Dupilumab Improves Chronic Spontaneous Urticaria Symptoms

Dupixent® (dupilumab) significantly reduced itch and hive activity in patients with chronic spontaneous urticaria, according to phase 3 trial data presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2024 Annual Scientific Meeting in Boston, Massachusetts.

In a press release from Regeneron Pharmaceuticals and Sanofi, the companies announced positive results from the phase 3 LIBERTY-CUPID Study C, evaluating dupilumab for the treatment of biologic-naïve patients with chronic spontaneous urticaria (CSU) inadequately controlled by antihistamines. 

Patients (n=151) receiving dupilumab showed improvement, with a reduction in itch severity score of 8.64 points vs. 6.10 in the placebo arm (P = 0.02). Additionally, 41% of those on dupilumab achieved well-controlled disease status versus 23% of placebo recipients (P = 0.005). Additionally, 30% of patients on dupilumab achieved a complete response, compared to 18% in the placebo group (P = 0.02).

“These data confirm results seen in the previous Study A and reinforce the potential of dupilumab to significantly alleviate symptoms for patients, helping them to better control this challenging disease," said Thomas B. Casale, MD, Professor of Internal Medicine at the University of South Florida, of the findings in a news release.

The safety profile of dupilumab was consistent with previous research; overall adverse events occurring at similar rates between dupilumab (53%) and placebo (53%). Common side effects included injection site reactions, accidental overdose, and COVID-19 infections. Regeneron and Sanofi plan to resubmit to U.S. regulatory authorities by year-end. If approved, dupilumab would become the first targeted therapy for CSU in over a decade.

Source: Regeneron/Sanofi press release. October 20, 2024.