{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T17:49:19Z","timestamp":1790704159691,"version":"4.1.0"},"reference-count":60,"publisher":"MDPI AG","issue":"16","license":[{"start":{"date-parts":[[2025,8,15]],"date-time":"2025-08-15T00:00:00Z","timestamp":1755216000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background and Aim: The therapeutic landscape for ulcerative colitis (UC) is rapidly evolving, with an increasing number of biologic agents available. This systematic review and meta-analysis synthesized randomized controlled trials (RCTs) data on biologic therapies for achieving key endoscopic and histologic endpoints in moderate to severe UC. Methods: A systematic search of MEDLINE, EMBASE, Cochrane Library, Web of Science and grey literature was conducted through November 2024. Separate meta-analyses were performed for induction and maintenance. A random-effects model was used to estimate relative risks (RR), with 95% confidence intervals (CI), and confidence in estimates was evaluated with the GRADE approach (Grading of Recommendation Assessment, Development and Evaluation). Results: We included 40 RCTs (13 therapies, 14,369 patients). Thirty-two trials provided data in induction and twenty-eight in maintenance. During induction, all biologic therapies, except mirikizumab and filgotinib 100 mg, demonstrated superiority over placebo (RR 2.02, 95% CI: 1.76\u20132.31, I2 = 72%) for endoscopic improvement. Upadacitinib showed the highest efficacy (RR 5.53, 95% CI: 3.78\u20138.09). For mucosal healing, all interventions were superior to placebo (RR 2.95, 95% CI: 2.11\u20134.13, I2 = 61%), except filgotinib 100 mg. Risankizumab showed the highest efficacy (RR 10.25, 95% CI: 2.49\u201342.11). In maintenance, all therapies showed superiority over placebo for endoscopic improvement. For mucosal healing all therapies were superior to placebo, except risankizumab. Upadacitinib 30 mg showed the highest efficacy (RR 4.01, 95% CI: 1.81\u20138.87). Conclusions: Biologic and small-molecule therapies demonstrated substantial efficacy in achieving key endpoints. Standardized outcome definitions and further head-to-head RCTs are essential to strengthen confidence in our findings.<\/jats:p>","DOI":"10.3390\/jcm14165789","type":"journal-article","created":{"date-parts":[[2025,8,15]],"date-time":"2025-08-15T14:24:28Z","timestamp":1755267868000},"page":"5789","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Efficacy of Biologic Agents and Small Molecules for Endoscopic Improvement and Mucosal Healing in Patients with Moderate-to-Severe Ulcerative Colitis: Systematic Review and Meta-Analysis"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-8716-5695","authenticated-orcid":false,"given":"Christos","family":"Mademlis","sequence":"first","affiliation":[{"name":"Gastroenterology and Hepatology Unit, Second Propaedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece"},{"name":"Second Propaedeutic Department of Internal Medicine, Hippokration General Hospital, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anastasia","family":"Katsoula","sequence":"additional","affiliation":[{"name":"Gastroenterology and Hepatology Unit, Second Propaedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece"},{"name":"Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5853-1352","authenticated-orcid":false,"given":"Theocharis","family":"Koufakis","sequence":"additional","affiliation":[{"name":"Second Propaedeutic Department of Internal Medicine, Hippokration General Hospital, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paschalis","family":"Paschos","sequence":"additional","affiliation":[{"name":"Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aristeidis","family":"Kefas","sequence":"additional","affiliation":[{"name":"Second Propaedeutic Department of Internal Medicine, Hippokration General Hospital, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2146-1194","authenticated-orcid":false,"given":"Lefteris","family":"Teperikidis","sequence":"additional","affiliation":[{"name":"Second Propaedeutic Department of Internal Medicine, Hippokration General Hospital, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niki","family":"Theodoridou","sequence":"additional","affiliation":[{"name":"Dermatology Unit of Gustave Roussy, 114 rue \u00c9douard-Vaillant, 94805 Villejuif Cedex, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Giouleme","sequence":"additional","affiliation":[{"name":"Gastroenterology and Hepatology Unit, Second Propaedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,8,15]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"46","DOI":"10.1053\/j.gastro.2011.10.001","article-title":"Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review","volume":"142","author":"Molodecky","year":"2012","journal-title":"Gastroenterology"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"744","DOI":"10.1093\/ecco-jcc\/jjz003","article-title":"The Evolution of Health Care Utilisation and Costs for Inflammatory Bowel Disease Over Ten Years","volume":"13","author":"Pillai","year":"2019","journal-title":"J. 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