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综述文章:炎症性肠病的新兴药物治疗。

Review article: emerging drug therapies in inflammatory bowel disease.

机构信息

Center for Inflammatory Bowel Diseases, Division of Gastroenterology, Beth-Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.

出版信息

Aliment Pharmacol Ther. 2022 Apr;55(7):789-804. doi: 10.1111/apt.16785. Epub 2022 Feb 15.

Abstract

BACKGROUND

The landscape of inflammatory bowel disease (IBD) treatment is rapidly expanding with the development of new therapeutic options.

AIM

To review the mechanisms of action and the available clinical trial data on emerging drug therapies for IBD.

METHODS

Pubmed, Medline and Cochrane databases were queried up to July 2021 using keywords "inflammatory bowel disease," "IBD," "Crohn's disease," "ulcerative colitis" and "trial," "phase" and "study." In addition, we manually reviewed the grey literature including clinical trial registries and abstracts from major gastroenterology conferences in 2020 and 2021 to include pertinent information.

RESULTS

In ulcerative colitis (UC), phase 2b and/or phase 3 studies met primary endpoints for S1P receptor agonists (estrasimod, ozanimod), anti-IL-23 agent (mirikizumab), anti-lymphocyte trafficking agents (ontamalimab, subcutaneous vedolizumab), JAK inhibitors (upadacitinib, filgotinib) and TLR9 agonist (cobitolimod). In Crohn's disease (CD), anti-IL-23 agents (risankizumab, mirikizumab, guselkumab), JAK inhibitors (upadacitinib, filgotinib) and anti-lymphocyte trafficking agents (ontamalimab, etrolizumab) met primary endpoints in randomised controlled clinical trials.

CONCLUSION

Several new IBD drug therapies have positive efficacy and safety data in early clinical trials, and there are several drugs in the therapeutic pipeline. As more treatments for CD and UC are approved for clinical use, research to assess predictors of response to therapy and head-to-head trials is needed to inform providers on how to best position therapeutic options for patients with IBD.

摘要

背景

随着新治疗选择的发展,炎症性肠病 (IBD) 的治疗领域正在迅速扩大。

目的

综述新兴 IBD 治疗药物的作用机制和现有临床研究数据。

方法

使用关键词“炎症性肠病”、“IBD”、“克罗恩病”、“溃疡性结肠炎”和“试验”、“阶段”和“研究”,在 Pubmed、Medline 和 Cochrane 数据库中进行了截至 2021 年 7 月的检索。此外,我们还手动查阅了包括临床试验登记处和 2020 年和 2021 年主要胃肠病会议摘要在内的灰色文献,以纳入相关信息。

结果

在溃疡性结肠炎 (UC) 中,S1P 受体激动剂(依特司莫单抗、奥扎那米单抗)、抗 IL-23 制剂(米利珠单抗)、抗淋巴细胞迁移剂(ontamalimab、皮下维多珠单抗)、JAK 抑制剂(upadacitinib、filgotinib)和 TLR9 激动剂(cobitolimod)的 2b 期和/或 3 期研究达到了主要终点。在克罗恩病 (CD) 中,抗 IL-23 制剂(risankizumab、mirikizumab、guselkumab)、JAK 抑制剂(upadacitinib、filgotinib)和抗淋巴细胞迁移剂(ontamalimab、etrolizumab)在随机对照临床试验中达到了主要终点。

结论

一些新的 IBD 药物治疗方法在早期临床试验中具有良好的疗效和安全性数据,并且在治疗管道中有几种药物。随着更多用于 CD 和 UC 的治疗方法获得临床批准,需要进行研究以评估治疗反应的预测因素,并进行头对头试验,为提供者提供有关如何为 IBD 患者最佳定位治疗选择的信息。

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