeps the level of ADAM-12 low in normal conditions. They believe that if they could alter Z-DNA-binding silencer, new therapies could be right around the corner.
"We are finding that in the placenta, where ADAM-12 is highly expressed, the repressor protein (Z-DNA-binding protein) is inactive. In other tissues, where ADAM-12 expression is low, the repressor is active," Alpana Ray said. "What we don't know is how it actually works. We know co-factors are at work here. If we can identify the class of proteins that interact with Z-DNA repressor, it could lead to many therapeutic applications."
Because ADAM-12 is a versatile gene, it may play a role in metastasis during which cancer cells travel throughout the body and spread to other organs.
"We know that ADAM-12 causes cells to anchor to one another, and we know that ADAM-12 allows cancer cells to proliferate," said Alpana Ray.
Bimal Ray notes that the next phase of the work would be to determine how the Z-DNA-binding protein works.
"Most of the success in cancer therapy lies in a combination of approaches and chemotherapies, and this could become another piece of the puzzle that leads to the cure," Bimal Ray said.
Source:
Steven Adams
University of Missouri-Columbia
Alpana Ray, research associate professor in the MU College of Veterinary Medicine, and a team of researchers including Bimal Ray, professor of Veterinary Pathobiology, have been studying the ADAM family of genes for several years. Alpana Ray's latest publication in the Proceedings of the National Academy of Sciences (PNAS) discusses one pathway by which the ADAM-12 gene could be regulated, a process that could eventually be used as part of a treatment plan.
Scientists know that ADAM-12 is normally found in very low levels in adults, but during cancer, arthritis and cardiac hypertrophy, ADAM-12 level goes up. The only time it is normal to find a high level of the gene is during pregnancy, when ADAM-12 can be found in the placenta.
At the molecular level, Ray's team found a Z-DNA-binding silencer element that keeps the level of ADAM-12 low in normal conditions. They believe that if they could alter Z-DNA-binding silencer, new therapies could be right around the corner.
"We are finding that in the placenta, where ADAM-12 is highly expressed, the repressor protein (Z-DNA-binding protein) is inactive. In other tissues, where ADAM-12 expression is low, the repressor is active," Alpana Ray said. "What we don't know is how it actually works. We know co-factors are at work here. If we can identify the class of proteins that interact with Z-DNA repressor, it could lead to many therapeutic applications."
Because ADAM-12 is a versatile gene, it may play a role in metastasis during which cancer cells travel throughout the body and spread to other organs.
"We know that ADAM-12 causes cells to anchor to one another, and we know that ADAM-12 allows cancer cells to proliferate," said Alpana Ray.
Bimal Ray notes that the next phase of the work would be to determine how the Z-DNA-binding protein works.
"Most of the success in cancer therapy lies in a combination of approaches and chemotherapies, and this could become another piece of the puzzle that leads to the cure," Bimal Ray said.
Source:
Steven Adams
University of Missouri-Columbia
вторник, 10 мая 2011 г.
Impact of body weight on the progression of knee osteoarthritis
Benefits of weight loss may depend on alignment of affected leg, study suggests -
A painful and sometimes crippling disease characterized by progressive cartilage loss, osteoarthritis (OA) of the knee
affects an estimated 6 percent of adults over age 30.
AT present, no treatments are available that have been shown to impede the destructive course of this disease, apart from
knee replacement surgery. Numerous studies have shown that being overweight increases the risk of developing knee OA, whose
sufferers, on average, tend to be heavy. While doctors routinely advise patients to lose weight, researchers have yet to
affirm the benefits of weight loss to prevent ongoing joint deterioration.
To better understand the effect of body weight on the course of knee OA, researchers at Boston University focused on an
important predictor of disease progression: limb malalignment, defined by joint space loss at the point where the thigh and
shin bones connect to the knee. Featured in the December 2004 issue of Arthritis & Rheumatism (interscience.wiley/journal/arthritis), their findings suggest that the benefits of weight
loss for knee OA patients depend on the degree of alignment in the affected leg.
The researchers recruited their subjects from two studies on quality of life conducted by the Veterans Administration of the
Boston Health Care System. 228 individuals with knee OA were selected; all but one completed a 30-month period of follow-up.
41 percent were women and the mean age was 66 years. Among the subjects, the diagnosis of OA was confirmed by radiographs in
394 knees. At the first follow-up examination, each subject was assessed for degree of alignment in the affected leg, which
was then categorized as moderate, severe, or neutral. Malaligned limbs could be either varus (bowlegged) or valgus
(knock-kneed). The body mass index (BMI) of each subject was also computed.
Of the total 394 knees studied, 90 showed disease progression. Weight gain did have a significant impact. For each 2-unit
increase in BMI, researchers found an 8 percent increase in the risk of disease progression. However, this effect was limited
to knees in the moderately malaligned legs. In neutrally aligned legs on the one end of the spectrum and severely maligned
legs on the other, body weight had no measurable effect on the risk of OA progression. "The effect of BMI on progression was
different at different levels of alignment, with the risk being much greater for limbs with moderate malalignment," affirms
the study's author, David T. Felson, M.D.
Why would the impact of body weight on knee OA be restricted to legs where malalignment was moderate? Dr. Felson offers
possible reasons. In patients with severe malalignment, the extreme stress already placed on local cartilage may be the only
risk factor required for continued structural deterioration. In patients with neutrally aligned limbs, the increased joint
loading that accompanies increased body weight would be distributed across much of the joint surface, thus protecting against
further damage. Since moderate alignment increases the stress on cartilage, the addition of excess weight effectively works
to aggravate the cartilage damage. For these patients, losing weight might relieve the stress and considerably slow disease
progression.
"Our findings, which need to be confirmed in other studies, suggest that prevention and treatment efforts for obesity and
knee OA could be efficiently targeted to those subjects with moderate malalignment," Dr. Felson concludes. "These findings
may have broad implications not just for the effect of body weight on OA, but for other risk factors that affect joint
loading."
Article: "The Effect of Body Weight on Progression of Knee Osteoarthritis Is Dependent on Alignment," David T. Felson, Joyce
Goggins, Jingbo Niu, Yuquing Zhang, and David J. Hunter, Arthritis & Rheumatism, December 2004; 50:12; pp. 3904-3909.
John Wiley & Sons, Inc
A painful and sometimes crippling disease characterized by progressive cartilage loss, osteoarthritis (OA) of the knee
affects an estimated 6 percent of adults over age 30.
AT present, no treatments are available that have been shown to impede the destructive course of this disease, apart from
knee replacement surgery. Numerous studies have shown that being overweight increases the risk of developing knee OA, whose
sufferers, on average, tend to be heavy. While doctors routinely advise patients to lose weight, researchers have yet to
affirm the benefits of weight loss to prevent ongoing joint deterioration.
To better understand the effect of body weight on the course of knee OA, researchers at Boston University focused on an
important predictor of disease progression: limb malalignment, defined by joint space loss at the point where the thigh and
shin bones connect to the knee. Featured in the December 2004 issue of Arthritis & Rheumatism (interscience.wiley/journal/arthritis), their findings suggest that the benefits of weight
loss for knee OA patients depend on the degree of alignment in the affected leg.
The researchers recruited their subjects from two studies on quality of life conducted by the Veterans Administration of the
Boston Health Care System. 228 individuals with knee OA were selected; all but one completed a 30-month period of follow-up.
41 percent were women and the mean age was 66 years. Among the subjects, the diagnosis of OA was confirmed by radiographs in
394 knees. At the first follow-up examination, each subject was assessed for degree of alignment in the affected leg, which
was then categorized as moderate, severe, or neutral. Malaligned limbs could be either varus (bowlegged) or valgus
(knock-kneed). The body mass index (BMI) of each subject was also computed.
Of the total 394 knees studied, 90 showed disease progression. Weight gain did have a significant impact. For each 2-unit
increase in BMI, researchers found an 8 percent increase in the risk of disease progression. However, this effect was limited
to knees in the moderately malaligned legs. In neutrally aligned legs on the one end of the spectrum and severely maligned
legs on the other, body weight had no measurable effect on the risk of OA progression. "The effect of BMI on progression was
different at different levels of alignment, with the risk being much greater for limbs with moderate malalignment," affirms
the study's author, David T. Felson, M.D.
Why would the impact of body weight on knee OA be restricted to legs where malalignment was moderate? Dr. Felson offers
possible reasons. In patients with severe malalignment, the extreme stress already placed on local cartilage may be the only
risk factor required for continued structural deterioration. In patients with neutrally aligned limbs, the increased joint
loading that accompanies increased body weight would be distributed across much of the joint surface, thus protecting against
further damage. Since moderate alignment increases the stress on cartilage, the addition of excess weight effectively works
to aggravate the cartilage damage. For these patients, losing weight might relieve the stress and considerably slow disease
progression.
"Our findings, which need to be confirmed in other studies, suggest that prevention and treatment efforts for obesity and
knee OA could be efficiently targeted to those subjects with moderate malalignment," Dr. Felson concludes. "These findings
may have broad implications not just for the effect of body weight on OA, but for other risk factors that affect joint
loading."
Article: "The Effect of Body Weight on Progression of Knee Osteoarthritis Is Dependent on Alignment," David T. Felson, Joyce
Goggins, Jingbo Niu, Yuquing Zhang, and David J. Hunter, Arthritis & Rheumatism, December 2004; 50:12; pp. 3904-3909.
John Wiley & Sons, Inc
понедельник, 9 мая 2011 г.
Etanercept Helps Restore Normal Growth In Children With Juvenile Arthritis
Significant Increase in Height, Weight, and BMI Percentiles Achieved With and Without Methotrexate.
Researchers from the Cincinnati Children's Hospital Medical Center observed a statistically significant increase in mean height, weight, and body mass index (BMI) percentiles in patients with juvenile idiopathic arthritis (JIA) who were treated with etanercept or etanercept plus methotrexate (MTX). JIA patients treated with MTX alone did not display an increase in growth percentiles. Results of the 3-year study are available online and in the November issue of Arthritis & Rheumatism, a journal published by Wiley-Blackwell on behalf of the American College of Rheumatology.
Juvenile idiopathic arthritis (JIA), one of the most common rheumatic diseases in children, causes significant pain and functional disability. According to a 2008 study by the National Arthritis Data Workgroup, there are close to 300,000 children in the U.S. with some form of juvenile arthritis. Prior studies show that JIA patients may experience impaired physical growth and development dependent upon the severity of chronic inflammation, longer duration of disease, and greater functional joint involvement.
"A realistic treatment goal for JIA patients should include therapy aimed at reducing inflammation in an effort to minimize disease-related disability and growth impairment," said lead author of the study Edward Giannini, DrPH, MSc. Dr. Giannini and colleagues conducted a 3-year, nonrandomized multi-center registry of 594 patients with polyarticular (90%) or systemic JIA who were treated with etanercept only, etanercept plus MTX, or MTX only.
Participants between the ages of 2 and 18 who enrolled in the registry were treated with etanercept twice weekly at a dose of 0.4 mg/kg or once weekly at a dose of 0.8 mg/kg. The height, weight, and BMI for each patient were recorded at baseline, years 1, 2, and 3, and compared with the U.S. Centers for Disease Control and Prevention standardized growth charts to obtain the percentiles.
The authors reported that the mean height in the etanercept group significantly increased by 4.8 percentile points by year 3. For those in the etanercept plus MTX group, a significant increase in mean height in years 1, 2, and 3 was also recorded 2.4, 3.3, and 5.6 percentile points, respectively. Similar significant increases in weight percentiles at years 1, 2 and 3, respectively, were observed in the etanercept-only group (7.4, 10.0, and 13.0) and in the etanercept plus MTX group (2.9, 6.9, and 8.4). BMI percentiles also increased significantly over the 3-year period, ranging from 9.6 to 13.8 percentile points in the etanercept-only group and from 2.1 to 5.2 percentile points in the etanercept plus MTX group.
"Studies have shown that growth retardation is associated with systemic inflammation and is a potentially permanent complication of JIA," explained Dr. Giannini. "Restoring normal growth development is a relevant goal of anti-inflammatory treatment in JIA patients and our study showed significant increases in height, weight, and BMI percentiles for those treated with etanercept alone or in combination with MTX." Significant changes in growth measures were not observed for patients receiving only MTX treatment.
Sources: Wiley - Blackwell, AlphaGalileo Foundation.
Researchers from the Cincinnati Children's Hospital Medical Center observed a statistically significant increase in mean height, weight, and body mass index (BMI) percentiles in patients with juvenile idiopathic arthritis (JIA) who were treated with etanercept or etanercept plus methotrexate (MTX). JIA patients treated with MTX alone did not display an increase in growth percentiles. Results of the 3-year study are available online and in the November issue of Arthritis & Rheumatism, a journal published by Wiley-Blackwell on behalf of the American College of Rheumatology.
Juvenile idiopathic arthritis (JIA), one of the most common rheumatic diseases in children, causes significant pain and functional disability. According to a 2008 study by the National Arthritis Data Workgroup, there are close to 300,000 children in the U.S. with some form of juvenile arthritis. Prior studies show that JIA patients may experience impaired physical growth and development dependent upon the severity of chronic inflammation, longer duration of disease, and greater functional joint involvement.
"A realistic treatment goal for JIA patients should include therapy aimed at reducing inflammation in an effort to minimize disease-related disability and growth impairment," said lead author of the study Edward Giannini, DrPH, MSc. Dr. Giannini and colleagues conducted a 3-year, nonrandomized multi-center registry of 594 patients with polyarticular (90%) or systemic JIA who were treated with etanercept only, etanercept plus MTX, or MTX only.
Participants between the ages of 2 and 18 who enrolled in the registry were treated with etanercept twice weekly at a dose of 0.4 mg/kg or once weekly at a dose of 0.8 mg/kg. The height, weight, and BMI for each patient were recorded at baseline, years 1, 2, and 3, and compared with the U.S. Centers for Disease Control and Prevention standardized growth charts to obtain the percentiles.
The authors reported that the mean height in the etanercept group significantly increased by 4.8 percentile points by year 3. For those in the etanercept plus MTX group, a significant increase in mean height in years 1, 2, and 3 was also recorded 2.4, 3.3, and 5.6 percentile points, respectively. Similar significant increases in weight percentiles at years 1, 2 and 3, respectively, were observed in the etanercept-only group (7.4, 10.0, and 13.0) and in the etanercept plus MTX group (2.9, 6.9, and 8.4). BMI percentiles also increased significantly over the 3-year period, ranging from 9.6 to 13.8 percentile points in the etanercept-only group and from 2.1 to 5.2 percentile points in the etanercept plus MTX group.
"Studies have shown that growth retardation is associated with systemic inflammation and is a potentially permanent complication of JIA," explained Dr. Giannini. "Restoring normal growth development is a relevant goal of anti-inflammatory treatment in JIA patients and our study showed significant increases in height, weight, and BMI percentiles for those treated with etanercept alone or in combination with MTX." Significant changes in growth measures were not observed for patients receiving only MTX treatment.
Sources: Wiley - Blackwell, AlphaGalileo Foundation.
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