Anakinra is a recombinant human inte rleukin-1 re c eptor antagonist (IL-1ra) recently approved by the FDA as a new therapy for patients with rheumatoid arthritis. Four clinical trials have been completed wh i ch have demonst rated that anakinra is an effe ct ive anti-rheum atic therapy either used alone or in combination with methot rex at e. The most frequent adve rs e events reported in the clinical trials are injection-site reactions which are generally mild to moderate and rapidly resolve. A large, prospective safety study wh i ch allowed a wide-va riety of comorbid conditions and concomitant medications demonstrated that anakinra therapy is a well-tolerated treatment for rheumatoid arthritis in the patient population seen by the practicing rheum at ol ogist. Unlike therapies designed to affect TNF-, there have not yet been reports of the development of tuberculosis or other fungal infections, demylinating syndromes or worsening of congestive heart failure. The safety profile of etanercept and infliximab were similar to that of anakinra in the phase I–phase III clinical trials. Unlike anakinra, these medicat ions we re not studied in the usual rheumatoid arthritis population which includes a number of patients with a wide variety of co-morbid disease and utilizing a number of concomitant anti-rheumatic medic ations. Post ap p rova l, s eve ra l safety concerns, including patients at risk for serious infection and the emergence of latent tuberculosis and other opportunistic infections have emerged with the use of anti TNF therapy.