Once-daily upadacitinib vs placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): Results from two replicate double-blind, randomised controlled phase 3 trials
The Lancet May 29, 2021
Guttman-Yassky E, Teixeira HD, Simpson EL, et al. - In the present study, the researchers tested the effectiveness and safety of upadacitinib compared with placebo for the treatment of moderate-to-severe atopic dermatitis. Adolescents, aged 12 to 17 years, and adults, aged 18 to 75 years, with moderate-to-severe atopic dermatitis (≥ 10% of body surface area affected by atopic dermatitis, Eczema Area and Severity Index [EASI] score of ≥ 16, validated Investigator's Global Assessment for Atopic Dermatitis [vIGA-AD] score of ≥ 3, and Worst Pruritus Numerical Rating Scale score of ≥ 4) were eligible. Utilizing an interactive response technology system, participants were randomly assigned (1:1:1) to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily for 16 weeks, stratified by baseline disease severity, geographical region, and age. Eight hundred forty-seven patients were randomly assigned to upadacitinib 15 mg (n = 281), upadacitinib 30 mg (n = 285), or placebo (n = 281) in the Measure Up 1 study between August 13, 2018, and December 23, 2019. Acne, upper respiratory tract infection, nasopharyngitis, headache, elevation in creatine phosphokinase levels, and atopic dermatitis were the most frequently reported treatment-emergent adverse events. In adolescents and adults with moderate-to-severe atopic dermatitis, monotherapy with upadacitinib seems to be a viable therapeutic option with a favourable benefit-risk ratio.
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