USA: Results from a phase 3 trial revealed that dupilumab is well-tolerated and causes significant improvement in patients with H1 antihistamine-resistant chronic spontaneous urticaria (CSU). The findings of the trial were presented at the annual meeting of the American Academy of Allergy, Asthma & Immunology and subsequently published in the Journal of Allergy and Clinical Immunology.
Chronic spontaneous urticaria (CSU) causes recurrent itchy hives and/or angioedema and significantly impacts the quality of life. Many patients experience a substantial disease burden despite treatment with recommended and escalated doses of H1 antihistamines. Considering this, Marcus Maurer, Charite-Universitatsmedizin Berlin, and colleagues aimed to evaluate the safety and efficacy of dupilumab in patients aged d >_6 years with CSU who remained symptomatic despite treatment with H1 antihistamines in LIBERTY-CSU CUPID Study A -- a randomized, placebo-controlled, 24-week, phase 3 trial.

The trial included patients on a standard or <_ 4-fold dose of antihistamines. They were randomized to receive add-on dupilumab (n 5 70) 300 mg (adults/adolescents >_ 60 kg) or 200 mg (adolescents < 60 kg/children >_ 30 kg) or matching placebo (n 5 68) subcutaneously every 2 weeks. change from baseline at Week 24 in Itch Severity Score over 7 days (ISS7) was the primary endpoint. Key secondary endpoints included Urticaria Activity Score over 7 days (UAS7).
Key findings of the study include:
Baseline characteristics were generally balanced across treatment groups.
Mean ISS7 and UAS7 (dupilumab/placebo) at baseline were 16.1/15.7 and 31.9/30.8, respectively.
At Week 24, least squares (LS) mean change in ISS7 (range:0-21) from baseline was -10.2/-6.0 for dupilumab/placebo, respectively (LS mean difference -4.2, P50.0005) and for UAS7 (range:0-42) was -20.5/-12.0 (difference -8.5).
Overall treatment-emergent adverse events (TEAEs) were comparable between dupilumab and placebo: 35 (50.0%)/40 (58.8%); occurrence of injection site reactions was 8 (11.4%)/9 (13.2%), conjunctivitis 0/1 (1.5%), and serious TEAEs 2 (2.9%)/5 (7.4%).
The researchers conclude, "dupilumab demonstrated clinically meaningful and statistically significant improvements in patients with H1 antihistamine- resistant CSU and was well tolerated."
Reference:
The study titled, "Dupilumab Significantly Reduces Itch and Hives in Patients With Chronic Spontaneous Urticaria: Results From a Phase 3 Trial (LIBERTY-CSU CUPID Study A)," was published in the Journal of Allergy and Clinical Immunology.
DOI: https://doi.org/10.1016/j.jaci.2021.12.002