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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2024, Vol. 29 ›› Issue (7): 768-774.doi: 10.12092/j.issn.1009-2501.2024.07.006

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

SONG Yao, PAN Chen, ZHAO Xiaohong, YANG Hongge, LI Ze, CUI Xiangli   

  1. Department of pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
  • Received:2024-02-29 Revised:2024-03-15 Online:2024-07-26 Published:2024-06-24

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: 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.

Key words: infliximab, adalimumab, vedolizumab, ustekinumab, lymphoma, FDA adverse event reporting system

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