P68: Dupilumab provides improvement in sleep in children aged ≥ 6 years with severe atopic dermatitis (AD) and adolescents with moderate‐to‐severe AD

J. A. Bernstein,M. Maurer, A. Gim, enez-Arnau, W. Soong, G. Sussman, M. Metz,B. Lanier,K. Sitz, M. Hide,E. Hua,A. Barve,T. Severin,R. Janocha, A. Paller, A. Wollenberg, E. Simpson, L. Beck, C.-h. Hong, D. Marcoux, Z. Chen, N. Levit, A. Bansal, A. Rossi, J. Chao

British Journal of Dermatology(2021)

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P67 High rate of complete response with ligelizumab in adults with moderate-to-severe chronic spontaneous urticaria J.A. Bernstein, M. Maurer, A. Gim enez-Arnau, W. Soong, G. Sussman, M. Metz, B. Lanier, K. Sitz, M. Hide, E. Hua, A. Barve, T. Severin and R. Janocha University of Cincinnati College of Medicine and Bernstein Clinical Research Center, Cincinnati, OH, USA; Department of Dermatology and Allergy, Charit e – Universit€atsmedizin Berlin, Berlin, Germany; Dermatology Department, Hospital del Mar-Parc de Salut Mar, Universitat Aut onoma de Barcelona, Barcelona, Spain; Alabama Allergy and Asthma Center, Clinical Research Center of Alabama, Birmingham, AL, USA; Division of Allergy and Clinical Immunology, University of Toronto, Toronto, Canada; Texas College of Osteopathic Medicine, University of North Texas, Fort Worth, TX, USA; Clinical Research Center, Little Rock Allergy and Asthma Clinic, Little Rock, AR, USA; Hiroshima University, Hiroshima, Japan; Shanghai Novartis Trading Ltd, Shanghai, China; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; and Novartis Pharma AG, Basel, Switzerland In adults with chronic spontaneous urticaria (CSU), ligelizumab – a humanized monoclonal anti-IgE antibody – demonstrated greater control of hives, itch and angioedema than omalizumab and placebo in the core phase IIb study. We aimed to assess the efficacy of ligelizumab 72 mg and 240 mg vs. omalizumab at weeks 4 and 12 in adults with moderate and severe CSU at baseline. Data were analysed from a randomized, double-blind, phase IIb study (NCT02477332) of ligelizumab [24, 72 or 240 mg every 4 weeks (Q4W) or 120-mg single dose) vs. omalizumab (300 mg Q4W) or placebo in adults with moderate-to-severe CSU [weekly Urticaria Activity Score (UAS7) ≥ 16]. UAS7 values were assigned to five activity bands: 28–42, severe; 16–27, moderate; 7–15, mild; 1–6, low; 0, urticaria-free. The percentage of patients with baseline moderate-to-severe CSU activity achieving complete symptom control (UAS7 = 0) or low/well-controlled disease activity (UAS7 ≤ 6) at weeks 4 and 12 in ligelizumab (72 mg and 240 mg) and omalizumab 300-mg arms are reported. At baseline, the distribution of patients with moderate-to-severe CSU activity was balanced across treatment groups (moderate: 23 8–37 6%; severe: 58 8–75%). At weeks 4 and 12, a higher percentage of patients with moderate or severe baseline disease activity achieved low/well-controlled disease activity (UAS7 ≤ 6) or complete symptom control (UAS7 = 0) with ligelizumab vs. omalizumab (Table 1).
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