Lymphoma risk in the treatment of Crohn's disease with four biologi-cal agents:a real world analysis of post-marketing surveillance data
10.12092/j.issn.1009-2501.2024.07.006
- VernacularTitle: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
- Author:
Yao SONG
1
;
Chen PAN
;
Xiaohong ZHAO
;
Hongge YANG
;
Ze LI
;
Xiangli CUI
Author Information
1. 首都医科大学附属北京友谊医院药剂科,北京 100050
- Keywords:
infliximab;
adalimumab;
vedolizum-ab;
ustekinumab;
lymphoma;
FDA adverse event re-porting system
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2024;29(7):768-774
- CountryChina
- Language:Chinese
-
Abstract:
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:Dis-proportionality analysis and Bayesian analysis were used in data mining to screen the suspected lym-phoma 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 pa-tients and middle-aged patients than elderly pa-tients(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 hospi-talization 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.
