Dados do Trabalho

Título

Dupilumab Reduces Disease Activity in Patients with Chronic Spontaneous Urticaria: LIBERTY-CSU CUPID Study A

Resumo

Introduction: Chronic spontaneous urticaria (CSU) is a chronic inflammatory disease characterized by wheals and/or angioedema that recur for >6 weeks. The overall goal of CSU treatment is to clear the signs and symptoms until urticaria shows spontaneous remission. Many patients with CSU fail to respond adequately to standard-of-care H1-antihistamines (H1-AH).

Methods: LIBERTY-CSU CUPID Study A (NCT04180488) was a randomized, placebo-controlled, 24-week, phase 3 trial that evaluated dupilumab efficacy and safety in patients aged ≥6 years with CSU who remained symptomatic despite H1-A1 treatment, and were omalizumab-naïve. Background therapy was study-defined H1-AH at up to 4-fold the approved dose. Endpoints included the proportion of patients with Urticaria Activity Score over 7 days (UAS7) ≤6 and UAS7 = 0 up to Week 36.

Results: In patients with CSU inadequately controlled with H1-AH, dupilumab treatment resulted in a numerically greater proportion of patients achieving well-controlled urticaria (UAS7 ≤6) from Week 8 and urticaria-free (UAS7 = 0) status from Week 14, vs placebo. At Week 24, 53.1% of dupilumab-treated patients achieved UAS7 ≤6 and 35.9% achieved UAS7 = 0 (vs 34.0% and 18.9% with placebo; P = 0.0379 and P = 0.0411, respectively). Following discontinuation of dupilumab at Week 24, the proportion of patients achieving well-controlled urticaria or urticaria-free (UAS7 ≤6 and UAS7 = 0) status remained numerically greater for dupilumab vs placebo to Week 36.

Conclusion: A numerically greater proportion of patients treated with dupilumab achieved well-controlled urticaria (UAS ≤6) or urticaria-free (UAS7 = 0) status vs placebo. Dupilumab safety was consistent with the known safety profile.