维得利珠单抗与英夫利昔单抗在中重度溃疡性结肠炎患者中的真实世界研究

孟锐萍; 黄宝宝; 刘恩; 林辉; 刘诚; 魏皓祺; 苏加庆; 周建云; 谢霞

doi:10.16016/j.2097-0927.202401072

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维得利珠单抗与英夫利昔单抗在中重度溃疡性结肠炎患者中的真实世界研究

临床医学 | 更新时间：2026-01-09

- 维得利珠单抗与英夫利昔单抗在中重度溃疡性结肠炎患者中的真实世界研究
- A real-world study of vedolizumab versus infliximab in patients with moderate to severe ulcerative colitis
- 陆军军医大学学报 2024年46卷第12期页码：1417-1424
- 作者机构：
  
  400037 重庆，陆军军医大学(第三军医大学)第二附属医院消化内科
- 作者简介：
  
  [ 谢霞, E-mail: xiexia0128@163.com XIE Xia, E-mail: xiexia0128@163.com
- 基金信息：
  
  医院青年博士人才孵化计划项目(2022YQB068);重庆市自然科学基金面上项目(CSTB2022NSCQ-MSX0184)
- DOI：10.16016/j.2097-0927.202401072
  中图分类号： R181.23;R392.11;R574.62
- 收稿：2024-01-18，
  
  修回：2024-04-07，
  
  纸质出版：2024-06-30
- 稿件说明：
移动端阅览
孟锐萍, 黄宝宝, 刘恩, 等. 维得利珠单抗与英夫利昔单抗在中重度溃疡性结肠炎患者中的真实世界研究[J]. 陆军军医大学学报, 2024,46(12):1417-1424.

Ruiping MENG, Baobao HUANG, En LIU, et al. A real-world study of vedolizumab versus infliximab in patients with moderate to severe ulcerative colitis[J]. Journal of Army Medical University, 2024, 46(12): 1417-1424.
孟锐萍, 黄宝宝, 刘恩, 等. 维得利珠单抗与英夫利昔单抗在中重度溃疡性结肠炎患者中的真实世界研究[J]. 陆军军医大学学报, 2024,46(12):1417-1424. DOI： 10.16016/j.2097-0927.202401072.

Ruiping MENG, Baobao HUANG, En LIU, et al. A real-world study of vedolizumab versus infliximab in patients with moderate to severe ulcerative colitis[J]. Journal of Army Medical University, 2024, 46(12): 1417-1424. DOI： 10.16016/j.2097-0927.202401072.

摘要

目的

通过多中心回顾性队列研究比较维得利珠(vedolizumab，VDZ)和英夫利昔单抗(infliximab，IFX)在中重度溃疡性结肠炎(ulcerative colitis，UC)患者中的疗效和安全性。

方法

收集2021年1月至2023年1月于西南地区三家医院就诊的中重度UC患者，所有患者均为生物制剂初始治疗且接受IFX或VDZ治疗至少14周。比较两组患者的14周及52周无激素缓解率、临床缓解率、内镜缓解率，并记录治疗期间的不良事件。分别以治疗14周和52周能否达到黏膜愈合为因变量，首先通过单因素分析探索影响14周和52周黏膜愈合的危险因素，再进行多因素logistic回归分析进一步明确影响14周和52周实现黏膜愈合的危险因素。

结果

共纳入151例中重度UC患者，在进行1∶1倾向性评分匹配(propensity score matching，PSM)后，每组各纳入57例患者进行分析比较。两组患者在14周及52周无激素缓解率、临床缓解率无明显差异(

0.05)；14周内镜缓

解率，VDZ组40.4%(23/57)明显高于IFX组22.8%(13/57)(

=0.044)，而52周内镜缓解率则无明显差异[64.5%(20/31)

59.5%(22/37)，

=0.669

]

。多因素Logistic回归分析结果显示，病变范围为左半结肠炎(E2)[vs全结肠炎(E3)

]

(OR：0.46，95%

：0.21~0.98，

=0.045)是影响14周实现黏膜愈合的独立危险因素；病程≥36个月(OR：0.25，95%

：0.09~0.66，

=0.005)是影响52周实现黏膜愈合的独立危险因素。两组不良事件发生率无统计学差异(1.8%

7.0%，

=0.360)。

结论

VDZ和IFX具有相似的疗效和安全性，均可作为中重度UC患者的一线选择。

Abstract

Objective

To compare the efficacy and safety of vedolizumab (VDZ) and infliximab (IFX) for moderate to severe ulcerative colitis (UC) patients through a multicenter retrospective cohort study.

Methods

All patients with moderate to severe UC who were naive to biologic agents and treated with IFX or VDZ for at least 14 weeks at 3 hospitals in Southwest China between January 2021 and January 2023 were retrospectively enrolled. The efficacy evaluation indicators

including steroid-free clinical remission rates

clinical remission rates and endoscopic remission rates at weeks 14 and 52 were compared between the 2 groups. The occurrence of adverse events during treatment were recorded. Taking whether mucosal healing could be achieved after 14 and 52 weeks of treatment as the dependent variable

firstly

univariate analysis was performed to analyze the risk factors affecting mucosal healing at weeks 14 and 52

and then multivariate logistic regression analysis was applied to identify the independent risk factors of mucosal healing at the 2 time points.

Results

A total of 151 patients with moderate to severe UC were included

after propensity score matching (PSM)

each group included 57 patients. There were no significant differences in the steroid-free clinical remission rate and clinical remission rate between the 2 groups at weeks 14 and 52

(

0.05). The endoscopic remission rate at week 14 was significantly higher in the VDZ group than the IFX group [40.4% (23/57)

22.8% (13/57)

=0.044

]

but no such difference was observed at week 52 [64.5% (20/31)

59.5% (22/37)

=0.669

]

. Multivariate logistic regression analysis showed that left-sided disease (E2) [

pancolitis (E3)

]

(

=0.46

95%

: 0.21~0.98

=0.045) was independent risk factor for mucosal healing at week 14 and a disease duration ≥36 months (

=0.25

95%

: 0.09~0.66

=0.005) was independent risk factor for mucosal healing at week 52. No statistical difference was observed in the incidence of adverse events between the 2 groups (1.8%

7.0%

=0.360).

Conclusion

VDZ and IFX have similar efficacy and safety

and both can be used as first-line options for patients with moderate to severe UC.

关键词

Keywords

references

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