Phase 3 trial of Arcalyst for prevention of gout flares

Regeneron announced that its Phase 3 study of Arcalyst (rilonacept injection) met its primary and secondary endpoints for the prevention of gout attacks. This trial, known as PRE-SURGE 1 (PREventative Study against URate-lowering drug-induced Gout Exacerbations), was a double-blind, placebo-controlled study whose primary endpoint was measured by the number of gout flares per patient over the first 16 weeks.  Study patients had initiated allopurinol therapy to lower their uric acid levels. Patients who received Arcalyst at a weekly, self-administered, subcutaneous dose of 160 milligrams (mg) had an 80% decrease in mean number of gout flares compared to the placebo group over the 16 week treatment period (0.21 flares vs. 1.06 flares, p<0.0001). Patients who received Arcalyst at a weekly dose of 80 mg had a 73% decrease compared to the placebo group (0.29 flares vs. 1.06 flares, p<0.0001).

With regard to secondary endpoints, treatment with Arcalyst reduced the proportion of patients who experienced two or more flares during the study period by up to 88% (3.7% with Arcalyst 160 mg, 5.0% with Arcalyst 80 mg, and 31.6% with placebo, p<0.0001). Additionally, treatment with Arcalyst reduced the proportion of patients who experienced at least one gout flare during the study period by up to 65% (16.3% with Arcalyst 160 mg, 18.8% with Arcalyst 80 mg, and 46.8% with placebo, p<0.001).
 
Arcalyst is an interleukin-1 (IL-1) blocker already indicated for the treatment of Cryopyrin-associated periodic syndromes (CAPS) including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS) in patients ≥12 years of age.
 
For more information call (877) REGN-777 or visit www.arcalyst.com.