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IL-1 trap for rheumatoid arthritis: full speed ahead.

BERLIN -- The investigational interleukin-1 inhibitor known as IL-1 trap has shown encouraging efficacy and safety in a phase II multicenter dose-ranging study of rheumatoid arthritis patients.

Since the highest dose studied--100 mg once weekly by subcutaneous injection--was the most effective and was also relatively well tolerated, future trials will explore higher doses, Clifford O. Bingham III, M.D., said at the annual European Congress of Rheumatology.

Interleukin-1 (IL-1) is a key cytokine in rheumatoid arthritis. It is involved in induction of the inflammatory cascade as well as processes destructive to joints, including osteoclast activation and synoviocyte proliferation.

The sole IL-1 inhibitor on the market--anakinra (Kineret), an IL-1 receptor antagonist--requires daily subcutaneous administration. IL-1 trap binds tightly to IL-1 and offers the advantage of once-weekly therapy.

Dr. Bingham reported on 201 patients with long-standing moderate to severe active rheumatoid arthritis who were randomized to 25, 50, or 100 mg/wk of IL-1 trap or placebo in a 12-week, double-blind, 38-center study sponsored by Regeneron Pharmaceuticals.

Overall, 46% of patients on the 100-mg dose attained at least a 20% reduction in disease signs and symptoms by American College of Rheumatology criteria, or ACR 20, compared with an unusually high 31% in the placebo arm, said Dr. Bingham of the Hospital for Joint Diseases, New York.

Both C-reactive protein and the erythrocyte sedimentation rate fell swiftly and dramatically in dose-dependent fashion. The Disease Activity Score-28 (DAS-28) decreased by a mean 1.12 points from a baseline value in excess of 5.5 in the 100-mg group. The most common adverse events involved injection site reactions, which affected 34% of subjects.


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Author:Jancin, Bruce
Publication:Internal Medicine News
Article Type:Brief Article
Geographic Code:1USA
Date:Nov 15, 2004
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