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Bernard A. Schwetz, DVM,PhD

JAMA. 2002;287:33.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA has approved anakinra (Kineret Amgen Inc, Thousand Oaks, Calif) as adjunctive therapy for reduction in signs and symptoms of moderately to severely active rheumatoid arthritis (RA) in patients 18 years of age or older in whom one or more disease-modifying antirheumatic drugs (DMARDs) have failed. Anakinra is indicated for use alone or in combination with DMARDs other than anti–tumor necrosis factor (TNF) therapies.

Safety and effectiveness of were evaluated in three randomized, placebo-controlled trials of 1392 patients at least 18 years of age with active RA. A fourth study assessed the drug's safety in 1414 similar patients who were DMARD free or received concurrent medications, including some DMARDs.

Anakinra was studied in combination with DMARDs (other than anti-TNF therapies) or as monotherapy. Results were assessed using American College of Rheumatology (ACR) response criteria. In all three studies, patients taking anakinra were more likely to . . . [Full Text of this Article]

Acting Principal Deputy Commissioner
Food and Drug Administration

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