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Ivarmacitinib for the Treatment of Adults with Severe Alopecia Areata: Results from a Phase 3 Trial

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机构： [1]Peking University People's Hospital, Beijing, China. [2]The Second Hospital of Anhui Medical University, Hefei, China. [3]Jiangsu People's Hospital, Nanjing, China. [4]Wuhan No. 1 Hospital, Wuhan, China. [5]China-Japan Friendship Hospital, Beijing, China. [6]Peking Union Medical College Hospital, Beijing, China. [7]Fudan University Affiliated Huashan Hospital, Shanghai, China. [8]Jiangxi Dermatology Hospital, Nanchang, China. [9]Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [10]Beijing Tongren Hospital Affiliated to Capital Medical University, Beijing, China. [11]Guangdong Provincial People's Hospital, Guangzhou, China. [12]Shenzhen People's Hospital, Shenzhen, China. [13]Hangzhou First People's Hospital, Hangzhou, China. [14]Hangzhou Third People's Hospital, Hangzhou, China. [15]The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China. [16]The First Hospital of Jilin University, Changchun, China. [17]Xiangya Hospital of Central South University, Changsha, China. [18]Hospital of Dermatology, Chinese Academy of Medical Sciences, Nanjing, China. [19]Shanghai Skin Disease Hospital, Shanghai, China. [20]The Second Xiangya Hospital of Central South University, Changsha, China. [21]Jiangsu Hengrui Pharmaceuticals Co. Ltd., Shanghai, China.

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关键词： Alopecia areata Clinical trial Ivarmacitinib JAK1 Inhibitor Efficacy Safety

摘要：

Ivarmacitinib, a selective Janus kinase 1 (JAK1) inhibitor, demonstrated efficacy in a phase 2 trial for moderate-to-severe alopecia areata (AA).To evaluate the efficacy and safety of ivarmacitinib in adults with severe AA (≥50% scalp hair loss, including alopecia totalis/universalis).In this randomized, double-blind, phase 3 trial, 330 patients were assigned (1:1:1) to ivarmacitinib 4 mg, 8 mg, or placebo once daily for 24 weeks. Placebo recipients were re-randomized to ivarmacitinib for a 28-week extension. The primary endpoint was the proportion achieving a Severity of Alopecia Tool (SALT) score ≤20 at Week 24.At Week 24, SALT ≤20 was achieved by 34.9% (4 mg), 40.6% (8 mg), and 9.0% (placebo). Absolute differences versus placebo were 25.6% (95% CI: 15.4-35.7) for 4 mg and 31.6% (21.5-41.8) for 8 mg (both p < 0.0001). Treatment-emergent adverse events occurred in 77.1%, 84.7%, and 75.5% of patients, respectively; most were mild or moderate. No deaths, major cardiovascular events, or thromboembolic events were reported.No active comparator was used.Once-daily ivarmacitinib 4 mg or 8 mg resulted in meaningful hair regrowth and demonstrated an acceptable safety profile in patients with severe AA.Copyright © 2025. Published by Elsevier Inc.

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大类 | 1 区

医学

小类 | 1 区皮肤病学

最新[2025]版：

大类 | 1 区

医学

小类 | 1 区皮肤病学

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第一作者机构： [1]Peking University People's Hospital, Beijing, China.

通讯作者：

通讯机构： [1]Peking University People's Hospital, Beijing, China. [*1]Department of Dermatology, Peking University People’s Hospital, XiZhiMenNan Street 11, Beijing 100044, China.

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Ivarmacitinib for the Treatment of Adults with Severe Alopecia Areata: Results from a Phase 3 Trial

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