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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



(72% reduction)

(p<0.0001)Key secondary endpointsProportion of patients with greater than or equal to 1 flare (% reduction compared to placebo) 56.1%


(54% reduction)



(63% reduction)

(p<0.0001)Proportion of patients with  greater than or equal to 2 flares (% reduction compared to placebo)32.9%


(74% reduction)



(82% reduction)

(p<0.0001)* One patient did not report flare data and was excluded from efficacy analyses Overall, the cumulative rate of infections was 27.4% in patients treated with ARCALYST 160 mg, 28.0% in patients treated with ARCALYST 80 mg, and 25.6% in placebo patients.  No deaths were reported in this study.

Specific adverse events that occurred at a frequency of at least 5% in any study group were: injection site reaction (17.9% with ARCALYST 160 mg, 12.2% with ARCALYST 80 mg, and 1.2% with placebo), upper respiratory tract infection (15.5% with ARCALYST 160 mg, 12.2% with ARCALYST 80 mg, and 12.2% with placebo), influenza viral infection (6.0% with ARCALYST 160 mg, 6.1% with ARCALYST 80 mg, and 7.3% with placebo), taking more than the recommended dose (4.8% with ARCALYST 160 mg, 7.3% with ARCALYST 80 mg, and 2.4% with placebo), and headache (1.2% with ARCALYST 160 mg, 6.1% with ARCALYST 80 mg, and 3.7% with placebo).

About the PRE-SURGE 1 StudyRegeneron previously announced the results of the identical North American-based PRE-SURGE 1 (PREventative Study against URate-lowering drug-induced Gout Exacerbations) study, a double-blind, placebo-controlled study which evaluated the number of gout flares per patient over the first 16 weeks following initiation of allopurinol therapy.  Patients who received ARCALYST at a weekly, self-administered, subcutaneous dose of 160 mg had an 80% decrease in mean numbe

SOURCE Regeneron Pharmaceuticals, Inc.
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