• John S Sundy, H Ralph Schumacher, Alan Kivitz, Steven P Weinstein, Richard Wu, Shirletta King-Davis, and Robert R Evans.
• From the Department of Medicine, Duke University Medical Center, Durham, North Carolina; Department of Rheumatology, VA Medical Center and University of Pennsylvania, Philadelphia; Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, Pennsylvania; Department of Clinical Sciences Immunology and Inflammation, Department of Biostatistics, and the Department of Clinical Operations, Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA.J.S. Sundy, MD, PhD, Department of Medicine, Duke University Medical Center; H.R. Schumacher, MD, Department of Rheumatology, VA Medical Center and University of Pennsylvania; A. Kivitz, MD, Department of Rheumatology, Altoona Center for Clinical Research; S.P. Weinstein, MD, PhD, Department of Clinical Sciences Immunology and Inflammation, Regeneron Pharmaceuticals Inc.; R. Wu, PhD, Department of Biostatistics, Regeneron Pharmaceuticals Inc.; S. King-Davis, RN, MS, Department of Clinical Operations, Regeneron Pharmaceuticals Inc.; R.R. Evans, PharmD, Department of Clinical Sciences Immunology and Inflammation, Regeneron Pharmaceuticals Inc. john.sundy@duke.edu.
• J Rheumatol. 2014 Aug 1; 41 (8): 1703-11.

ObjectiveTo 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).MethodsThis phase III study was conducted in the United States, South Africa, Europe, and Asia. Adults (n = 1315, 18-80 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.ResultsDemographic and clinical characteristics were similar between treatments; predominantly male (87.8%), mean age 52.7 ± 11.3 years. Patients with ≥ 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 < 0.0001), fewer patients with ≥ 1 and ≥ 2 gout flares (p < 0.0001), and 64.9% fewer gout flare days (p < 0.0001) relative to placebo.ConclusionWeekly 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. Clinicaltrials.gov identifier NCT00856206; EudraCT No. 2008-007784-16.

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