One-year data from a two-year
Phase III study demonstrated that ACTEMRA(R) (tocilizumab) significantly
inhibited the progression of structural joint damage in patients with
rheumatoid arthritis (RA). Late-breaking results from the LITHE study will
be featured as an oral presentation during the American College of
Rheumatology (ACR) Annual Scientific Meeting (October 24-28) in San
Francisco. Fourteen additional abstracts, which evaluate ACTEMRA, a novel
interleukin-6 (IL-6) receptor inhibitor, in patients with moderately to
severely active RA, will also be presented during the meeting.
"The LITHE study demonstrated that treatment with ACTEMRA inhibited
structural joint damage, which is a major cause of disability and loss of
physical function for RA patients," said Joel Kremer, M.D., investigator in
the LITHE study and Director of Research at The Center for Rheumatology in
Albany, New York. "It is critical to stop joint damage as quickly as
possible to avoid joint deformity and to help patients maintain their
quality of life."
In the study, the mean change in the combined Genant-modified Sharp
score(1), which assesses progression of both joint erosion and joint space
narrowing, was lower among ACTEMRA (8 mg/kg and 4 mg/kg) plus
methotrexate-treated patients versus methotrexate plus placebo-treated
patients (0.3, 0.3 versus 1.1, respectively; p
At one year, the study also showed that there was improved physical
function following treatment with ACTEMRA, as measured by the Health
Assessment Questionnaire Disability Index (HAQ-DI).(4)
About the LITHE Study
LITHE (TociLIzumab Safety and THE Prevention of Structural Joint
Damage), a three-arm, randomized, double-blind, placebo-controlled study,
was designed to evaluate the efficacy and safety of ACTEMRA (8 mg/kg or 4
mg/kg) plus methotrexate compared with placebo plus methotrexate in RA
patients for the prevention of structural joint damage, improvement in
physical function and disease signs and symptoms. Patients received either
ACTEMRA intravenously every four weeks plus methotrexate weekly or placebo
infusions every four weeks plus methotrexate weekly. The study included
nearly 1,200 patients from 137 sites in 15 countries, including the United
States.
ACTEMRA was generally well tolerated; the most common adverse events
reported most frequently in the ACTEMRA arms of the LITHE study were
serious infections.
About ACTEMRA(R) (tocilizumab)
ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting
monoclonal antibody being studied for the treatment of RA. Studies
demonstrate that reducing the activity of IL-6, one of several key
cytokines involved in the inflammatory process, relieves both inflammation
of the joints and certain systemic effects of RA. The extensive clinical
development program conducted by Roche includes five Phase III clinical
studies and has enrolled more than 4,000 patients in 41 countries,
including the United States. Four Phase III studies are completed and have
reported meeting their primary endpoints. A fifth Phase III study, the
LITHE study evaluating ACTEMRA in RA is an ongoing two-year study, which is
expected to report complete data evaluating the effects of ACTEMRA on the
inhibition of structural joint damage in 2009. ACTEMRA is currently under
review in the United States and Europe.
ACTEMRA is part of a co-development agreement between Roche and Chugai
Pharmaceutical Co. In June 2005, ACTEMRA was launched by Chugai in Japan as
a therapy for Castleman's disease; in April 2008, additional indications
for rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset
juvenile idiopathic arthritis were also approved in Japan.
The serious adverse reactions reported in ACTEMRA clinical studies
include serious infections, gastrointestinal perforations and
hypersensitivity reactions including anaphylaxis. The most common adverse
reactions reported in clinical studies were upper respiratory tract
infection, nasopharyngitis, headache, hypertension and increased ALT.
Increases in liver enzymes (ALT and AST) were seen in patients; these
increases were generally mild and reversible, with no evidence of hepatic
injuries. Laboratory changes, including increases in lipids (total
cholesterol, LDL, HDL, triglycerides) and decreases in neutrophils and
platelets, were seen in patients without association with clinical
outcomes. Treatments that suppress the immune system, such as ACTEMRA, may
cause an increase in the risk of malignancies.
About IL-6
IL-6 is a common protein found in all joints in the body and is a
natural substance that can raise inflammation. Everyone has IL-6 in their
body, but people with RA may have too much.
When approved, ACTEMRA will be the first and only medication to
specifically target IL-6 in patients with RA.
About Rheumatoid Arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune disease
characterized by inflammation of the membrane lining in the joints. This
inflammation causes a loss of joint shape and function, resulting in pain,
stiffness and swelling, ultimately leading to irreversible joint
destruction and disability. Characteristics of RA include redness,
swelling, pain and movement limitation around joints of the hands, feet,
elbows, knees and neck that leads to loss of function. In addition, the
systemic symptoms of RA include fatigue, decreased hemoglobin, osteoporosis
and may contribute to shortening life expectancy by affecting major organ
systems. After 10 years, less than 50 percent of patients can continue to
work or function normally on a daily basis. RA affects more than 21 million
people worldwide with approximately 1.3 million adults affected in the
United States.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
pharmaceuticals headquarters of the Roche Group, one of the world's leading
research-oriented healthcare groups with core businesses in pharmaceuticals
and diagnostics. For more than 100 years in the U.S., Roche has been
committed to developing innovative products and services that address
prevention, diagnosis and treatment of diseases, thus enhancing people's
health and quality of life. An employer of choice, in 2007 Roche was named
Top Company of the Year by Med Ad News, one of the Top 20 Employers
(Science) and ranked the No. 1 Company to Sell For (Selling Power). In
previous years, Roche has been named as a Top Company for Older Workers
(AARP) and one of the Best Companies to Work For in America (Fortune). For
additional information about the U.S. pharmaceuticals business, visit our
websites: rocheusa or roche.us.
All trademarks used or mentioned in this release are protected by law.
References
(1) The Genant-modified Sharp score focuses on 14 specific sites for
evidence of bone erosion and 13 sites for narrowing of the joint space both
key measures of ongoing structural damage to the joints. Erosion scores are
assigned to each of the specified sites, with 0 representing "no erosion"
and 3.5 representing "destruction of the joint." Joint space narrowing
scores are assigned to each of the specified sites, with 0 representing "no
narrowing" and 4 representing "total loss of the joint space." Increases in
the scores indicate the extent of additional erosion, joint space narrowing
or overall structural damage (both scores combined) that have occurred
since treatment began.
(2) ACR20, ACR50 and ACR70 represent the percentage of reduction (20%,
50% or 70%) in certain RA symptoms and measures the number of tender and
swollen joints, pain, patient's and physician's global assessments and
certain laboratory markers. An ACR70 response is considered exceptional and
represents a significant improvement in a patient's condition.
(3) The Disease Activity Score (DAS)28 is a combined index that
measures disease activity in patients with RA. It combines information from
28 tender and swollen joints (range0-28), erythrocyte sedimentation rate,
and a general health assessment on a visual analog scale. The level of
disease activity is interpreted as low (DAS28 less than or equal to 3.2),
moderate (3.25.1).
DAS28
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