Interleukin-1 (IL-1) is one of the main inflammatory mediators associated with development of rheumatoid arthritis (RA). Deficiency in secretion of the natural IL-1 antagonist was found in RA patients, and enhanced joint inflammation. This finding was confirmed by numerous studies using the animal model of the disease. Two randomized, multicenter clinical trials with anakinra, a recombinant IL-1 receptor antagonist (rHHHuIL-1Ra), revealed that application of anakinra with or without methotrexate induces remission (ACR 20) in 38-71% of patients with RA. Induction of remission was dose and treatment-time-dependent. The present paper reviews theoretical application of rHuIL-1Ra in patients with RA and summarizes results of published clinical trials of the drug.