Regeneron announced results from its second Phase 3 study of Arcalyst (rilonacept) for the treatment of gout patients initiating allopurinol therapy. This trial, known as the global PRE-SURGE 2 (PREventative Study against URate-lowering drug-induced Gout Exacerbations), was a double-blind, placebo-controlled study whose primary efficacy endpoint was the number of gout flares per patient over the first 16 weeks following initiation of allopurinol therapy. Arcalyst met the primary and all secondary study endpoints. Patients who received Arcalyst at a weekly, self-administered, subcutaneous dose of either 160mg or 80mg had a 72% decrease in mean number of gout flares compared to the placebo group (p<0.0001).

With regard to secondary endpoints, Arcalyst compared with placebo, 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 80mg (p=0.0001). Additionally, treatment with Arcalyst reduced the proportion of patients who experienced two or more flares by 82% for Arcalyst 160mg (p<0.0001) and by 74% for Arcalyst 80mg (p=0.0002).

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.

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