Data mining and analysis of adverse event signals of ciltacabtagene autoleucel based on FAERS

WANG Hui-ying; TIAN Li-juan

doi:10.20251/j.cnki.1003-3734.2025.13.014

Abstract：Objective:To conduct mining and analyzing of the adverse drug event(ADE)signals of ciltacabtagene autoleucel for its rational and safe clinical use.Methods:ADE data from the FAERS database were collected from Q1 2022 to Q2 2024 with ciltacabtagene autoleucel as primary suspect drug,and valid signals for ADEs were screened using the reporting odds ratio(ROR),proportional reporting ratio(PRR),muti-item Gamma Poisson shrinker(MGPS),and Bayesian confidence propagation neural network(BCPNN)methods.Results:A total of 1364 ADE reports were retrieved with ciltacabtagene autoleucel as primary suspect drug,and the percentage of ADEs with serious outcomes(resulting in hospitalization or prolonged hospitalization,death,life-threatening,and disability)was 41.3%.A total of 556 preferred terms(PTs)were mined from the ADE reports involving 24 system organ class(SOCs),and after excluding signals that were not related to the adverse drug reactions,the PTs that met the four assays were collected.There were 68 positive signals,of which 14 ADEs were not included in the specification,including cytomegalovirus pneumonia,immune-mediated small bowel colitfis,large bowel perforation,squamous cell carcinoma of the skin,and basal cell carcinoma.The onset of adverse events was concentrated in the 1st month after the initiation of ciltacabtagene autoleucel treatment and occurred in 6.91%of patients after 1 year of treatment.Conclusion:In addition to paying close attention to adverse reactions documented in the insert,it is also important to be alert to the occurrence of potential adverse events when treating patients with relapsed refractory multiple myeloma with ciltacabtagene autoleucel,and long-term follow-up is recommended for patients using ciltacabtagene autoleucel.