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In chronic spontaneous urticaria inadequately controlled by H1-antihistamines, dupilumab effectively improves itch severity and urticaria activity at 24 weeks.
A phase 3 randomized clinical trial, LIBERTY-CSU CUPID-C, confirms that dupilumab improves disease activity in chronic spontaneous urticaria (CSU) sufferers who remain symptomatic despite treatment with histamine 1-receptor antagonists (H1-AHs).
CSU is marked by recurrent pruritic hives and/or angioedema, and a substantial proportion of patients continue to experience symptoms despite standard-of-care antihistamine therapy. Dupilumab, which blocks interleukin-4 (IL-4)/interleukin-13 (IL-13) signalling, was evaluated in this trial as a treatment option for anti-immunoglobulin E (IgE)-naive patients.
Study design and participants
The LIBERTY-CSU CUPID-C trial replicated the design of the earlier CUPID-A trial and included patients from 10 countries across Asia, Europe, North America and South America. The analysis included 151 patients aged 6–80 years, with a mean age of 44.7 ± 16.9 years; 106 (70.2%) were female. Notably:
Dupilumab substantially improves itch and hives
At week 24, dupilumab was found to produce remarkable improvements in both Itch Severity Score over 7 days (ISS7) and UAS7 compared with placebo (Table 1).
The findings indicate that dupilumab provides an additional decrease in both itch severity and hives/overall urticaria activity beyond placebo in those inadequately controlled with H1-AHs.
Pooled CUPID-A and CUPID-C findings
The combined analysis of 289 participants from CUPID-A and CUPID-C further demonstrated greater improvements in UAS7 and ISS7 with dupilumab, strengthening the evidence for its efficacy in anti-IgE-naive CSU. Safety findings were generally consistent with the established safety profile of dupilumab. In the pooled analysis, treatment-emergent adverse events were noted in 77 subjects (53.5%) receiving dupilumab vs. 81 subjects (55.9%) receiving placebo.
Clinical relevance
The CUPID-C trial replicates and substantiates the findings from CUPID-A, showing that dupilumab successfully mitigates itch, hives, and overall urticaria activity in anti-IgE-naive CSU sufferers whose disease remains uncontrolled despite H1-antihistamine care. The results support the role of IL-4/IL-13 pathway inhibition as a therapeutic strategy in CSU.
JAMA Dermatology
Dupilumab in Patients With Chronic Spontaneous Urticaria: Phase 3 LIBERTY-CSU CUPID Randomized Clinical Trials
Thomas B Casale et al.
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