Phase 3 Data Supports Dupilumab’s Approval for CSU, with Thomas Casale, MD

Dupilumab (Dupixent) reduced itch and urticaria activity in patients with chronic spontaneous urticaria (CSU) who were uncontrolled with H1-antihistamines, regardless of body mass index (BMI).^1,2

These findings, from the phase 3 LIBERTY-CSU CUPID Study A and Study C (NCT04180488), were presented at the 2025 American Academy of Allergy, Asthma, and Immunology/World Allergy Organization Joint Congress, February 28-March 3, in San Diego, California, by Thomas Casale, MD, professor of internal medicine at Morsani College of Medicine, University of South Florida.

HCPLive spoke with Casale to learn more about dupilumab, which is up for FDA review for CSU with a target action date of April 18, 2025.³ Casale went over the safety and efficacy data seen in the studies, as well as a subgroup analysis that demonstrated no difference in improvements even at the upper limits of normal or in the obese range of BMI.

“I think this will give individuals some reassurance that this drug will work with chronic urticaria, and although not tracking as much with other T2-high disease, if you do have, for example, asthma, you are more likely to have urticaria than the normal population, and if you have a drug that can treat multiple comorbid conditions, I think that also makes a positive statement for the development program for dupilumab for urticaria,” Casale said.

REFERENCES

1. Casale T, Saini S, Bernstein J, et al. Dupilumab Improves Itch and Urticaria Activity In Patients With Chronic Spontaneous Urticaria: Pooled Results From Two Phase 3 Trials (LIBERTY-CSU CUPID Study A and Study C). Late-breaking abstract presented at AAAAI 2025 in San Diego from February 28 – March 3.

2. Casale T, Maurer M, Gimenez-Arnau A, et al. Dupilumab Improves Signs And Symptoms Of Chronic Spontaneous Urticaria Regardless Of Baseline Body Mass Index. Presented at: AAAAI/WAO Joint Congress, San Diego; 2/28-3/3. Abstract 589.

3. Press Release: Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria. News release. Sanofi. November 15, 2024. Accessed March 6, 2025. https://www.sanofi.com/en/media-room/press-releases/2024/2024-11-15-06-00-00-2981756