Marc Ferrante, Laurent Peyrin-Biroulet, Perttu Arkkila, Alessandro Armuzzi, Jean-Frédéric Colombel, Silvio Danese, Roberto Faggiani, Jordi Guardiola, Stephen B Hanauer, Jorgen Jahnsen, Walter Reinisch, Xavier Roblin, Philip J Smith, Taek Sang Kwon, Seungmin Kim, Kyoungwan Nam, Raja Atreya
{"title":"炎症性肠病患者通过1年维多单抗或皮下英夫利昔单抗维持治疗缺乏疗效导致的治疗停药率：系统文献综述和荟萃分析","authors":"Marc Ferrante, Laurent Peyrin-Biroulet, Perttu Arkkila, Alessandro Armuzzi, Jean-Frédéric Colombel, Silvio Danese, Roberto Faggiani, Jordi Guardiola, Stephen B Hanauer, Jorgen Jahnsen, Walter Reinisch, Xavier Roblin, Philip J Smith, Taek Sang Kwon, Seungmin Kim, Kyoungwan Nam, Raja Atreya","doi":"10.1177/17562848251383767","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Infliximab (IFX) and vedolizumab (VDZ), frequently used biologics in inflammatory bowel disease (IBD), are available as intravenous (IV) and subcutaneous (SC) formulations; however, comparative data are limited.</p><p><strong>Objectives: </strong>To compare the rates of discontinuation due to lack of efficacy during maintenance treatment with infliximab (subcutaneous) and vedolizumab (intravenous and subcutaneous) in patients with moderate-to-severe IBD.</p><p><strong>Design: </strong>Systematic literature review and meta-analysis.</p><p><strong>Data sources and methods: </strong>Three medical databases, PubMed, Embase, and the Cochrane Library, were systematically searched from January 2010 to May 2024 to identify phases I-III randomized controlled trials. The primary outcome was discontinuation of study drug due to lack of efficacy (per definitions used in the included studies) during maintenance treatment (PROSPERO number CRD42023438330). Rates of discontinuation due to adverse events during maintenance treatment were examined in additional exploratory analyses.</p><p><strong>Results: </strong>We identified three eligible clinical trials in IBD for subcutaneous infliximab (591 patients) and five for vedolizumab (intravenous and subcutaneous formulations; 2117 patients). Rates of discontinuation due to lack of efficacy (per individual study definition) were significantly lower in patients treated with subcutaneous infliximab (0.05 (95% confidence interval (CI): 0.03, 0.06)) than in patients treated with vedolizumab (0.29 (95% CI: 0.20, 0.38)); rates remained significantly lower with subcutaneous infliximab versus vedolizumab, respectively, in the subgroups of patients with Crohn's disease (0.05 (95% CI: 0.02, 0.07) vs 0.37 (95% CI: 0.27, 0.47)) or ulcerative colitis (0.05 (95% CI: 0.02, 0.07) vs 0.24 (95% CI: 0.11, 0.36)). Rates of discontinuation due to adverse events were lower in subcutaneous infliximab-treated patients (0.04 (95% CI: 0.02, 0.05) than in vedolizumab-treated patients (0.08 (95% CI: 0.05, 0.11)).</p><p><strong>Conclusion: </strong>In this meta-analysis, rates of discontinuation due to lack of efficacy during maintenance treatment were lower with subcutaneous infliximab than with vedolizumab (intravenous and subcutaneous formulations) in patients with moderate-to-severe IBD.</p><p><strong>Trial registration: </strong>PROSPERO number CRD42023438330.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251383767"},"PeriodicalIF":3.4000,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12511697/pdf/","citationCount":"0","resultStr":"{\"title\":\"Treatment discontinuation rates due to lack of efficacy through 1 year of maintenance treatment with vedolizumab or subcutaneous infliximab in patients with inflammatory bowel disease: a systematic literature review and meta-analysis.\",\"authors\":\"Marc Ferrante, Laurent Peyrin-Biroulet, Perttu Arkkila, Alessandro Armuzzi, Jean-Frédéric Colombel, Silvio Danese, Roberto Faggiani, Jordi Guardiola, Stephen B Hanauer, Jorgen Jahnsen, Walter Reinisch, Xavier Roblin, Philip J Smith, Taek Sang Kwon, Seungmin Kim, Kyoungwan Nam, Raja Atreya\",\"doi\":\"10.1177/17562848251383767\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Infliximab (IFX) and vedolizumab (VDZ), frequently used biologics in inflammatory bowel disease (IBD), are available as intravenous (IV) and subcutaneous (SC) formulations; however, comparative data are limited.</p><p><strong>Objectives: </strong>To compare the rates of discontinuation due to lack of efficacy during maintenance treatment with infliximab (subcutaneous) and vedolizumab (intravenous and subcutaneous) in patients with moderate-to-severe IBD.</p><p><strong>Design: </strong>Systematic literature review and meta-analysis.</p><p><strong>Data sources and methods: </strong>Three medical databases, PubMed, Embase, and the Cochrane Library, were systematically searched from January 2010 to May 2024 to identify phases I-III randomized controlled trials. The primary outcome was discontinuation of study drug due to lack of efficacy (per definitions used in the included studies) during maintenance treatment (PROSPERO number CRD42023438330). Rates of discontinuation due to adverse events during maintenance treatment were examined in additional exploratory analyses.</p><p><strong>Results: </strong>We identified three eligible clinical trials in IBD for subcutaneous infliximab (591 patients) and five for vedolizumab (intravenous and subcutaneous formulations; 2117 patients). Rates of discontinuation due to lack of efficacy (per individual study definition) were significantly lower in patients treated with subcutaneous infliximab (0.05 (95% confidence interval (CI): 0.03, 0.06)) than in patients treated with vedolizumab (0.29 (95% CI: 0.20, 0.38)); rates remained significantly lower with subcutaneous infliximab versus vedolizumab, respectively, in the subgroups of patients with Crohn's disease (0.05 (95% CI: 0.02, 0.07) vs 0.37 (95% CI: 0.27, 0.47)) or ulcerative colitis (0.05 (95% CI: 0.02, 0.07) vs 0.24 (95% CI: 0.11, 0.36)). Rates of discontinuation due to adverse events were lower in subcutaneous infliximab-treated patients (0.04 (95% CI: 0.02, 0.05) than in vedolizumab-treated patients (0.08 (95% CI: 0.05, 0.11)).</p><p><strong>Conclusion: </strong>In this meta-analysis, rates of discontinuation due to lack of efficacy during maintenance treatment were lower with subcutaneous infliximab than with vedolizumab (intravenous and subcutaneous formulations) in patients with moderate-to-severe IBD.</p><p><strong>Trial registration: </strong>PROSPERO number CRD42023438330.</p>\",\"PeriodicalId\":48770,\"journal\":{\"name\":\"Therapeutic Advances in Gastroenterology\",\"volume\":\"18 \",\"pages\":\"17562848251383767\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-10-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12511697/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Gastroenterology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17562848251383767\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Gastroenterology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17562848251383767","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Treatment discontinuation rates due to lack of efficacy through 1 year of maintenance treatment with vedolizumab or subcutaneous infliximab in patients with inflammatory bowel disease: a systematic literature review and meta-analysis.
Background: Infliximab (IFX) and vedolizumab (VDZ), frequently used biologics in inflammatory bowel disease (IBD), are available as intravenous (IV) and subcutaneous (SC) formulations; however, comparative data are limited.
Objectives: To compare the rates of discontinuation due to lack of efficacy during maintenance treatment with infliximab (subcutaneous) and vedolizumab (intravenous and subcutaneous) in patients with moderate-to-severe IBD.
Design: Systematic literature review and meta-analysis.
Data sources and methods: Three medical databases, PubMed, Embase, and the Cochrane Library, were systematically searched from January 2010 to May 2024 to identify phases I-III randomized controlled trials. The primary outcome was discontinuation of study drug due to lack of efficacy (per definitions used in the included studies) during maintenance treatment (PROSPERO number CRD42023438330). Rates of discontinuation due to adverse events during maintenance treatment were examined in additional exploratory analyses.
Results: We identified three eligible clinical trials in IBD for subcutaneous infliximab (591 patients) and five for vedolizumab (intravenous and subcutaneous formulations; 2117 patients). Rates of discontinuation due to lack of efficacy (per individual study definition) were significantly lower in patients treated with subcutaneous infliximab (0.05 (95% confidence interval (CI): 0.03, 0.06)) than in patients treated with vedolizumab (0.29 (95% CI: 0.20, 0.38)); rates remained significantly lower with subcutaneous infliximab versus vedolizumab, respectively, in the subgroups of patients with Crohn's disease (0.05 (95% CI: 0.02, 0.07) vs 0.37 (95% CI: 0.27, 0.47)) or ulcerative colitis (0.05 (95% CI: 0.02, 0.07) vs 0.24 (95% CI: 0.11, 0.36)). Rates of discontinuation due to adverse events were lower in subcutaneous infliximab-treated patients (0.04 (95% CI: 0.02, 0.05) than in vedolizumab-treated patients (0.08 (95% CI: 0.05, 0.11)).
Conclusion: In this meta-analysis, rates of discontinuation due to lack of efficacy during maintenance treatment were lower with subcutaneous infliximab than with vedolizumab (intravenous and subcutaneous formulations) in patients with moderate-to-severe IBD.
Trial registration: PROSPERO number CRD42023438330.
期刊介绍：
Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area.
The editors welcome original research articles across all areas of gastroenterology and hepatology.
The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.
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