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对乌司奴单抗原发性或继发性无反应的炎症性肠病患者可从剂量递增或再诱导中获益。

IBD Patients with Primary or Secondary Nonresponse to Ustekinumab Benefit from Dose Escalation or Reinduction.

作者信息

Vernia Filippo, Monaco Sabrina, Latella Giovanni

机构信息

Division of Gastroenterology, Hepatology, and Nutrition, Department of Life, Health and Environmental Sciences, University of L'Aquila, 67100 L'Aquila, Italy.

出版信息

J Clin Med. 2024 Jul 9;13(14):3993. doi: 10.3390/jcm13143993.

DOI:10.3390/jcm13143993
PMID:39064033
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11277193/
Abstract

Ustekinumab is a monoclonal antibody approved for the treatment of IBD. This drug has a well-established efficacy; however, patients may not respond or lose response. The availability of other biological therapies prompts the need for comparative data between different agents to suggest first- or second-line strategies. Aim of this review is to compare the effectiveness of ustekinumab to other biologics in Crohn's disease and ulcerative colitis, as well as report the available data on dose escalation and reinduction. A systematic electronic search of the English literature was performed up to November 2023, using Medline (PubMed), Web of Science, Scopus and the Cochrane Library. Conference proceedings were also screened. Out of 659 citations, 80 relevant articles were selected and included in the present narrative review. Head-to-head comparisons of different biological drugs are relatively scarce, mostly deriving from indirect comparison or retrospective studies. Overall available data indicate similar effectiveness in the treatment of IBD patients. Dose escalation and reinduction strategies are well documented, but the optimal treatment schedule is still to be defined. Response and remission rates vary in different studies, and a proportion of patients fail to achieve clinical and endoscopic outcomes. However, both approaches are effective and safe in nonresponders and secondary loss of response. IBD patients may benefit from dose escalation or reinduction. Both strategies prove effective in regaining response in a proportion of patients, avoiding unnecessary early switch. Head-to-head trials are still needed to determine the exact placement of this drug compared to other biologics.

摘要

乌司奴单抗是一种被批准用于治疗炎症性肠病的单克隆抗体。这种药物疗效确切;然而,患者可能无反应或失去反应。其他生物疗法的出现促使需要不同药物之间的比较数据,以提出一线或二线治疗策略。本综述的目的是比较乌司奴单抗与其他生物制剂在克罗恩病和溃疡性结肠炎中的有效性,并报告剂量递增和再诱导的现有数据。截至2023年11月,使用Medline(PubMed)、科学网、Scopus和考克兰图书馆对英文文献进行了系统的电子检索。还筛选了会议论文集。在659篇文献中,选择了80篇相关文章并纳入本叙述性综述。不同生物药物的直接比较相对较少,大多来自间接比较或回顾性研究。总体现有数据表明,在治疗炎症性肠病患者方面有效性相似。剂量递增和再诱导策略有充分记录,但最佳治疗方案仍有待确定。不同研究中的缓解率和反应率各不相同,一部分患者未能实现临床和内镜下的治疗效果。然而,这两种方法在无反应者和继发反应丧失者中都是有效且安全的。炎症性肠病患者可能从剂量递增或再诱导中获益。两种策略在使一部分患者恢复反应方面均被证明有效,避免了不必要的过早换药。与其他生物制剂相比,仍需要直接比较试验来确定这种药物的确切定位。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cff/11277193/8642d3932d0e/jcm-13-03993-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cff/11277193/5eae9dddb50f/jcm-13-03993-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cff/11277193/4eff06d74b3d/jcm-13-03993-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cff/11277193/8642d3932d0e/jcm-13-03993-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cff/11277193/5eae9dddb50f/jcm-13-03993-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cff/11277193/4eff06d74b3d/jcm-13-03993-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cff/11277193/8642d3932d0e/jcm-13-03993-g003.jpg

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本文引用的文献

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J Crohns Colitis. 2024 Oct 15;18(10):1615-1621. doi: 10.1093/ecco-jcc/jjae063.
2
Intensification with Intravenous Ustekinumab in Refractory Crohn's Disease.静脉注射乌司奴单抗强化治疗难治性克罗恩病
J Clin Med. 2024 Jan 24;13(3):669. doi: 10.3390/jcm13030669.
3
Comparing clinical trial population representativeness to real-world users of 17 biologics approved for immune-mediated inflammatory diseases: An external validity analysis of 66,639 biologic users from the Italian VALORE project.
比较临床试验人群代表性与免疫介导的炎症性疾病 17 种获批生物制剂的真实世界使用者:来自意大利 VALORE 项目的 66639 名生物制剂使用者的外部有效性分析。
Pharmacol Res. 2024 Feb;200:107074. doi: 10.1016/j.phrs.2024.107074. Epub 2024 Jan 15.
4
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.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
J Clin Med. 2023 Mar 26;12(7):2503. doi: 10.3390/jcm12072503.
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Comparison of the Persistence of Anti-TNF Agents and Ustekinumab in Patients with Crohn's Disease: A Study Based on the Korean National Database.克罗恩病患者中抗 TNF 药物与乌司奴单抗持久性的比较:一项基于韩国国家数据库的研究
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