Safety of upadacitinib in atopic dermatitis in randomized clinical trials across 6 years

作者：Christopher G. Bunick, Alan D. Irvine, Jonathan I. Silverberg, Emma Guttman‐Yassky, Mona Shahriari, Xing‐Hua Gao, Stephan Weidinger, Norito Katoh, Namita Vigna, Deanne M. Dilley, Elvira D’Andrea, Henrique D. Teixeira, Andrew M. Platt, Gweneth F. Levy · 发表于：Journal of the European Academy of Dermatology and Venereology · 年份：2025 · DOI：10.1111/jdv.70172 · 被引用次数：10 · 研究领域：Dermatology and Skin Diseases、Psoriasis: Treatment and Pathogenesis、Asthma and respiratory diseases

BACKGROUND: Atopic dermatitis (AD) is a common inflammatory skin disease characterized by eczematous lesions, dry skin and intense pruritus. Upadacitinib, a selective JAK1 inhibitor approved for moderate-to-severe AD in adults and adolescents, is a once-daily oral treatment. OBJECTIVES: To evaluate the long-term safety profile of the treatment of moderate-to-severe AD with upadacitinib 15 mg (UPA15) or 30 mg (UPA30) across 6 years. METHODS: Safety data for adverse events (AEs), including treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs) from three global phase 3 studies (MeasureUp 1, MeasureUp 2 and ADUp), were analysed. Data were included for all adolescent and adult patients (12-75 years) receiving at least 1 dose of UPA15 or UPA30 across 6 years. RESULTS: Serious adverse event rates were similar for UPA15 (6.6 events [E] per 100 patient-years [PY]) and UPA30 (7.4 E/100 PY). Nasopharyngitis was the most frequently reported adverse event (UPA15, 9.8 E/100 PY; UPA30, 9.3 E/100 PY) excluding COVID-19. Event rates for serious infections were similar for both groups (UPA15, 2.2 E/100PY; UPA30, 2.6 E/100 PY). Rates of most AESIs were similar between UPA15 and UPA30, except for those known to be dose dependent: herpes zoster, hepatic disorder, neutropenia and CPK elevation. Adjudicated major adverse cardiovascular event incidence rates were 0.2 n/100PY and <0.1 n/100PY for UPA15 and UPA30, respectively. Adjudicated venous thromboembolic event...