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ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Neuropharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1561020
This article is part of the Research Topic Repurposing Medications: Bridging Chronic Disease Management and Dementia Prevention View all 3 articles
A Real-World Pharmacovigilance Study of Adverse Drug Reactions Associated with Lecanemab and Aducanumab Based on WHO-VigiAccess and FAERS Databases
Provisionally accepted- Wenzhou People’s Hospital, Wenzhou, China
Background: Lecanemab and Aducanumab are two novel anti-amyloid beta (Aβ) therapies for Alzheimer's disease (AD) that have shown promise in slowing cognitive decline. However, their safety profiles remain unclear due to limited real-world evidence. This study aims to analyze and compare adverse drug reactions (ADRs) of these drugs using data from the WHO-VigiAccess and FAERS databases.Methods: A retrospective analysis was conducted using ADR data from the VigiAccess and FAERS databases, focusing on System Organ Class (SOC) and Preferred Term (PT) classifications. Descriptive statistics and reporting odds ratio (ROR) analysis were employed to evaluate and compare ADR profiles.Results: Lecanemab and Aducanumab exhibited distinct ADRs. Results from both the VigiAccess and FAERS databases indicated that the most SOC associated with both drugs was nervous system disorders (34.7% in VigiAccess, 36.8% in FAERS). Further multivariable logistic regression analysis revealed that Aducanumab was associated with a higher risk of nervous system disorders (OR = 4.72, 95% CI: 3.53-6.39, P < 0.001). Among the reported AEs, headache was the most frequently reported for Lecanemab (9.4% in VigiAccess, 8.96% in FAERS), while Aducanumab was primarily associated with amyloid-related imaging abnormalities (ARIA) (19.1% in VigiAccess, 23.58% in FAERS). In the blood and lymphatic systems, Anemia was observed in both drugs. However, thrombocyto-penia was more prevalent in Lecanemab, while platelet dysfunction and myelosuppression were more frequently observed in Aducanumab. Additionally, hospitalization and mortality rates were higher for Aducanumab compared to Lecanemab.Conclusion: This study compared the ADRs of Lecanemab and Aducanumab, revealing that ARIA was the most common AE for both drugs. However, Lecanemab showed a lower risk of ARIA, cerebral hemorrhage, and severe events. These findings emphasize the need for further clinical research to clarify the long-term safety and efficacy of both drugs.
Keywords: lecanemab, aducanumab, Alzheimer's disease (AD), VigiAccess, FAERS
Received: 15 Jan 2025; Accepted: 03 Mar 2025.
Copyright: © 2025 Hu, Zhao, Mao, He, Zhang, Ye and Yang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Xiaokai Yang, Wenzhou People’s Hospital, Wenzhou, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.