{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T17:21:14Z","timestamp":1790270474248,"version":"4.1.0"},"reference-count":51,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,5,30]],"date-time":"2025-05-30T00:00:00Z","timestamp":1748563200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>Studies on anti-A\u03b2 drugs for the treatment of Alzheimer\u2019s 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Research design and methods<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 1,409 ADE reports in which an anti-A\u03b2 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 \u2018nervous system disorders\u2019 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, \u201ccerebral microbleeds,\u201d \u201camyloid protein related imaging abnormalities (ARIA),\u201d and \u201ccentral nervous system superficial squamous cell hyperplasia\u201d 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\u00a0days vs. 146\u00a0days).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fphar.2025.1593989","type":"journal-article","created":{"date-parts":[[2025,5,30]],"date-time":"2025-05-30T05:42:50Z","timestamp":1748583770000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":11,"title":["Comparison of safety of lecanemab and aducanumab: a real-world disproportionality analysis using the FDA adverse event reporting system"],"prefix":"10.3389","volume":"16","author":[{"given":"Lingti","family":"Kong","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaohu","family":"Yang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jian","family":"Xu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,5,30]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"22","DOI":"10.1038\/d41586-020-03084-9","article-title":"Are infections seeding some cases of Alzheimer's disease?","volume":"587","author":"Abbott","year":"2020","journal-title":"Nature"},{"key":"B2","doi-asserted-by":"publisher","first-page":"343","DOI":"10.1016\/j.ncl.2023.01.001","article-title":"Sex differences in Alzheimer's disease","volume":"41","author":"Aggarwal","year":"2023","journal-title":"Neurol. 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