HealthDay News — Olokizumab is superior to placebo and noninferior to adalimumab in patients with rheumatoid arthritis receiving maintenance methotrexate, according to a study published in the August 25 issue of the New England Journal of Medicine.

Josef S. Smolen, MD, from the Medical University of Vienna, and colleagues conducted a 24-week, phase 3 trial involving patients with rheumatoid arthritis and inadequate response to methotrexate to receive subcutaneous olokizumab (64mg every 2 or 4 weeks), adalimumab (40mg every 2 weeks), or placebo in a 2:2:2:1 ratio (464, 479, 462, and 243 patients, respectively); all continued receiving methotrexate. An American College of Rheumatology 20 (ACR20) response (≥20% fewer tender and swollen joints and ≥20% improvement in 3 of 5 other domains) at week 12 was examined as the primary end point, with each olokizumab dose tested for superiority to placebo.

The researchers found that 44.4% of patients receiving placebo had an ACR20 response at week 12 compared with 70.3% receiving olokizumab every 2 weeks (difference vs placebo, 25.9 percentage points), 71.4% receiving olokizumab every 4 weeks (difference, 27.0 percentage points), and 66.9% receiving adalimumab (difference, 22.5 percentage points). With respect to the percentage of patients with an ACR20 response at week 12, both olokizumab doses were noninferior to adalimumab. About 70% of patients who received olokizumab had adverse events, most commonly infections.

“Longer and larger trials are required to determine the efficacy and safety of olokizumab in patients with rheumatoid arthritis,” the authors write.

The study was funded by R-Pharm, the manufacturer of olokizumab.

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