Unveiling the safety profile of lecanemab: A comprehensive analysis of adverse events using FDA adverse event reporting system data

Background Lecanemab, a novel monoclonal antibody targeting amyloid-β, has shown promise in treating Alzheimer's disease. Comprehensive post-marketing safety data analysis is crucial to understand its real-world risk profile. Objective This study aimed to evaluate the safety profile of lecanemab using data from the FDA Adverse Event Reporting System (FAERS), with a focus on nervous system disorders and amyloid-related imaging abnormalities. Methods We conducted a disproportionality analysis using the FAERS database to evaluate the safety signals associated with lecanemab. Reporting odds ratio (ROR), proportional reporting ratio, empirical Bayesian geometric mean, and information component were calculated at both system organ class (SOC) and preferred term (PT) levels. Additionally, we performed a time-to-onset analysis using Weibull shape parameter estimation. Results Analysis at the SOC level revealed significant signals for nervous system disorders (ROR: 7.32, 95% CI: 6.69–8.00). At the PT level, strong signals were observed for amyloid-related imaging abnormalities, particularly those associated with microhemorrhages and oedema (ROR: 4122.81 and 3922.78, respectively). Headache was the most frequently reported adverse event (200 cases), followed by chills (107 cases) and fatigue (97 cases). Time-to-onset analysis showed a median time of 33 days (range: 1–1283) for all adverse events, with neurological events occurring slightly later (median: 42 days, range: 1–1260). Conclusions Our findings highlight a distinct safety profile for lecanemab, with a predominant impact on the nervous system and a notable association with imaging abnormalities. These results underscore the importance of vigilant monitoring and further research to optimize the risk-benefit profile of lecanemab in clinical practice.