The use of anakinra, an interleukin-1 receptor antagonist, in the treatment of rheumatoid arthritis.

Interleukin-1 (IL-1) is a primary cytokine that is involved in the pathogenesis of rheumatoid arthritis; it contributes to inflammation and joint destruction. Anakinra (Kineret) is an IL-1 receptor antagonist that blocks the biologic activity of IL-1. It was approved by the U.S. Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis in 2001. Anakinra is safe and effective in the treatment of rheumatoid arthritis, both as monotherapy and in combination with other disease-modifying antirheumatic drugs. This article reviews the preclinical, clinical, and postmarketing data on the safety and efficacy of anakinra in the treatment of rheumatoid arthritis and focuses on the pivotal clinical trials that led to FDA approval.