Zhong Xiaoyan, Luo Jianchun, Huang Yuexi, Wang Shurong, Huang Yilan
Department of Pharmacy, The Affiliated Hospital, Southwest Medical University, Luzhou, China.
Department of Critical Care Medicine, The Affiliated Hospital, Southwest Medical University, Luzhou, China.
PLoS One. 2025 May 12;20(5):e0322849. doi: 10.1371/journal.pone.0322849. eCollection 2025.
Janus kinase inhibitors (JAKinibs) are increasingly used for autoimmune diseases, prompting concerns about their cardiovascular safety. This study aims to assess the cardiovascular safety of JAKinibs in real-world settings. We conducted a retrospective analysis of FDA Adverse Event Reporting System (FAERS) data from the fourth quarter of 2012 to the second quarter of 2023, focusing on cardiovascular adverse events (AEs) associated with JAKinibs. We used disproportionality analysis to calculate reporting odds ratios (RORs) and identify signals of increased cardiovascular risk. This study identified 13,556 reports of cardiovascular AEs associated with JAKinibs in the FAERS database. Compared to the full database, Baricitinib exhibited significant signals for embolic and thrombotic events (ROR025 = 5.58), ischemic heart disease (ROR025 = 1.56), and cardiac arrhythmias (ROR025 = 1.14). Tofacitinib was associated with the signal for hypertension (ROR025 = 1.05), and upadacitinib was linked to embolic and thrombotic events (ROR025 = 1.23). When compared to TNF-α inhibitors, upadacitinib, baricitinib and tofacitinib showed 7, 6, and 2 positive signals, respectively (all ROR025 > 1). These findings highlight the need for careful cardiovascular monitoring and risk assessment for patients receiving JAKinibs, particularly those with pre-existing cardiovascular risk factors or older age.
Janus激酶抑制剂（JAK抑制剂）越来越多地用于治疗自身免疫性疾病，这引发了人们对其心血管安全性的担忧。本研究旨在评估JAK抑制剂在实际应用中的心血管安全性。我们对2012年第四季度至2023年第二季度美国食品药品监督管理局不良事件报告系统（FAERS）的数据进行了回顾性分析，重点关注与JAK抑制剂相关的心血管不良事件（AE）。我们使用不成比例分析来计算报告比值比（ROR），并识别心血管风险增加的信号。本研究在FAERS数据库中确定了13556例与JAK抑制剂相关的心血管AE报告。与整个数据库相比，巴瑞替尼在栓塞和血栓形成事件（ROR0.25 = 5.58）、缺血性心脏病（ROR0.25 = 1.56）和心律失常（ROR0.25 = 1.14）方面表现出显著信号。托法替布与高血压信号相关（ROR0.25 = 1.05），乌帕替尼与栓塞和血栓形成事件相关（ROR0.25 = 1.23）。与肿瘤坏死因子-α抑制剂相比，乌帕替尼、巴瑞替尼和托法替布分别显示出7个、6个和2个阳性信号（所有ROR0.25 > 1）。这些发现凸显了对接受JAK抑制剂治疗的患者，尤其是那些已有心血管危险因素或年龄较大的患者，进行仔细的心血管监测和风险评估的必要性。
