Arcalyst reduces gout flares 81% in Ph II trial

The USA's Regeneron Pharmaceuticals' Arcalyst (rilonacept) produced a statistically-significant reduction versus placebo in the incidence of gout flares in a mid-stage trial. In this double-blind, placebo-controlled study involving 83 patients, the mean number of flares per patient over the first 12 weeks of urate-lowering therapy was 0.79 with placebo and 0.15 with Arcalyst (p=0.0011), an 81% drop.

In the first 12 weeks of therapy, 45.2% of patients treated with placebo experienced a gout flare and, of those, 47.4% had more than one flare. Among those receiving Arcalyst, only 14.6% experienced a gout flare (p=0.0037 vs placebo) and none had more than one flare. No serious drug-related adverse events were reported in patients on Arcalyst, the firm noted. Injection-site reaction was the most commonly reported negative reaction with Arcalyst treatment. Detailed data from the study will be presented at a future scientific conference. Regneron added that all the secondary endpoints of the trial were met.