Gastroenterology Institute, Sheba Medical Center Tel Hashomer, Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel.
Centre for Liver and Digestive Disorders, Royal Infirmary of Edinburgh, Edinburgh, UK.
J Crohns Colitis. 2018 Jan 24;12(2):245-257. doi: 10.1093/ecco-jcc/jjx143.
Vedolizumab [VDZ] is an anti-integrin monoclonal antibody effective in ulcerative colitis [UC] and Crohn's disease [CD]. Several real-world experience [RWE] studies with VDZ have been published to date. The aim of this systematic review was to summarise the available real-life experience with VDZ.
We performed a systematic review of the available RWE studies of VDZ in CD and UC. We performed a pooled analysis of the available efficacy and safety data for induction and maintenance treatment in adult cohorts. A narrative review of VDZ use in special clinical settings was also performed.
Nine studies including 1565 [571 UC, 994 CD] adult patients were identified. In CD, clinical response and remission were achieved in 54% (95% confidence interval [CI] 41-66%) and 22% [95% CI 13-35%] by Week 6 and in 49% [95% CI 37-51%] and 32% [95% CI 23-42%] by Week 14; at Week 52, 45% [95% CI 28-64%] and 32% [95% CI 12-62] of the patients responded, and were in clinical remission, respectively. In UC, clinical response and remission were achieved in 43% [95% CI 37-49] and 25% [95% CI 12-45] by Week 6, respectively, and in 51% [95% CI 43-61%]and 30% [95% CI 24-36%] by Week 14/22, respectively; at week 52, clinical response and remission were achieved in 48% and 39% of the patients, respectively. Adverse effects were mostly minor and occurred in 30.6% of the patients; infections were reported in 3.4% of the patients.
VDZ is efficacious in CD and UC and has a favourable safety profile in RWE studies.
维得利珠单抗（VDZ）是一种有效的抗整合素单克隆抗体，可用于治疗溃疡性结肠炎（UC）和克罗恩病（CD）。迄今为止，已有多项维得利珠单抗的真实世界经验（RWE）研究发表。本系统综述的目的是总结目前维得利珠单抗的真实世界经验。
我们对 CD 和 UC 中维得利珠单抗的现有 RWE 研究进行了系统综述。我们对成人队列的诱导和维持治疗的可用疗效和安全性数据进行了汇总分析。还对维得利珠单抗在特殊临床环境中的应用进行了叙述性综述。
共确定了 9 项研究，包括 1565 名（571 例 UC，994 例 CD）成年患者。在 CD 中，第 6 周时，54%（95%CI 41-66%）和 22%（95%CI 13-35%）的患者达到临床缓解和缓解，第 14 周时，54%（95%CI 41-66%）和 22%（95%CI 13-35%）的患者达到临床缓解和缓解；第 52 周时，分别有 45%（95%CI 28-64%）和 32%（95%CI 12-62%）的患者出现应答并达到临床缓解。在 UC 中，第 6 周时，43%（95%CI 37-49%）和 25%（95%CI 12-45%）的患者达到临床缓解和缓解，第 14/22 周时，51%（95%CI 43-61%）和 30%（95%CI 24-36%）的患者达到临床缓解和缓解；第 52 周时，分别有 48%和 39%的患者达到临床缓解和缓解。不良反应主要为轻度，发生在 30.6%的患者中；报告了 3.4%的患者发生感染。
维得利珠单抗在 CD 和 UC 中具有疗效，在 RWE 研究中具有良好的安全性。
