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. 2025 Apr 1:16:1561020.
doi: 10.3389/fphar.2025.1561020. eCollection 2025.

A real-world pharmacovigilance study of adverse drug reactions associated with lecanemab and aducanumab based on WHO-VigiAccess and FAERS databases

Haoxiang Hu #  1 , Yunhan Zhao #  1 , Jiesheng Mao  1 , Jianghai He  1 , Yihan Zhang  1 , Hongyu Ye  1 , Xiaokai Yang  1
Affiliations

A real-world pharmacovigilance study of adverse drug reactions associated with lecanemab and aducanumab based on WHO-VigiAccess and FAERS databases

Haoxiang Hu et al. Front Pharmacol. .

Abstract

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: FAERS; VigiAccess; aducanumab; alzheimer’s disease (AD); lecanemab.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
The flowchart of this study. Footnotes: SOC, System Organ Class; PT, Preferred Term.
FIGURE 2
FIGURE 2
Baseline Characteristics of Lecanemab and Aducanumab Distribution. Footnotes: (A) The distribution of Lecanemab and Aducanumab by gender, and age group in VigiAccess and FAERS databases; (B) The distribution of Lecanemab and Aducanumab by country in FAERS database; (C) The distribution of Lecanemab and Aducanumab by reporting year in VigiAccess and FAERS databases.
FIGURE 3
FIGURE 3
Distribution of SOC for Lecanemab and Aducanumab. Footnotes: (A) The distribution of SOC in VigiAccess; (B) The distribution of SOC in FAERS; SOC, System Organ Class.
FIGURE 4
FIGURE 4
Forest Plot of PT Distribution for Lecanemab and Aducanumab in VigiAccess and FAERS Databases Footnotes: PT, Preferred Term; ROR, Reporting odds ratio.
FIGURE 5
FIGURE 5
Identification of serious adverse events for Lecanemab and Aducanumab using VigiAccess and FAERS databases.
See this image and copyright information in PMC

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