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Wednesday 17th August, 2005
Adalimumab and methotrexate is about five times more effective than
methotrexate alone, according to a new systematic review of studies.
For people with long-standing rheumatoid arthritis,
combined treatment with the new ?biologic? drug adalimumab
and methotrexate is about five times more effective than
methotrexate alone, according to a new systematic review of
In six randomized controlled trials, comprising 2381 people with
at least 10 years of
rheumatoid arthritis, the authors report that adalimumab
methotrexate decreased pain and swelling in patients
who fail to respond to standard treatment.
Adalimumab ?is even more active when used combined with
methotrexate,? according to lead reviewer Federico Navarro-Sarabia,
M.D., chair of rheumatology at the Hospital Universitario Virgen
Macarena in Seville, Spain, and colleagues. ?More people had
improved symptoms with adalimumab alone than with fake injections,
but the improvement was not as much as when adalimumab was taken in
The review appears in the latest issue of The Cochrane Library, a
publication of The Cochrane Collaboration, an international
organization that evaluates medical research. Systematic reviews
draw evidence-based conclusions about medical practice after
considering both the content and quality of existing medical trials
on a topic.
The reviewers found that after six months, 43 percent of all
subjects on adalimumab plus
methotrexate had achieved a 50-percent
improvement in symptoms, compared with 9 percent of all subjects
receiving placebo plus
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In the longest-running study, X-rays showed that adalimumab
injections slowed progression of joint damage more than placebo.
Adalimumab was given in injections of 40 milligrams every other
week or 20 milligrams per week.
The reviewers determined clinical effectiveness of each drug by
measuring patients? improvement using a symptom scale devised by the
American College of Rheumatology. They measured disease progression
using European League Against Rheumatism radiologic criteria.
They found that the rate of side effects was not significantly
different between the adalimumab and placebo groups, but noted that
the long-term side effects of adalimumab treatment have not yet been
Adalimumab works by preventing a protein called tumor necrosis
factor (TNF) from signaling the release of joint-damaging
substances. The other FDA-approved TNF blockers are etanercept (Enbrel)
and infliximab (Remicade). Adalimumab is approved for the treatment
of moderate to severe rheumatoid arthritis in adults who do not
respond to other treatments.
Methotrexate is the most widely used of ?disease modifying
antirheumatic drugs? among rheumatoid arthritis patients. Although DMARDs play an important role in arthritis treatment, only one,
leflunomide, was developed specifically for
Methotrexate was developed as a cancer treatment.
?What we might be seeing here is a synergistic effect,? said
Scott Zashin, M.D., coauthor of a book on TNF blockers for
arthritis, and clinical assistant professor at the University of
Texas-Southwestern Medical School in Dallas. ?Doctors and patients
need to know, and this review supports the claim, that combination
therapy will generally have a more robust effect, though some
patients will do well on either drug alone. For patients with
long-standing disease, this review affirms combination therapy as
the standard of care.?
Addressing future research priorities, the reviewers wrote, ?The
available clinical trials with adalimumab are short-term studies
(six-months duration) and there is only one twelve-month study.
Long-term efficacy and safety studies are needed.?
Rheumatoid arthritis is an autoimmune disease which develops when
certain cells of the immune system malfunction and attack healthy
joints. The cause of rheumatoid arthritis is unknown. The primary
focus of the inflammation is in the synovium, the lining tissue of
the joint. Inflammatory chemicals released by the immune cells cause
swelling and damage to cartilage and bone.
More than 2 million Americans suffer from
according to the American College of Rheumatology. About 75 percent
of those affected are women. While the disease appears most commonly
between the ages of 40 and 60, it can develop at any age.
By Bruce Sylvester, Contributing Writer
Navarro-Sarabia F, et al. Adalimumab for treating rheumatoid
arthritis. The Cochrane Database of Systematic Reviews 2005, Issue