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维多珠单抗作为克罗恩病一线治疗失败后抗TNF与优特克单抗的短期和长期疗效比较:一项多中心回顾性队列研究

Comparison of Short- and Long-Term Effectiveness between Anti-TNF and Ustekinumab after Vedolizumab Failure as First-Line Therapy in Crohn's Disease: A Multi-Center Retrospective Cohort Study.

作者信息

Albshesh Ahmad, Bannon Lian, Sharar Fischler Tali, Truyens Marie, Vavricka Stephan R, Tepes Katja, Pugliese Daniela, Savarino Edoardo V, Zittan Eran, Drobne David, Roblin Xavier, Bar-Gil Shitrit Ariella, Armuzzi Alessandro, Lobaton Triana, Maharshak Nitsan, Yanai Henit, Ben-Horin Shomron, Kopylov Uri

机构信息

Sheba Medical Center, Department of Gastroenterology, Tel Hashomer, Ramat Gan 5262100, Israel.

Sackler School of Medicine, Tel-Aviv University, Tel-Aviv 52621, Israel.

出版信息

J Clin Med. 2023 Mar 26;12(7):2503. doi: 10.3390/jcm12072503.

Abstract

BACKGROUND

The effectiveness of anti-TNF or ustekinumab (UST) as a second-line biologic after vedolizumab (VDZ) failure has not yet been described.

AIMS AND METHODS

In this retrospective multicenter cohort study, We aim to investigate the effectiveness of anti-TNF and UST as second-line therapy in patients with Crohn's disease (CD) who failed VDZ as a first-line treatment. The primary outcome was clinical response at week 16-22. Secondary outcomes included the rates of clinical remission, steroid-free clinical remission, CRP normalization, and adverse events.

RESULTS

Fifty-nine patients who failed on VDZ as a first-line treatment for CD were included; 52.8% patients received anti-TNF and 47.2% UST as a second-line therapy. In initial period (Week 16-22), the clinical response and remission rate was similar between both groups: 61.2% vs. 68%, = 0.8 and 48.3% vs. 56%, = 0.8 on anti-TNF and UST therapy, respectively. Furthermore, in the maintenance period the rate was similar: 75% vs. 82.3%, = 0.8 and 62.5% vs. 70.5%, = 0.8, respectively. Of the patients, 12 out of the 59 stopped the therapy, without a significant difference between the two groups ( = 0.6).

CONCLUSION

Second-line biological therapy after VDZ failure therapy was effective in >60% of the patients with CD. No differences in effectiveness were detected between the use of anti-TNF and UST as a second line.

摘要

背景

抗TNF或优特克单抗(UST)作为维多珠单抗(VDZ)治疗失败后的二线生物制剂的有效性尚未见报道。

目的和方法

在这项回顾性多中心队列研究中,我们旨在调查抗TNF和UST作为一线治疗失败的克罗恩病(CD)患者的二线治疗的有效性。主要结局是第16 - 22周的临床缓解。次要结局包括临床缓解率、无激素临床缓解率、C反应蛋白(CRP)正常化率和不良事件发生率。

结果

纳入59例一线使用VDZ治疗失败的CD患者;52.8%的患者接受抗TNF作为二线治疗,47.2%的患者接受UST作为二线治疗。在初始阶段(第16 - 22周),两组的临床缓解率和缓解率相似:抗TNF治疗组和UST治疗组分别为61.2%对68%,P = 0.8和48.3%对56%,P = 0.8。此外,在维持阶段,该比率也相似:分别为75%对82.3%,P = 0.8和62.5%对70.5%,P = 0.8。59例患者中有12例停止治疗,两组之间无显著差异(P = 0.6)。

结论

VDZ治疗失败后的二线生物治疗对超过60%的CD患者有效。抗TNF和UST作为二线治疗在有效性方面未检测到差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d56/10095015/456e4ef49e6d/jcm-12-02503-g001.jpg

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