Efficacy and Safety of Upadacitinib in Patients With Moderate-to-Severe Atopic Dermatitis: Phase 3 Randomized Clinical Trial Results Through 140 Weeks

作者：Alan D. Irvine, Vimal H. Prajapati, Emma Guttman‐Yassky, Eric L. Simpson, Kim Papp, Andrew Blauvelt, Chia‐Yu Chu, Hwanhee Hong, Linda Stein Gold, Marjolein de Bruin‐Weller, Thomas Bieber, Kenji Kabashima, David Rosmarin, Cristina Sancho, Brian Calimlim, Ayman Grada, Yang Yang, Xiaoqiang Wu, Gweneth Levy, Eliza M. Raymundo, Henrique D. Teixeira, Jonathan I. Silverberg · 发表于：American Journal of Clinical Dermatology · 年份：2025 · DOI：10.1007/s40257-025-00975-3 · 被引用次数：7 · 研究领域：Dermatology and Skin Diseases、Asthma and respiratory diseases、Psoriasis: Treatment and Pathogenesis

BACKGROUND: Upadacitinib is an oral selective Janus kinase inhibitor approved to treat moderate-to-severe atopic dermatitis (AD) in adults and adolescents; long-term efficacy and safety data beyond 1 year are needed. OBJECTIVE: The aim was to evaluate the long-term efficacy and safety of upadacitinib treatment through 140 weeks in patients with moderate-to-severe AD. METHODS: Measure Up 1 (MeUp1; NCT03569293), Measure Up 2 (MeUp2; NCT03607422), and AD Up (NCT03568318) are ongoing, phase 3, randomized clinical trials evaluating upadacitinib 15 mg (UPA15) and 30 mg (UPA30) in adults and adolescents with moderate-to-severe AD. This interim analysis evaluated efficacy and safety through week 140. At baseline, patients were randomized 1:1:1 to receive once-daily UPA15, UPA30, or placebo alone (MeUp1/2) or with concomitant topical corticosteroids (AD Up). At week 16, patients initially randomized to placebo were rerandomized 1:1 to UPA15 or UPA30. Skin and itch efficacy assessments included achievement of ≥ 75%/≥ 90%/100% improvement from baseline in Eczema Area and Severity Index (EASI 75/90/100), validated Investigator Global Assessment for AD score of clear/almost clear (vIGA-AD 0/1), and ≥ 4-point improvement from baseline in Worst Pruritus Numerical Rating Scale (∆WP-NRS≥4). Safety assessments included incidence of treatment-emergent adverse events. RESULTS: A total of 2782 patients were randomized in MeUp1/2 or AD Up. Efficacy response rates, including optimal outcomes such a...