Castañeda-Estévez Elisabet, Vergara-Dangond Cristina, Steiner Martina, Paredes-Romero Maria Beatriz, Esteban-Vázquez Ana, Cobo-Ibañez Tatiana, Trives-Folguera Laura, Romero-Bogado Maria Liz, De La Cámara-Fernández Isabel, Richi-Alberti Patricia, Acosta-Alfaro Ana, De la Osa-Subtil Iría, Muñoz-Fernández Santiago
Department of Rheumatology, Hospital Universitario Infanta Sofía, FIIB HUIS HHEN, Universidad Europea, 28702 Madrid, Spain.
Department of Medicine, Faculty of Biomedical and Health Sciences, European University of Madrid, 28670 Madrid, Spain.
Pharmaceuticals (Basel). 2024 Dec 27;18(1):22. doi: 10.3390/ph18010022.
Janus kinase inhibitors (JAKi) have revolutionized the treatment of various inflammatory and immune disorders. Concerns about the potential increased risk of major adverse cardiovascular events (MACEs) associated with JAKi use led to a European Medicines Agency (EMA) health alert recommending restricting the use of JAKi in high-risk populations. This study aims to determine the proportion of patients who developed any cardiovascular, ischemic, neoplastic, or thrombotic adverse event in a cohort of patients receiving, or who have received, JAKi treatment between January 2017 and September 2023. In addition, we studied the impact of the alert in the clinical practice of our Rheumatology department. In this retrospective, observational study, 101 patients were analysed, predominantly women (72.3%), with a mean age of 57.6 years. The most common diagnoses were rheumatoid arthritis (60.4%) and psoriatic arthritis (18.8%). The most frequent adverse events were infections (5.9%) and neoplasms (2.9%). Deep vein thrombosis and haemorrhagic stroke each occurred in 1% of patients, with no cases of ischemic stroke or ischemic heart disease. When the health alert was published, 75 patients were on treatment with JAKi, and 33 met the alert criteria. Of these, 12.1% changed treatment due to the alert, 9% had no other therapeutic options, 57.5% were in clinical remission or had low disease activity, and 9% maintained treatment at their own request. These findings suggest that, in this patient cohort, JAKi use did not result in new MACE cases. The alert concerning the use of JAKi has had a limited impact in our clinical practice.
Janus激酶抑制剂（JAKi）彻底改变了各种炎症和免疫疾病的治疗方法。对与使用JAKi相关的主要不良心血管事件（MACE）潜在风险增加的担忧，导致欧洲药品管理局（EMA）发布健康警报，建议在高风险人群中限制使用JAKi。本研究旨在确定在2017年1月至2023年9月期间接受或已接受JAKi治疗的患者队列中发生任何心血管、缺血性、肿瘤性或血栓性不良事件的患者比例。此外，我们研究了该警报对我们风湿科临床实践的影响。在这项回顾性观察研究中，分析了101例患者，其中大多数为女性（72.3%），平均年龄为57.6岁。最常见的诊断是类风湿关节炎（60.4%）和银屑病关节炎（18.8%）。最常见的不良事件是感染（5.9%）和肿瘤（2.9%）。深静脉血栓形成和出血性中风在1%的患者中各有发生，无一例缺血性中风或缺血性心脏病病例。当健康警报发布时，75例患者正在接受JAKi治疗，33例符合警报标准。其中，12.1%的患者因警报而改变治疗，9%的患者没有其他治疗选择，57.5%的患者处于临床缓解或疾病活动度较低，9%的患者根据自己的要求维持治疗。这些发现表明，在该患者队列中，使用JAKi并未导致新的MACE病例。关于使用JAKi的警报在我们的临床实践中影响有限。
