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ARCALYST® (rilonacept) Meets Primary and All Secondary Endpoints in Second Phase 3 Trial for Prevention of Gout Flares in Patients Initiating Uric Acid-Lowering Therapy
Date:2/28/2011

0 mg, 8.8% with ARCALYST 80 mg, and 7.6% with placebo), lower respiratory tract infection (0% with ARCALYST 160 mg, 5.0% with ARCALYST 80 mg, and 2.5% with placebo), musculoskeletal pain/discomfort (6.2% with ARCALYST 160 mg, 7.5% with ARCALYST 80 mg, and 8.9% with placebo), and headache, (3.7% with ARCALYST 160 mg, 6.3% with ARCALYST 80 mg, and 1.3% with placebo).

About the RE-SURGE StudyThe global RE-SURGE (REview of Safety Using Rilonacept in preventing Gout Exacerbations) study, was a double-blind, placebo-controlled study primarily focused on evaluation of safety. The trial was conducted in the United States, South Africa, Germany, and parts of Asia.  A total of 1,315 patients who were at risk for gout flares because they were initiating or taking uric acid-lowering drug treatment were randomly assigned in a 1:3 ratio to receive either weekly placebo injections (n=330) for 16 weeks or weekly subcutaneous injections of ARCALYST dosed at 320 mg as an initial loading dose and 160 mg thereafter (n=985) for a total of 16 weeks.  In this trial, a gout flare was defined as patient-reported acute articular pain typical of a gout attack that was deemed (by the patient and/or the investigator) to require treatment with an anti-inflammatory therapeutic.

Overall, the cumulative rate of infections was 20.1% in patients treated with ARCALYST and 19.1% in placebo patients.  Serious infections were reported in 0.5% of patients treated with ARCALYST® (rilonacept) and 0.9% of placebo patients.  Deaths were reported for 0.3% of patients treated with ARCALYST and 0.9% of placebo patients.

Specific adverse events that occurred at a frequency of at least 5% in any study group were: injection site reaction (15.2% with ARCALYST and 3.3 % with placebo), musculoskeletal pain/ discomfort (11.2% with ARCALYST and 9.7% with placebo), headaches (9.5% with ARCALYST and 8.8% with placebo), joint
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SOURCE Regeneron Pharmaceuticals, Inc.
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