Adverse events associated with lecanemab: A disproportionality analysis of data from the FDA adverse event reporting system

BackgroundLecanemab, a monoclonal antibody targeting amyloid-β plaques, is FDA-approved for early Alzheimer's disease (AD) treatment. However, safety data from daily clinical practice is limited.ObjectiveThis study aims to assess the adverse events (AEs) linked to lecanemab using the FDA Adverse Event Reporting System (FAERS) to inform better safety management.MethodsA retrospective pharmacovigilance study was conducted using FAERS data from Q1 2023 to Q2 2024. Disproportionality analysis, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS), was applied to evaluate AEs where lecanemab was the primary suspect drug.ResultsFrom Q1 2023 to Q2 2024, 917 AEs related to lecanemab were recorded in the FAERS database, with 67.2% of patients aged between 65 and 85 years and 54.5% involving women. Disproportionality analysis identified significant AEs across 22 organ systems, particularly nervous system and psychiatric disorders. Common AEs included headache, amyloid-related imaging abnormalities, and infusion-related reactions, while sleep-related issues like somnolence, abnormal dreams, and poor-quality sleep were notable. Median onset time was 48 days, with serious outcomes in 14.3% of cases, including 70 hospitalizations and 15 deaths.ConclusionsThis pharmacovigilance analysis confirms known AEs of lecanemab and highlights new safety concerns, particularly its impact on sleep. These findings underscore the importance of ongoing monitoring and research to enhance lecanemab's safety profile in AD treatment. However, due to the limitations of FAERS, our analysis is imperfect in terms of important AEs such as therapy-related brain loss and death.