Data-mining and analysis of adverse events signals for infliximab based on FAERS database

doi:10.19803/j.1672-8629.20230523

Abstract

Abstract: Objective To provide a reference for the safety in clinical use by exploring the risk signals of infliximab-related adverse drug events (ADE). Methods ADE data related to infliximab from FDA Adverse Event Reporting System (FAERS) were collected from the 1st quarter of 2004 to the 1st quarter of 2023. Data mining was performed using the reporting odds ratio (ROR) method and the Bayesian confidence propagation neural network (BCPNN) method. Results The number of ADE reports met the threshold criteria was 175 930 with 963 signals obtained, involving 26 system organ classes(SOC). The main ADE of infliximab were observed in gastrointestinal diseases, infectious and invasive diseases, systemic diseases and various reactions at the site of administration, benign, malignant and tumors of unknown nature, and various musculoskeletal and connective tissue diseases, which are consistent with the drug’s instructions. In addition, the risk of cardiovascular diseases, renal injury and skin and subcutaneous tissue-like disorders that may result from infliximab was identified in this study. Conclusion When applying infliximab, in addition to the ADE documented in the drug package insert, close attention should also be paid to ADE not mentioned in the instruction to improve the safety of patients medication.

Key words: infliximab, risk signal, adverse drug event, FDA adverse event reporting system (FAERS)

CLC Number:

R994.11

YOU Xiaoyan, ZHENG Yingying, WANG Xianying. Data-mining and analysis of adverse events signals for infliximab based on FAERS database[J]. Chinese Journal of Pharmacovigilance, 2024, 21(3): 335-340.

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