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维得利珠单抗治疗炎症性肠病的产品评价。

A product review of vedolizumab in inflammatory bowel disease.

机构信息

Inflammatory Bowel Disease Center, Division of Gastroenterology, Department of Medicine, University of California San Diego , La Jolla , CA , USA.

Robarts Clinical Trials Inc ., London , ON , Canada.

出版信息

Hum Vaccin Immunother. 2019;15(10):2482-2490. doi: 10.1080/21645515.2019.1591139. Epub 2019 May 7.

Abstract

Vedolizumab is a monoclonal antibody to the α4β7 integrin that selectively reduces intestinal lymphocyte trafficking, thereby providing a safe and effective treatment option for patients with inflammatory bowel disease (IBD). This product review outlines the unique mechanism of vedolizumab in addition to efficacy, safety, pharmacokinetic and pharmacodynamic data from clinical trials, observational studies and meta-analyses. Vedolizumab has been shown to be effective as a first- or second-line induction and maintenance therapy in both ulcerative colitis (UC) and Crohn's disease (CD). Prolonged induction therapy may increase efficacy, particularly in tumor necrosis factor-alpha-exposed CD patients. To date, no drug-specific safety signals have been identified. In addition to the presence of an apparent exposure-response relationship, vedolizumab has demonstrated consistent pharmacodynamic effects on α4β7, mucosal vascular addressin cell adhesion molecule 1 and other cell adhesion molecules. Future efforts should focus on identifying predictive biomarkers capable of guiding personalized IBD treatment with vedolizumab.

摘要

维得利珠单抗是一种针对 α4β7 整合素的单克隆抗体,可选择性地减少肠道淋巴细胞迁移,从而为炎症性肠病(IBD)患者提供一种安全有效的治疗选择。本产品评价除了介绍维得利珠单抗的作用机制外,还概述了临床试验、观察性研究和荟萃分析中有关其疗效、安全性、药代动力学和药效学的数据。维得利珠单抗已被证明可有效作为溃疡性结肠炎(UC)和克罗恩病(CD)的一线或二线诱导和维持治疗药物。延长诱导治疗可能会提高疗效,尤其是在 TNF-α 暴露的 CD 患者中。迄今为止,尚未发现特定于药物的安全性信号。除了存在明显的暴露-反应关系外,维得利珠单抗还对 α4β7、黏膜血管地址素细胞黏附分子 1 和其他细胞黏附分子表现出一致的药效学作用。未来的研究应集中于确定能够指导个体化 IBD 治疗的预测性生物标志物。

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