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Rheumatology 2003; 42: II29-II35
© 2003 British Society for Rheumatology

Original Article

Addressing the safety of anakinra in patients with rheumatoid arthritis

R. M. Fleischmann

St Paul University Hospital, Dallas, TX, USA.

Correspondence to: Correspondence to: R. M. Fleischmann, St Paul University Hospital, Department of Rheumatology, 5939 Harry Hines Boulevard, Suite 400, Dallas, TX 75235, USA. E-mail: royfleischmann{at}radiantresearch.com

Anakinra (Kineret®; Amgen Inc., Thousand Oaks, CA) is the first and only recombinant human interleukin-1 receptor antagonist available for therapeutic use. It has been approved by the US Food and Drug Administration and the European Commission for the treatment of patients with rheumatoid arthritis (RA). Anakinra, as an anti-rheumatic therapy, has been assessed in five placebo-controlled clinical trials, either alone or in combination with methotrexate. These trials have shown anakinra to be efficacious and well tolerated by most patients, with the most frequently reported adverse events being mild-to-moderate injection-site reactions that generally resolved rapidly. One of these trials was a large, prospective safety study, which included typical RA patients with a wide variety of co-morbid conditions and receiving concomitant medications. This confirmed that anakinra is a well-tolerated treatment in an RA population representative of that seen by the practising rheumatologist.

KEY WORDS: Anakinra, Biological response modifier, DMARD, Interleukin-1 receptor antagonist, Rheumatoid arthritis, Safety, Tuberculosis


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