Dupilumab is Effective for Chronic Spontaneous Urticaria, According to LIBERTY-CUPID Trial

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Regeneron Pharmaceuticals, Inc. and Sanofi will announce findings from LIBERTY-CUPID Study C that confirm the safety and efficacy of dupilumab (Dupixent) in treating uncontrolled chronic spontaneous urticaria (CSU).¹ Nearly half of patients reached well-controlled disease status and saw a significant reduction in itching and hives.

These results align with dupilumab’s existing safety profile among other dermatological indications. The phase 3 trial met its primary and secondary endpoints back in September.² The results from the latest study are being presented at the 2024 American College of Allergy, Asthma, and Immunology (ACAAI) Annual Scientific Meeting in Boston, Massachusetts from October 24 to 28.

The randomized, double-blind trial involved 151 participants aged 6 years and older who had not previously used omalizumab; 74 received dupilumab and 77 received a placebo. The patients began this treatment while continuing the use of standard-care H1 antihistamines.

Well-controlled disease status was achieved in 41% of patients. Researchers utilized the weekly itch severity score (ISS7) and weekly urticaria activity score (UAS7) to measure results at baseline and at 24 weeks. When compared to placebo, these improvements were noted:

• ISS7 (8.64- vs. 6.10-point reduction from baseline; p = 0.02)
• UAS7 (15.86- vs. 11.21-point reduction from baseline; p = 0.02).
• Well-controlled disease status (UAS7 ≤6; 41% vs. 23%; p = 0.005)
• Complete response (UAS7 = 0; 30% vs. 18%; p = 0.02)

The investigators noted adverse effects such as injection site reactions, accidental overdoses, and COVID-19 diagnoses but these were observed in both patient groups. Adverse events were more commonly found with dupilumab compared to placebo.

The IL-4 and IL-13 inhibitor has been approved for the treatment of CSU in Japan and the United Arab Emirates. It is also under regulatory review in the US and if approved, it would be the first targeted therapy for CSU in more than 10 years. Regeneron and Sanofi plan to submit this data to the FDA by the end of the year.³

In a press release, Thomas B. Casale, MD, Professor of Internal Medicine at the Morsani College of Medicine at the University of South Florida, said, "These data confirm results seen in the previous Study A and reinforce the potential of Dupixent to significantly alleviate symptoms for patients, helping them to better control this challenging disease.”¹

References

1. Dupixent® (dupilumab) late-breaking positive phase 3 data in chronic spontaneous urticaria to be presented at ACAAI. News release. Regeneron. October 24, 2024. Accessed October 24, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-late-breaking-positive-phase-3-data-chronic

2. Dupixent (dupilumab) phase 3 trial confirms significant improvements in itch and hives for patients with chronic spontaneous urticaria (CSU). News release. BioSpace. September 11, 2024. Accessed October 24, 2024. https://www.biospace.com/press-releases/dupixent-dupilumab-phase-3-trial-confirms-significant-improvements-in-itch-and-hives-for-patients-with-chronic-spontaneous-urticaria-csu

3. Regeneron and Sanofi provide update on Dupixent (dupilumab) sBLA for chronic spontaneous urticaria. News release. Regeneron. October 20, 2023. Accessed October 24, 2024. https://www.biospace.com/press-releases/dupixent-dupilumab-phase-3-trial-confirms-significant-improvements-in-itch-and-hives-for-patients-with-chronic-spontaneous-urticaria-csu