Analysis of adverse drug events of cemiplimab based on FAERS database

LU Wei-jin; ZHU Ze-feng; HUANG Li-wu; YAN Kao-ling; WU Xiao-song

doi:10.3969/j.issn.1672-8157.2023.06.024

Abstract：Objective:To explore the risk signals of adverse drug events(ADEs)of cemiplimab for its clinical safe application.Methods:Openvigil 2.1 was sourced from the U.S.Food and Drug Administration's Adverse Event Reporting System(FAERS)database.The ADEs reports of cimiplimab were collected through Openvigil 2.1 database from September 28th,2018 to March 31th,2023.The reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods were applied to analyze the ADEs risk signals of cemiplimab.The preferred term(PT)and system organ class(SOC)were described and classified by the Medical Dictionary for Regulatory Activitie(version 24.0)(MedDRA 24.0).Results:A total of 642 ADEs reports with cemiplimab as the primary suspected drug were collected,and 79 PT signals and 20 SOCs were obtained.Common ADEs included rash,pyrexia,general physical health deterioration and sepsis,etc.,and they were mainly related to immune system diseases(10.20%),various injuries,poisoning as well as operational complications(10.20%)and respiratory system diseases,chest and mediastinal diseases(8.16%),etc.The adverse reaction signals such as haemorrhage,interstitial lung disease,dysphagia,hepatic enzyme increase,pneumocephalus,eosinophilic fasciitis,femoral neck fracture and fluid intake reduction were not mentioned in the drug instructions of cemiplimab among the top of 20 PT reports and 20 signal intensities.Conclusion:The incidence of immune-related adverse reactions in clinical application of cemiplimab are basically consistent with the drug instructions.In addition to the ADEs recorded in the drug instructions,attention should also be paid to the risks of haemorrhage,interstitial lung disease,dysphagia in clinical application of cemiplimab.