{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T02:38:39Z","timestamp":1789180719690,"version":"build-2803163510"},"reference-count":39,"publisher":"The Journal of Rheumatology","issue":"8","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Rheumatol"],"published-print":{"date-parts":[[2014,8]]},"abstract":"<jats:sec><jats:title>Objective.<\/jats:title><jats:p>To evaluate the safety and efficacy of once-weekly subcutaneous rilonacept 160 mg for prevention of gout flares in patients initiating or continuing urate-lowering therapy (ULT).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods.<\/jats:title><jats:p>This phase III study was conducted in the United States, South Africa, Europe, and Asia. Adults (n = 1315, 18\u201380 yrs) with gout, who were initiating or continuing ULT, were randomized to treatment with weekly subcutaneous injections of rilonacept 160 mg or placebo for 16 weeks followed by a 4-week safety followup. The primary endpoint was safety, assessed by adverse events (AE) and laboratory values. Efficacy was a secondary endpoint.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results.<\/jats:title><jats:p>Demographic and clinical characteristics were similar between treatments; predominantly male (87.8%), mean age 52.7 \u00b1 11.3 years. Patients with \u2265 1 AE were 66.6% with rilonacept versus 59.1% placebo, with slightly more AE-related withdrawals with rilonacept (4.7% vs 3.0%) because of the greater incidence of injection site reactions (15.2% rilonacept, 3.3% placebo). Serious AE were similar in both groups, as were serious infections (0.9% placebo, 0.5% rilonacept); no tuberculosis or opportunistic infections occurred. Most common AE were headache, arthralgia, injection site erythema, accidental overdose, and pain in extremity. Of the 6 deaths, only 1 in the placebo group was considered treatment-related. At Week 16, rilonacept resulted in 70.3% fewer gout flares per patient (p &lt; 0.0001), fewer patients with \u2265 1 and \u2265 2 gout flares (p &lt; 0.0001), and 64.9% fewer gout flare days (p &lt; 0.0001) relative to placebo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion.<\/jats:title><jats:p>Weekly subcutaneous administration of rilonacept 160 mg showed no new safety signals. The safety profile was consistent with previous studies. Rilonacept also significantly reduced the risk of gout flares.<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"Clinicaltrials.gov\" xlink:type=\"simple\">Clinicaltrials.gov<\/jats:ext-link>identifier<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT00856206\">NCT00856206<\/jats:ext-link>; EudraCT No. 2008-007784-16.<\/jats:p><\/jats:sec>","DOI":"10.3899\/jrheum.131226","type":"journal-article","created":{"date-parts":[[2014,7,16]],"date-time":"2014-07-16T04:56:46Z","timestamp":1405486606000},"page":"1703-1711","source":"Crossref","is-referenced-by-count":63,"title":["Rilonacept for Gout Flare Prevention in Patients Receiving Uric Acid-lowering Therapy: Results of RESURGE, a Phase III, International Safety Study"],"prefix":"10.3899","volume":"41","author":[{"given":"John S.","family":"Sundy","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H. 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