Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): Results from a randomised, double-blind, placebo-controlled, phase 3 trial
The Lancet May 29, 2021
Reich K, Teixeira HD, de Bruin-Weller M, et al. - Researchers undertook this randomised, double-blind, placebo-controlled, phase 3 trial (AD Up) to determine whether upadacitinib plus topical corticosteroids has efficacy as well as safety, relative to placebo, for the treatment of moderate-to-severe atopic dermatitis. Participants were adults (aged 18–75 years) and adolescents (aged 12–17 years) with chronic atopic dermatitis that was moderate to severe. Participants were randomized (1:1:1) to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily, all in combination with topical corticosteroids for 16 weeks. Significantly higher proportion of patients achieved EASI-75 [at least a 75% reduction in Eczema Area and Severity Index [EASI] score from baseline] and a validated Investigator's Global Assessment for atopic dermatitis response, at week 16, in the upadacitinib 15 mg plus topical corticosteroid group and the upadacitinib 30 mg plus topical corticosteroids group, vs the placebo group. Overall, findings demonstrated good tolerability of upadacitinib plus topical corticosteroids as well as the superiority of this treatment regimen over placebo plus topical corticosteroids. In adults and adolescents with moderate-to-severe atopic dermatitis, a positive benefit–risk profile of upadacitinib as combination therapy was evident.
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