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 Aug. 25 issue of the New England Journal of Medicine.
Josef S. Smolen, M.D., 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 (64 mg every two or four weeks), adalimumab (40 mg every two 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 percent fewer tender and swollen joints and ≥20 percent improvement in three of five 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 percent of patients receiving placebo had an ACR20 response at week 12 compared with 70.3 percent receiving olokizumab every two weeks (difference versus placebo, 25.9 percentage points), 71.4 percent receiving olokizumab every four weeks (difference, 27.0 percentage points), and 66.9 percent 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 percent 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.