Signal mining for cutaneous adverse events associated with antibody-drug conjugates based on FAERS database
10.12173/j.issn.1005-0698.202406012
- VernacularTitle:基于FAERS数据库的抗体药物偶联物相关皮肤不良事件信号挖掘
- Author:
Mengying QIAN
1
;
Yongyi ZHANG
;
Qing SHAN
;
Yan CHEN
;
Bing LI
;
Jinmin GUO
Author Information
1. 山东第二医科大学药学院(山东潍坊 261053)
- Keywords:
Antibody-drug conjugate;
Cutaneous adverse event;
FAERS database;
Data mining;
Pharmacovigilance
- From:
Chinese Journal of Pharmacoepidemiology
2024;33(10):1091-1098
- CountryChina
- Language:Chinese
-
Abstract:
Objective To mine and analyze cutaneous adverse drug event(ADE)of eight antibody-drug conjugates(ADC),and to ensure the safe clinical use of ADC drugs.Methods The data was obtained from the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)for the period from the third quarter of 2011 to the fourth quarter of 2023.The cutaneous ADE associated with 8 eight ADC drugs were identified through the process of specification and standardization of nomenclature.The potential ADE signals were detected using the reporting odds ratio and Bayesian confidence propagation neural network methods.Results A total of 124 234 ADE reports were identified with the 8 ADC drugs as the first suspected drugs,including 5 184 reports of cutaneous ADEs adverse reactions,involving 3 225 patients.A total of 72 preferred term signals were detected for the 8 ADC drugs.The highest number of signals were detected for enfortumab vedotin,followed by ado-trastuzumab emtansine and brentuximab vedotin.Except for detrolizumab,the first-day incidence of cutaneous ADEs associated with the remaining 7 ADC drugs was less than 30％.The median time of occurrence for the 7 drugs,excluding brentuximab vedotin,was within one course of treatment(21 d).Conclusion The risks of cutaneous ADEs was variable with ADC drugs,occurs early in treatment and poses a potential life-threatening danger.Therefore,clinical vigilance and close monitoring of skin conditions are essential during ADC drug use.
