Mitha E, Schumacher HR, Fouche L et al., Rilonacept for gout flare prevention during initiation of uric acid-lowering therapy: results from the PRESURGE-2 international, phase 3, randomized, placebo-controlled trial. Rheumatology, (2013) 52:1285-1292.doi:10.1093/rheumatology/ket114
Rilonacept significantly reduces the occurrence of gouty flares in patients starting on allopurinol(Drug information on allopurinol) as uric acid-lowering therapy (ULT). More than 70% who got the interleukin-1 inhibitor before ULT had no flares at all during the international phase 3 clinical trial called PRESURGE-2.
The trial involves 248 hyperuricemic gout patients from South Africa, Germany, and Asia who have had two or more flares within the past year. When initiating ULT with allopurinol, they were randomized to once-weekly subcutaneous rilonacept 80 mg, rilonacept 160 mg, or placebo for 16 weeks.
At 16 weeks the participants, predominantly male and racially diverse (half white, one third Asian, and 13% black), saw a reduction in flares by 71.8% with the 80 mg dose and by 72.6% with the 160 mg dose. Among subjects on placebo the reduction was only 43.9%. Most completed the study.
The proportion of patients without any flares was higher with both doses of rilonacept than with placebo. Numbers of adverse events (AEs) were similar across the three groups, mostly mild injection site reactions with rilonacept, and no serious drug-related AEs or deaths.