Clinical Report: Real-World Safety Evaluation of Lecanemab
Overview
This study evaluates the safety profile of lecanemab, a monoclonal antibody for Alzheimer's disease, using the FAERS database and a multicenter cohort. Key findings include a high incidence of nervous system disorders and the identification of age as a risk factor for adverse events.
Background
Lecanemab has been approved for treating Alzheimer's disease, which affects millions globally and poses a significant healthcare burden. Continuous monitoring of its safety profile is crucial due to the potential for serious adverse events.
Data Highlights
Data Source
Findings
FAERS Analysis
2,764 AEs from 1,389 users; 12 positive SDRs identified
Cohort Study
29.05% of patients experienced AEs; infusion-related reactions most common
Age Risk Factor
OR (95% CI): 1.109 (1.011–1.215), P = 0.028
Key Findings
75% of prioritized SDRs in FAERS were nervous system disorders, primarily ARIA.
29.05% of patients in the cohort study experienced adverse events.
Infusion-related reactions were the most common AEs reported.
Age was identified as a significant risk factor for AE occurrence.
Pre-treatment significantly reduced the incidence of AEs.
Gene enrichment analysis suggested links between lecanemab-related genes and AEs.
Clinical Implications
Healthcare providers should be aware of the potential for serious adverse events associated with lecanemab, particularly ARIA.
Conclusion
The study highlights the importance of ongoing safety evaluations for lecanemab in real-world settings.
