Journal of dermatological science | 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).
Abstract
BACKGROUND\nTwo 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).\n\n\nOBJECTIVES\nTo 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.\n\n\nMETHODS\nA pooled analysis of two 16-week phase 3 studies in adults with moderate-to-severe AD (N\u2009=\u20091379) inadequately controlled with/inadvisable for topical medications, randomized to dupilumab 300\u2009mg once weekly (qw), every 2 weeks (q2w), or placebo.\n\n\nRESULTS\nDupilumab significantly improved all pre-specified efficacy endpoints versus placebo (P\u2009<\u20090.0001), 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\u2009<\u20090.0001). 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.\n\n\nCONCLUSIONS\nDupilumab 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.