Characteristics of adverse events and clinical risks of Lecanemab based on FAERS data

Objective: This study aims to analyze the distribution of adverse events (AEs) related to Lecanemab in real-world settings based on FAERS database data.

Methods: Using the FAERS database, AE data related to Lecanemab was collected from Q3 2023 to Q2 2024. Signal mining was conducted using frequency and Bayesian methods to identify positive signals associated with Lecanemab.

Results: A total of 8,284,874 AE reports were collected, with 894 related to Lecanemab. Signal mining identified 22 SOCs, involving 46 PTs. Nervous system disorders had the highest report count, with Amyloid-Related Imaging Abnormalities (ARIA) being the most prominent AE, with high report numbers and signal strength, manifesting as brain edema, microhemorrhages, and iron deposits in the brain. Additionally, infusion-related reactions were common, including headache, chills, and fever. The study also revealed some new potential AEs, such as anger, cognitive disorder, disorientation, and abnormal dreams. Although these psychiatric symptoms had a lower report count, their high signal strength suggests that Lecanemab may impact patients' mental states. Rare but severe AEs, such as encephalitis, pancreatic carcinoma, and subdural hematoma, had low report numbers but high signal strength, highlighting potential risks for these severe events, especially in high-risk patients with relevant medical histories.

Conclusion: This study unveils certain potential risks associated with Lecanemab in real-world applications. Further clinical studies are needed to validate these findings and provide guidance for safe medication practices.