Effect of upadacitinib on atopic hand eczema in patients with moderate‐to‐severe atopic dermatitis: Results from two randomized phase 3 trials

医学 安慰剂 特应性皮炎 湿疹面积及严重程度指数 析因分析 内科学 随机对照试验 手部湿疹 皮肤科生活质量指数 疾病严重程度 胃肠病学 过敏 皮肤病科 免疫学 疾病 接触性皮炎 替代医学 病理
作者
Eric L. Simpson,K. Rahawi,Xiaofei Hu,Alvina D. Chu,C. Nduaka,S. Jazayeri,Peter Lio,Charles Lynde,Marie L. A. Schuttelaar
出处
期刊:Journal of The European Academy of Dermatology and Venereology [Wiley]
卷期号:37 (9): 1863-1870 被引量:24
标识
DOI:10.1111/jdv.19194
摘要

Approximately 60% of patients with atopic dermatitis have involvement of the hands adding to the burden of disease.This analysis aims to evaluate the effect of upadacitinib monotherapy on atopic hand eczema in patients with moderate-to-severe AD over 16 weeks in the Measure Up 1 and 2 studies.Data from patients (ages 12-75) randomized 1:1:1 to receive upadacitinib 15 mg, 30 mg, or placebo once daily in the Measure Up 1 and 2 studies were analysed for impact on atopic hand eczema assessed using the Hand Eczema Severity Index (HECSI). The percent change from baseline in HECSI score was a prespecified additional endpoint at all visits. The proportion of patients with at least a 75% improvement in HECSI score (HECSI 75) was evaluated post hoc.Patients treated with upadacitinib 15 mg or 30 mg experienced greater improvement in HECSI score compared with placebo as early as Week 1, which was maintained through Week 16. At Week 16, the mean change from baseline in HECSI score for patients receiving upadacitinib 15 mg, 30 mg, and placebo was -68%, -74%, and -15% in Measure Up 1 and -68%, -74% and +21% (positive change indicates worsening for placebo) in Measure Up 2, respectively. A greater proportion of upadacitinib-treated patients achieved HECSI 75 compared with placebo at all timepoints beginning at Week 1 through Week 16.Upadacitinib 15 mg and 30 mg monotherapy provided rapid and sustained improvement in atopic hand eczema compared with placebo through Week 16 in patients with moderate-to-severe AD. At Week 16, the observed mean improvements in HECSI score in upadacitinib-treated patients were clinically meaningful based on previous interpretability studies. These results suggest that upadacitinib may be an effective treatment option for atopic hand eczema in patients with moderate-to-severe AD.
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