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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

TARRYTOWN, N.Y., Feb. 28, 2011 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced that in a second Phase 3 study (PRE-SURGE 2) in gout patients initiating allopurinol therapy, ARCALYST (rilonacept) met the primary and all secondary study endpoints. The primary endpoint was the number of gout flares per patient over the 16-week treatment period. Patients who received ARCALYST at a weekly, self-administered, subcutaneous dose of either 160 milligrams (mg) or 80 mg had a 72% decrease in mean number of gout flares compared to the placebo group (p<0.0001).  These results were consistent with those previously reported in the first, identical Phase 3 efficacy study (PRE-SURGE 1).

ARCALYST (also known as IL-1 Trap) also met all secondary endpoints of the study. Compared to placebo, treatment with ARCALYST reduced the proportion of patients who experienced at least one gout flare during the study period by 63% for ARCALYST 160mg (p<0.0001) and by 54% for ARCALYST 80 mg (p=0.0001). Compared to placebo, treatment with ARCALYST reduced the proportion of patients who experienced two or more flares by 82% for ARCALYST 160 mg (p<0.0001) and by 74% for ARCALYST 80 mg (p=0.0002).

ARCALYST was generally well tolerated with the incidence of serious adverse events generally well-balanced across the placebo and ARCALYST groups.  Injection site reactions, usually considered mild, were reported more commonly with ARCALYST than with placebo.

"Gout, a serious and sometimes debilitating disease, is rapidly growing in prevalence throughout the world. Unfortunately, its management is often hampered by the occurrence of painful gout flares early during treatment with standard-of-care uric acid-lowering therapy," stated George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories. "We are pleased that this study confirmed t
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SOURCE Regeneron Pharmaceuticals, Inc.
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