(235) Dupilumab improves signs and symptoms of Chronic Spontaneous Urticaria regardless of baseline body mass index

Background: : Chronic spontaneous urticaria (CSU) is a chronic inflammatory skin disease. body mass index (BMI) may impact age at onset, duration, and treatment outcomes.

Objective: : To evaluate the effective response to add-on dupilumab and improvement in symptoms of CSU.

Methods: : LIBERTY-CSU CUPID Study A (NCT04180488), a double-blind phase 3 trial, evaluated dupilumab in omalizumab-naive patients aged ≥6 years with CSU remaining symptomatic despite H1-antihistamine treatment. Patients were randomized to add-on dupilumab (adults/adolescents ≥60 kg, 300 mg; adolescents < 60 kg/children ≥30 kg, 200 mg; n=70) or matching placebo (n=68) subcutaneously every 2 weeks. Efficacy was evaluated using Itch Severity Score over 7 days (ISS7; range 0–21) and Urticaria Activity Score over 7 days (UAS7; range 0–42).

Results: : Baseline characteristics were well balanced between subgroups (BMI < 25 kg/m² [dupilumab/placebo], n=33/24; ≥25 kg/m² to < 30 kg/m², n=18/23; ≥30 kg/m², n=19/20). At Week 24, overall, dupilumab vs placebo significantly improved ISS7 (least squares mean change from baseline: −10.2 vs −6.0; P=0.0005) and UAS7 scores (−20.5 vs −12.0; P=0.0003). Stratification by baseline BMI ( < 25 kg/m²; ≥25 to < 30 kg/m²; ≥30 kg/m²) revealed consistent ISS7 improvement in patients receiving dupilumab vs placebo across baseline BMI subgroups (−10.6 vs −4.8; −9.6 vs −6.9; −9.0 vs −5.5; Pinteraction=0.6342) and a consistent UAS7 improvement across baseline BMI subgroups (−21.3 vs −9.3; −19.2 vs −14.5; −17.5 vs −10.5; Pinteraction=0.5338).

Conclusions: : Dupilumab vs placebo treatment of omalizumab-naive patients with CSU inadequately controlled with antihistamines significantly improved itch severity and urticaria activity regardless of baseline BMI. Overall safety was generally consistent with the known dupilumab safety profile.

Sponsorship:: Sanofi and Regeneron Pharmaceuticals Inc.