韦多利珠单抗治疗溃疡性结肠炎:基于证据的安全性、疗效和治疗地点综述。

Core Evidence Pub Date : 2020-04-01 eCollection Date: 2020-01-01 DOI:10.2147/CE.S179053
Noritaka Takatsu, Takashi Hisabe, Daijiro Higashi, Toshiharu Ueki, Toshiyuki Matsui
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引用次数: 10

摘要

引言:选择性阻断整合素和粘膜粘附分子是治疗溃疡性结肠炎(UC)的一种很有前途的策略。韦多利珠单抗(VDZ)是一种抗α4β7整合素的人源化IgG1单克隆抗体,通过与α4β7-整合素结合,选择性阻断白细胞向胃肠道的运输。目的:在这篇综述中,我们概述了VDZ的独特机制,以及其疗效、安全性,以及从临床试验、观察性研究和荟萃分析中获得的药代动力学和药效学数据。证据综述:在VDZ诱导治疗中,暴露-疗效与临床缓解和临床反应呈正相关。目前尚无药物特异性安全信号。治疗地点:VDZ已被证明是UC的一线或二线诱导和维持治疗的有效方法。结论:VDZ是UC患者安全有效的治疗方案。延长VDZ诱导治疗可能有助于改善UC患者的预后,特别是那些以前接受过肿瘤坏死因子-α治疗的患者。VDZ和其他生物制品的前瞻性面对面研究将更清楚地改变VDZ的定位。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Vedolizumab in the Treatment of Ulcerative Colitis: An Evidence-Based Review of Safety, Efficacy, and Place of Therapy.

Introduction: Selective blockade of the integrins and mucosal adhesion molecules is a promising therapeutic strategy for ulcerative colitis (UC). Vedolizumab (VDZ), a humanized IgG1 monoclonal antibody against α4β7 integrin, selectively blocks the trafficking of the leukocytes into the gastrointestinal tract through its binding with the α4β7 integrin.

Aim: In this review, we provide an overview of the unique mechanism of VDZ, along with its efficacy, safety, and pharmacokinetic and pharmacodynamic data obtained from clinical trials, observational studies, and meta-analyses.

Evidence review: A positive exposure-efficacy relationship with regard to clinical remission and clinical response was apparent in VDZ induction therapy. No drug-specific safety signals are currently available.

Place in therapy: VDZ has been shown to be effective as first- or second-line induction and maintenance therapy in UC.

Conclusion: VDZ is a safe and effective treatment option for patients with UC. Prolonged VDZ induction therapy may contribute to improved outcomes in patients with UC, particularly those previously treated with tumor necrosis factor-α. Prospective head-to-head study of VDZ and other biologics would alter the positioning of VDZ much more clearly.

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Core Evidence
Core Evidence PHARMACOLOGY & PHARMACY-
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期刊介绍: Core Evidence evaluates the evidence underlying the potential place in therapy of drugs throughout their development lifecycle from preclinical to postlaunch. The focus of each review is to evaluate the case for a new drug or class in outcome terms in specific indications and patient groups The emerging evidence on new drugs is reviewed at key stages of development and evaluated against unmet needs
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