Signal mining and analysis of adverse events for lecanemab based on the FAERS database
10.12173/j.issn.1005-0698.202411039
- VernacularTitle:基于FAERS数据库的仑卡奈单抗不良事件信号挖掘与分析
- Author:
Wen ZHANG
1
;
Min LI
;
Erping LIU
;
Wenting TAO
;
Rui CAI
;
Weixian ZHOU
Author Information
1. 常州市妇幼保健院药学部(江苏常州 213000)
- Publication Type:Journal Article
- Keywords:
Lecanemab;
FAERS database;
Drug adverse events;
Signal mining
- From:
Chinese Journal of Pharmacoepidemiology
2025;34(2):166-174
- CountryChina
- Language:Chinese
-
Abstract:
Objective To mine the risk signals of adverse drug events(ADEs)related to lecanemab through the U.S.Food and Drug Adminstration Adverse Event Reporting System(FAERS)database,to provide a reference for the safe clinical use of lecanemab.Methods Data on adverse events related to lecanemab from the fourth quarter,2010 to the second quarter 2024 in the FAERS were collected.Potential ADE signals were mined using the reporting odds ratio(ROR)method,Medicines and Healthcare Products Regulatory Agency(MHRA)method,Bayesian confidence propagation neural network(BCPNN)method and multi-item gamma Poisson shrinker(MGPS)method.The top 30 ADEs in terms of report frequency and signal strength,as well as ADEs categorized by system organ class(SOC),were statistically analyzed.Results A total of 868 adverse event reports related to lecanemab were collected,involving 1,986 instances of ADEs with 38 related ADE identified,the proportion of serious ADEs was 23.39％,and 87.15％of ADEs occurred in the first 3 months after the initiation of the drug.The top 30 PT signals in reported cases were headache,chills,fatigue,effusion type amyloid-related imaging abnormalities(ARIA-E),hemorrhage-type amyloid-related imaging abnormalities(ARIA-H),and so on.The top 30 signals in terms of signal intensity mainly included ARIA-E,ARIA-H,brain fog,infusion-related reactions.ADEs related to nervous system diseases were the most common.Fifteen new suspected or serious ADEs not recorded in the instructions were discovered,such as brain fog,formication,status epilepticus.Conclusion Risk assessment of patients'medication should be conducted before clinical use of lecanemab,especially in the first 3 months of the medication period,focus should be placed on monitoring common ADEs,such as ARIA-E,ARIA-H,infusion-related reactions.Attention also needs to be paid to the newly discovered suspected ADEs,to ensure the patients'medication safety.
