Wu Shuangshuang, Qi Yiming, Jiang Cheng, Zheng Junxian
Zhejiang Academy of Traditional Chinese Medicine, Tongde Hospital of Zhejiang Province, Hangzhou, Zhejiang, China.
College of Integrated Traditional Chinese and Western Medicine Clinical Medicine, Tongde Hospital of Zhejiang Province Affiliated to Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
Expert Opin Drug Saf. 2025 Apr;24(4):469-478. doi: 10.1080/14740338.2024.2448205. Epub 2025 Jan 2.
Aducanumab, a monoclonal antibody, received approval for the treatment of Alzheimer's disease in 2021. However, it remains controversial over the security of this drug. In this study, aducanumab-related adverse events (AEs) were evaluated through data mining based on the FDA Adverse Event Reporting System (FAERS) database.
The AE reports induced by aducanumab as the primary suspected drug were extracted from the FAERS database. The clinical characteristics of aducanumab-associated reports were analyzed. The potential new AE signals of aducanumab were explored using four disproportionality analysis methods. Furthermore, the difference in aducanumab-associated AE signals was investigated concerning sex, age, weight, dose, onset time, and continent.
In total, 328 reports and 793 AEs associated with aducanumab were identified. Six new AEs were identified. No significant sex and weight difference in aducanumab-related signals was found. Notably, nervous system disorders, especially 'amyloid related imaging abnormality-edema/effusion' and 'amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits,' were more frequently to be reported within 121-240 days, particularly in Europe.
This study contributes real-world evidence regarding the safety of aducanumab.
单克隆抗体药物阿杜卡那单抗于2021年获批用于治疗阿尔茨海默病。然而，该药物的安全性仍存在争议。在本研究中，基于美国食品药品监督管理局不良事件报告系统（FAERS）数据库，通过数据挖掘对阿杜卡那单抗相关不良事件（AE）进行了评估。
从FAERS数据库中提取以阿杜卡那单抗作为主要怀疑药物引发的AE报告。分析了阿杜卡那单抗相关报告的临床特征。使用四种不成比例分析方法探索阿杜卡那单抗潜在的新AE信号。此外，还研究了阿杜卡那单抗相关AE信号在性别、年龄、体重、剂量、发病时间和大洲方面的差异。
共识别出328份与阿杜卡那单抗相关的报告以及793起AE。识别出六种新的AE。未发现阿杜卡那单抗相关信号在性别和体重方面存在显著差异。值得注意的是，神经系统疾病，尤其是“淀粉样蛋白相关成像异常-水肿/积液”和“淀粉样蛋白相关成像异常-微出血和含铁血黄素沉积”，在121-240天内报告更为频繁，尤其是在欧洲。
本研究为阿杜卡那单抗的安全性提供了真实世界的证据。
