{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T21:25:49Z","timestamp":1790717149959,"version":"4.1.0"},"reference-count":37,"publisher":"MDPI AG","issue":"13","license":[{"start":{"date-parts":[[2025,6,21]],"date-time":"2025-06-21T00:00:00Z","timestamp":1750464000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Celltrion, Inc. (Incheon, Republic of Korea)"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background\/Objectives: Direct comparative data for infliximab and vedolizumab are limited due to lack of head-to-head trials. This systematic review and meta-analysis compared the efficacy and safety of infliximab and vedolizumab as intravenous or subcutaneous maintenance treatments for adults with moderately to severely active Crohn\u2019s disease or ulcerative colitis. Methods: Medical databases, PubMed, Embase, and the Cochrane Library were systematically searched from January 2010 to May 2024 to identify Phase 1 to 3 randomized controlled trials. The primary and co-primary outcomes were the proportions of patients achieving clinical remission and clinical response at one year, respectively. Safety was also analyzed (PROSPERO CRD42023483599). Data for each outcome were pooled using a two-sided random-effects model in separate analyses for Crohn\u2019s disease and ulcerative colitis. Results: Seven eligible Crohn\u2019s disease trials and eight eligible ulcerative colitis trials contributed data for 1910 and 2372 patients, respectively. For Crohn\u2019s disease, higher proportions of infliximab-treated patients achieved clinical remission (0.64 [95% confidence interval: 0.60\u20130.68]) and\/or clinical response (0.71 [0.67\u20130.75]) at one year compared with vedolizumab-treated patients (0.40 [0.35\u20130.46] and 0.47 [0.43\u20130.51], respectively). For ulcerative colitis, similar proportions of infliximab- and vedolizumab-treated patients achieved clinical remission (0.54 [0.38\u20130.71] vs. 0.40 [0.35\u20130.44]) and\/or clinical response (0.52 [0.45\u20130.58] vs. 0.58 [0.51\u20130.65]) at one year. Safety results showed no significant differences. Conclusions: An indirect comparison of maintenance treatment with infliximab and vedolizumab demonstrated that infliximab yields significantly better efficacy than vedolizumab in Crohn\u2019s disease, whereas both agents yielded similar efficacy in ulcerative colitis.<\/jats:p>","DOI":"10.3390\/jcm14134419","type":"journal-article","created":{"date-parts":[[2025,6,23]],"date-time":"2025-06-23T07:42:34Z","timestamp":1750664554000},"page":"4419","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Efficacy and Safety of Infliximab and Vedolizumab Maintenance Therapy in Patients with Crohn\u2019s Disease and Ulcerative Colitis: A Systematic Review and Meta-Analysis"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5762-5042","authenticated-orcid":false,"given":"Bruce E.","family":"Sands","sequence":"first","affiliation":[{"name":"Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2536-6618","authenticated-orcid":false,"given":"Laurent","family":"Peyrin-Biroulet","sequence":"additional","affiliation":[{"name":"Department of Hepato-Gastroenterology and INSERM U954 NGERE, University Hospital of Nancy, University of Lorraine, 54500 Nancy, France"},{"name":"Paris IBD Center, Groupe Hospitalier Priv\u00e9 Ambroise Par\u00e9-Hartmann, 92200 Neuilly-sur-Seine, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6807-9822","authenticated-orcid":false,"given":"Stefan","family":"Schreiber","sequence":"additional","affiliation":[{"name":"Department of Medicine I, University Hospital Schleswig-Holstein, 24105 Kiel, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7341-1351","authenticated-orcid":false,"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, IRCCS San Raffaele Hospital, 20132 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1572-0118","authenticated-orcid":false,"given":"Alessandro","family":"Armuzzi","sequence":"additional","affiliation":[{"name":"IBD Center, IRCCS Humanitas Research Hospital, Rozzano, 20089 Milan, Italy"},{"name":"Department of Biomedical Sciences, Humanitas University, 20072 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6347-409X","authenticated-orcid":false,"given":"Anthony","family":"Buisson","sequence":"additional","affiliation":[{"name":"Department of Hepato-Gastroenterology, University Hospital Estaing of Clermont-Ferrand, 63100 Clermont-Ferrand, France"},{"name":"Department of Hepatogastroenterology, Universit\u00e9 Clermont Auvergne, 63000 Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2337-2902","authenticated-orcid":false,"given":"Mathurin","family":"Fumery","sequence":"additional","affiliation":[{"name":"CHU Amiens, Universit\u00e9 de Picardie Jules Verne, Unit\u00e9 P\u00e9ritox, 80054 Amiens, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9724-054X","authenticated-orcid":false,"given":"Axel","family":"Dignass","sequence":"additional","affiliation":[{"name":"Department of Medicine I, Agaplesion Markus Hospital, Goethe University Frankfurt, 60431 Frankfurt am Main, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3231-6950","authenticated-orcid":false,"given":"Nick","family":"Powell","sequence":"additional","affiliation":[{"name":"Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London W12 0NN, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4368-1961","authenticated-orcid":false,"given":"Nicholas A.","family":"Kennedy","sequence":"additional","affiliation":[{"name":"Royal Devon University Healthcare NHS Foundation Trust, Exeter EX2 5DW, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5124-0897","authenticated-orcid":false,"given":"Sebastian","family":"Zeissig","sequence":"additional","affiliation":[{"name":"Center for Regenerative Therapies Dresden, Technische Universit\u00e4t Dresden, 01307 Dresden, Germany"},{"name":"Department of Internal Medicine A, University Medicine Greifswald, 17475 Greifswald, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7766-0141","authenticated-orcid":false,"given":"Taek","family":"Kwon","sequence":"additional","affiliation":[{"name":"Celltrion, Inc., Incheon 22014, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9173-4047","authenticated-orcid":false,"given":"Seungmin","family":"Kim","sequence":"additional","affiliation":[{"name":"Celltrion, Inc., Incheon 22014, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-7945-3716","authenticated-orcid":false,"given":"Kyoungwan","family":"Nam","sequence":"additional","affiliation":[{"name":"Celltrion, Inc., Incheon 22014, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3268-932X","authenticated-orcid":false,"given":"Stephen B.","family":"Hanauer","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,6,21]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1093\/ecco-jcc\/jjab178","article-title":"ECCO guidelines on therapeutics in ulcerative colitis: Medical treatment","volume":"16","author":"Raine","year":"2022","journal-title":"J. Crohns Colitis"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1093\/ecco-jcc\/jjz180","article-title":"ECCO guidelines on therapeutics in Crohn\u2019s disease: Medical treatment","volume":"14","author":"Torres","year":"2020","journal-title":"J. Crohns Colitis"},{"key":"ref_3","doi-asserted-by":"crossref","unstructured":"Peyrin-Biroulet, L., Arkkila, P., Armuzzi, A., Danese, S., Guardiola, J., Jahnsen, J., Lees, C., Louis, E., Lukas, M., and Reinisch, W. (2022). Comparative efficacy and safety of infliximab and vedolizumab therapy in patients with inflammatory bowel disease: A systematic review and meta-analysis. BMC Gastroenterol., 22.","DOI":"10.1186\/s12876-022-02347-1"},{"key":"ref_4","doi-asserted-by":"crossref","unstructured":"Peyrin-Biroulet, L., Arkkila, P., Armuzzi, A., Danese, S., Ferrante, M., Jordi, G., Jahnsen, J., Louis, E., Lukas, M., and Reinisch, W. (2024). Comparative efficacy and safety of subcutaneous infliximab and vedolizumab in patients with Crohn\u2019s disease and ulcerative colitis included in randomised controlled trials. BMC Gastroenterol., 24.","DOI":"10.1186\/s12876-024-03163-5"},{"key":"ref_5","unstructured":"European Medicines Agency (2024, October 10). Entyvio Summary of Product Characteristics. Available online: https:\/\/www.ema.europa.eu\/documents\/product-information\/entyvio-epar-product-information_en.pdf."},{"key":"ref_6","unstructured":"European Medicines Agency (2024, October 10). Remsima Summary of Product Characteristics. Available online: https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/remsima-epar-product-information_en.pdf."},{"key":"ref_7","unstructured":"US Food and Drug Administration (2024, October 10). ZYMFENTRA Prescribing Information, Available online: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/761358s000lbl.pdf."},{"key":"ref_8","unstructured":"Takeda (2024, October 10). Press Release: U.S. FDA Approves Subcutaneous Administration of Takeda\u2019s ENTYVIO\u00ae (Vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis. Available online: https:\/\/www.takeda.com\/newsroom\/newsreleases\/2023\/US-FDA-Approves-Subcutaneous-Administration-of-Takeda-ENTYVIO-vedolizumab-for-Maintenance-Therapy-in-Moderately-to-Severely-Active-Ulcerative-Colitis\/."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"919","DOI":"10.1053\/j.gastro.2024.05.006","article-title":"Subcutaneous infliximab (CT-P13) as maintenance therapy for inflammatory bowel disease: Two randomized phase 3 trials (LIBERTY)","volume":"167","author":"Hanauer","year":"2024","journal-title":"Gastroenterology"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"27","DOI":"10.1093\/ecco-jcc\/jjab133","article-title":"Efficacy and safety of subcutaneous vedolizumab in patients with moderately to severely active Crohn\u2019s disease: Results from the VISIBLE2 randomised trial","volume":"16","author":"Vermeire","year":"2022","journal-title":"J. Crohns Colitis"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"562","DOI":"10.1053\/j.gastro.2019.08.027","article-title":"Efficacy and safety of vedolizumab subcutaneous formulation in a randomized trial of patients with ulcerative colitis","volume":"158","author":"Sandborn","year":"2020","journal-title":"Gastroenterology"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"264","DOI":"10.1136\/gutjnl-2022-328052","article-title":"Efficacy of biological therapies and small molecules in induction and maintenance of remission in luminal Crohn\u2019s disease: Systematic review and network meta-analysis","volume":"72","author":"Barberio","year":"2023","journal-title":"Gut"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"1002","DOI":"10.1016\/S2468-1253(21)00312-5","article-title":"Comparative efficacy and safety of biologic therapies for moderate-to-severe Crohn\u2019s disease: A systematic review and network meta-analysis","volume":"6","author":"Singh","year":"2021","journal-title":"Lancet Gastroenterol. Hepatol."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"161","DOI":"10.1016\/S2468-1253(21)00377-0","article-title":"Efficacy and safety of biologics and small molecule drugs for patients with moderate-to-severe ulcerative colitis: A systematic review and network meta-analysis","volume":"7","author":"Lasa","year":"2022","journal-title":"Lancet Gastroenterol. Hepatol."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"i574","DOI":"10.1093\/ecco-jcc\/jjac190.0575","article-title":"P445 Network meta-analysis to evaluate the comparative efficacy of intravenous and subcutaneous infliximab and vedolizumab in the maintenance treatment of adult patients with Crohn\u2019s disease and ulcerative colitis","volume":"17","author":"Bossuyt","year":"2023","journal-title":"J. Crohns Colitis"},{"key":"ref_16","unstructured":"Kim, S., and Kwon, T. (2024, October 10). Systematic Review and Meta-Analysis of Efficacy and Safety of Infliximab and Vedolizumab Maintenance Therapy in Patients with Crohn\u2019s Disease and Ulcerative Colitis. Available online: https:\/\/www.crd.york.ac.uk\/PROSPERO\/display_record.php?RecordID=483599."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"n71","DOI":"10.1136\/bmj.n71","article-title":"The PRISMA 2020 statement: An updated guideline for reporting systematic reviews","volume":"372","author":"Page","year":"2021","journal-title":"BMJ"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"d5928","DOI":"10.1136\/bmj.d5928","article-title":"The Cochrane Collaboration\u2019s tool for assessing risk of bias in randomised trials","volume":"343","author":"Higgins","year":"2011","journal-title":"BMJ"},{"key":"ref_19","unstructured":"Knezevic, A. (2024, December 18). Overlapping Confidence Intervals and Statistical Significance. Available online: https:\/\/cscu.cornell.edu\/wp-content\/uploads\/ci.pdf."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"1383","DOI":"10.1056\/NEJMoa0904492","article-title":"Infliximab, azathioprine, or combination therapy for Crohn\u2019s disease","volume":"362","author":"Colombel","year":"2010","journal-title":"N. Engl. J. Med."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"2304","DOI":"10.1016\/S0140-6736(17)30068-5","article-title":"Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): A 52-week, randomised, double-blind, non-inferiority trial","volume":"389","author":"Olsen","year":"2017","journal-title":"Lancet"},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"681","DOI":"10.1007\/s40259-020-00438-7","article-title":"Efficacy and safety of CT-P13 in inflammatory bowel disease after switching from originator infliximab: Exploratory analyses from the NOR-SWITCH main and extension trials","volume":"34","author":"Goll","year":"2020","journal-title":"BioDrugs"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"1699","DOI":"10.1016\/S0140-6736(18)32196-2","article-title":"Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn\u2019s disease: An international, randomised, double-blind, phase 3 non-inferiority study","volume":"393","author":"Ye","year":"2019","journal-title":"Lancet"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"2340","DOI":"10.1053\/j.gastro.2021.02.068","article-title":"Randomized controlled trial: Subcutaneous vs. intravenous infliximab CT-P13 maintenance in inflammatory bowel disease","volume":"160","author":"Schreiber","year":"2021","journal-title":"Gastroenterology"},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"711","DOI":"10.1056\/NEJMoa1215739","article-title":"Vedolizumab as induction and maintenance therapy for Crohn\u2019s disease","volume":"369","author":"Sandborn","year":"2013","journal-title":"N. Engl. J. Med."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"97","DOI":"10.1097\/MIB.0000000000000979","article-title":"Vedolizumab as induction and maintenance therapy for Crohn\u2019s disease in patients naive to or who have failed tumor necrosis factor antagonist therapy","volume":"23","author":"Sands","year":"2017","journal-title":"Inflamm. Bowel Dis."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"2462","DOI":"10.1056\/NEJMoa050516","article-title":"Infliximab for induction and maintenance therapy for ulcerative colitis","volume":"353","author":"Rutgeerts","year":"2005","journal-title":"N. Engl. J. Med."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"1588","DOI":"10.1016\/j.cgh.2021.07.038","article-title":"Comparative efficacy for infliximab vs. vedolizumab in biologic naive ulcerative colitis","volume":"20","author":"Narula","year":"2022","journal-title":"Clin. Gastroenterol. Hepatol."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"699","DOI":"10.1056\/NEJMoa1215734","article-title":"Vedolizumab as induction and maintenance therapy for ulcerative colitis","volume":"369","author":"Feagan","year":"2013","journal-title":"N. Engl. J. Med."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"229","DOI":"10.1016\/j.cgh.2016.08.044","article-title":"Efficacy of vedolizumab induction and maintenance therapy in patients with ulcerative colitis, regardless of prior exposure to tumor necrosis factor antagonists","volume":"15","author":"Feagan","year":"2017","journal-title":"Clin. Gastroenterol. Hepatol."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"1215","DOI":"10.1056\/NEJMoa1905725","article-title":"Vedolizumab versus adalimumab for moderate-to-severe ulcerative colitis","volume":"381","author":"Sands","year":"2019","journal-title":"N. Engl. J. Med."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1016\/j.jaad.2009.07.052","article-title":"Meta-analysis comparing efficacy of benzoyl peroxide, clindamycin, benzoyl peroxide with salicylic acid, and combination benzoyl peroxide\/clindamycin in acne","volume":"63","author":"Seidler","year":"2010","journal-title":"J. Am. Acad. Dermatol."},{"key":"ref_33","first-page":"e1177","article-title":"Crohn\u2019s disease and ulcerative colitis show unique cytokine profiles","volume":"9","author":"Nemeth","year":"2017","journal-title":"Cureus"},{"key":"ref_34","doi-asserted-by":"crossref","unstructured":"Pagnini, C., and Cominelli, F. (2021). Tumor necrosis factor\u2019s pathway in Crohn\u2019s disease: Potential for intervention. Int. J. Mol. Sci., 22.","DOI":"10.3390\/ijms221910273"},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"i1782","DOI":"10.1093\/ecco-jcc\/jjad212.1113","article-title":"Treatment of patients with moderate-to-severe Crohn\u2019s disease with subcutaneous infliximab leads to an endoscopic response across all segments of the colon and terminal ileum: A post hoc analysis of the LIBERTY-CD study","volume":"18","author":"Sands","year":"2024","journal-title":"J. Crohns Colitis"},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"e74","DOI":"10.1016\/j.cgh.2021.02.032","article-title":"Comparative risk of serious infections with tumor necrosis factor \u03b1 antagonists vs. vedolizumab in patients with inflammatory bowel diseases","volume":"20","author":"Singh","year":"2022","journal-title":"Clin. Gastroenterol. Hepatol."},{"key":"ref_37","unstructured":"Higgins, J.P.T., Thomas, J., Chandler, J., Cumpston, M., Li, T., Page, M.J., and Welch, V.A.e. (2024, October 10). Cochrane Handbook for Systematic Reviews of Interventions Version 6.3 (Updated February 2022). Available online: www.training.cochrane.org\/handbook."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/13\/4419\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T17:56:09Z","timestamp":1760032569000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/13\/4419"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6,21]]},"references-count":37,"journal-issue":{"issue":"13","published-online":{"date-parts":[[2025,7]]}},"alternative-id":["jcm14134419"],"URL":"https:\/\/doi.org\/10.3390\/jcm14134419","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,6,21]]}}}