Kong Lingti, Yang Xiaohu, Xu Jian
Department of Pharmacy, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China.
School of Pharmacy, Bengbu Medical University, Bengbu, China.
Front Pharmacol. 2025 May 30;16:1593989. doi: 10.3389/fphar.2025.1593989. eCollection 2025.
Studies on anti-Aβ drugs for the treatment of Alzheimer's disease (AD) have garnered significant attention; however, their safety still requires further research and monitoring. Although recent studies have analyzed the adverse drug events (ADEs) of lecanemab and aducanumab separately, there is a lack of comparison between these two drugs, and no exploration of gender differences. This study aims to compare the adverse reaction signals of lecanemab and aducanumab, also exploring the differences between genders.
We analyzed ADEs reported by patients using lecanemab and aducanumab, using the FDA adverse event reporting system (FAERS). The data was classified using the preferred terms (PTs) and systemic organ categories (SOCs). Four positive signal detection algorithms were used, namely, the Ratio-to-Ratio (ROR), proportional reporting ratio (PRR), multi item gamma poisson shrinker (MGPS), and bayesian belief propagation neural network (BCPNN). Additionally, the time-to-onset of ADEs was also compared between the two drugs and between male and female patients.
A total of 1,409 ADE reports in which an anti-Aβ antibody drug was primarily suspected were included in the study, comprising 892 cases (63.31%) of lecanemab and 517 cases (36.69%) of aducanumab. For both lecanemab and aducanumab, only the SOC 'nervous system disorders' met the criteria for positive signal for all four algorithms. The number of positive PT signals related to lecanemab and aducanumab was 40 and 33, respectively. Among them, "cerebral microbleeds," "amyloid protein related imaging abnormalities (ARIA)," and "central nervous system superficial squamous cell hyperplasia" all exhibited strong signals, regardless of drug or sex of the patient. Additionally, there were some differences in PT signals between male and female patients, and some new PT signals that were not included in the drug labels were identified. The median time-to-onset of lecanemab was shorter than that of aducanumab (33 days vs. 146 days).
Four signal calculation methods were used to assess potential adverse reaction signals of lecanemab and aducanumab. This study identified some new PT signals and some PT signals showed gender differences. The median time-to-onset of ADEs due to lecanemab is shorter than that due to aducanumab.
用于治疗阿尔茨海默病（AD）的抗淀粉样蛋白β（Aβ）药物研究备受关注；然而，其安全性仍需进一步研究和监测。尽管近期研究分别分析了乐卡奈单抗和阿杜卡奈单抗的药物不良事件（ADEs），但这两种药物之间缺乏比较，且未探讨性别差异。本研究旨在比较乐卡奈单抗和阿杜卡奈单抗的不良反应信号，并探究性别差异。
我们使用美国食品药品监督管理局不良事件报告系统（FAERS）分析了使用乐卡奈单抗和阿杜卡奈单抗的患者报告的ADEs。数据按照首选术语（PTs）和系统器官类别（SOCs）进行分类。使用了四种阳性信号检测算法，即比值比（ROR）、比例报告比（PRR）、多项目伽马泊松收缩器（MGPS）和贝叶斯信念传播神经网络（BCPNN）。此外，还比较了两种药物以及男性和女性患者之间ADEs的发病时间。
本研究共纳入1409份主要怀疑为抗Aβ抗体药物的ADE报告，其中乐卡奈单抗892例（63.31%），阿杜卡奈单抗517例（36.69%）。对于乐卡奈单抗和阿杜卡奈单抗，只有“神经系统疾病”这一系统器官类别在所有四种算法中均符合阳性信号标准。与乐卡奈单抗和阿杜卡奈单抗相关的阳性PT信号数量分别为40个和33个。其中，“脑微出血”“淀粉样蛋白相关成像异常（ARIA）”和“中枢神经系统浅表鳞状细胞增生”无论在药物还是患者性别方面均表现出强烈信号。此外，男性和女性患者在PT信号方面存在一些差异，并且识别出了一些未包含在药物标签中的新PT信号。乐卡奈单抗的中位发病时间短于阿杜卡奈单抗（分别为33天和146天）。
使用四种信号计算方法评估乐卡奈单抗和阿杜卡奈单抗的潜在不良反应信号。本研究识别出一些新的PT信号，且部分PT信号存在性别差异。乐卡奈单抗所致ADEs的中位发病时间短于阿杜卡奈单抗。
