Comparative Analysis of Adverse Events in Ranibizumab and Aflibercept for Intraocular Injection Based on FAERS
OBJECTIVE To mining and comparative overall analysis of adverse event(ADE)signals associated with both intraocular injectable ranibizumab and aflibercept using the US FDA Adverse Event Reporting System(FAERS)data,providing a reference for clinical safe medication in the treatment of neovascular fundus disorders.METHODS ADE reports relative to ranibizumab and aflibercept from 2004 to 2022 were collected for a total of 76 quarters in the FAERS,and after removing duplicate data using SQL language,ADEs were standardized and categorized using the Medical Dictionary for Drug Regulatory Activities(MedDRA).Data mining of ADE reports was performed using the reporting odd ratio method,proportional reporting ratio method and the Bayesian method to analyze the differences in adverse event signals between the two drugs and to obtain new ADE signals by comparing them with the drug package inserts.RESULTS There were a total of 21 175 ADE reports for ranibizumab as the primary suspect drug and 21 764 ADE reports for aflibercept.Ranibizumab and aflibercept ADEs involved roughly similar systems,with more than 50％of ADEs being ocular organ disorders,followed by nervous system ADEs.Totally 678 ADE signals were mined(including 402 of ranibizumab and 276 of aflibercept),ranibizumab has a higher signal intensity and frequency of ADE in retinal pigment epithelial tears,retinal edema and vitreous hemorrhage ocular ADEs compared to aflibercept,while aflibercept was higher than ranibizumab in nine ADEs,including endophthalmitis,noninfectious endophthalmitis,and vitreous inflammation,and the high risk signals for the two drugs existence of variability.Compared with the drug package inserts,new ADE signals of the presence of subretinal fluid,vitrectomy,and death were discovered in the two drugs.CONCLUSION The FAERS database showed that the overall distribution of ADEs of the two drugs was basically consistent,but the safety of the two drugs had their own advantages and disadvantages.It is recommended that the clinical use of ranibizumab should focus on the monitoring of retina-related ADEs,and the application of aflibercept should focus on ocular infections and systemic ADEs,especially the new ADEs unearthed in this excavation.
ranibizumabafliberceptadverse drug eventreported odds ratio(ROR)proportional reporting ratio(PRR)Bayesian methodsignal mining
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