• J. Dermatol. Sci. · May 2019

    Efficacy and safety of dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis: a pooled analysis of two phase 3 randomized trials (LIBERTY AD SOLO 1 and LIBERTY AD SOLO 2).

    • Diamant Thaçi, L SimpsonEricEDepartment of Dermatology, Oregon Health and Science University, Portland, OR, USA., Mette Deleuran, Yoko Kataoka, Zhen Chen, Abhijit Gadkari, Laurent Eckert, Bolanle Akinlade, GrahamNeil M HNMHRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA., Gianluca Pirozzi, and Marius Ardeleanu.
    • Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany. Electronic address: diamant.thaci@uksh.de.
    • J. Dermatol. Sci. 2019 May 1; 94 (2): 266-275.

    BackgroundTwo phase 3 trials with identical design, LIBERTY AD SOLO 1 (NCT02277743) and LIBERTY AD SOLO 2 (NCT02277769), confirmed dupilumab efficacy and safety versus placebo in adults with moderate-to-severe atopic dermatitis (AD).ObjectivesTo report a pooled analysis of these trials to further explore dupilumab's effects on AD clinical parameters, patient-reported outcomes (PROs), symptoms of anxiety/depression, health-related quality of life (HRQoL), and safety.MethodsA pooled analysis of two 16-week phase 3 studies in adults with moderate-to-severe AD (N = 1379) inadequately controlled with/inadvisable for topical medications, randomized to dupilumab 300 mg once weekly (qw), every 2 weeks (q2w), or placebo.ResultsDupilumab significantly improved all pre-specified efficacy endpoints versus placebo (P < 0.0001), including clinical severity outcomes and PROs, symptoms of anxiety/depression, and HRQoL, consistent with previously published results. In post-hoc analyses, among patients reporting at least some baseline pain/discomfort on the EuroQoL-5D, no pain/discomfort at Week 16 was reported by 43%/46%/14% of dupilumab qw/q2w/placebo-treated patients (P < 0.0001). The distribution of dupilumab-treated patients within pre-defined score categories on the Investigator's Global Assessment (0-1/2/3/4) and Eczema Area and Severity Index (≥90%/≥75-<90%/≥50-<75%/<50%) steadily and consistently improved over time versus marginal changes with placebo. Dupilumab significantly improved pruritus within 1-3 days of treatment initiation. No new safety signals were observed. Injection-site reactions and conjunctivitis were more common with dupilumab; AD exacerbation and non-herpetic skin infections more frequent with placebo.ConclusionsDupilumab versus placebo significantly improved objective AD signs, subjective PROs, symptoms of anxiety/depression, and HRQoL, with a favorable benefit-risk profile in adults with moderate-to-severe AD.Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.

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