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13.
Treatment of rheumatoid arthritis with recombinant human interleukin-1 receptrantagonist
Bresnihan, Barry ...
Objective. To evaluate the efficacy and safety of interleukin-1 receptor antagonist (IL-1Ra) in patients with rheumatoid arthritis (RA). Methods. 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. Patient were randomized to 1 of 4 treatment groups: placebo or a single, self-administratedsubcutaneous injection of IL-1Ra at a daily dose of 30 mg, 75 mg, or 150 mg. Results. 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 similar in the 4 treatment groups. The clinical parameters of disease activity were similar in each treatment group and were consistent with active and severe RA. At 24 weeks, ofthe pateints who received 150 mg/day IL-1Ra, 43% met the American Vollege ofTheumatology criteria for response (the primary efficacy measure), 44% met the Paulus criteria, and statistically significant improvements were seen in the number of swollen joints, number of tender joints, investigator's assessment of disease activity, patient's assessment of disease activity, painscore on a visual analog scale, duration of morning stiffness. Health Assessment Qusteionnaire score, C-reactive protein level, and erythrocyte sedimentation rate. Abstract truncated at 2000 characters.
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