Armuzzi Alessandro, Vermeire Séverine, Chaparro María, Biedermann Patricia, Brown Rebecca, McStravick Megan, Meyer Marlies, Schreiber Stefan
IBD Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
United European Gastroenterol J. 2025 May;13(4):552-565. doi: 10.1002/ueg2.12705. Epub 2024 Dec 21.
Vedolizumab is approved for the treatment of moderately to severely active Crohn's disease (CD). Real-world evidence is essential for understanding the effectiveness and benefit-risk profile of vedolizumab outside clinical trial settings.
To identify, systematically review and assess the real-world effectiveness and treatment persistence of vedolizumab in patients with CD, particularly over long-term follow-up periods and among populations with differing treatment experience, and to compare with the treatment persistence of anti-tumour necrosis factor (TNF)-α treatment.
Literature searches were conducted to identify studies published from 2014 to 2022. Relevant congress searches were conducted (2015-2022) using Embase or by hand. Data on adults with CD treated with vedolizumab or anti-TNFα treatment in a real-world setting were extracted for meta-analysis.
Data from 73 studies, including 29,894 patients with CD, reported ≥ 1 outcome of interest for this analysis. Vedolizumab treatment persistence rate was 65.3% (95% confidence interval [CI] 60.2-70.1) at 1 year and 54.8% (95% CI 43.9-65.3) at 2 years. The treatment persistence rate with vedolizumab versus anti-TNFα treatment was 84.6% (95% CI 70.2-92.8) versus 75.3% (95% CI 69.7-80.2) at 1 year and 70.6% (95% CI 60.7-78.8) versus 64.6% (95% CI 56.7-71.8) at 2 years. The mucosal healing rate at 1 year was 40.6% (95% CI 34.2-47.3). Clinical remission rates were 39.4% (95% CI 33.9-45.1) at 1 year and 34.3% (95% CI 18.1-55.2) at 2 years. Corticosteroid-free clinical remission rates were 33.2% (95% CI 28.5-38.3) at 1 year and 20.4% (95% CI 12.5-31.5) at 2 years. All clinical outcome rates were higher in biologic-naive than in biologic-experienced patients.
Real-world use of vedolizumab was associated with favourable long-term effectiveness and treatment persistence. Vedolizumab is a suitable first-line biological option for biologic-naive patients with CD.
维多珠单抗已被批准用于治疗中度至重度活动性克罗恩病（CD）。真实世界证据对于了解维多珠单抗在临床试验环境之外的有效性和效益风险概况至关重要。
识别、系统评价和评估维多珠单抗在CD患者中的真实世界有效性和治疗持续性，特别是在长期随访期间以及在具有不同治疗经验的人群中，并与抗肿瘤坏死因子（TNF）-α治疗的治疗持续性进行比较。
进行文献检索以识别2014年至2022年发表的研究。使用Embase或手动进行相关会议检索（2015 - 2022年）。提取在真实世界环境中接受维多珠单抗或抗TNFα治疗的成年CD患者的数据进行荟萃分析。
来自73项研究的数据，包括29,894例CD患者，报告了≥1项本分析感兴趣的结果。维多珠单抗治疗1年时的持续性率为65.3%（95%置信区间[CI]60.2 - 70.1），2年时为54.8%（95%CI 43.9 - 65.3）。维多珠单抗与抗TNFα治疗的治疗持续性率在1年时为84.6%（95%CI 70.2 - 92.8）对75.3%（95%CI 69.7 - 80.2），2年时为70.6%（95%CI 60.7 - 78.8）对64.6%（95%CI 56.7 - 71.8）。1年时的黏膜愈合率为40.6%（95%CI 34.2 - 47.3）。临床缓解率在1年时为39.4%（95%CI 33.9 - 45.1），2年时为34.3%（95%CI 18.1 - 55.2）。无皮质类固醇临床缓解率在1年时为33.2%（95%CI 28.5 - 38.3），2年时为20.4%（95%CI 12.5 - 31.5）。所有临床结局率在初治生物制剂患者中高于有生物制剂治疗经验的患者。
维多珠单抗的真实世界使用与良好的长期有效性和治疗持续性相关。维多珠单抗是初治生物制剂的CD患者合适的一线生物制剂选择。
