Adalimumab Safe Way to Boost Response to Standard Antirheumatic Treatment

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Adalimumab Safe Way to Boost Response to Standard Antirheumatic Treatment

NEW YORK (Reuters Health) Jan 06 - Adalimumab is a safe and effective

addition to standard therapy for patients with active rheumatoid arthritis

(RA) whose response to traditional therapy is inadequate, according to

results of the Safety Trial of Adalimumab in Rheumatoid Arthritis (STAR).

In fact, the findings are so outstanding that " what was once considered to

be a good response to standard antirheumatic therapy has become inadequate, "

Dr. E. Furst and his colleagues maintain in their article, published

in the Journal of Rheumatology for December.

Adalimumab (Humira, Abbott Laboratories) is a fully human monoclonal

antibody to tumor necrosis factor-alpha. In the 24-week STAR trial, 318

patients were randomly assigned to receive adalimumab 40 mg s.c. every other

week, and 318 were randomized to placebo.

Patients continued their baseline doses of other drugs, which could include

traditional disease modifying antirheumatic drugs such as methotrexate or an

antimalarial drug, along with a corticosteroid, nonsteroidal

anti-inflammatory drugs, and analgesics.

In the adalimumab group, 28.9% achieved an American College of Rheumatology

(ACR)50 response, versus 11.3% in the placebo group. Significantly more in

the active treatment group also achieved ACR20 and ACR70 responses (p <

0.001). Significant differences between groups emerged as early as 2 weeks

after starting treatment.

Nine patients in the adalimumab group and 8 in the placebo group

discontinued treatment because of adverse events. Rates of infections,

adverse events, serious adverse events, and severe or life-threatening

adverse events were also similar between groups.

Overall, changes in hematology and biochemistry variables were similar

between groups. However, adalimumab was associated with increased

anti-inflammatory activity, as demonstrated by changes in hemoglobin, white

blood cells, platelets and lymphocytes.

Thus, in a situation that resembles actual clinical practice, Dr. Furst's

group concludes that adalimumab provides " significant, rapid, and sustained

improvements in signs and symptoms of RA. "

J Rheumatol 2003;30:2563-2571.