基于FAERS对氘可来昔替尼不良事件信号的挖掘与分析

Mining and Analysis of Adverse Event Signals of Deucravacitinib Based on FAERS

摘要: 目的：基于美国食品药品监督管理局不良事件报告系统数据库(FDA Adverse Event Reporting System, FAERS)分析研究全球首款原创性氘代新药氘可来昔替尼的不良事件，为临床安全使用提供参考。方法：提取氘可来昔替尼2022年9月9日至2024年12月31日的FAERS数据，采用比例失衡法和贝叶斯法对数据进行挖掘分析，并且利用国际医学用语词典对药品不良事件(Adverse Drug Event, ADE)进行系统归类和安全评估。结果：在限定的检索时间段内，共提取到以氘可来昔替尼为首要怀疑药物的不良事件报告1117份，挖掘出阳性风险信号26个，共涉及6个系统器官，其中皮肤及皮下组织类疾病产生的阳性风险信号最多，共有11个。经过二元Logistic回归分析，发现使用该药的女性患者发生严重ADE的概率显著高于男性患者。结论：FAERS中氘可来昔替尼相关不良事件报告较少，但仍存在一定的不良事件风险。这项研究为其使用和不良事件的管理提供了重要参考。

Abstract: Aim: Based on the FDA Adverse Event Reporting System (FAERS) database, we analyzed and studied the adverse events of the world’s first original deuterated drug, deucravacitinib, in order to provide a reference for safe clinical use. Methods: The FAERS data of deucravacitinib from September 9, 2022 to December 31, 2024 were extracted, and the data were mined and analyzed using the proportional imbalance and Bayesian methods, and the Adverse Drug Events (ADEs) were systematically categorized and evaluated for safety using the Medical Dictionary for Regulatory Activities. Results: Within the limited search time period, a total of 1117 adverse event reports were extracted with deucravacitinib as the first suspected drug, and 26 positive risk signals were unearthed, involving a total of 6 systems and organs, of which the skin and subcutaneous tissue class of diseases generated the most positive risk signals, with a total of 11. After binary logistic regression analysis, it was found that female patients using the drug were significantly more likely to develop a serious ADE than male patients. Conclusion: Adverse events associated with deucravacitinib are less frequently reported in FAERS, but some risk of adverse events still exists. This study provides an important reference for its use and management of adverse events.