Effectiveness and Treatment Persistence of Vedolizumab Compared to Anti-Tumour Necrosis Factor-α in Patients With Crohn's Disease: A Systematic Literature Review and Meta-Analysis.
Alessandro Armuzzi, Séverine Vermeire, María Chaparro, Patricia Biedermann, Rebecca Brown, Megan McStravick, Marlies Meyer, Stefan Schreiber
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引用次数: 0
Abstract
Background: 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.
Objective: 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.
Methods: 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.
Results: 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.
Conclusion: 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.
背景：Vedolizumab被批准用于治疗中度至重度活动性克罗恩病（CD）。真实世界的证据对于了解维多单抗在临床试验之外的有效性和获益-风险概况至关重要。目的：识别、系统回顾和评估vedolizumab在CD患者中的实际疗效和治疗持久性，特别是在长期随访期间和不同治疗经验的人群中，并与抗肿瘤坏死因子(TNF)-α治疗的治疗持久性进行比较。方法：检索2014 - 2022年发表的文献。使用Embase或手工进行相关大会检索（2015-2022）。在现实环境中，成人CD患者接受vedolizumab或抗tnf α治疗的数据被提取用于荟萃分析。结果：来自73项研究的数据，包括29,894例CD患者，报告了≥1个本分析感兴趣的结局。Vedolizumab治疗1年的持续率为65.3%(95%可信区间[CI] 60.2-70.1)， 2年的持续率为54.8% （95% CI 43.9-65.3）。1年时，vedolizumab与抗tnf α治疗的治疗持续率分别为84.6% （95% CI 70.2-92.8）和75.3% (95% CI 69.7-80.2)； 2年时，vedolizumab与tnf α治疗的治疗持续率分别为70.6% （95% CI 60.7-78.8）和64.6% （95% CI 56.7-71.8）。1年黏膜愈合率为40.6% （95% CI 34.2-47.3）。1年临床缓解率为39.4% (95% CI 33.9-45.1)， 2年临床缓解率为34.3% （95% CI 18.1-55.2）。1年无皮质类固醇临床缓解率为33.2% (95% CI 28.5-38.3)， 2年为20.4% （95% CI 12.5-31.5）。所有临床转归率在未接受生物制剂治疗的患者中均高于有生物制剂治疗经验的患者。结论：实际使用vedolizumab与良好的长期有效性和治疗持久性相关。Vedolizumab是一种适合于乳糜泻初治患者的一线生物治疗方案。
期刊介绍：
United European Gastroenterology Journal (UEG Journal) is the official Journal of the United European Gastroenterology (UEG), a professional non-profit organisation combining all the leading European societies concerned with digestive disease. UEG’s member societies represent over 22,000 specialists working across medicine, surgery, paediatrics, GI oncology and endoscopy, which makes UEG a unique platform for collaboration and the exchange of knowledge.
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