Phase III trial of Dupixent shows efficacy in chronic spontaneous urticaria.- Regeneron + Sanofi

Topline results from the randomized, double-blind, placebo-controlled Phase III trial, which met primary and all key secondary endpoints at week 24, were announced in July 2021.

Data presented at AAAAI 2022 showed that patients who added Dupixent to standard-of-care antihistamines nearly doubled the reduction in itch and urticaria activity compared to standard-of-care alone with continuous improvement out to 24 weeks. These patients experienced a: 63% reduction in itch severity with Dupixent versus 35% with placebo, as measured by a 0-21 point itch severity scale (10.24 point reduction with Dupixent versus 6.01 point reduction with placebo, p<0.001), the primary endpoint in the u.s. (secondary endpoint in the eu). 65% reduction in urticaria activity (itch and hive) severity with dupixent versus 37% with placebo, as measured by a 0-42 point urticaria activity scale (20.53 point reduction with dupixent versus 12.00 point reduction with placebo, p><0.001), the primary endpoint in eu (secondary endpoint in the u.s.).></0.001),></0.001),>

The trial demonstrated safety results similar to the known safety profile of Dupixent in its approved dermatological indications For the 24-week treatment period, overall rates of adverse events were generally similar between the Dupixent and placebo groups (50% Dupixent, 59% placebo). The most common adverse event was injection site reactions (11% Dupixent, 13% placebo). These results will be presented in a late-breaking session at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting.