Real-world safety profile of lecanemab: A disproportionality analysis of adverse events in the FDA adverse event reporting system

Abstract

Background

Lecanemab, an antiamyloid monoclonal antibody, has emerged as a treatment option for Alzheimer disease. However, there is a pressing need for real-world evidence to inform clinical practice, particularly regarding its safety profile.

Objectives

This study aimed to analyze adverse events (AEs) associated with lecanemab using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods

All cases reporting AEs were included if reported during the study period, from January 1, 2023, to June 30, 2024, during which a total of 1,307,937 cases were reported in the FAERS database. A disproportionality analysis was conducted to assess adverse reactions associated with lecanemab. Reporting odds ratios (RORs) with 95% CIs were extracted from OpenVigil 2.1-MedDRA-v24 for lecanemab-related events.

Results

The analysis identified a total of 1679 AEs associated with lecanemab during the study period. The strongest safety signal was observed for amyloid-related imaging abnormalities (ARIAs), particularly ARIA with hemosiderin deposits in the brain parenchyma or on the pial surface (microhemorrhages, ROR 11,221.5 [95% CI 5706.2–22,067.5]) and ARIA with brain edema or sulcal effusion (edema/effusion, ROR 8927.3 [95% CI 5243.6–15,199.1]). Other notable AEs included infusion-related reactions (ROR 24.9 [95% CI 18.9–32.8]), headache (ROR 10.2 [95% CI 8.6–12.2]), and confusional states (ROR 15.0 [95% CI 11.4–19.7]).

Conclusion

This study underscores the importance of vigilant monitoring for ARIA and other neurologic and psychiatric AEs associated with lecanemab in real-world clinical settings. The findings highlight the need for ongoing postmarket surveillance to ensure patient safety and guide clinical decision making.