Song Lijuan, Yang Nan, Xing Xinglong, Zhao Yicong, Di Jingkai
Department of General Surgery, The Second Affiliated Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
Department of Orthopedics, The Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences Tongji Shanxi Hospital, Taiyuan, Shanxi, China.
Front Pharmacol. 2025 Apr 25;16:1512806. doi: 10.3389/fphar.2025.1512806. eCollection 2025.
This research is designed to explore the connection between tumor necrosis factor-α (TNF-α) blocker drugs and thrombotic adverse events.
The study included data from the FDA Adverse Event Reporting System (FAERS) spanning from the first quarter of 2004 to the first quarter of 2024. We employed the disproportional analysis approach to analyze the signals of thrombosis-related adverse events associated with TNF-α blockers. Moreover, subgroup analyses were conducted to investigate the circumstances of different age and gender groups. Additionally, the induction time and Weibull distribution were utilized for the further interpretation of the data.
During the study period, among 1,382,627 patients in the FAERS database who had adverse events linked to TNF-α inhibitors, 9,714 could be attributed to thrombosis-related adverse events. In the remaining patients, different types of infection events accounted for a large proportion of the proportion. (N = 165,765) Thrombosis-related adverse event signals were detected in all five types of TNF-α inhibitor drugs. Among them, in the analysis of adalimumab, the adverse event signal of postpartum thrombosis was the strongest, and the positive signal of axillary vein thrombosis was the weakest. The analysis based on gender subgroups discovered some positive signals of adverse events that were not observed in the overall population. The Weibull distribution analysis indicated that all five drugs exhibited an premature aging type characteristic, and their induction decreased gradually over time.
This study suggests that TNF - α blockers are associated with various adverse events of thrombosis, with different risks in different patient groups and treatment stages. Clinical doctors should assess individual thrombosis risk and closely monitor coagulation related indicators when using TNF - α inhibitors. This study offers valuable insights for optimizing treatment and improving safety.
本研究旨在探讨肿瘤坏死因子-α（TNF-α）阻断剂药物与血栓形成不良事件之间的联系。
该研究纳入了美国食品药品监督管理局不良事件报告系统（FAERS）中2004年第一季度至2024年第一季度的数据。我们采用不成比例分析方法来分析与TNF-α阻断剂相关的血栓形成不良事件信号。此外，进行了亚组分析以调查不同年龄和性别组的情况。另外，利用诱导时间和威布尔分布对数据进行进一步解读。
在研究期间，FAERS数据库中1382627例有与TNF-α抑制剂相关不良事件的患者中，9714例可归因于血栓形成相关不良事件。在其余患者中，不同类型的感染事件占比很大（N = 165765）。在所有五种类型的TNF-α抑制剂药物中均检测到血栓形成相关不良事件信号。其中，在阿达木单抗的分析中，产后血栓形成的不良事件信号最强，腋静脉血栓形成的阳性信号最弱。基于性别亚组的分析发现了一些在总体人群中未观察到的不良事件阳性信号。威布尔分布分析表明，所有五种药物均呈现早衰型特征，且其诱导随时间逐渐降低。
本研究表明，TNF-α阻断剂与多种血栓形成不良事件相关，在不同患者群体和治疗阶段存在不同风险。临床医生在使用TNF-α抑制剂时应评估个体血栓形成风险并密切监测凝血相关指标。本研究为优化治疗和提高安全性提供了有价值的见解。
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