Thomas B. Casale, MD

Casale discussed data from the phase 3 LIBERTY-CSU CUPID studies evaluating dupilumab’s use in urticaria.

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).

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.

 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.

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.

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.

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.

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 

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Casale discussed data from the phase 1b/2a BEACON study he presented at the AAAAI/WAO Joint Congress.

Investigating Briquilimab’s Efficacy and Safety for CSU, with Thomas Casale, MD

Briquilimab was well-tolerated and seemed to control disease in patients with chronic spontaneous urticaria (CSU) according to new data from the phase 1b/2a BEACON study (NCT06162728).

These findings 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, Internal Medicine, Morsani College of Medicine, University of South Florida.

® spoke with Casale to learn more about briquilimab, which is an aglycosylated antibody that potently inhibits SCF/c-Kit signaling and induces apoptosis of mast cells. He shared data he presented at the congress and why briquilimab may have potential as a treatment in people with CSU refractory to omalizumab. In terms of safety, he noted that due to briquilimab’s mechanism of action, some participants may experience hypogeusia, skin and hair color changes, and neutropenia, but no clinically significant changes were identified in the study.

“With the approval of omalizumab, that made a big difference, because a number of patients do respond and they get better, but there's always a caveat to that, and that is, there are certain patients that don't respond as well, and there are certain patients that respond, but it takes them a long time to respond, and in those patients, it's a very troubling problem for them… And I think having some options like briquilimab, which in this initial study, appears to work very rapidly and has a sustained relief, is a very good option,” Casale said.

Casale's disclosures include Sanofi, Genentech, Regeneron, Novartis, Jasper and Celldex.

Casale T, Majeed S, Tucker E, et al. Initial results from BEACON, a phase 1b/2a dose escalation study of the anti-c-Kit briquilimab antibody in adults with chronic spontaneous urticaria (CSU). Presented at: 2025 AAAAI/WAO Joint Congress, February 28-March 3. Abstract L24

Thomas B. Casale, MD

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