Ji Huanhuan, Zhao Zongren, Zhao Chuanwei
Department of Neurosurgery, Affiliated Huaian Hospital of Xuzhou Medical University, Huaian, Jiangsu, China.
Department of Cardiology, The Second People's Hospital of Baoshan, Baoshan, Yunnan, China.
PLoS One. 2025 Jul 14;20(7):e0328076. doi: 10.1371/journal.pone.0328076. eCollection 2025.
Aducanumab, a monoclonal antibody targeting amyloid-beta plaques, has been introduced as a pivotal therapeutic agent for Alzheimer's disease (AD). Although it offers promising benefits in the treatment of early-stage Alzheimer's disease, a thorough evaluation of its safety profile and potential adverse events (AEs) is essential to ensure patient safety.
This retrospective pharmacovigilance study analyzed data from the FDA Adverse Event Reporting System (FAERS) database to evaluate AEs associated with Aducanumab. Employing a case/non-case methodology, the study utilized signal detection algorithms, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS), to identify AEs signals related to Aducanumab use.
The study encompassed a total of 11517459 reports, with 431 specifically citing Aducanumab. A substantial number of AEs were identified, particularly among the elderly population and those with pre-existing neurological conditions. The most frequently reported AEs were related to the nervous system, including "amyloid-related imaging abnormalities" such as edema/effusion and microhemorrhages. Other affected system organ classes (SOCs) included psychiatric disorders and general disorders and administration site conditions. Specific preferred terms (PTs) linked with Aducanumab included "confusional state," "disorientation," and "cerebral microhemorrhage." Unexpected AEs such as "subdural hematoma" and "head injury" were also noted, indicating a broader safety profile that requires further investigation.
The study's findings underscore the necessity for close monitoring of Aducanumab use, especially in elderly patients with AD. The identification of both expected and unexpected AEs emphasizes the need for ongoing pharmacovigilance and additional research to fully understand the safety profile of Aducanumab in clinical practice.
Strength: Utilized multiple signal detection algorithms (ROR, PRR, BCPNN, MGPS) to enhance robustness of pharmacovigilance findings. Limitation: Reliance on spontaneous FAERS reports, which are prone to underreporting, overreporting, and reporting bias.
阿杜卡努单抗是一种靶向β淀粉样蛋白斑块的单克隆抗体，已被引入作为治疗阿尔茨海默病（AD）的关键治疗药物。尽管它在治疗早期阿尔茨海默病方面具有潜在益处，但全面评估其安全性概况和潜在不良事件（AE）对于确保患者安全至关重要。
这项回顾性药物警戒研究分析了美国食品药品监督管理局不良事件报告系统（FAERS）数据库中的数据，以评估与阿杜卡努单抗相关的不良事件。该研究采用病例/非病例方法，利用信号检测算法，包括报告比值比（ROR）、比例报告比值比（PRR）、贝叶斯置信传播神经网络（BCPNN）和多项目伽马泊松收缩器（MGPS），来识别与使用阿杜卡努单抗相关的不良事件信号。
该研究共纳入11517459份报告，其中431份特别提及阿杜卡努单抗。识别出大量不良事件，尤其是在老年人群和已有神经系统疾病的患者中。报告最频繁的不良事件与神经系统有关，包括“淀粉样蛋白相关成像异常”，如水肿/积液和微出血。其他受影响的系统器官类别（SOC）包括精神障碍以及全身性障碍和给药部位情况。与阿杜卡努单抗相关的特定首选术语（PT）包括“意识模糊状态”、“定向障碍”和“脑微出血”。还注意到“硬膜下血肿”和“头部损伤”等意外不良事件，这表明其安全性概况更广泛，需要进一步研究。
该研究结果强调了密切监测阿杜卡努单抗使用情况的必要性，尤其是在老年AD患者中。预期和意外不良事件的识别强调了持续进行药物警戒和开展更多研究以全面了解阿杜卡努单抗在临床实践中安全性概况的必要性。
优势：使用多种信号检测算法（ROR、PRR、BCPNN、MGPS）来增强药物警戒结果的稳健性。局限性：依赖自发的FAERS报告，这些报告容易出现漏报、过度报告和报告偏倚。
