Dupilumab for chronic spontaneous urticaria: results from phase 3 trials

Published: February 28, 2024

Chronic spontaneous urticaria (CSU) is a skin disease with recurring itchy hives (wheals) and skin swellings (angioedema) that occur for more than 6 weeks without any known cause. Symptoms include itching, burning, and pain, which can have a significant impact on patients’ quality of life. Current treatments for CSU include H1 antihistamines (H1-AH) and omalizumab, but there are patients who do not experience symptom relief from either treatment. Case reports have demonstrated improvement of CSU signs and symptoms after treatment with dupilumab, which has a different treatment target than omalizumab and is effective in multiple diseases, including atopic dermatitis (eczema) and asthma.

In a recent study published in The Journal of Allergy and Clinical Immunology (JACI), Maurer et al. (doi: 10.1016/j.jaci.2024.01.028; NCT04180488) reported key results on the safety and efficacy of dupilumab from two independent trials in patients with CSU inadequately controlled with H1-AH: CUPID Study A included patients aged 6 years and older without prior omalizumab use; and CUPID Study B included patients aged 12 years and older who were intolerant of or had not responded adequately to prior omalizumab treatment. Patients received dupilumab 300 mg or placebo every two weeks for 24 weeks, while they remained on their background dose of H1-AH throughout the study. The primary endpoint was either change from baseline over 7 days in the Urticaria Activity Score (UAS7; measures severity of both itch and hives) or Itch Severity Score (ISS7) at week 24, with the other as a key secondary endpoint, depending on regional regulatory requirements. Safety data was pooled from the two studies.

Study A met its primary endpoint and the results demonstrated clinically and statistically significant improvement in both itch, hives, and urticaria activity with dupilumab treatment compared with placebo at week 24. While Study B did not meet its primary endpoint, patients who were intolerant of or who did not respond to omalizumab did show improvements in urticaria activity after 24 weeks of dupilumab treatment. These findings are important for patients who do not respond to H1-AH or omalizumab treatment. The overall safety profile of dupilumab was consistent with the known safety profile of this drug.

Dupilumab significantly reduced urticaria disease activity in omalizumab-naïve patients with CSU uncontrolled with standard of care and demonstrated a trend for improvement in patients who were intolerant of or incomplete responders to omalizumab treatment and standard of care. These findings provide valuable insight for clinicians considering treatment options for these patient populations, which have limited available treatment options.

The Journal of Allergy and Clinical Immunology (JACI) is an official scientific journal of the AAAAI and is the most-cited journal in the field of allergy and clinical immunology.

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