基于FAERS数据库的JAK抑制剂引起白内障不良事件的信号挖掘

Signal Mining of JAK Inhibitors Causing Cataract Adverse Events Based on FAERS Database

目的基于FAERS数据库研究JAK抑制剂与白内障之间的关系,以期为临床的安全使用提供参考。方法提取2013年第3季度至2023年第1季度的FAERS数据,检索使用JAK抑制剂后报告白内障的病例,使用比例失衡法和贝叶斯法进行信号挖掘,同时分析JAK抑制剂相关白内障患者的基本特征、临床结局、发生时间等。结果共提取150012份JAK抑制剂不良事件报告,白内障不良事件报告603份。托法替布、乌帕替尼、阿布昔替尼3种JAK抑制剂信号检测结果为阳性,其中乌帕替尼与白内障的风险信号最高〔ROR 4.71,95%CI:4.09~5.42;PRR 4.67,χ^(2)(566.71);IC 2.21;EBGM 4.64〕,其次是阿布昔替尼〔ROR 3.75,95%CI:1.40~10.02;PRR 3.73,χ^(2)(5.49);IC 1.90;EBGM 3.72〕,托法替布导致白内障风险信号最低〔ROR 2.07,95%CI:1.88~2.29;PRR 2.61,χ^(2)(216.71);IC 1.03;EBGM 2.05〕。托法替布、乌帕替尼、阿布昔替尼的中位发病时间分别为11个月,10个月,10个月。结论托法替布、乌帕替尼、阿布昔替尼3种JAK抑制剂与白内障存在相关性,在临床上使用时应关注其诱发白内障的风险,监测相关症状,有效保障患者的用药安全。

OBJECTIVE The relationship between JAK inhibitors and cataract was studied based on FAERS database in order to provide reference for safe clinical use.METHODS FAERS data from the third quarter of 2013 to the first quarter of 2023 were extracted,and cases of cataract reported after using JAK inhibitors were retrieved.Signal mining was performed using disproportional-imbalance method and Bayesian method.At the same time,basic characteristics,clinical outcome and occurrence time of JAK inhibiter-related cataract were analyzed.RESULTS A total of 150,012 JAK inhibitor adverse event reports and 603 cataract adverse event reports were extracted.Tofacitib,upatinib,and abhicitinib were positive for JAK inhibitors,among which upatinib had the highest risk signal for cataract〔ROR 4.71,95%CI:4.09~5.42;PRR 4.67,χ^(2)(566.71);IC 2.21;EBGM 4.64〕,followed by Abhicitinib〔ROR 3.75,95%CI:1.40~10.02;PRR 3.73,χ^(2)(5.49);IC 1.90;EBGM 3.72〕,Topharatib caused the lowest risk signal for cataract〔ROR 2.07,95%CI:1.88~2.29;PRR 2.61,χ^(2)(216.71);IC 1.03;EBGM 2.05〕.The median onset time of Tofacitib,upatinib and abhitinib was 11 months,10 months and 10 months,respectively.CONCLUSION Three JAK inhibitors,Tofacitib,Upatinib and Aboxitinib,are associated with cataract.Attention should be paid to the risk of cataract induced by Tofacitib,and related symptoms should be monitored during clinical use,so as to effectively ensure the drug safety of patients.