四种生物制剂治疗克罗恩病相关淋巴瘤风险:一项上市后监测数据的真实世界研究  

Lymphoma risk in the treatment of Crohn's disease with four biological agents:a real world analysis of post-marketing surveillance data

作　　者：宋尧 潘晨 赵晓红 杨鸿鸽 李泽 崔向丽 SONG Yao;PAN Chen;ZHAO Xiaohong;YANG Hongge;LI Ze;CUI Xiangli(Department of pharmacy,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China)

机构地区：[1]首都医科大学附属北京友谊医院药剂科,北京100050

出　　处：《中国临床药理学与治疗学》2024年第7期768-774,共7页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：北京市医院管理中心创新梦工厂经费资助项目(202101)。

摘　　要：目的:挖掘和评价英夫利西单抗、阿达木单抗、维得利珠单抗、乌司奴单抗这四种生物制剂和淋巴瘤不良事件的关联性和特点,为临床应用的安全性提供参考。方法:基于FARES数据(2012年10月至2023年6月),应用比例失衡法和贝叶斯分析法对四种生物制剂治疗克罗恩病与淋巴瘤发生的相关性进行挖掘和评价,并且比较不良事件的预后。结果:四种生物制剂共筛选出淋巴瘤相关事件705例。这些事件中青年患者和中年患者远高于老年患者(25.11%vs.22.41%vs.12.2%),男性略多于女性(42.84%vs.35.60%)。四种生物制剂中,英夫利昔单抗ROR[3.40,95%CI=(3.03,3.82)]、PRR[3.38,95%CI=(3.01,3.79)]、IC(1.14,IC-2SD=1.02)和EBGM(2.21,EBGM05=2.01)值最大。四种生物制剂死亡比例和住院比例无显著性差异。结论:英夫利昔单抗与淋巴瘤关联性最强,临床使用时应警惕淋巴瘤风险。AIM:To determine the link between infliximab,adalimumab,vedolizumab,ustekinumab and risk of lymphoma in order to provide reference for the safety of clinical application.METHODS:Disproportionality analysis and Bayesian analysis were used in data mining to screen the suspected lymphoma after the use of four biological agents based on the FAERS data from October 2012 to June 2023.The fatality and hospitalization rates of this four biological agents associated lymphoma were also investigated.RESULTS:Totally 705 cases of four biological agents associated lymphoma were collected.Four biological agents associated lymphoma appeared to influent more young patients and middle-aged patients than elderly patients(25.11%vs.22.41%vs.12.2%).There were slightly more male than females(42.84%vs.35.60%).Infliximab has the highest reporting odds ratio[ROR3.40,95%CI=(3.03,3.82)],proportional ratio[PRR3.38,95%CI=(3.01,3.79)],information component(IC1.14,IC-2SD=1.02)and empirical Bayes geometric mean(EBGM2.21,EBGM05=2.01).Significant difference in the fatality rate and hospitalization rate among four biological agents were not found.CONCLUSION:Infliximab showed a strongest lymphoma association than the other three biological agents.Lymphoma risk should be vigilant when using infliximab.

关 键 词：英夫利西单抗 阿达木单抗 维得利珠单抗 乌司奴单抗 淋巴瘤 美国食品药品监督管理局不良事件报告系统 

分 类 号：R735.2[医药卫生—肿瘤]