{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T20:21:46Z","timestamp":1787775706542,"version":"build-2784847793"},"reference-count":34,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","license":[{"start":{"date-parts":[[2024,9,19]],"date-time":"2024-09-19T00:00:00Z","timestamp":1726704000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-sa\/4.0"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Vedolizumab is an approved ulcerative colitis (UC) treatment. Multiple large randomized clinical trials have demonstrated the drug\u2019s efficacy and safety. However, real-world data from Middle Eastern countries are spare. The study aims to evaluate the clinical efficacy of vedolizumab (VDZ) therapy in advanced therapy experienced UC patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>A retrospective electronic chart review of a cohort study of 153 moderately to severely active UC patients who failed or were intolerant to TNF antagonists and received vedolizumab from two large tertiary care centers was performed. Rates of clinical response and remission were retrospectively evaluated at 3,6, and 12 months post VDZ therapy using Patient Simple Clinical Colitis Activity Index (P-SCCAI); clinical response was defined as a decrease in P-SCCAI \u22653, and clinical remission was defined as a P-SCCAI score of \u22643 points. Logistic regression analysis was used to identify predictors of response to vedolizumab.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      A total of 153 UC patients had sufficient data for analysis. Clinical remission rates were 61.9% for patients on vedolizumab every 8 weeks and 89.3% for those receiving every 4 (Q4) weeks dosing. A significant reduction in CRP and improvement of albumin post vedolizumab treatment were observed, and corticosteroids were stopped in most patients. In a multiple logistic regression analysis, several factors were found to influence the clinical effectiveness of VDZ in inducing remission. Female gender was associated with a higher likelihood of remission [OR =3.09, 95% CI = (1.05\u20139.13),\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = 0.04]. Conversely, a greater number of biologics used prior to VDZ treatment was associated with a lower likelihood of remission [OR =0.418, 95% CI = (0.203\u20130.859),\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = 0.017]. Patients with extensive disease (E3) had an increased likelihood of remission [OR =3.81, 95% CI = (1.32\u201310.97),\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = 0.0129]. Additionally, a VDZ dosing frequency of Q4 weeks was associated with a significantly higher likelihood of remission [OR =6.08, 95% CI = (1.73\u201321.39),\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = 0.0049]. No significant safety signals were reported.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>In this current real-world study, vedolizumab effectively achieved clinical response and remission in most advanced therapy experienced UC patients treated for up to 12 months. Future studies with larger sample sizes and more robust study designs should be conducted to further validate the results of this study.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.4103\/sjg.sjg_249_24","type":"journal-article","created":{"date-parts":[[2024,9,18]],"date-time":"2024-09-18T06:00:23Z","timestamp":1726639223000},"page":"34-40","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":9,"title":["The effectiveness of vedolizumab in advanced therapy-experienced ulcerative colitis patients: Real world data from the Inflammatory Bowel Disease of the Middle East (IBD-ME) Registry group"],"prefix":"10.4103","volume":"31","author":[{"given":"Nahla","family":"Azzam","sequence":"first","affiliation":[{"name":"Department of Medicine, Division of Gastroenterology, College of Medicine, King Saud University, Riyadh, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Othman","family":"Alharbi","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Gastroenterology, College of Medicine, King Saud University, Riyadh, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mansour","family":"Altuwaijri","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Gastroenterology, College of Medicine, King Saud University, Riyadh, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yazed","family":"Alruthia","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia"},{"name":"Department of Clinical Pharmacy, Pharmacoeconomics Research Unit, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heba","family":"Alfarhan","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Division of Gastroenterology, Thunayan Al Ghanim Gastroenterology Center at Al Amiri Hospital, Kuwait City, Kuwait"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suliman","family":"Alshankiti","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Gastroenterology, College of Medicine, King Saud University, Riyadh, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Faris","family":"Nafisah","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Gastroenterology, College of Medicine, King Saud University, Riyadh, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qusay","family":"Ajlan","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Gastroenterology, College of Medicine, King Saud University, Riyadh, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abdulrahman","family":"Aljebreen","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Gastroenterology, College of Medicine, King Saud University, Riyadh, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Majid","family":"Almadi","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Gastroenterology, College of Medicine, King Saud University, Riyadh, Saudi Arabia"},{"name":"Department of Medicine, Division of Gastroenterology, The McGill University Health Center, Montreal General Hospital, McGill University, Montreal, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6975-1297","authenticated-orcid":false,"given":"Mahmoud H.","family":"Mosli","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia"},{"name":"Inflammatory Bowel Disease Unit, King Abdulaziz University Hospital, Jeddah, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2024,9,19]]},"reference":[{"key":"R1-20250106","doi-asserted-by":"crossref","first-page":"2769","DOI":"10.1016\/S0140-6736(17)32448-0","article-title":"Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century:A systematic review of population-based studies","volume":"390","author":"Ng","year":"2017","journal-title":"Lancet"},{"key":"R2-20250106","doi-asserted-by":"crossref","first-page":"571","DOI":"10.1016\/S0140-6736(23)00966-2","article-title":"Ulcerative colitis","volume":"402","author":"Le","year":"2023","journal-title":"Lancet"},{"key":"R3-20250106","first-page":"e44895","article-title":"Anxiety and depression in patients with inflammatory bowel disease at King Fahad Specialist Hospital, Qassim Region","volume":"15","author":"Alnafisah","year":"2023","journal-title":"Cureus"},{"key":"R4-20250106","doi-asserted-by":"crossref","first-page":"256","DOI":"10.4103\/sjg.SJG_175_20","article-title":"Disability and quality of life before and during the COVID-19 outbreak:A cross-sectional study in inflammatory bowel disease patients","volume":"26","author":"Azzam","year":"2020","journal-title":"Saudi J Gastroenterol"},{"key":"R5-20250106","first-page":"339","article-title":"Environmental risk factors for inflammatory bowel disease","volume":"6","author":"Molodecky","year":"2010","journal-title":"Gastroenterol Hepatol (N Y)"},{"key":"R6-20250106","doi-asserted-by":"crossref","first-page":"1504","DOI":"10.1053\/j.gastro.2004.01.063","article-title":"Clinical epidemiology of inflammatory bowel disease:Incidence, prevalence, and environmental influences","volume":"126","author":"Loftus","year":"2004","journal-title":"Gastroenterology"},{"key":"R7-20250106","doi-asserted-by":"crossref","first-page":"720","DOI":"10.1038\/nrgastro.2015.150","article-title":"The global burden of IBD:From 2015 to 2025","volume":"12","author":"Kaplan","year":"2015","journal-title":"Nat Rev Gastroenterol Hepatol"},{"key":"R8-20250106","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1159\/000518003","article-title":"Incidence, prevalence, and clinical epidemiology of inflammatory bowel disease in the Arab World:A systematic review and meta-analysis","volume":"6","author":"Mosli","year":"2021","journal-title":"Inflamm Intest Dis"},{"key":"R9-20250106","doi-asserted-by":"crossref","first-page":"883","DOI":"10.1080\/17474124.2018.1503052","article-title":"Epidemiology, disease burden, and treatment challenges of ulcerative colitis in Africa and the Middle East","volume":"12","author":"Sharara","year":"2018","journal-title":"Expert Rev Gastroenterol Hepatol"},{"key":"R10-20250106","doi-asserted-by":"crossref","first-page":"17525","DOI":"10.3748\/wjg.v20.i46.17525","article-title":"Clinical epidemiology of ulcerative colitis in Arabs based on the Montr\u00e9al classification","volume":"20","author":"Alharbi","year":"2014","journal-title":"World J Gastroenterol"},{"key":"R11-20250106","doi-asserted-by":"crossref","first-page":"16","DOI":"10.4103\/1319-3767.105915","article-title":"Emerging inflammatory bowel disease in Saudi outpatients:A report of 693 cases","volume":"19","author":"Al-Mofarreh","year":"2013","journal-title":"Saudi J Gastroenterol"},{"key":"R12-20250106","doi-asserted-by":"crossref","first-page":"1102","DOI":"10.1080\/13696998.2020.1791889","article-title":"The cost-effectiveness of biologic versus non-biologic treatments and the health-related quality of life among a sample of patients with inflammatory bowel disease in a tertiary care center in Saudi Arabia","volume":"23","author":"AlRuthia","year":"2020","journal-title":"J Med Econ"},{"key":"R13-20250106","doi-asserted-by":"crossref","first-page":"384","DOI":"10.14309\/ajg.0000000000000152","article-title":"ACG clinical guideline:Ulcerative colitis in adults","volume":"114","author":"Rubin","year":"2019","journal-title":"Am J Gastroenterol"},{"key":"R14-20250106","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"},{"issue":"(Suppl 1)","key":"R15-20250106","first-page":"S1","article-title":"Saudi Arabia consensus guidance for the diagnosis and management of adults with inflammatory bowel disease","volume":"29","author":"Mosli","year":"2022","journal-title":"Saudi J Gastroenterol"},{"key":"R16-20250106","doi-asserted-by":"crossref","first-page":"94","DOI":"10.4321\/S1130-01082004000200002","article-title":"Infliximab induces clinical, endoscopic, and histological responses in refractory ulcerative colitis","volume":"96","author":"Bermejo","year":"2004","journal-title":"Rev Esp Enferm Dig"},{"key":"R17-20250106","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":"R18-20250106","doi-asserted-by":"crossref","first-page":"257","DOI":"10.1053\/j.gastro.2011.10.032","article-title":"Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis","volume":"142","author":"Sandborn","year":"2012","journal-title":"Gastroenterology"},{"key":"R19-20250106","doi-asserted-by":"crossref","first-page":"874","DOI":"10.14309\/ajg.0000000000000183","article-title":"A treat-to-target update in ulcerative colitis:A systematic review","volume":"114","author":"Ungaro","year":"2019","journal-title":"Am J Gastroenterol"},{"key":"R20-20250106","doi-asserted-by":"crossref","first-page":"1385","DOI":"10.1016\/j.cgh.2016.04.039","article-title":"Biologic therapies and risk of infection and malignancy in patients with inflammatory bowel disease:A systematic review and network meta-analysis","volume":"14","author":"Bonovas","year":"2016","journal-title":"Clin Gastroenterol Hepatol"},{"key":"R21-20250106","doi-asserted-by":"crossref","first-page":"2107","DOI":"10.1002\/ibd.22940","article-title":"Exclusive antagonism of the a4 b7 integrin by vedolizumab confirms the gut-selectivity of this pathway in primates","volume":"18","author":"Fedyk","year":"2012","journal-title":"Inflamm Bowel Dis"},{"key":"R22-20250106","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":"R23-20250106","doi-asserted-by":"crossref","first-page":"890","DOI":"10.1016\/j.crohns.2012.11.007","article-title":"The patient simple clinical colitis activity index (P-SCCAI) can detect ulcerative colitis (UC) disease activity in remission:A comparison of the P-SCCAI with clinician-based SCCAI and biological markers","volume":"7","author":"Bennebroek","year":"2013","journal-title":"J Crohns Colitis"},{"key":"R24-20250106","doi-asserted-by":"crossref","first-page":"e0165435","DOI":"10.1371\/journal.pone.0165435","article-title":"Systematic review with network meta-analysis:Comparative efficacy of biologics in the treatment of moderately to severely active ulcerative colitis","volume":"11","author":"Vickers","year":"2016","journal-title":"PLoS One"},{"key":"R25-20250106","doi-asserted-by":"crossref","first-page":"162","DOI":"10.1111\/apt.14422","article-title":"Systematic review with network meta-analysis:First- and second-line pharmacotherapy for moderate-severe ulcerative colitis","volume":"47","author":"Singh","year":"2018","journal-title":"Aliment Pharmacol Ther"},{"key":"R26-20250106","doi-asserted-by":"crossref","first-page":"849","DOI":"10.1093\/ibd\/izx067","article-title":"Vedolizumab as induction and maintenance for inflammatory bowel disease:12-month effectiveness and safety","volume":"24","author":"Christensen","year":"2018","journal-title":"Inflamm Bowel Dis"},{"key":"R27-20250106","doi-asserted-by":"crossref","first-page":"839","DOI":"10.1136\/gutjnl-2015-311079","article-title":"The safety of vedolizumab for ulcerative colitis and Crohn's disease","volume":"66","author":"Colombel","year":"2017","journal-title":"Gut"},{"key":"R28-20250106","doi-asserted-by":"crossref","first-page":"439","DOI":"10.1177\/2050640617722310","article-title":"Efficacy of vedolizumab for induction of clinical response and remission in patients with moderate to severe inflammatory bowel disease who failed at least two TNF antagonists","volume":"6","author":"De","year":"2018","journal-title":"United European Gastroenterol J"},{"key":"R29-20250106","doi-asserted-by":"crossref","first-page":"17562848211024769","DOI":"10.1177\/17562848211024769","article-title":"The real-world outcomes of vedolizumab in patients with ulcerative colitis in Korea:A multicenter retrospective study","volume":"14","author":"Ye","year":"2021","journal-title":"Therap Adv Gastroenterol"},{"key":"R30-20250106","doi-asserted-by":"crossref","first-page":"41","DOI":"10.14740\/gr934w","article-title":"Comparative effectiveness of vedolizumab vs. infliximab induction therapy in ulcerative colitis:Experience of a real-world cohort at a tertiary inflammatory bowel disease center","volume":"11","author":"Allamneni","year":"2018","journal-title":"Gastroenterology Res"},{"key":"R31-20250106","doi-asserted-by":"crossref","first-page":"1805","DOI":"10.1093\/ibd\/izz057","article-title":"Comparative efficacy of vedolizumab and adalimumab in ulcerative colitis patients previously treated with infliximab","volume":"25","author":"Favale","year":"2019","journal-title":"Inflamm Bowel Dis"},{"key":"R32-20250106","doi-asserted-by":"crossref","first-page":"211","DOI":"10.1186\/s12876-020-01332-w","article-title":"Real-world clinical effectiveness, and safety of vedolizumab and anti-tumor necrosis factor alpha treatment in ulcerative colitis and Crohn's disease patients:A German retrospective chart review","volume":"20","author":"Helwig","year":"2020","journal-title":"BMC Gastroenterol"},{"key":"R33-20250106","doi-asserted-by":"crossref","first-page":"1243080","DOI":"10.3389\/fphar.2023.1243080","article-title":"Effectiveness of vedolizumab and ustekinumab as second biologic agent in achieving target outcomes in tumor necrosis factor antagonists experienced patients with inflammatory bowel disease (enroll-ex study)","volume":"14","author":"Alrashed","year":"2023","journal-title":"Front Pharmacol"},{"key":"R34-20250106","doi-asserted-by":"crossref","first-page":"1345","DOI":"10.1038\/s41395-018-0162-0","article-title":"Vedolizumab for ulcerative colitis:Treatment outcomes from the VICTORY Consortium","volume":"113","author":"Narula","year":"2018","journal-title":"Am J Gastroenterol"}],"container-title":["Saudi Journal of Gastroenterology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ovid.com\/10.4103\/sjg.sjg_249_24","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T19:39:55Z","timestamp":1787773195000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/10.4103\/sjg.sjg_249_24"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9,19]]},"references-count":34,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2025]]}},"URL":"https:\/\/doi.org\/10.4103\/sjg.sjg_249_24","relation":{},"ISSN":["1319-3767","1998-4049"],"issn-type":[{"value":"1319-3767","type":"print"},{"value":"1998-4049","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,9,19]]},"assertion":[{"value":"2024-07-10","name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-08-23","name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}}]}}