View article

To evaluate the efficacy and safety of interleukin‐1 receptor antagonist (IL‐1Ra) in patients with rheumatoid arthritis (RA).

Patients with active and severe RA (disease duration <8 years) were recruited into a 24‐week, double‐blind, randomized, placebo‐controlled, multicenter study. Doses of nonsteroidal antiinflammatory drugs and/or oral corticosteroids (≤10 mg prednisolone daily) remained constant throughout the study. Any disease‐modifying antirheumatic drugs that were being administered were discontinued at least 6 weeks prior to enrollment. Patients were randomized to 1 of 4 treatment groups: placebo or a single, self‐administered subcutaneous injection of IL‐1Ra at a daily dose of 30 mg, 75 mg, or 150 mg.

A total of 472 patients were recruited. At enrollment, the mean age, sex ratio, disease duration, and percentage of patients with rheumatoid factor and erosions were …