Department of Biomedical Informatics, School of Medicine, Pusan National University, Yangsan, Republic of Korea.
Department of Anatomy, School of Medicine, Pusan National University, Yangsan, Republic of Korea.
J Eur Acad Dermatol Venereol. 2024 Jan;38(1):52-61. doi: 10.1111/jdv.19426. Epub 2023 Aug 25.
Janus kinase (JAK) inhibitors have been recently approved by the FDA and are widely used in the treatment of patients with atopic dermatitis. However, a comprehensive safety profile of JAK inhibitors in patients with atopic dermatitis has not been analysed. This study aimed to establish clinical evidence for the safety of systemic JAK inhibitors in patients with atopic dermatitis. Medline, Embase, Clinicaltrials.gov, Cochrane Central Register of Controlled Trials (CENTRAL) and International Clinical Trials Registry Platform (ICTRP) were considered for search databases. Randomized controlled trials reporting the adverse events of systemic therapy in patients with atopic dermatitis were included. The risk of 11 adverse events was compared between the JAK inhibitors and placebo groups. Fourteen randomized controlled trials were analysed published between 2019 and 2022. The JAK inhibitors included in the analysis were abrocitinib (10, 30, 100 and 200 mg), baricitinib (1, 2 and 4 mg) and upadacitinib (7.5, 15 and 30 mg). The risk of herpes zoster, headache, acne, elevated blood creatinine phosphokinase and nausea was significantly increased, but the risk of serious infection, non-melanoma skin cancer (NMSC), malignancies other than NMSC, major adverse cardiovascular event, venous thromboembolism and nasopharyngitis was not increased. This study provides comprehensive clinical evidence on the risk of various adverse events in patients with atopic dermatitis. However, since the follow-up periods of the studies analysed in this review were mostly limited to 16 weeks or less, it is recommended that comprehensive long-term observational studies be conducted to determine any potential adverse events associated with major cardiovascular events or malignancies, which typically have prolonged courses.
Janus 激酶 (JAK) 抑制剂最近已获得 FDA 批准，并广泛用于治疗特应性皮炎患者。然而，尚未对 JAK 抑制剂在特应性皮炎患者中的全面安全性概况进行分析。本研究旨在为 JAK 抑制剂在特应性皮炎患者中的安全性建立临床证据。检索数据库考虑了 Medline、Embase、Clinicaltrials.gov、Cochrane 中央对照试验注册中心 (CENTRAL) 和国际临床试验注册平台 (ICTRP)。纳入报告特应性皮炎患者全身治疗不良事件的随机对照试验。比较了 JAK 抑制剂组和安慰剂组 11 种不良事件的风险。分析了 2019 年至 2022 年期间发表的 14 项随机对照试验。纳入分析的 JAK 抑制剂包括阿布昔替尼（10、30、100 和 200mg）、巴瑞替尼（1、2 和 4mg）和乌帕替尼（7.5、15 和 30mg）。带状疱疹、头痛、痤疮、血肌酸磷酸激酶升高和恶心的风险显著增加，但严重感染、非黑色素瘤皮肤癌 (NMSC)、NMSC 以外的恶性肿瘤、主要不良心血管事件、静脉血栓栓塞和鼻咽炎的风险并未增加。本研究提供了特应性皮炎患者各种不良事件风险的综合临床证据。然而，由于本综述分析的研究的随访期大多限于 16 周或更短，建议进行全面的长期观察性研究，以确定与主要心血管事件或恶性肿瘤相关的任何潜在不良事件，这些事件通常具有较长的病程。
