作为近年来发展迅速的新型药物,Janus激酶抑制剂(JAKinibs)由于血栓栓塞可能的不良反应而引起了争议。本研究的目的是分析和评估血栓栓塞事件与JAKinibs的使用之间的关联。根据食品和药物管理局不良事件报告系统的最新数据。
进行了不相称性分析,利用FAERS中2012年1月1日至2021年9月30日的数据。对于每个药物-不良事件对,计算报告比值比(ROR)和信息成分(IC).
在FAERS内共检测到15个阳性安全性信号:鲁索替尼与门静脉血栓形成显着相关(ROR025=3.49,IC025=1.50);托法替尼速释伴肺栓塞(ROR025=2.09,IC025=1.02)和血栓形成(ROR025=1.15,IC025=0.18);托法替尼延长释放伴肺栓塞025(IC门静脉血栓形成(ROR025=1.97,IC025=0.63),肺栓塞(ROR025=7.90,IC025=2.94),血栓形成(ROR025=2.04,IC025=0.93)和静脉血栓形成(ROR025=2.15,IC025=0.81);upadacitinib伴肺栓塞(ROR025=1.25,IC025=0.25),肺血栓形成(ROR025=5.32,IC025=2.33)和血栓形成(ROR025=2.72,IC025=1.39);和菲尔戈替尼合并肺栓塞(ROR025=4.83,IC025=2.10)。在对血栓栓塞事件发生时间的分析中,没有发现明显可识别的模式。研究中发现了一些具有栓塞和血栓形成事件的安全性信号(标准化MedDRA查询)。
这项药物警戒研究涵盖了已经上市的8种JAKinib,并根据过去的安全信息提供新的安全信号。其中一些信号仍然需要更多的医学证据。
As a new type of drug developed rapidly in recent years, Janus kinase inhibitors (JAKinibs) have caused controversy due to possible adverse reactions of thromboembolism. The aim of this study was to analyse and evaluate the association between thromboembolic events and the use of JAKinibs, on the base of the latest data in the Food and Drug Administration\'s Adverse Event Reporting System.
A disproportionality analysis was conducted, utilizing data from 1 January 2012 to 30 September 2021 in the FAERS. For each drug-adverse event pair, reporting odds ratio (ROR) and information components (IC) were calculated.
A total of 15 positive safety signals were detected within the FAERS: ruxolitinib was significantly associated with portal vein thrombosis (ROR025 = 3.49, IC025 = 1.50); tofacitinib immediate release with pulmonary embolism (ROR025 = 2.09, IC025 = 1.02) and thrombosis (ROR025 = 1.15, IC025 = 0.18); tofacitinib extended release with pulmonary embolism (ROR025 = 1.27, IC025 = 0.26) and thrombosis (ROR025 = 1.29, IC025 = 0.33); baricitinib with deep vein thrombosis (ROR025 = 8.27, IC025 = 3.00), portal vein thrombosis (ROR025 = 1.97, IC025 = 0.63), pulmonary embolism (ROR025 = 7.90, IC025 = 2.94), thrombosis (ROR025 = 2.04, IC025 = 0.93) and venous thrombosis (ROR025 = 2.15, IC025 = 0.81); upadacitinib with pulmonary embolism (ROR025 = 1.25, IC025 = 0.25), pulmonary thrombosis (ROR025 = 5.32, IC025 = 2.33) and thrombosis (ROR025 = 2.72, IC025 = 1.39); and filgotinib with pulmonary embolism (ROR025 = 4.83, IC025 = 2.10). In the analysis of the time to onset of thromboembolic events, no obviously recognizable pattern was found. Several safety signals with embolic and thrombotic events (Standardised MedDRA Query) were found in the study.
This pharmacovigilance study covered 8 types of JAKinib that are already on the market, and provided new safety signals based on past safety information. Some of these signals still need more medical evidence.