Comparative risk of serious infections and tuberculosis in Korean patients with inflammatory bowel disease treated with non-anti-TNF biologics or anti-TNF-α agents: a nationwide population-based cohort study

被引:3
作者
Kim, Min Jee [2 ]
Kim, Ye-Jee [3 ]
Jeong, Daehyun [4 ]
Kim, Seonok [3 ]
Hong, Seokchan [5 ]
Park, Sang Hyoung [1 ]
Jo, Kyung-Wook [2 ]
机构
[1] Univ Ulsan, Asan Med Ctr, Dept Internal Med, Div Gastroenterol,Coll Med, 88 Olymp Ro 43 Gil, Seoul 05505, South Korea
[2] Univ Ulsan, Asan Med Ctr, Dept Internal Med, Div Pulmonol & Crit Care Med,Coll Med, 8 Olymp Ro 43 Gil, Seoul 05505, South Korea
[3] Univ Ulsan, Coll Med, Asan Med Ctr, Dept Clin Epidemiol & Biostat, Seoul, South Korea
[4] Sahmyook Med Ctr, Dept Pulmonol, Seoul, South Korea
[5] Univ Ulsan, Asan Med Ctr, Dept Internal Med, Div Rheumatol,Coll Med, Seoul, South Korea
基金
新加坡国家研究基金会;
关键词
inflammatory bowel disease; serious infections; TNF; tuberculosis; ustekinumab; vedolizumab; OPPORTUNISTIC INFECTIONS; CROHNS-DISEASE; REINFECTION; VEDOLIZUMAB; INFLIXIMAB; SAFETY; TRENDS;
D O I
10.1177/17562848241265013
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background: The risk of serious infection and active tuberculosis in patients with inflammatory bowel disease (IBD) has not been concurrently evaluated based on the use of anti-tumor necrosis factor (TNF)-alpha agents versus non-anti-TNF biologics (vedolizumab/ustekinumab) in the Korean population.Objectives: We compared the risk of serious infection and active tuberculosis in Korean patients with IBD treated with non-anti-TNF biologics (vedolizumab/ustekinumab) or anti-TNF-alpha agents.Design: This study was a population-based cohort analysis of nationwide administrative claims data.Methods: Health Insurance Review and Assessment Service claims data (representing 97% of the South Korean population) from between January 2007 and February 2021 were reviewed, and adults with IBD who initiated vedolizumab/ustekinumab or anti-TNF-alpha treatment (n = 6123) between 2017 and 2020 were enrolled. Intergroup differences in the risk of serious infection requiring hospitalization/emergency department visits or active tuberculosis during the follow-up period were analyzed.Results: In the patients treated with anti-TNF-alpha agents or vedolizumab/ustekinumab during a mean follow-up of 1.55 +/- 1.05 and 0.84 +/- 0.69 years, the incidence rates of serious infection were 9.43/100 and 6.87/100 person-years, respectively. Multivariable analysis showed no significant intergroup difference in the risk of serious infection with vedolizumab/ustekinumab or anti-TNF-alpha treatment; the adjusted relative risk of vedolizumab/ustekinumab compared with anti-TNF-alpha agents was 0.81 (95% confidence interval 0.46-1.44, p = 0.478). Among patients treated with anti-TNF-alpha agents and vedolizumab/ustekinumab, the incidence rates of active tuberculosis were 0.87 and 0.37 per 100 person-years, respectively. The relative risk of vedolizumab/ustekinumab compared with anti-TNF-alpha agents was 0.31 (95% confidence interval 0.07-1.26, p = 0.101). In a subset analysis comparing vedolizumab and ustekinumab with anti-TNF-alpha agents, similar results were observed.Conclusion: In Korean patients with IBD, non-anti-TNF biologics (vedolizumab/ustekinumab) tended to be associated with a lower risk of serious infection or active tuberculosis than anti-TNF-alpha agents.
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页数:14
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