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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

he efficacy findings from the PRE-SURGE 1 trial demonstrating that treatment with ARCALYST reduced the incidence of such flares. With these positive Phase 3 trials in patients with gout initiating uric acid-lowering therapy, we plan to submit a supplemental Biologics License Application for U.S. regulatory approval in mid-2011."  

Regeneron also announced the results from a third Phase 3 study (RE-SURGE), which evaluated the safety of ARCALYST versus placebo over 16 weeks in 1,315 patients who were at risk for gout flares while initiating or taking uric acid-lowering drug treatment. In this study, ARCALYST® (rilonacept) was generally well tolerated, and the safety profile was consistent with that reported in the PRE-SURGE 1 and PRE-SURGE 2 studies.  Specifically, other than injection site reactions, the incidence of treatment-emergent adverse events was generally well-balanced among the 985 patients who received ARCALYST at a weekly, self-administered, subcutaneous dose of 160 mg and the 330 patients who received placebo.

In the RE-SURGE Phase 3 safety study, injection site reactions, usually considered mild, were reported more commonly with ARCALYST (15.2%) than with placebo (3.3%). 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 and 0.9% of placebo patients. Deaths were reported for 0.3% of patients treated with ARCALYST and 0.9% of placebo patients.

In this safety study, efficacy was evaluated as a secondary endpoint, and all secondary endpoints were achieved. Compared to placebo, patients who received ARCALYST had a 71% decrease in mean number of patient-reported gout flares (p<0.0001). Compared to placebo, treatment with ARCALYST reduced the proportion of patients who reported at least one gout flare during the study period by 50% (p<0.0001) and reduced the proportion of
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SOURCE Regeneron Pharmaceuticals, Inc.
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