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一项回顾性研究表明,对于接受优特克单抗或维多珠单抗治疗的炎症性肠病患者,联合治疗与临床或内镜缓解率的提高无关。

Combination therapy is not associated with improved rates of clinical or endoscopic remission in patients with inflammatory bowel disease treated with ustekinumab or vedolizumab: a retrospective study.

作者信息

Jeffrey Angus W, Picardo Sherman, Menon Shankar, So Kenji, Venugopal Kannan

机构信息

Department of Gastroenterology, Royal Perth Hospital, Perth, Australia.

出版信息

Ann Gastroenterol. 2023 Jul-Aug;36(4):430-436. doi: 10.20524/aog.2023.0808. Epub 2023 May 29.

DOI:10.20524/aog.2023.0808
PMID:37396006
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10304522/
Abstract

BACKGROUND

Management of inflammatory bowel disease (IBD) involves biological agents, often in combination with thiopurines or methotrexate. The aim of our study was to compare clinical and endoscopic outcomes in IBD patients treated with vedolizumab or ustekinumab, as monotherapy or in combination with thiopurines or methotrexate.

METHODS

We conducted a retrospective cohort study of all patients aged ≥18 years with a diagnosis of ulcerative colitis or Crohn's disease, commenced on vedolizumab or ustekinumab between October 2015 and March 2022. Primary outcome was clinical remission or response calculated by partial Mayo score (remission: <3; response: improvement >1) for ulcerative colitis or Harvey-Bradshaw index (<5, >2 respectively) for Crohn's disease over 1 year. Secondary endpoints were treatment failure, relapse, endoscopic remission at 1 year. Statistical analysis was done using 2-sample Student's and chi-square tests.

RESULTS

A total of 159 IBD patients were included in the study, 85 (53%) on vedolizumab and 74 (47%) on ustekinumab. For those on vedolizumab, 61 (72%) patients had ulcerative colitis, and 24 (28%) has Crohn's disease. All patients on ustekinumab had Crohn's disease. Mean disease duration in was 9.4 and 13.5 years respectively. There was no difference in clinical response or remission for vedolizumab or ustekinumab monotherapy compared to combination therapy at 1 year. There was also no difference in treatment failure, relapse or endoscopic remission.

CONCLUSION

Combining vedolizumab or ustekinumab with an immunomodulator is not superior to monotherapy in terms of clinical response or endoscopic remission up to 1 year in IBD.

摘要

背景

炎症性肠病(IBD)的治疗涉及生物制剂,通常与硫唑嘌呤或甲氨蝶呤联合使用。我们研究的目的是比较接受维多珠单抗或乌司奴单抗单药治疗或与硫唑嘌呤或甲氨蝶呤联合治疗的IBD患者的临床和内镜检查结果。

方法

我们对2015年10月至2022年3月期间开始使用维多珠单抗或乌司奴单抗治疗的所有年龄≥18岁、诊断为溃疡性结肠炎或克罗恩病的患者进行了一项回顾性队列研究。主要结局是根据部分梅奥评分(缓解:<3;反应:改善>1)计算的溃疡性结肠炎的临床缓解或反应,或根据克罗恩病的哈维-布拉德肖指数(分别为<5、>2)计算的1年内的临床缓解或反应。次要终点是治疗失败、复发、1年时的内镜缓解。使用双样本t检验和卡方检验进行统计分析。

结果

共有159例IBD患者纳入研究,85例(53%)接受维多珠单抗治疗,74例(47%)接受乌司奴单抗治疗。接受维多珠单抗治疗的患者中,61例(72%)患有溃疡性结肠炎,24例(28%)患有克罗恩病。所有接受乌司奴单抗治疗的患者均患有克罗恩病。平均病程分别为9.4年和13.5年。与联合治疗相比,维多珠单抗或乌司奴单抗单药治疗1年时的临床反应或缓解没有差异。治疗失败、复发或内镜缓解也没有差异。

结论

在IBD患者中,将维多珠单抗或乌司奴单抗与免疫调节剂联合使用在1年内的临床反应或内镜缓解方面并不优于单药治疗。

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本文引用的文献

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Use of Azathioprine in Ulcerative Colitis: A Comprehensive Review.硫唑嘌呤在溃疡性结肠炎中的应用:一项全面综述。
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Combination Therapy Does Not Improve Rate of Clinical or Endoscopic Remission in Patients with Inflammatory Bowel Diseases Treated With Vedolizumab or Ustekinumab.在接受维得利珠单抗或乌司奴单抗治疗的炎症性肠病患者中,联合治疗并未提高临床或内镜缓解率。
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A Review of the Clinical Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Vedolizumab.维得利珠单抗的临床药代动力学、药效学和免疫原性评价。
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