基于美国食品药品监督管理局不良事件报告系统儿童使用度普利尤单抗不良事件分析OA

Objective:To explore the safety of dupilumab in children aged＜18 years in the real world,and provide reference for post-marketing studies and rational clinical use of the drugs.Methods:Adverse drug event(ADE)reports of children＜18 years with dupilumab as primary suspect were collected from the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database from Mar.28th,2017 to Mar.31st,2024.Risk signals of ADE associated with dupilumab in children were mined by using reported odds ratio(ROR)and Mantel-Haenszel risk adjustment(MHRA)methods.ADE and severe ADE of long-term use of dupilumab in children were explored.Results:A total of 20,515 ADE reports were collected from children aged＜18 years with dupliuzumab as the primary suspect drugs.A total of 164 ADE signals were mined,including 14 organ systems.ADE were primarily concentrated in diseases of the skin and subcutaneous tissue,systemic diseases,various reactions at the site of administration,and diseases of the eye.Some ADE were found not to be listed in the drug instructions.Differences in high-frequency ADE were observed among different age groups.Totally 881 ADE reports with ADE more than 13 weeks were included in the long-term drug safety study.And 1,070 severe ADE reports were obtained,with some severe ADE already reported in relevant literature.Conclusion:It is necessary to do a good job in screening children before using dupilumab,strictly monitor the related ADE,and be alert to the occurrence of severe ADE.