{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T10:06:48Z","timestamp":1782122808044,"version":"3.54.5"},"reference-count":23,"publisher":"Public Library of Science (PLoS)","issue":"7","license":[{"start":{"date-parts":[[2025,7,14]],"date-time":"2025-07-14T00:00:00Z","timestamp":1752451200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>Aducanumab, a monoclonal antibody targeting amyloid-beta plaques, has been introduced as a pivotal therapeutic agent for Alzheimer\u2019s disease (AD). Although it offers promising benefits in the treatment of early-stage Alzheimer\u2019s disease, a thorough evaluation of its safety profile and potential adverse events (AEs) is essential to ensure patient safety.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>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.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>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 \u201camyloid-related imaging abnormalities\u201d 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 \u201cconfusional state,\u201d \u201cdisorientation,\u201d and \u201ccerebral microhemorrhage.\u201d Unexpected AEs such as \u201csubdural hematoma\u201d and \u201chead injury\u201d were also noted, indicating a broader safety profile that requires further investigation.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusions<\/jats:title>\n<jats:p>The study\u2019s 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.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec005\">\n<jats:title>Strengths and limitations of this study<\/jats:title>\n<jats:p>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.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0328076","type":"journal-article","created":{"date-parts":[[2025,7,14]],"date-time":"2025-07-14T17:23:00Z","timestamp":1752513780000},"page":"e0328076","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":3,"title":["Unveiling Aducanumab\u2019s safety profile: A comprehensive pharmacovigilance analysis"],"prefix":"10.1371","volume":"20","author":[{"given":"Huanhuan","family":"Ji","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-7408-766X","authenticated-orcid":true,"given":"Zongren","family":"Zhao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chuanwei","family":"Zhao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2025,7,14]]},"reference":[{"issue":"4","key":"pone.0328076.ref001","doi-asserted-by":"crossref","first-page":"322","DOI":"10.1056\/NEJMoa1304839","article-title":"Two phase 3 trials of bapineuzumab in mild-to-moderate Alzheimer\u2019s disease","volume":"370","author":"S Salloway","year":"2014","journal-title":"N Engl J Med"},{"issue":"7618","key":"pone.0328076.ref002","doi-asserted-by":"crossref","first-page":"50","DOI":"10.1038\/nature19323","article-title":"The antibody aducanumab reduces A\u03b2 plaques in Alzheimer\u2019s disease","volume":"537","author":"J Sevigny","year":"2016","journal-title":"Nature"},{"issue":"1","key":"pone.0328076.ref003","doi-asserted-by":"crossref","first-page":"83","DOI":"10.1186\/s12929-023-00976-6","article-title":"Clinical trials of new drugs for Alzheimer disease: a 2020-2023 update","volume":"30","author":"L-K Huang","year":"2023","journal-title":"J Biomed Sci"},{"issue":"4","key":"pone.0328076.ref004","doi-asserted-by":"crossref","first-page":"311","DOI":"10.1056\/NEJMoa1312889","article-title":"Phase 3 trials of solanezumab for mild-to-moderate Alzheimer\u2019s disease","volume":"370","author":"RS Doody","year":"2014","journal-title":"N Engl J Med"},{"issue":"8","key":"pone.0328076.ref005","article-title":"Comparative Study of Safety and Efficacy of Angiotensin-Receptor Blockers and Anti Amyloid-\u00df Monoclonal Antibodies for the Treatment of Alzheimer\u2019s Disease: A Systematic Review","volume":"15","author":"K Shahid","year":"2023","journal-title":"Cureus"},{"issue":"2","key":"pone.0328076.ref006","doi-asserted-by":"crossref","first-page":"213","DOI":"10.1055\/s-0039-1681041","article-title":"Alzheimer\u2019s Disease Including Focal Presentations","volume":"39","author":"N Villain","year":"2019","journal-title":"Semin Neurol"},{"key":"pone.0328076.ref007","doi-asserted-by":"crossref","first-page":"114","DOI":"10.1016\/j.pneurobio.2012.12.001","article-title":"A conceptual framework and ethics analysis for prevention trials of Alzheimer Disease","volume":"110","author":"KR Peters","year":"2013","journal-title":"Prog Neurobiol"},{"issue":"11","key":"pone.0328076.ref008","doi-asserted-by":"crossref","first-page":"2292","DOI":"10.1002\/alz.12643","article-title":"New developments of biofluid-based biomarkers for routine diagnosis and disease trajectories in frontotemporal dementia","volume":"18","author":"M Del Campo","year":"2022","journal-title":"Alzheimers Dement"},{"issue":"11","key":"pone.0328076.ref009","doi-asserted-by":"crossref","DOI":"10.1016\/S1470-2045(16)30312-6","article-title":"21st century pharmacovigilance: efforts, roles, and responsibilities","volume":"17","author":"PJ Pitts","year":"2016","journal-title":"Lancet Oncol"},{"issue":"2","key":"pone.0328076.ref010","article-title":"Emerging Causes of Drug-Induced Anaphylaxis: A Review of Anaphylaxis-Associated Reports in the FDA Adverse Event Reporting System (FAERS)","volume":"9","author":"RJ Yu","year":"2021","journal-title":"J Allergy Clin Immunol Pract"},{"key":"pone.0328076.ref011","first-page":"37","article-title":"The role of pharmacovigilance in Alzheimer\u2019s disease drug development","volume":"5","author":"CA Szekely","year":"2019","journal-title":"Alzheimer Dementia"},{"issue":"2","key":"pone.0328076.ref012","first-page":"719","article-title":"A phase III randomized trial of gantenerumab in prodromal Alzheimer\u2019s disease","volume":"5","author":"S Ostrowitzki","year":"2018","journal-title":"Alzheimers Res Ther"},{"issue":"6","key":"pone.0328076.ref013","doi-asserted-by":"crossref","first-page":"643","DOI":"10.1111\/joim.12816","article-title":"Biomarkers for Alzheimer\u2019s disease: current status and prospects for the future","volume":"284","author":"K Blennow","year":"2018","journal-title":"J Intern Med"},{"issue":"1","key":"pone.0328076.ref014","doi-asserted-by":"crossref","first-page":"18","DOI":"10.1186\/s13195-016-0189-7","article-title":"Bapineuzumab for mild to moderate Alzheimer\u2019s disease in two global, randomized, phase 3 trials","volume":"8","author":"R Vandenberghe","year":"2016","journal-title":"Alzheimers Res Ther"},{"issue":"3","key":"pone.0328076.ref015","doi-asserted-by":"crossref","first-page":"512","DOI":"10.1111\/psyg.12944","article-title":"Aducanumab for the treatment of Alzheimer\u2019s disease: a systematic review","volume":"23","author":"A Rahman","year":"2023","journal-title":"Psychogeriatrics"},{"issue":"20","key":"pone.0328076.ref016","doi-asserted-by":"crossref","first-page":"4260","DOI":"10.1016\/j.cell.2023.08.021","article-title":"Alzheimer\u2019s disease: From immunotherapy to immunoprevention","volume":"186","author":"M Jucker","year":"2023","journal-title":"Cell"},{"issue":"10","key":"pone.0328076.ref017","doi-asserted-by":"crossref","first-page":"1037","DOI":"10.1016\/S1474-4422(15)00093-9","article-title":"Multimodal imaging in Alzheimer\u2019s disease: validity and usefulness for early detection","volume":"14","author":"S Teipel","year":"2015","journal-title":"Lancet Neurol"},{"key":"pone.0328076.ref018","first-page":"1","article-title":"Comparing musculoskeletal and connective tissue disorder risks of teriparatide and abaloparatide in osteoporosis: an analysis based on FDA adverse event reporting system (FAERS)","volume":"18","author":"MT Wen","year":"2024","journal-title":"Expert Opinion Drug Safe"},{"issue":"11","key":"pone.0328076.ref019","doi-asserted-by":"crossref","first-page":"1106","DOI":"10.2174\/1570159X18666200528142429","article-title":"Recent Advancements in Pathogenesis, Diagnostics and Treatment of Alzheimer\u2019s Disease","volume":"18","author":"S Khan","year":"2020","journal-title":"Curr Neuropharmacol"},{"issue":"2","key":"pone.0328076.ref020","doi-asserted-by":"crossref","first-page":"245","DOI":"10.1016\/j.therap.2016.02.007","article-title":"Pharmacovigilance implemented by patients: A necessity in the 21st century","volume":"71","author":"J Lafond","year":"2016","journal-title":"Therapie"},{"issue":"6","key":"pone.0328076.ref021","doi-asserted-by":"crossref","first-page":"427","DOI":"10.1002\/pds.1742","article-title":"Quantitative signal detection using spontaneous ADR reporting","volume":"18","author":"A Bate","year":"2009","journal-title":"Pharmacoepidemiol Drug Saf"},{"issue":"1","key":"pone.0328076.ref022","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1056\/NEJMoa2212948","article-title":"Lecanemab in Early Alzheimer\u2019s Disease","volume":"388","author":"CH van Dyck","year":"2023","journal-title":"N Engl J Med"},{"issue":"1","key":"pone.0328076.ref023","doi-asserted-by":"crossref","first-page":"99","DOI":"10.1186\/s13195-018-0409-4","article-title":"A phase III randomized trial of gantenerumab in prodromal Alzheimer\u2019s disease [published correction appears in Alzheimers Res Ther]","volume":"10","author":"S Ostrowitzki","year":"2018","journal-title":"Alzheimers Res Ther"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0328076","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,7,14]],"date-time":"2025-07-14T17:23:05Z","timestamp":1752513785000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0328076"}},"subtitle":[],"editor":[{"given":"Ashima","family":"Nayyar","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,7,14]]},"references-count":23,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2025,7,14]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0328076","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,7,14]]}}}