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BioDrugs. 2015 Feb;29(1):57-67. doi: 10.1007/s40259-014-0113-2.
Vedolizumab (Entyvio™) is a humanized monoclonal antibody α4β7 integrin-receptor antagonist indicated for the treatment of adult patients with moderately to severely active ulcerative colitis or Crohn's disease. This article reviews the pharmacological properties of intravenous infusions of vedolizumab and its clinical efficacy in adult patients with these diseases. In phase III clinical trials, patients with ulcerative colitis had significantly higher rates of clinical response and clinical remission when treated with vedolizumab than when receiving placebo at both 6 and 52 weeks. However, outcomes with vedolizumab in patients with Crohn's disease were mixed. In a study that evaluated both clinical remission rate and CDAI-100 response rate as primary endpoints, only the clinical remission rate at 6 weeks was significantly higher with vedolizumab than placebo. In another trial, there was no significant between-group difference in the clinical remission rate in TNF-antagonist failure patients at 6 weeks (primary endpoint), although there was a significant difference at 10 weeks. In the Crohn's disease study that included maintenance treatment, vedolizumab was significantly more effective at 52 weeks than placebo in both endpoints (clinical remission was the only primary endpoint in the maintenance study). Vedolizumab was generally well tolerated in these trials. As vedolizumab is a specific α4β7 integrin antagonist, with gut-specific effects, it is unlikely to be associated with the development of progressive multifocal leukoencephalopathy, a risk observed with the less selective α4β7/α4β1 integrin antagonist natalizumab. Vedolizumab is a useful addition to the treatment options available for patients with moderately to severely active ulcerative colitis and Crohn's disease.
维得利珠单抗（Entyvio™）是一种人源化单克隆抗体 α4β7 整合素受体拮抗剂，用于治疗中重度活动性溃疡性结肠炎或克罗恩病的成年患者。本文综述了维得利珠单抗静脉输注的药理学特性及其在这些疾病成年患者中的临床疗效。在 III 期临床试验中，溃疡性结肠炎患者在第 6 和第 52 周时接受维得利珠单抗治疗时，临床应答率和临床缓解率明显高于安慰剂组。然而，维得利珠单抗在克罗恩病患者中的疗效结果喜忧参半。在一项评估临床缓解率和 CDAI-100 应答率作为主要终点的研究中，只有第 6 周的临床缓解率显著高于安慰剂组。在另一项试验中，6 周时 TNF 拮抗剂失败患者的临床缓解率在组间无显著差异（主要终点），但在第 10 周时有显著差异。在包括维持治疗的克罗恩病研究中，维得利珠单抗在两个终点的 52 周时都显著优于安慰剂（维持研究中仅临床缓解率为主要终点）。在这些试验中，维得利珠单抗总体耐受性良好。由于维得利珠单抗是一种特异性的 α4β7 整合素拮抗剂，具有肠道特异性作用，因此不太可能与进展性多灶性白质脑病的发生相关，而进展性多灶性白质脑病是一种与不太选择性的 α4β7/α4β1 整合素拮抗剂那他珠单抗相关的风险。维得利珠单抗是中重度活动性溃疡性结肠炎和克罗恩病患者治疗选择的有用补充。
