Dupixent improves itch, hives in phase 3 chronic spontaneous urticaria trial

Dupixent reduced both itch and hives in patients with moderate to severe chronic spontaneous urticaria in a pivotal phase 3 trial, Regeneron and Sanofi announced in a press release.

Dupixent (dupilumab) met all of the primary and key secondary endpoints at 24-weeks in a trial of 138 biologic-naive patients. Patients received either standard-of-care antihistamines plus Dupixent or antihistamines alone.

Itch severity was reduced 63% in the Dupixent group compared with 35% in the placebo group (P < .001), while urticaria activity, which includes itch and hives, was reduced by 65% in the Dupixent group compared with 37% in the placebo group (P < .001).

“The chronic nature of [chronic spontaneous urticaria], coupled with intense itch, causes both a physical and emotional burden on people who have not found an effective treatment,” John Reed, MD, PhD, global head of research and development at Sanofi, said in the release. “This is the fifth inflammatory disease in which Dupixent has demonstrated a significant improvement in symptoms and disease manifestations in phase 3 pivotal studies.”

Safety results showed treatment-emergent adverse events in 50% of the Dupixent group and 59% of the placebo group, with injection site reactions reported as the most common adverse event in both groups.