Bringing the clinical experience with anakinra to the patient.

The recombinant interleukin-1 receptor antagonist, anakinra (Kineret; Amgen Inc., Thousand Oaks, CA), has been approved by the US Food and Drug Administration and the European Commission for the treatment of patients with active rheumatoid arthritis (RA). Approval was granted following the extensive evaluation of anakinra in five pivotal clinical trials that assessed its efficacy and safety in RA patients. These studies have indicated that anakinra has a favourable risk-benefit profile, producing rapid and sustained reductions in the signs and symptoms of RA, as measured by improvements in the American College of Rheumatology response criteria, particularly in patient-reported indicators of function and disability. The data from these trials suggest that anakinra is likely to provide a useful therapeutic option to clinicians and also meet the treatment expectations of patients with RA; however, further studies are underway to investigate additional benefits that anakinra may offer, particularly in patients with existing co-morbidities.