Phase 2 trial shows that rilonacept reduces gout flares during initiation of allopurinol therapy
MONDAY, Jan. 9 (HealthDay News) -- The use of rilonacept significantly reduces gout flare-ups in the first few months following initiation of urate-lowering therapy (ULT), according to research published online Jan. 4 in Arthritis & Rheumatism.
H. Ralph Schumacher Jr., M.D., of the University of Pennsylvania and VA Medical Center in Philadelphia, and colleagues conducted a randomized, double-blind, 16-week, phase 2 clinical trial, in which 42 participants received placebo and 41 participants received rilonacept (loading dose 320 mg followed by 160 mg weekly). The predominantly white, non-Hispanic male participants (mean age of 51 years) received 300 mg/day of allopurinol, titrated to serum urate <6 mg/dL. Flare-ups were self-reported by patients via an interactive telephone voice response system.
During a 12-week period, the researchers observed an average of 0.15 acute gout flares per patient in those receiving rilonacept, compared with 0.79 flare-ups per patient in those receiving placebo. Only 14.6 percent of patients receiving rilonacept experienced one or more gout attacks during ULT, while 45.2 percent of those on placebo suffered flare-ups. Adverse events were similar between the two groups.
"Prevention of gout flares with an agent that has an acceptable safety and tolerability profile could potentially contribute to increased long-term adherence with ULT and thus better maintenance of reduced serum urate levels and better disease control," the authors write. "Further evaluation of rilonacept in this disease is warranted, for both prevention and treatment of acute flares."
The study was funded by Regeneron Pharmaceuticals Inc., the manufacturer of rilonacept; several authors disclosed financial relationships with pharmaceutical companies, including Regeneron.
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