Department of Gastroenterology and Gastrointestinal Endoscopy, Pontifical Catholic University of Rio Grande do Sul.
Department of Gastroenterology and Gastrointestinal Endoscopy, Porto Alegre Health Science's Federal University, Porto Alegre, Brazil.
Eur J Gastroenterol Hepatol. 2024 Sep 1;36(9):1068-1074. doi: 10.1097/MEG.0000000000002817. Epub 2024 Jul 2.
Ustekinumab and vedolizumab are key treatment options for Crohn's disease patients who fail anti-tumor necrosis factor (TNF) therapy. This updated meta-analysis aims to compare the efficacy and safety of these two drugs. We performed a systematic review in PubMed, Embase , and Cochrane databases searching for randomized and nonrandomized studies comparing vedolizumab versus ustekinumab in patients with Crohn's disease with previous anti-TNF failure or intolerance. The primary outcome was steroid-free clinical remission (SFR) at the pos-induction (12-16 weeks) and maintenance period (48-52 weeks). The odds ratio (OR) was used for binary outcomes with their respective 95% confidence interval (CI). Heterogeneity was assessed using the Cochran Q test and I2 statistics. This meta-analysis included 11 studies and 2724 patients. There was a significant difference favoring ustekinumab in SFR at pos-induction (OR, 1.44; 95% CI, 1.11-1.88; P = 0.006; I2 = 27%) and maintenance periods (OR, 1.86; 95% CI, 1.23-2.82; P = 0.003; I2 = 80%), in clinical remission at pos-induction period (OR, 2.04; 95% CI, 1.58-2.63; P < 0.001; I2 = 3%), and in treatment discontinuation due to adverse events (OR, 0.31; 95% CI, 0.16-0.60; P < 0.001; I2 = 0%). In patients with Crohn's disease with prior anti-TNF failure, ustekinumab showed higher SFR during both the pos-induction and maintenance period and a lower rate of treatment discontinuation due to adverse events.
乌司奴单抗和维得利珠单抗是抗 TNF 治疗失败或不耐受的克罗恩病患者的关键治疗选择。本更新的荟萃分析旨在比较这两种药物的疗效和安全性。我们在 PubMed、Embase 和 Cochrane 数据库中进行了系统评价，检索了比较维得利珠单抗与乌司奴单抗在抗 TNF 治疗失败或不耐受的克罗恩病患者中的随机和非随机研究。主要结局是诱导后（12-16 周）和维持期（48-52 周）无激素临床缓解（SFR）。二分类结局采用比值比（OR）及其相应的 95%置信区间（CI）。采用 Cochran Q 检验和 I2 统计量评估异质性。本荟萃分析纳入了 11 项研究和 2724 例患者。乌司奴单抗在诱导后（OR，1.44；95%CI，1.11-1.88；P ＝ 0.006；I2 ＝ 27%）和维持期（OR，1.86；95%CI，1.23-2.82；P ＝ 0.003；I2 ＝ 80%）、诱导期临床缓解（OR，2.04；95%CI，1.58-2.63；P ＜0.001；I2 ＝ 3%）和因不良反应停药（OR，0.31；95%CI，0.16-0.60；P ＜0.001；I2 ＝ 0%）方面均有显著优势。在抗 TNF 治疗失败的克罗恩病患者中，乌司奴单抗在诱导后和维持期均有更高的 SFR，且因不良反应停药率更低。
