Mining and analysis of risk signals for avelumab-induced adverse events based on FAERS database

Gu Yongzheng; Ling Tao; Chen Gang

doi:10.3969/j.issn.1672-8157.2025.05.043

Abstract：Objective To mine and analyze the positive signals for avelumab-induced adverse drug events(ADE)so as to pro-vide reference for the safe drug use in clinical practice.Methods The data of avelumab-induced ADEs from FDA adverse event reporting system(FAERS)were analyzed,and the time period was from the first quarter of 2017 to the first quarter of 2024.The sig-nals were mined by means of proportional reporting ratio(PRR)and reporting odds ratio(ROR).Results A total of 1 890 ADE re-ports of avelumab were obtained.The age of patients was mainly 18-85 years old(72.48%),and the gender was mainly male(63.07%).A total of 221 ROR positive risk signals were screened out,involving 21 systems and organ classifications.The ADEs with high fre-quency were basically consistent with the drug instructions,such as infusion-related reactions,diarrhea,fatigue,thrombocytopenia,and loss of appetite.The preferred terms(PT)with strong signals of adverse drug reactions(ADR)included death,paraneoplastic encephalomyelitis,polyneuropathy,hyperprogressive tumor,autoimmune myocarditis,tumor pseudoprogression,immune-mediated hepatitis,and polymyalgia rheumatica.Among them,myositis occurred more frequently as a new ADE among the top 20 ADRs in signal intensity.Conclusion Patients should be evaluated before the use of avelumab.Due to the high signal intensity and high frequency of myositis,patients should be monitored for suspicious symptoms of myositis,especially when combined with other programmed death-1(PD-1)inhibitors,related adverse reactions may be superimposed.During the treatment period,close attention should be paid to the patient's immune indicators.Any abnormalities should be intervened in a timely manner.