Northwestern University researchers are the first to design a bioactive nanomaterial that promotes the growth of new cartilage in vivo and without the use of expensive growth factors. Minimally invasive, the therapy activates the bone marrow stem cells and produces natural cartilage. No conventional therapy can do this.
The results will be published online the week of Feb. 1 by the Proceedings of the National Academy of Sciences (PNAS).
"Unlike bone, cartilage does not grow back, and therefore clinical strategies to regenerate this tissue are of great interest," said Samuel I. Stupp, senior author, Board of Trustees Professor of Chemistry, Materials Science and Engineering, and Medicine, and director of the Institute for BioNanotechnology in Medicine. Countless people - amateur athletes, professional athletes and people whose joints have just worn out -- learn this all too well when they bring their bad knees, shoulders and elbows to an orthopaedic surgeon.
Damaged cartilage can lead to joint pain and loss of physical function and eventually to osteoarthritis, a disorder with an estimated economic impact approaching $65 billion in the United States. With an aging and increasingly active population, this figure is expected to grow.
"Cartilage does not regenerate in adults. Once you are fully grown you have all the cartilage you'll ever have," said first author Ramille N. Shah, assistant professor of materials science and engineering at the McCormick School of Engineering and Applied Science and assistant professor of orthopaedic surgery at the Feinberg School of Medicine. Shah is also a resident faculty member at the Institute for BioNanotechnology in Medicine.
Type II collagen is the major protein in articular cartilage, the smooth, white connective tissue that covers the ends of bones where they come together to form joints.
"Our material of nanoscopic fibers stimulates stem cells present in bone marrow to produce cartilage containing type II collagen and repair the damaged joint," Shah said. "A procedure called microfracture is the most common technique currently used by doctors, but it tends to produce a cartilage having predominantly type I collagen which is more like scar tissue."
The Northwestern gel is injected as a liquid to the area of the damaged joint, where it then self-assembles and forms a solid. This extracellular matrix, which mimics what cells usually see, binds by molecular design one of the most important growth factors for the repair and regeneration of cartilage. By keeping the growth factor concentrated and localized, the cartilage cells have the opportunity to regenerate.
Together with Nirav A. Shah, a sports medicine orthopaedic surgeon and former orthopaedic resident at Northwestern, the researchers implanted their nanofiber gel in an animal model with cartilage defects.
The animals were treated with microfracture, where tiny holes are made in the bone beneath the damaged cartilage to create a new blood supply to stimulate the growth of new cartilage. The researchers tested various combinations: microfracture alone; microfracture and the nanofiber gel with growth factor added; and microfracture and the nanofiber gel without growth factor added.
They found their technique produced much better results than the microfracture procedure alone and, more importantly, found that addition of the expensive growth factor was not required to get the best results. Instead, because of the molecular design of the gel material, growth factor already present in the body is enough to regenerate cartilage.
The matrix only needed to be present for a month to produce cartilage growth. The matrix, based on self-assembling molecules known as peptide amphiphiles, biodegrades into nutrients and is replaced by natural cartilage.
The PNAS paper is titled "Supramolecular Design of Self-assembling Nanofibers for Cartilage Regeneration." In addition to Stupp, Ramille Shah and Nirav Shah, other authors of the paper are Marc M. Del Rosario Lim, Caleb Hsieh and Gordon Nuber, all from Northwestern.
The National Institutes of Health and the company Nanotope supported the research.
Source:
Wendy Leopold
Northwestern University
воскресенье, 19 июня 2011 г.
суббота, 18 июня 2011 г.
Arthritis Foundation Convenes Country's Top Researchers For Biennial Conference
More than 200 leading
researchers committed to discovering new technologies and therapies to
prevent and treat arthritis will meet April 20 - 23 in Atlanta, GA, for the
2007 Arthritis Research Conference, organized by the Arthritis Foundation.
Some of the most promising and innovative research to be presented at the
conference pertains to using stem cells to advance cartilage regeneration
for patients with osteoarthritis. Other exciting developments include new
approaches to manipulating a special type of white blood cell known as the
B lymphocyte in ways that can diminish inflammation in diseases such as
rheumatoid arthritis.
"As the nation's largest private, not-for-profit funder of arthritis
research, this conference is very exciting for all of us here at the
Arthritis Foundation," said John H. Klippel, M.D., president and CEO of the
Arthritis Foundation. "The three-day event is an opportunity for the best
and brightest minds in arthritis research to develop research
collaborations that will pave the way to a cure."
Scientists predict that recent revelations in the area of stem cell
research will lead to treatments that heal damaged cartilage and tissue,
thereby greatly reducing or eliminating the number of joint replacement
surgeries. Scientists hope introducing stem cells into areas where
cartilage and tissue are already damaged may initiate a process of
rebuilding healthy tissue and preventing further joint degradation. Many
are optimistic that treatments using stem cells to 'jump-start' tissue
regeneration will be available within the next decade.
One of the most significant advances in recent years has been the
development of biologics -- drugs which are based on substances produced by
living cells. This is an important and very successful example of a class
of biologic drugs that are now a common treatment for several types of
arthritis. The class of biologics known as TNF inhibitors, block the action
of one of the major mediators of inflammation in the body and have become
important treatments for diseases such as rheumatoid arthritis, psoriatic
arthritis, and juvenile arthritis. TNF release results in inflammation of
the joints in patients with the diseases noted above. Research sponsored by
the Foundation is leading to therapies that can halt the chemical cascade
that leads to TNF production at very early stages of these diseases. This
approach can prevent the appearance of arthritis before any tissue damage
can occur.
"Combining the best and brightest minds in arthritis research and
advanced technologies for studying the cause of disease at its most basic
levels is enabling great advances," said Dr. John H. Hardin, chief
scientific officer of the Arthritis Foundation.
The three-day conference begins at 10:00 a.m. Friday, April 20.
Researchers from across the country will share research, best practices and
theories that will propel the next generation of arthritis research. The
conference consists of three primary sessions:
-- Plenary Session: Translation in Arthritis Medicine
-- Basic Science Symposium: Signaling and Regulation in the Joint
-- Clinical Science Symposium: New Perspectives on Inflammatory Disease
About The Arthritis Foundation
The Arthritis Foundation is the leading health organization addressing
the needs of some 46 million Americans living with arthritis, the nation's
number- one cause of disability. Founded in 1948, with headquarters in
Atlanta, the Arthritis Foundation has chapters and 150 community service
points located throughout the country.
The Arthritis Foundation is the largest private, not-for-profit
contributor to arthritis research in the world, funding more than $380
million in research grants since 1948. The foundation helps individuals
take control of arthritis by providing public health education; pursuing
public policy and legislation; and conducting evidence-based programs to
improve the quality of life for those living with arthritis.
Arthritis Foundation
arthritis
researchers committed to discovering new technologies and therapies to
prevent and treat arthritis will meet April 20 - 23 in Atlanta, GA, for the
2007 Arthritis Research Conference, organized by the Arthritis Foundation.
Some of the most promising and innovative research to be presented at the
conference pertains to using stem cells to advance cartilage regeneration
for patients with osteoarthritis. Other exciting developments include new
approaches to manipulating a special type of white blood cell known as the
B lymphocyte in ways that can diminish inflammation in diseases such as
rheumatoid arthritis.
"As the nation's largest private, not-for-profit funder of arthritis
research, this conference is very exciting for all of us here at the
Arthritis Foundation," said John H. Klippel, M.D., president and CEO of the
Arthritis Foundation. "The three-day event is an opportunity for the best
and brightest minds in arthritis research to develop research
collaborations that will pave the way to a cure."
Scientists predict that recent revelations in the area of stem cell
research will lead to treatments that heal damaged cartilage and tissue,
thereby greatly reducing or eliminating the number of joint replacement
surgeries. Scientists hope introducing stem cells into areas where
cartilage and tissue are already damaged may initiate a process of
rebuilding healthy tissue and preventing further joint degradation. Many
are optimistic that treatments using stem cells to 'jump-start' tissue
regeneration will be available within the next decade.
One of the most significant advances in recent years has been the
development of biologics -- drugs which are based on substances produced by
living cells. This is an important and very successful example of a class
of biologic drugs that are now a common treatment for several types of
arthritis. The class of biologics known as TNF inhibitors, block the action
of one of the major mediators of inflammation in the body and have become
important treatments for diseases such as rheumatoid arthritis, psoriatic
arthritis, and juvenile arthritis. TNF release results in inflammation of
the joints in patients with the diseases noted above. Research sponsored by
the Foundation is leading to therapies that can halt the chemical cascade
that leads to TNF production at very early stages of these diseases. This
approach can prevent the appearance of arthritis before any tissue damage
can occur.
"Combining the best and brightest minds in arthritis research and
advanced technologies for studying the cause of disease at its most basic
levels is enabling great advances," said Dr. John H. Hardin, chief
scientific officer of the Arthritis Foundation.
The three-day conference begins at 10:00 a.m. Friday, April 20.
Researchers from across the country will share research, best practices and
theories that will propel the next generation of arthritis research. The
conference consists of three primary sessions:
-- Plenary Session: Translation in Arthritis Medicine
-- Basic Science Symposium: Signaling and Regulation in the Joint
-- Clinical Science Symposium: New Perspectives on Inflammatory Disease
About The Arthritis Foundation
The Arthritis Foundation is the leading health organization addressing
the needs of some 46 million Americans living with arthritis, the nation's
number- one cause of disability. Founded in 1948, with headquarters in
Atlanta, the Arthritis Foundation has chapters and 150 community service
points located throughout the country.
The Arthritis Foundation is the largest private, not-for-profit
contributor to arthritis research in the world, funding more than $380
million in research grants since 1948. The foundation helps individuals
take control of arthritis by providing public health education; pursuing
public policy and legislation; and conducting evidence-based programs to
improve the quality of life for those living with arthritis.
Arthritis Foundation
arthritis
пятница, 17 июня 2011 г.
Centocor, Inc. Submits Application To FDA Requesting Approval Of Golimumab For The Treatment Of Rheumatoid Arthritis
Centocor, Inc. announced
that a Biologics License Application (BLA) has been submitted to the U.S.
Food and Drug Administration (FDA) requesting the approval of golimumab
(CNTO 148) as a monthly subcutaneous treatment for adults with active forms
of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Golimumab, Centocor's next-generation human anti-TNF-alpha monoclonal
antibody, is being studied as an every four week subcutaneous injection and
is also being studied as an intravenous (IV) infusion therapy. In February
2008, Centocor submitted a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMEA) requesting the approval of golimumab as a
monthly subcutaneous treatment for the same indications.
"This submission marks a major milestone in the clinical development
program of golimumab, and we look forward to working with the FDA to bring
golimumab to market," said Jerome A. Boscia, M.D., senior vice president,
Clinical R&D, Centocor, Inc. "We remain focused on our commitment to
innovation in the field of biomedicines, to addressing the ongoing needs of
patients living with these debilitating diseases and to physicians in need
of additional therapeutic options to effectively treat their patients."
Five pivotal Phase 3 trials support the BLA, which include the
GOlimumab Before Employing methotrexate as the First-line Option in the
treatment of Rheumatoid arthritis of Early onset (GO-BEFORE) study; the
GOlimumab FOR subjects With Active RA Despite MTX (GO-FORWARD) study; and A
Multicenter, Randomized, Double-blind, Placebo-controlled Trial of
Golimumab, a Human Anti-TNF-alpha Monoclonal Antibody, Administered
Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously
Treated with Biologic Anti-TNF-alpha Agent(s) (GO-AFTER) study were
recently presented at the European League Against Rheumatism Annual
Congress. In November 2007, primary endpoint study findings from the
Golimumab - A Randomized Evaluation of Safety and Efficacy in Subjects with
Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody (GO-REVEAL)
trial and the Golimumab - A Randomized Study in Ankylosing Spondylitis
Subjects of a Novel Anti-TNF mAB Injection (SC) Given Every Four Weeks
(GO-RAISE) trial were reported at the American College of Rheumatology
Annual Scientific Meeting.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic and debilitating disease that
affects approximately 1.3 million people in the United States and more than
three million people in Europe. Signs and symptoms of RA include pain,
stiffness and motion restriction in multiple joints. Because RA is a
progressive disease, it can cause permanent joint deformity and severe
disability if not diagnosed early or if initial treatment is delayed. RA
can occur at any age, but is most common in adults 30-50 years old and is
two-to-three times more prevalent in women than in men. The cause of RA is
unknown, although genetic factors may contribute to the disease.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic inflammatory arthropathy manifesting
with joint pain and swelling that can lead to joint destruction and
debilitation. It is frequently associated with inflamed, scaly, red patches
of skin psoriasis and psoriasis nail involvement. Symptoms may include
stiffness and tenderness of the joints and surrounding tissue and reduced
range of motion. Joints of the hands, wrists, knees, ankles, feet, lower
back and neck are commonly affected. Psoriasis affects an estimated two to
three percent of the world's population, and approximately one out of three
patients affected by psoriasis may develop psoriatic arthritis. Both men
and women are equally affected by psoriatic arthritis, most commonly
between the ages 30 and 50, in the peak of their productive years.
About Ankylosing Spondylitis
Ankylosing spondylitis (AS) is a painful and progressive form of spinal
arthritis and symptoms of inflammatory back pain often first present in
people before age 35. It typically begins in the late teens and early
twenties and in severe cases may result in fusing spinal vertebrae and may
cause structural damage to hips and other joints. Often misdiagnosed as
"just back pain" or undifferentiated arthritis, AS is a systemic
inflammatory disease that, in addition to its effect on the spine, can
affect internal organs, peripheral joints and vision. The Arthritis
Research Campaign estimates that on the European continent, AS prevalence
ranges from 0.2 to 1 percent of the entire population. The Spondylitis
Association of America estimates that between 350,000 and one million
people in the U.S. suffer from ankylosing spondylitis.
About Golimumab
Golimumab, Centocor, Inc.'s next-generation human anti-tumor necrosis
factor (TNF)-alpha monoclonal antibody, is currently in the most
comprehensive Phase 3 development program to date for an anti-TNF-alpha
biologic therapy. With ongoing studies for the treatment of rheumatoid
arthritis, psoriatic arthritis and ankylosing spondylitis, golimumab is
being studied as an every four week subcutaneous injection and an
intravenous (IV) infusion therapy. Golimumab targets and neutralizes both
the soluble and membrane-bound forms of TNF-alpha.
Centocor discovered golimumab and has exclusive marketing rights to the
product in the United States. Pending regulatory approval, Schering-Plough
will assume exclusive marketing rights outside the United States except in
Japan, Indonesia and Taiwan where golimumab will be co-marketed by
Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki
Kaisha; Hong Kong, where golimumab will be exclusively marketed by
Janssen-Cilag; and China where golimumab will be exclusively marketed by
Xian-Janssen.
About Centocor, Inc.
Centocor is harnessing the power of world-leading research and
biomanufacturing to deliver innovative biomedicines that transform
patients' lives. Centocor has already brought innovation to the treatment
of adult and pediatric Crohn's disease, rheumatoid arthritis, ankylosing
spondylitis, psoriatic arthritis, ulcerative colitis and psoriasis.
The world leader in monoclonal antibody production and technology,
Centocor has brought critical biologic therapies to patients suffering from
debilitating immune disorders. Centocor is a wholly-owned subsidiary of
Johnson & Johnson.
CENTOCOR DISCLOSURE NOTICE: This press release contains
"forward-looking statements" as defined in the Private Securities
Litigation Reform Act of 1995. These statements are based on current
expectations of future events. If underlying assumptions prove inaccurate
or unknown risks or uncertainties materialize, actual results could vary
materially from Centocor's expectations and projections. Risks and
uncertainties include general industry conditions and competition; economic
conditions, such as interest rate and currency exchange rate fluctuations;
technological advances and patents attained by competitors; challenges
inherent in new product development, including obtaining regulatory
approvals; domestic and foreign health care reforms and governmental laws
and regulations; and trends toward health care cost containment. A further
list and description of these risks, uncertainties and other factors can be
found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for
the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well
as subsequent filings, are available online at sec, jnj or
on request from Johnson & Johnson. Centocor does not undertake to update
any forward-looking statements as a result of new information or future
events or developments.
Centocor, Inc.
jnj
that a Biologics License Application (BLA) has been submitted to the U.S.
Food and Drug Administration (FDA) requesting the approval of golimumab
(CNTO 148) as a monthly subcutaneous treatment for adults with active forms
of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Golimumab, Centocor's next-generation human anti-TNF-alpha monoclonal
antibody, is being studied as an every four week subcutaneous injection and
is also being studied as an intravenous (IV) infusion therapy. In February
2008, Centocor submitted a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMEA) requesting the approval of golimumab as a
monthly subcutaneous treatment for the same indications.
"This submission marks a major milestone in the clinical development
program of golimumab, and we look forward to working with the FDA to bring
golimumab to market," said Jerome A. Boscia, M.D., senior vice president,
Clinical R&D, Centocor, Inc. "We remain focused on our commitment to
innovation in the field of biomedicines, to addressing the ongoing needs of
patients living with these debilitating diseases and to physicians in need
of additional therapeutic options to effectively treat their patients."
Five pivotal Phase 3 trials support the BLA, which include the
GOlimumab Before Employing methotrexate as the First-line Option in the
treatment of Rheumatoid arthritis of Early onset (GO-BEFORE) study; the
GOlimumab FOR subjects With Active RA Despite MTX (GO-FORWARD) study; and A
Multicenter, Randomized, Double-blind, Placebo-controlled Trial of
Golimumab, a Human Anti-TNF-alpha Monoclonal Antibody, Administered
Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously
Treated with Biologic Anti-TNF-alpha Agent(s) (GO-AFTER) study were
recently presented at the European League Against Rheumatism Annual
Congress. In November 2007, primary endpoint study findings from the
Golimumab - A Randomized Evaluation of Safety and Efficacy in Subjects with
Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody (GO-REVEAL)
trial and the Golimumab - A Randomized Study in Ankylosing Spondylitis
Subjects of a Novel Anti-TNF mAB Injection (SC) Given Every Four Weeks
(GO-RAISE) trial were reported at the American College of Rheumatology
Annual Scientific Meeting.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic and debilitating disease that
affects approximately 1.3 million people in the United States and more than
three million people in Europe. Signs and symptoms of RA include pain,
stiffness and motion restriction in multiple joints. Because RA is a
progressive disease, it can cause permanent joint deformity and severe
disability if not diagnosed early or if initial treatment is delayed. RA
can occur at any age, but is most common in adults 30-50 years old and is
two-to-three times more prevalent in women than in men. The cause of RA is
unknown, although genetic factors may contribute to the disease.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic inflammatory arthropathy manifesting
with joint pain and swelling that can lead to joint destruction and
debilitation. It is frequently associated with inflamed, scaly, red patches
of skin psoriasis and psoriasis nail involvement. Symptoms may include
stiffness and tenderness of the joints and surrounding tissue and reduced
range of motion. Joints of the hands, wrists, knees, ankles, feet, lower
back and neck are commonly affected. Psoriasis affects an estimated two to
three percent of the world's population, and approximately one out of three
patients affected by psoriasis may develop psoriatic arthritis. Both men
and women are equally affected by psoriatic arthritis, most commonly
between the ages 30 and 50, in the peak of their productive years.
About Ankylosing Spondylitis
Ankylosing spondylitis (AS) is a painful and progressive form of spinal
arthritis and symptoms of inflammatory back pain often first present in
people before age 35. It typically begins in the late teens and early
twenties and in severe cases may result in fusing spinal vertebrae and may
cause structural damage to hips and other joints. Often misdiagnosed as
"just back pain" or undifferentiated arthritis, AS is a systemic
inflammatory disease that, in addition to its effect on the spine, can
affect internal organs, peripheral joints and vision. The Arthritis
Research Campaign estimates that on the European continent, AS prevalence
ranges from 0.2 to 1 percent of the entire population. The Spondylitis
Association of America estimates that between 350,000 and one million
people in the U.S. suffer from ankylosing spondylitis.
About Golimumab
Golimumab, Centocor, Inc.'s next-generation human anti-tumor necrosis
factor (TNF)-alpha monoclonal antibody, is currently in the most
comprehensive Phase 3 development program to date for an anti-TNF-alpha
biologic therapy. With ongoing studies for the treatment of rheumatoid
arthritis, psoriatic arthritis and ankylosing spondylitis, golimumab is
being studied as an every four week subcutaneous injection and an
intravenous (IV) infusion therapy. Golimumab targets and neutralizes both
the soluble and membrane-bound forms of TNF-alpha.
Centocor discovered golimumab and has exclusive marketing rights to the
product in the United States. Pending regulatory approval, Schering-Plough
will assume exclusive marketing rights outside the United States except in
Japan, Indonesia and Taiwan where golimumab will be co-marketed by
Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki
Kaisha; Hong Kong, where golimumab will be exclusively marketed by
Janssen-Cilag; and China where golimumab will be exclusively marketed by
Xian-Janssen.
About Centocor, Inc.
Centocor is harnessing the power of world-leading research and
biomanufacturing to deliver innovative biomedicines that transform
patients' lives. Centocor has already brought innovation to the treatment
of adult and pediatric Crohn's disease, rheumatoid arthritis, ankylosing
spondylitis, psoriatic arthritis, ulcerative colitis and psoriasis.
The world leader in monoclonal antibody production and technology,
Centocor has brought critical biologic therapies to patients suffering from
debilitating immune disorders. Centocor is a wholly-owned subsidiary of
Johnson & Johnson.
CENTOCOR DISCLOSURE NOTICE: This press release contains
"forward-looking statements" as defined in the Private Securities
Litigation Reform Act of 1995. These statements are based on current
expectations of future events. If underlying assumptions prove inaccurate
or unknown risks or uncertainties materialize, actual results could vary
materially from Centocor's expectations and projections. Risks and
uncertainties include general industry conditions and competition; economic
conditions, such as interest rate and currency exchange rate fluctuations;
technological advances and patents attained by competitors; challenges
inherent in new product development, including obtaining regulatory
approvals; domestic and foreign health care reforms and governmental laws
and regulations; and trends toward health care cost containment. A further
list and description of these risks, uncertainties and other factors can be
found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for
the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well
as subsequent filings, are available online at sec, jnj or
on request from Johnson & Johnson. Centocor does not undertake to update
any forward-looking statements as a result of new information or future
events or developments.
Centocor, Inc.
jnj
четверг, 16 июня 2011 г.
RCGP Comment On MHRA Announcemnet Re: NSAIDs And Coxibs
RCGP comment on the announcement made by the Medicines and Healthcare Products Regulatory Agency (MHRA) on the safety of selective and non-selective NSAIDs.
"The Royal College of General Practitioners (RCGP) would like to reassure patients who are on a small dose of non-selective NSAIDs and coxibs for a short period of time that this study indicates little risk. For patients on a high dosage for a long period of time, there is a small increase in risk but they should discuss this or any other concerns with their GP at their next routine appointment or with their pharmacist. GPs will work with patients to select a drug and a dosage that is right for them based on this latest information and on the patient's clinical history.
"The RCGP would like to reiterate its longstanding advice to restrain the use of NSAIDs and coxibs for definite clinical indications to the lowest possible dose and for the shortest period of time. If long term treatment is needed, then that need must be reviewed periodically."
Professor Mayur Lakhani, RCGP Chairman
For further information please go to:
Royal College of General Practitioners
"The Royal College of General Practitioners (RCGP) would like to reassure patients who are on a small dose of non-selective NSAIDs and coxibs for a short period of time that this study indicates little risk. For patients on a high dosage for a long period of time, there is a small increase in risk but they should discuss this or any other concerns with their GP at their next routine appointment or with their pharmacist. GPs will work with patients to select a drug and a dosage that is right for them based on this latest information and on the patient's clinical history.
"The RCGP would like to reiterate its longstanding advice to restrain the use of NSAIDs and coxibs for definite clinical indications to the lowest possible dose and for the shortest period of time. If long term treatment is needed, then that need must be reviewed periodically."
Professor Mayur Lakhani, RCGP Chairman
For further information please go to:
Royal College of General Practitioners
среда, 15 июня 2011 г.
FDA Expands REMICADE(R) Psoriatic Arthritis Indication: Anti-TNF Shown To Inhibit Joint Damage And Improve Physical Function
Centocor, Inc. announced today
that the U.S. Food and Drug Administration (FDA) has extended its approval
for REMICADE(R) (infliximab) for inhibiting progression of structural
damage and improving physical function in patients with psoriatic
arthritis, in addition to reducing signs and symptoms of active arthritis.
The approval is based on one-year data from the double-blind,
placebo-controlled trial IMPACT 2 and two-year data from the double-blind,
placebo-controlled trial IMPACT. Findings from IMPACT 2 showed that at week
24, REMICADE-treated patients had less structural damage as assessed
radiographically compared with patients receiving placebo (mean change
-0.70 vs. 0.82, P < 0.001), and REMICADE- treated patients were more than
twice as likely to achieve a clinically meaningful improvement in physical
function compared with patients receiving placebo (54 percent vs. 22
percent, respectively).
An immune-mediated inflammatory disease, psoriatic arthritis affects
approximately one million men and women in the U.S.(i) and is often
characterized by symptoms of joint inflammation and skin lesions. First
approved in 1998 for Crohn's disease, REMICADE has been used to treat over
770,000 patients worldwide living with gastroenterologic, rheumatologic and
dermatologic inflammatory diseases.
"The study findings supporting this approval show that treatment with
infliximab can slow the progression in joint destruction often associated
with this disease," said Arthur Kavanaugh, MD, Professor of Medicine at the
University of California at San Diego and lead study investigator. "A
significant proportion of infliximab-treated patients showed improvement in
physical function in addition to improvement in both joint and skin
symptoms, an important treatment outcome in a potentially debilitating
inflammatory disease like psoriatic arthritis."
One-year radiographic analyses from IMPACT 2 showed that treatment with
REMICADE resulted in significant inhibition of the progression of
structural damage, compared with placebo (as measured by the change from
baseline in van der Heijde-Sharp [vdH-S] score modified for psoriatic
arthritis by adding measurement for distal interphalangeal joints of the
hands). In this method, a higher change in score indicates greater
progression of structural damage, while lower change in score indicates
less progression of structural damage. At 24 weeks of treatment,
REMICADE-treated patients experienced a mean change (+/- standard
deviation) in vdH-S score of -0.70 (+/- 2.53) from baseline, compared with
an average change of 0.82 (+/- 2.62) in the placebo group (P < 0.001). At
week 54, patients who received a full 54-week regimen of REMICADE
experienced a mean change of -0.94 (+/- 3.40) from baseline, compared with
an average change of 0.53 (+/- 2.60) in patients who crossed over from
placebo to REMICADE (P = 0.001) at week 16 or 24.
In terms of the skin component of the disease, 50 percent of REMICADE-
treated patients in IMPACT 2 maintained at least 75 percent improvement
from baseline, as assessed by Psoriasis Area Severity Index (PASI 75), in
psoriasis at one year, and 64 percent of REMICADE-treated patients in
IMPACT maintained PASI 75 through two years. Moreover, 42 percent of
REMICADE-treated patients in IMPACT 2 achieved PASI 90, or near total skin
clearance, at one year, and 48 percent in IMPACT achieved PASI 90 through
two years.
REMICADE-treated patients demonstrated significant improvement in
physical function as measured by the Health Assessment
Questionnaire-Disability Index (HAQ-DI). The HAQ-DI assesses the difficulty
a patient has accomplishing tasks in eight functional areas (dressing,
arising, eating, walking, hygiene, reaching, gripping and other activities
of daily living). By week 14 of the IMPACT 2 trial, patients in the
REMICADE group experienced a median improvement of 43 percent, compared
with zero percent in the placebo group (P < 0.001), and results were
maintained through one year. At week 54 of IMPACT 2, there was a median 50
percent improvement in HAQ-DI score from baseline in the group randomized
to REMICADE, and a 46 percent improvement in placebo patients who switched
to REMICADE. At week 16 of the IMPACT trial, REMICADE- treated patients
demonstrated a median improvement in HAQ-DI score of 50 percent versus two
percent in the placebo group (P < 0.01); these responses were generally
sustained through two years.
In May 2005, REMICADE was approved in the United States for reducing
signs and symptoms of active arthritis in patients with psoriatic
arthritis. In September 2004, REMICADE received European Union (EU)
approval, in combination with methotrexate, for the treatment of active and
progressive psoriatic arthritis in patients who have responded inadequately
to disease-modifying anti-rheumatic drugs (DMARDs). Additionally, in July
2006, the European Commission approved the use of REMICADE for the
treatment of active and progressive psoriatic arthritis in patients who
have responded inadequately to DMARDs to be used in combination with
methotrexate or alone in patients who show intolerance to methotrexate or
in whom methotrexate is contraindicated.
About IMPACT/IMPACT 2
The Infliximab Multinational Psoriatic Arthritis Controlled Trial
(IMPACT) was a Phase 2b randomized, double-blind, placebo-controlled study
that involved 104 patients with active psoriatic arthritis (defined as
affecting at least five joints) who failed at least one DMARD. Patients
received either REMICADE (5 mg/kg) or placebo, administered at weeks 0, 2,
6 and 14. The REMICADE group continued on maintenance treatments every
eight weeks through week 94. Beginning at week 16, patients randomized to
the placebo group received an induction regimen of REMICADE followed by
maintenance treatment every eight weeks through week 94. Hands and feet
radiographs were taken at screening and at weeks 50 and 98. Physical
function was measured at multiple visits including screening and at weeks
16, 22, 50 and 94.
REMICADE was generally well tolerated in this study, with one REMICADE
and one placebo patient experiencing serious adverse events (AEs) in the
placebo- controlled portion of the study through week 16. Fourteen patients
out of 104 experienced serious AEs from week 16 through 50 in
placebo/REMICADE crossover and REMICADE groups together. In the second year
of IMPACT, seven patients out of 78 treated with REMICADE were reported
with serious AEs. No deaths, cases of tuberculosis or other opportunistic
infections were reported and serious infections were uncommon. There were
no serious infusion reactions. One patient had a serious AE relating to
malignancy: a ductal adenocarcinoma of the pancreas three months after week
98. See "Important Safety Information" below.
The Induction and Maintenance of Psoriatic Arthritis Clinical Trial 2
(IMPACT 2) was a Phase 3, randomized, double-blind, placebo-controlled
study of 200 patients with active psoriatic arthritis (defined as affecting
at least five joints). The study evaluated the safety and efficacy of
REMICADE in patients who had an inadequate response to DMARDs or
nonsteroidal anti- inflammatory drugs (NSAIDs). Patients received REMICADE
(5 mg/kg) at weeks 0, 2, 6 and every 8 weeks until week 46 or placebo at
weeks 0, 2, 6, 14 and 22. Placebo patients with less than 10 percent
improvement in both swollen and tender joints at week 16 entered early
escape and received REMICADE at weeks 16, 18 and 22 (n=47). At week 24,
placebo patients who did not qualify for early escape received REMICADE at
weeks 24, 26, 30, 38 and 46. Patients randomized to REMICADE who had less
than 20 percent improvement in combined swollen and tender joint count at
week 38 received REMICADE 10 mg/kg at weeks 38 and 46 (n=15). Patients were
allowed concomitant methotrexate use at a stable dose. Hand and foot
radiographs were taken at weeks 0, 24 and 54. Physical function was
measured at multiple visits including weeks 0, 14, 24 and 54.
Through 54 weeks, 12 percent of patients in combined REMICADE treatment
groups experienced serious AEs (during average follow-up of 42.8 weeks) as
compared to 6 percent of placebo patients (average follow-up 20.2 weeks).
No deaths, cases of tuberculosis or other opportunistic infections or
serious infusion reactions were reported; serious infections were uncommon.
Two patients reported an AE of malignancy: one case of basal cell carcinoma
in the placebo group and one case of stage I Hodgkin lymphoma in the
REMICADE group. The only laboratory abnormalities that occurred more
frequently with REMICADE compared with placebo were asymptomatic liver
enzyme test elevations. See "Important Safety Information" below.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic inflammatory arthropathy manifesting
with joint pain and swelling that can lead to joint destruction and
debilitation. It is frequently associated with inflamed, scaly, red patches
of skin psoriasis. Symptoms may include stiffness and tenderness of the
joints and surrounding tissue, reduced range of motion, nail changes and
redness and pain of the eye (uveitis). Joints of the hands, wrists, knees,
ankles, feet, lower back and neck are commonly affected. Psoriasis affects
an estimated two to three percent of the world's population, and
approximately one out of three patients affected by psoriasis may develop
psoriatic arthritis. Both men and women are equally affected by psoriatic
arthritis, most commonly between the ages of 30 and 50, in the peak of
their productive years.
About REMICADE
REMICADE is the global market leader among anti-tumor necrosis factor
alpha (TNF-alpha) therapies and has demonstrated broad clinical utility in
Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis
(AS), psoriatic arthritis (PsA), ulcerative colitis (UC), and pediatric
Crohn's disease (PCD). The safety and efficacy of REMICADE have been well
established in clinical trials over the past 14 years and with more than
770,000 patients treated worldwide through commercial experience.
In the U.S., REMICADE, in combination with methotrexate, is indicated
for reducing signs and symptoms, inhibiting the progression of structural
damage and improving physical function in patients with moderately to
severely active RA. REMICADE is the only biologic indicated for reducing
signs and symptoms and inducing and maintaining clinical remission in adult
and pediatric patients with moderately to severely active CD who have had
an inadequate response to conventional therapy. REMICADE is also indicated
for reducing the number of draining enterocutaneous and rectovaginal
fistulas and maintaining fistula closure in patients with fistulizing CD.
In December 2004, REMICADE was approved for reducing signs and symptoms in
patients with active AS. In May 2005, REMICADE was approved for reducing
signs and symptoms of active arthritis in patients with PsA. Additionally,
in September 2005, REMICADE was approved for reducing signs and symptoms,
achieving clinical remission and mucosal healing, and eliminating
corticosteroid use in patients with moderately to severely active UC who
have had an inadequate response to conventional therapy. This approval
makes REMICADE the first and only biologic approved for the treatment of
moderate to severe UC. In addition, on May 19, 2006, REMICADE was approved
for reducing signs and symptoms and inducing and maintaining clinical
remission in pediatric patients with moderately to severely active Crohn's
disease who have had an inadequate response to conventional therapy. This
approval establishes REMICADE as the first and only biologic therapy
approved for the treatment of PCD.
REMICADE is unique among available anti-TNF biologic therapies. Unlike
self-administered therapies that require patients to inject themselves
frequently, REMICADE is the only anti-TNF biologic administered directly by
caregivers in the clinic or office setting. In RA (3 mg/kg), CD (5 mg/kg),
PsA (5 mg/kg), UC (5 mg/kg), and PCD (5 mg/kg) REMICADE is a two-hour
infusion administered every 8 weeks, following a standard induction regimen
that requires treatment at weeks 0, 2 and 6. As a result, REMICADE patients
may require as few as six treatments each year. In AS (5 mg/kg), REMICADE
is a two-hour infusion administered every 6 weeks, following a standard
induction regimen that requires treatment at weeks 0, 2 and 6.
Important Safety Information
Many people with heart failure should not take REMICADE; so prior to
treatment you should discuss any heart condition with your doctor. Tell
your doctor right away if you develop new or worsening symptoms of heart
failure (such as shortness of breath or swelling of your ankles or feet).
There are reports of serious infections, including tuberculosis (TB),
sepsis and pneumonia. Some of these infections have been fatal. Tell your
doctor if you have had recent or past exposure to people with TB. Your
doctor will evaluate you for TB and perform a skin test. If you have latent
(inactive) TB, your doctor should begin TB treatment before you start
REMICADE. REMICADE can lower your ability to fight infections, so if you
are prone to or have a history of infections, or develop any signs of an
infection such as fever, fatigue, cough, or the flu while taking REMICADE,
tell your doctor right away. Also tell your doctor if you have lived in a
region where histoplasmosis or coccidioidomycosis is common.
Reports of a type of blood cancer called lymphoma in patients on
REMICADE or other TNF blockers are rare but occur more often than expected
for people in general. People who have been treated for rheumatoid
arthritis, Crohn's disease, ankylosing spondylitis, or psoriatic arthritis
for a long time, particularly those with highly active disease may be more
prone to develop lymphoma. Cancers, other than lymphoma, have also been
reported. Children and young adults who have been treated for Crohn's
disease with REMICADE have developed a rare type of lymphoma that often
results in death. These patients also were receiving drugs known as
azathioprine or 6-mercaptopurine. If you take REMICADE or other TNF
blockers, your risk for developing lymphoma or other cancers may increase.
You should also tell your doctor if you have had or develop lymphoma or
other cancers or if you have a lung disease called chronic obstructive
pulmonary disease (COPD). Reactivation of hepatitis B virus has been
reported in patients who are carriers of this virus and are taking TNF
blockers, such as REMICADE. Some of these cases have been fatal. Tell your
doctor if you know or think you may be a carrier of hepatitis B virus.
There have been rare cases of serious liver injury in people taking
REMICADE, some fatal. Contact your doctor immediately if you develop
symptoms such as jaundice (yellow skin and eyes), dark brown urine,
right-sided abdominal pain, fever, or severe fatigue.
Blood disorders have been reported, some fatal. Tell your doctor if you
develop possible signs of blood disorders such as persistent fever,
bruising, bleeding, or paleness while taking REMICADE. Nervous system
disorders have also been reported. Tell your doctor if you have or have had
a disease that affects the nervous system, or if you experience any
numbness, weakness, tingling, or visual disturbances while taking REMICADE.
Serious infusion reactions have been reported with REMICADE, including
hives, difficulty breathing, and low blood pressure. Reactions have
occurred during or after infusions. In clinical studies, some people
experienced the following common side effects: respiratory infections (that
may include sinus infections and sore throat), coughing, and stomach pain
or mild reactions to infusion such as rash or itchy skin.
Please read important information about REMICADE, including full U.S.
prescribing information, at remicade.
About Centocor
Centocor is harnessing the power of world-leading research and
biomanufacturing to deliver innovative biomedicines that transform
patients' lives. Centocor has already brought innovation to the treatment
of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic
arthritis, ulcerative colitis and pediatric Crohn's disease.
The world leader in monoclonal antibody production and technology,
Centocor has brought critical biologic therapies to patients suffering from
debilitating immune disorders. Centocor, Inc. is a wholly owned subsidiary
of Johnson & Johnson.
(i) National Institute of Arthritis and Musculoskeletal and Skin
Disorders. Questions and Answers About Psoriasis. U.S. Department of Health
and Human Services, National Institutes of Health; 2003. NIH Publication
No. 03-5040.
Centocor, Inc.
remicade
View drug information on Remicade.
that the U.S. Food and Drug Administration (FDA) has extended its approval
for REMICADE(R) (infliximab) for inhibiting progression of structural
damage and improving physical function in patients with psoriatic
arthritis, in addition to reducing signs and symptoms of active arthritis.
The approval is based on one-year data from the double-blind,
placebo-controlled trial IMPACT 2 and two-year data from the double-blind,
placebo-controlled trial IMPACT. Findings from IMPACT 2 showed that at week
24, REMICADE-treated patients had less structural damage as assessed
radiographically compared with patients receiving placebo (mean change
-0.70 vs. 0.82, P < 0.001), and REMICADE- treated patients were more than
twice as likely to achieve a clinically meaningful improvement in physical
function compared with patients receiving placebo (54 percent vs. 22
percent, respectively).
An immune-mediated inflammatory disease, psoriatic arthritis affects
approximately one million men and women in the U.S.(i) and is often
characterized by symptoms of joint inflammation and skin lesions. First
approved in 1998 for Crohn's disease, REMICADE has been used to treat over
770,000 patients worldwide living with gastroenterologic, rheumatologic and
dermatologic inflammatory diseases.
"The study findings supporting this approval show that treatment with
infliximab can slow the progression in joint destruction often associated
with this disease," said Arthur Kavanaugh, MD, Professor of Medicine at the
University of California at San Diego and lead study investigator. "A
significant proportion of infliximab-treated patients showed improvement in
physical function in addition to improvement in both joint and skin
symptoms, an important treatment outcome in a potentially debilitating
inflammatory disease like psoriatic arthritis."
One-year radiographic analyses from IMPACT 2 showed that treatment with
REMICADE resulted in significant inhibition of the progression of
structural damage, compared with placebo (as measured by the change from
baseline in van der Heijde-Sharp [vdH-S] score modified for psoriatic
arthritis by adding measurement for distal interphalangeal joints of the
hands). In this method, a higher change in score indicates greater
progression of structural damage, while lower change in score indicates
less progression of structural damage. At 24 weeks of treatment,
REMICADE-treated patients experienced a mean change (+/- standard
deviation) in vdH-S score of -0.70 (+/- 2.53) from baseline, compared with
an average change of 0.82 (+/- 2.62) in the placebo group (P < 0.001). At
week 54, patients who received a full 54-week regimen of REMICADE
experienced a mean change of -0.94 (+/- 3.40) from baseline, compared with
an average change of 0.53 (+/- 2.60) in patients who crossed over from
placebo to REMICADE (P = 0.001) at week 16 or 24.
In terms of the skin component of the disease, 50 percent of REMICADE-
treated patients in IMPACT 2 maintained at least 75 percent improvement
from baseline, as assessed by Psoriasis Area Severity Index (PASI 75), in
psoriasis at one year, and 64 percent of REMICADE-treated patients in
IMPACT maintained PASI 75 through two years. Moreover, 42 percent of
REMICADE-treated patients in IMPACT 2 achieved PASI 90, or near total skin
clearance, at one year, and 48 percent in IMPACT achieved PASI 90 through
two years.
REMICADE-treated patients demonstrated significant improvement in
physical function as measured by the Health Assessment
Questionnaire-Disability Index (HAQ-DI). The HAQ-DI assesses the difficulty
a patient has accomplishing tasks in eight functional areas (dressing,
arising, eating, walking, hygiene, reaching, gripping and other activities
of daily living). By week 14 of the IMPACT 2 trial, patients in the
REMICADE group experienced a median improvement of 43 percent, compared
with zero percent in the placebo group (P < 0.001), and results were
maintained through one year. At week 54 of IMPACT 2, there was a median 50
percent improvement in HAQ-DI score from baseline in the group randomized
to REMICADE, and a 46 percent improvement in placebo patients who switched
to REMICADE. At week 16 of the IMPACT trial, REMICADE- treated patients
demonstrated a median improvement in HAQ-DI score of 50 percent versus two
percent in the placebo group (P < 0.01); these responses were generally
sustained through two years.
In May 2005, REMICADE was approved in the United States for reducing
signs and symptoms of active arthritis in patients with psoriatic
arthritis. In September 2004, REMICADE received European Union (EU)
approval, in combination with methotrexate, for the treatment of active and
progressive psoriatic arthritis in patients who have responded inadequately
to disease-modifying anti-rheumatic drugs (DMARDs). Additionally, in July
2006, the European Commission approved the use of REMICADE for the
treatment of active and progressive psoriatic arthritis in patients who
have responded inadequately to DMARDs to be used in combination with
methotrexate or alone in patients who show intolerance to methotrexate or
in whom methotrexate is contraindicated.
About IMPACT/IMPACT 2
The Infliximab Multinational Psoriatic Arthritis Controlled Trial
(IMPACT) was a Phase 2b randomized, double-blind, placebo-controlled study
that involved 104 patients with active psoriatic arthritis (defined as
affecting at least five joints) who failed at least one DMARD. Patients
received either REMICADE (5 mg/kg) or placebo, administered at weeks 0, 2,
6 and 14. The REMICADE group continued on maintenance treatments every
eight weeks through week 94. Beginning at week 16, patients randomized to
the placebo group received an induction regimen of REMICADE followed by
maintenance treatment every eight weeks through week 94. Hands and feet
radiographs were taken at screening and at weeks 50 and 98. Physical
function was measured at multiple visits including screening and at weeks
16, 22, 50 and 94.
REMICADE was generally well tolerated in this study, with one REMICADE
and one placebo patient experiencing serious adverse events (AEs) in the
placebo- controlled portion of the study through week 16. Fourteen patients
out of 104 experienced serious AEs from week 16 through 50 in
placebo/REMICADE crossover and REMICADE groups together. In the second year
of IMPACT, seven patients out of 78 treated with REMICADE were reported
with serious AEs. No deaths, cases of tuberculosis or other opportunistic
infections were reported and serious infections were uncommon. There were
no serious infusion reactions. One patient had a serious AE relating to
malignancy: a ductal adenocarcinoma of the pancreas three months after week
98. See "Important Safety Information" below.
The Induction and Maintenance of Psoriatic Arthritis Clinical Trial 2
(IMPACT 2) was a Phase 3, randomized, double-blind, placebo-controlled
study of 200 patients with active psoriatic arthritis (defined as affecting
at least five joints). The study evaluated the safety and efficacy of
REMICADE in patients who had an inadequate response to DMARDs or
nonsteroidal anti- inflammatory drugs (NSAIDs). Patients received REMICADE
(5 mg/kg) at weeks 0, 2, 6 and every 8 weeks until week 46 or placebo at
weeks 0, 2, 6, 14 and 22. Placebo patients with less than 10 percent
improvement in both swollen and tender joints at week 16 entered early
escape and received REMICADE at weeks 16, 18 and 22 (n=47). At week 24,
placebo patients who did not qualify for early escape received REMICADE at
weeks 24, 26, 30, 38 and 46. Patients randomized to REMICADE who had less
than 20 percent improvement in combined swollen and tender joint count at
week 38 received REMICADE 10 mg/kg at weeks 38 and 46 (n=15). Patients were
allowed concomitant methotrexate use at a stable dose. Hand and foot
radiographs were taken at weeks 0, 24 and 54. Physical function was
measured at multiple visits including weeks 0, 14, 24 and 54.
Through 54 weeks, 12 percent of patients in combined REMICADE treatment
groups experienced serious AEs (during average follow-up of 42.8 weeks) as
compared to 6 percent of placebo patients (average follow-up 20.2 weeks).
No deaths, cases of tuberculosis or other opportunistic infections or
serious infusion reactions were reported; serious infections were uncommon.
Two patients reported an AE of malignancy: one case of basal cell carcinoma
in the placebo group and one case of stage I Hodgkin lymphoma in the
REMICADE group. The only laboratory abnormalities that occurred more
frequently with REMICADE compared with placebo were asymptomatic liver
enzyme test elevations. See "Important Safety Information" below.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic inflammatory arthropathy manifesting
with joint pain and swelling that can lead to joint destruction and
debilitation. It is frequently associated with inflamed, scaly, red patches
of skin psoriasis. Symptoms may include stiffness and tenderness of the
joints and surrounding tissue, reduced range of motion, nail changes and
redness and pain of the eye (uveitis). Joints of the hands, wrists, knees,
ankles, feet, lower back and neck are commonly affected. Psoriasis affects
an estimated two to three percent of the world's population, and
approximately one out of three patients affected by psoriasis may develop
psoriatic arthritis. Both men and women are equally affected by psoriatic
arthritis, most commonly between the ages of 30 and 50, in the peak of
their productive years.
About REMICADE
REMICADE is the global market leader among anti-tumor necrosis factor
alpha (TNF-alpha) therapies and has demonstrated broad clinical utility in
Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis
(AS), psoriatic arthritis (PsA), ulcerative colitis (UC), and pediatric
Crohn's disease (PCD). The safety and efficacy of REMICADE have been well
established in clinical trials over the past 14 years and with more than
770,000 patients treated worldwide through commercial experience.
In the U.S., REMICADE, in combination with methotrexate, is indicated
for reducing signs and symptoms, inhibiting the progression of structural
damage and improving physical function in patients with moderately to
severely active RA. REMICADE is the only biologic indicated for reducing
signs and symptoms and inducing and maintaining clinical remission in adult
and pediatric patients with moderately to severely active CD who have had
an inadequate response to conventional therapy. REMICADE is also indicated
for reducing the number of draining enterocutaneous and rectovaginal
fistulas and maintaining fistula closure in patients with fistulizing CD.
In December 2004, REMICADE was approved for reducing signs and symptoms in
patients with active AS. In May 2005, REMICADE was approved for reducing
signs and symptoms of active arthritis in patients with PsA. Additionally,
in September 2005, REMICADE was approved for reducing signs and symptoms,
achieving clinical remission and mucosal healing, and eliminating
corticosteroid use in patients with moderately to severely active UC who
have had an inadequate response to conventional therapy. This approval
makes REMICADE the first and only biologic approved for the treatment of
moderate to severe UC. In addition, on May 19, 2006, REMICADE was approved
for reducing signs and symptoms and inducing and maintaining clinical
remission in pediatric patients with moderately to severely active Crohn's
disease who have had an inadequate response to conventional therapy. This
approval establishes REMICADE as the first and only biologic therapy
approved for the treatment of PCD.
REMICADE is unique among available anti-TNF biologic therapies. Unlike
self-administered therapies that require patients to inject themselves
frequently, REMICADE is the only anti-TNF biologic administered directly by
caregivers in the clinic or office setting. In RA (3 mg/kg), CD (5 mg/kg),
PsA (5 mg/kg), UC (5 mg/kg), and PCD (5 mg/kg) REMICADE is a two-hour
infusion administered every 8 weeks, following a standard induction regimen
that requires treatment at weeks 0, 2 and 6. As a result, REMICADE patients
may require as few as six treatments each year. In AS (5 mg/kg), REMICADE
is a two-hour infusion administered every 6 weeks, following a standard
induction regimen that requires treatment at weeks 0, 2 and 6.
Important Safety Information
Many people with heart failure should not take REMICADE; so prior to
treatment you should discuss any heart condition with your doctor. Tell
your doctor right away if you develop new or worsening symptoms of heart
failure (such as shortness of breath or swelling of your ankles or feet).
There are reports of serious infections, including tuberculosis (TB),
sepsis and pneumonia. Some of these infections have been fatal. Tell your
doctor if you have had recent or past exposure to people with TB. Your
doctor will evaluate you for TB and perform a skin test. If you have latent
(inactive) TB, your doctor should begin TB treatment before you start
REMICADE. REMICADE can lower your ability to fight infections, so if you
are prone to or have a history of infections, or develop any signs of an
infection such as fever, fatigue, cough, or the flu while taking REMICADE,
tell your doctor right away. Also tell your doctor if you have lived in a
region where histoplasmosis or coccidioidomycosis is common.
Reports of a type of blood cancer called lymphoma in patients on
REMICADE or other TNF blockers are rare but occur more often than expected
for people in general. People who have been treated for rheumatoid
arthritis, Crohn's disease, ankylosing spondylitis, or psoriatic arthritis
for a long time, particularly those with highly active disease may be more
prone to develop lymphoma. Cancers, other than lymphoma, have also been
reported. Children and young adults who have been treated for Crohn's
disease with REMICADE have developed a rare type of lymphoma that often
results in death. These patients also were receiving drugs known as
azathioprine or 6-mercaptopurine. If you take REMICADE or other TNF
blockers, your risk for developing lymphoma or other cancers may increase.
You should also tell your doctor if you have had or develop lymphoma or
other cancers or if you have a lung disease called chronic obstructive
pulmonary disease (COPD). Reactivation of hepatitis B virus has been
reported in patients who are carriers of this virus and are taking TNF
blockers, such as REMICADE. Some of these cases have been fatal. Tell your
doctor if you know or think you may be a carrier of hepatitis B virus.
There have been rare cases of serious liver injury in people taking
REMICADE, some fatal. Contact your doctor immediately if you develop
symptoms such as jaundice (yellow skin and eyes), dark brown urine,
right-sided abdominal pain, fever, or severe fatigue.
Blood disorders have been reported, some fatal. Tell your doctor if you
develop possible signs of blood disorders such as persistent fever,
bruising, bleeding, or paleness while taking REMICADE. Nervous system
disorders have also been reported. Tell your doctor if you have or have had
a disease that affects the nervous system, or if you experience any
numbness, weakness, tingling, or visual disturbances while taking REMICADE.
Serious infusion reactions have been reported with REMICADE, including
hives, difficulty breathing, and low blood pressure. Reactions have
occurred during or after infusions. In clinical studies, some people
experienced the following common side effects: respiratory infections (that
may include sinus infections and sore throat), coughing, and stomach pain
or mild reactions to infusion such as rash or itchy skin.
Please read important information about REMICADE, including full U.S.
prescribing information, at remicade.
About Centocor
Centocor is harnessing the power of world-leading research and
biomanufacturing to deliver innovative biomedicines that transform
patients' lives. Centocor has already brought innovation to the treatment
of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic
arthritis, ulcerative colitis and pediatric Crohn's disease.
The world leader in monoclonal antibody production and technology,
Centocor has brought critical biologic therapies to patients suffering from
debilitating immune disorders. Centocor, Inc. is a wholly owned subsidiary
of Johnson & Johnson.
(i) National Institute of Arthritis and Musculoskeletal and Skin
Disorders. Questions and Answers About Psoriasis. U.S. Department of Health
and Human Services, National Institutes of Health; 2003. NIH Publication
No. 03-5040.
Centocor, Inc.
remicade
View drug information on Remicade.
вторник, 14 июня 2011 г.
Moderate Weight Loss Helps Reduce Risk Of Osteoarthritis In The Knee, Maintaining Weight Provides No Benefit
Here's another good reason to lose even a moderate amount of weight: it could reduce your risk of developing osteoarthritis in your knees.
People who are overweight and lose just 5 percent of their weight are less likely to develop osteoarthritis of the knee, or knee OA, compared to people who gain weight, according to data from a large ongoing study by the Thurston Arthritis Research Center at the University of North Carolina at Chapel Hill School of Medicine.
"We hear a lot of messages about how obesity affects cardiovascular disease and diabetes, but arthritis is often overlooked," says Lauren Abbate, a third-year medical student at UNC and lead investigator of the knee OA paper, presented Monday, Oct. 19, 2009, at the American College of Rheumatology scientific meeting in Philadelphia.
"OA is painful and debilitating. Effective treatments are limited and there's not a cure. But if we can get people to lose weight we may reduce their risk and reduce the pain and disability associated with this condition," Abbate says.
More than 27 million Americans have OA, the most common joint disease affecting middle-aged and older people. OA causes progressive damage to the joint cartilage and changes in the structures around the joint, which 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.
Abbate and her colleagues used data from the Johnston County Osteoarthritis Project, one of the largest ongoing population-based studies of arthritis in the world. It began at Thurston in 1990 and is funded by the Centers for Disease Control and Prevention and the National Institutes of Health.
The researchers included 1,480 men and women 45 and older who were disease-free in at least one knee and followed them for approximately six years to see who developed radiographic OA - disease confirmed by X-rays; almost two-thirds were women, and more than 25 percent were African Americans.
They then divided people into categories based on weight change: people who lost 5 percent or more of their total body weight, people who maintained within 3 percent above or below their weight and those who gained at least 5 percent more than their weight.
"It was our hope that people who maintained weight would have reduced risk, but obesity is such a strong risk factor for OA, that maintaining weight showed no significant benefit," says Abbate, who recently finished her doctoral degree in epidemiology from the UNC Gillings School of Global Public Health. She also has a master's of science in public health from the school.
Weight loss can be difficult to achieve. But, Abbate says, people can aim for losing a certain percentage of their weight instead of shooting for an ideal number. "For someone who weighs 200 pounds, losing 5 percent just means losing 10 pounds," she says.
Abbate's paper was one of several research highlights at the ACR meeting for UNC's Thurston Arthritis Research Center. Abbate and two other UNC medical students, Joshua Knight, a second-year student, and Shelby Addison, a third-year student, won research awards. Amanda Nelson, M.D., a fellow at Thurston, won a fellowship award.
"We have placed a high priority on working with medical and graduate students and being open to collaborating," says Joanne Jordan, M.D., the center director and Herman and Louise Smith Distinguished Professor of Medicine at UNC's School of Medicine. Jordan received the ACR's Award of Distinction for Excellence in Investigative Mentoring.
"We take our role as the arthritis research center for the people of North Carolina very seriously," Jordan said. "That is why we are always looking for ways to bring our research findings to the community and to learn from the community."
Source
University of North Carolina at Chapel Hill School of Medicine
People who are overweight and lose just 5 percent of their weight are less likely to develop osteoarthritis of the knee, or knee OA, compared to people who gain weight, according to data from a large ongoing study by the Thurston Arthritis Research Center at the University of North Carolina at Chapel Hill School of Medicine.
"We hear a lot of messages about how obesity affects cardiovascular disease and diabetes, but arthritis is often overlooked," says Lauren Abbate, a third-year medical student at UNC and lead investigator of the knee OA paper, presented Monday, Oct. 19, 2009, at the American College of Rheumatology scientific meeting in Philadelphia.
"OA is painful and debilitating. Effective treatments are limited and there's not a cure. But if we can get people to lose weight we may reduce their risk and reduce the pain and disability associated with this condition," Abbate says.
More than 27 million Americans have OA, the most common joint disease affecting middle-aged and older people. OA causes progressive damage to the joint cartilage and changes in the structures around the joint, which 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.
Abbate and her colleagues used data from the Johnston County Osteoarthritis Project, one of the largest ongoing population-based studies of arthritis in the world. It began at Thurston in 1990 and is funded by the Centers for Disease Control and Prevention and the National Institutes of Health.
The researchers included 1,480 men and women 45 and older who were disease-free in at least one knee and followed them for approximately six years to see who developed radiographic OA - disease confirmed by X-rays; almost two-thirds were women, and more than 25 percent were African Americans.
They then divided people into categories based on weight change: people who lost 5 percent or more of their total body weight, people who maintained within 3 percent above or below their weight and those who gained at least 5 percent more than their weight.
"It was our hope that people who maintained weight would have reduced risk, but obesity is such a strong risk factor for OA, that maintaining weight showed no significant benefit," says Abbate, who recently finished her doctoral degree in epidemiology from the UNC Gillings School of Global Public Health. She also has a master's of science in public health from the school.
Weight loss can be difficult to achieve. But, Abbate says, people can aim for losing a certain percentage of their weight instead of shooting for an ideal number. "For someone who weighs 200 pounds, losing 5 percent just means losing 10 pounds," she says.
Abbate's paper was one of several research highlights at the ACR meeting for UNC's Thurston Arthritis Research Center. Abbate and two other UNC medical students, Joshua Knight, a second-year student, and Shelby Addison, a third-year student, won research awards. Amanda Nelson, M.D., a fellow at Thurston, won a fellowship award.
"We have placed a high priority on working with medical and graduate students and being open to collaborating," says Joanne Jordan, M.D., the center director and Herman and Louise Smith Distinguished Professor of Medicine at UNC's School of Medicine. Jordan received the ACR's Award of Distinction for Excellence in Investigative Mentoring.
"We take our role as the arthritis research center for the people of North Carolina very seriously," Jordan said. "That is why we are always looking for ways to bring our research findings to the community and to learn from the community."
Source
University of North Carolina at Chapel Hill School of Medicine
понедельник, 13 июня 2011 г.
Vioxx Successor Arcoxia May Have Similar Heart Attack Risks
Arcoxia, a new experimental painkiller Merck & Co hope will become the successor of Vioxx, which was taken off the market because of its heart attack risks, may have similar risks, say scientists who looked at 23 clinical trials comparing several painkillers.
You can read about this new report in JAMA (the Journal of the American Medical Association).
In fact, the report showed that Vioxx and diclofenac carried similar cardiovascular risks (diclofenac is a much older painkiller). According to a Merck study, Arcoxia and diclofenac (Voltaren) have the same risks.
Vioxx raises cardiovascular risk by approximately 35%, diclofenac raises cardiovascular risk by about 40%. Voltaren (diclofenac) is currently sold in 62 countries.
By arguing that Arcoxia is no worse than diclofenac will not logically get it approved by the FDA if Vioxx and diclofenac carried similar risks. Arcoxia has already been turned down by the FDA (2004) because of insufficient safety data.
If you found the information above confusing, perhaps the alternative explanation below may make it clearer.
1. Vioxx was taken off the market some time ago because of heart attack and stroke risk.
2. Voltaren (diclofenac) is still sold in 62 countries and has similar risks to Vioxx.
3. Merck compares Arcoxia, a new experimental drug, to diclofenac, saying Arcoxia has similar risks. As the drug is still on the market it is saying Arcoxia is not more dangerous than a drug which is still on the market.
4. Why would the FDA approve Arcoxia if it has similar risks to diclofenac, which has similar risks to Vioxx?
"COX-2 Inhibitors, Other NSAIDs, and Cardiovascular Risk"
"The Seduction of Common Sense"
David J. Graham, MD, MPH
JAMA. 2006;296:(doi:10.1001/jama.296.13.jed60058).
Click Here To Read Article Online
Written by:
View drug information on Vioxx.
You can read about this new report in JAMA (the Journal of the American Medical Association).
In fact, the report showed that Vioxx and diclofenac carried similar cardiovascular risks (diclofenac is a much older painkiller). According to a Merck study, Arcoxia and diclofenac (Voltaren) have the same risks.
Vioxx raises cardiovascular risk by approximately 35%, diclofenac raises cardiovascular risk by about 40%. Voltaren (diclofenac) is currently sold in 62 countries.
By arguing that Arcoxia is no worse than diclofenac will not logically get it approved by the FDA if Vioxx and diclofenac carried similar risks. Arcoxia has already been turned down by the FDA (2004) because of insufficient safety data.
If you found the information above confusing, perhaps the alternative explanation below may make it clearer.
1. Vioxx was taken off the market some time ago because of heart attack and stroke risk.
2. Voltaren (diclofenac) is still sold in 62 countries and has similar risks to Vioxx.
3. Merck compares Arcoxia, a new experimental drug, to diclofenac, saying Arcoxia has similar risks. As the drug is still on the market it is saying Arcoxia is not more dangerous than a drug which is still on the market.
4. Why would the FDA approve Arcoxia if it has similar risks to diclofenac, which has similar risks to Vioxx?
"COX-2 Inhibitors, Other NSAIDs, and Cardiovascular Risk"
"The Seduction of Common Sense"
David J. Graham, MD, MPH
JAMA. 2006;296:(doi:10.1001/jama.296.13.jed60058).
Click Here To Read Article Online
Written by:
View drug information on Vioxx.
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