Department of Gastroenterology and Hepatology, Herlev Hospital, University of Copenhagen, Borgmester Ib Juuls Vej 1, 2730 Denmark; Gastrounit, Medical Section, Hvidovre University Hospital, Hvidovre, Kettegaard Alle 30, 2650 Denmark; Copenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, University of Copenhagen, Hvidovre Hospital, Hvidovre, Kettegaard Alle 30, 2650 Denmark.
Gastrounit, Medical Section, Hvidovre University Hospital, Hvidovre, Kettegaard Alle 30, 2650 Denmark; Copenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, University of Copenhagen, Hvidovre Hospital, Hvidovre, Kettegaard Alle 30, 2650 Denmark.
Dig Liver Dis. 2022 Sep;54(9):1168-1178. doi: 10.1016/j.dld.2021.11.014. Epub 2021 Dec 10.
The efficacy and safety of vedolizumab in bio-naïve patients with ulcerative colitis (UC) and Crohn's disease (CD) remain unknown.
To perform a meta-analysis regarding vedolizumab as first line of biological therapy for UC or CD.
A systematic review of Medline, EMBASE, and Cochrane databases per December 2020 was undertaken. Meta-analysis was conducted using random-effects models.
This systematic review identified 79 eligible studies with 4,520 and 3,494 bio-naïve patients with UC and CD, respectively, and 8,105 and 11,140 bio-exposed patients. Among bio-naïve patients with UC, a total of 40.0% (95%CI 27.0-54.0, I=86%) and 63.9% (95%CI 47.0-79.2, I=36%) achieved clinical remission at weeks 14 and 52, respectively. The corresponding rates in CD were 54.0% (95%CI 42.0-66.0, I=23%), and 61.7% (95%CI 55.2-68.1, I=0%). Bio-naïvety was associated with a higher probability of clinical remission at week 52 in UC (relative risk (RR)=1.32 (95%CI 1.14-1.53)), while this was only apparent until week 26 in CD (RR=1.60 (95%CI 1.30-1.95)). Finally, bio-naïve UC patients had a lower risk of serious adverse events (RR=0.29 (95%CI 0.09-0.95)).
Vedolizumab was found to have a favorable efficacy and safety profile in bio-naïve patients with UC and CD. The findings have implications in the management of IBD.
维得利珠单抗在溃疡性结肠炎（UC）和克罗恩病（CD）的生物初治患者中的疗效和安全性尚不清楚。
对维得利珠单抗作为 UC 或 CD 的一线生物治疗药物进行meta 分析。
对 2020 年 12 月之前的 Medline、EMBASE 和 Cochrane 数据库进行系统检索。采用随机效应模型进行荟萃分析。
本系统综述共纳入 79 项研究，其中 UC 生物初治患者 4520 例，CD 生物初治患者 3494 例，生物暴露患者 8105 例和 11140 例。在 UC 的生物初治患者中，分别有 40.0%（95%CI 27.0-54.0，I=86%）和 63.9%（95%CI 47.0-79.2，I=36%）在第 14 周和第 52 周达到临床缓解。CD 患者的相应比例分别为 54.0%（95%CI 42.0-66.0，I=23%）和 61.7%（95%CI 55.2-68.1，I=0%）。生物初治与 UC 患者第 52 周时临床缓解的可能性更高相关（相对风险（RR）=1.32（95%CI 1.14-1.53）），而在 CD 中仅在第 26 周时如此（RR=1.60（95%CI 1.30-1.95））。最后，生物初治 UC 患者发生严重不良事件的风险较低（RR=0.29（95%CI 0.09-0.95））。
维得利珠单抗在 UC 和 CD 的生物初治患者中具有良好的疗效和安全性。研究结果对 IBD 的管理具有重要意义。
