{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T00:17:19Z","timestamp":1793146639074,"version":"4.5.0"},"reference-count":33,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2025,12,8]],"date-time":"2025-12-08T00:00:00Z","timestamp":1765152000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,5,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and aims<\/jats:title>\n                    <jats:p>Patients with ulcerative colitis (UC) have an elevated thromboembolic risk. The comparative risks associated with advanced therapies (ADTs) remain unclear.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this retrospective cohort study, we utilized the Japanese Medical Data Vision claims database to assess patients with UC who initiated treatment with tumor necrosis factor (TNF) inhibitors, vedolizumab, or tofacitinib. We evaluated the cumulative incidence and hazard ratios (HRs) for venous thromboembolisms (VTEs), cardiovascular events (CVEs), and major adverse cardiovascular events (MACEs). The tofacitinib dose was modeled as a time-varying covariate.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In total, 8125 TNF inhibitor users, 1218 tofacitinib users, and 2469 vedolizumab users were analyzed. Compared with TNF inhibitors, vedolizumab was associated with a lower risk of VTE (HR ,50, 95% CI 0.30-0.81) and CVE (HR 0.47, 95% CI, 0.27-0.81), with no difference in MACE. Tofacitinib 5\u2009mg and 10\u2009mg administration twice daily (BID) showed no significant differences vs TNF inhibitors, though point estimates were lower at 5\u2009mg and higher at 10\u2009mg. Concomitant 5-aminosalicylic acid was associated with a lower incidence of VTE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Vedolizumab demonstrated a favorable thromboembolic and cardiovascular safety profile compared with TNF inhibitors, whereas tofacitinib did not increase the risk at either dose. Concomitant 5-aminosalicylic acid may have a preventive effect against VTE. These findings may aid therapeutic decision-making for UC patients with elevated thrombotic risk.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ibd\/izaf302","type":"journal-article","created":{"date-parts":[[2025,11,19]],"date-time":"2025-11-19T13:08:12Z","timestamp":1763557692000},"page":"904-913","source":"Crossref","is-referenced-by-count":3,"title":["Thromboembolic Risk in Ulcerative Colitis Patients on Advanced Therapy: A Real-World Data Analysis"],"prefix":"10.1093","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3369-5059","authenticated-orcid":false,"given":"Yu","family":"Nishida","sequence":"first","affiliation":[{"name":"Department of Gastroenterology, Graduate School of Medicine, Osaka Metropolitan University , Osaka,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8808-5672","authenticated-orcid":false,"given":"Shuhei","family":"Hosomi","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Graduate School of Medicine, Osaka Metropolitan University , Osaka,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Fujimoto","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Graduate School of Medicine, Osaka Metropolitan University , Osaka,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yumie","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Graduate School of Medicine, Osaka Metropolitan University , Osaka,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rieko","family":"Nakata","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Graduate School of Medicine, Osaka Metropolitan University , Osaka,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirotsugu","family":"Maruyama","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Graduate School of Medicine, Osaka Metropolitan University , Osaka,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masaki","family":"Ominami","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Graduate School of Medicine, Osaka Metropolitan University , Osaka,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuji","family":"Nadatani","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Graduate School of Medicine, Osaka Metropolitan University , Osaka,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shusei","family":"Fukunaga","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Graduate School of Medicine, Osaka Metropolitan University , Osaka,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Otani","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Graduate School of Medicine, Osaka Metropolitan University , Osaka,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fumio","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Graduate School of Medicine, Osaka Metropolitan University , Osaka,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuhiro","family":"Fujiwara","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Graduate School of Medicine, Osaka Metropolitan University , Osaka,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,12,8]]},"reference":[{"key":"2026050317365583400_izaf302-B1","doi-asserted-by":"crossref","first-page":"181","DOI":"10.2174\/1389450116666150202161500","article-title":"Cardiovascular complications in inflammatory bowel disease","volume":"16","author":"Schicho","year":"2015","journal-title":"Curr Drug Targets"},{"key":"2026050317365583400_izaf302-B2","doi-asserted-by":"crossref","first-page":"469","DOI":"10.1016\/j.crohns.2013.09.021","article-title":"Thromboembolic events and cardiovascular mortality in inflammatory bowel diseases: a meta-analysis of observational studies","volume":"8","author":"Fumery","year":"2014","journal-title":"J Crohns Colitis"},{"key":"2026050317365583400_izaf302-B3","doi-asserted-by":"crossref","first-page":"657","DOI":"10.1016\/S0140-6736(09)61963-2","article-title":"Venous thromboembolism during active disease and remission in inflammatory bowel disease: a cohort study","volume":"375","author":"Grainge","year":"2010","journal-title":"Lancet"},{"key":"2026050317365583400_izaf302-B4","doi-asserted-by":"crossref","first-page":"1307","DOI":"10.1053\/j.gastro.2024.10.001","article-title":"AGA living clinical practice guideline on pharmacological management of moderate-to-severe ulcerative colitis","volume":"167","author":"Singh","year":"2024","journal-title":"Gastroenterology"},{"key":"2026050317365583400_izaf302-B5","doi-asserted-by":"crossref","first-page":"2084","DOI":"10.1016\/j.cgh.2024.03.042","article-title":"Ozanimod in patients with moderate to severe ulcerative colitis naive to advanced therapies","volume":"22","author":"Sands","year":"2024","journal-title":"Clin Gastroenterol Hepatol"},{"key":"2026050317365583400_izaf302-B6","doi-asserted-by":"crossref","first-page":"576","DOI":"10.1136\/ard.2010.129916","article-title":"Tumour necrosis factor antagonist use and associated risk reduction of cardiovascular events among patients with rheumatoid arthritis","volume":"70","author":"Greenberg","year":"2011","journal-title":"Ann Rheum Dis"},{"key":"2026050317365583400_izaf302-B7","doi-asserted-by":"crossref","first-page":"480","DOI":"10.1136\/annrheumdis-2014-206624","article-title":"The effects of tumour necrosis factor inhibitors, methotrexate, non-steroidal anti-inflammatory drugs and corticosteroids on cardiovascular events in rheumatoid arthritis, psoriasis and psoriatic arthritis: a systematic review and meta-analysis","volume":"74","author":"Roubille","year":"2015","journal-title":"Ann Rheum Dis"},{"key":"2026050317365583400_izaf302-B8","doi-asserted-by":"crossref","first-page":"518","DOI":"10.1093\/rheumatology\/keq316","article-title":"Tumour necrosis factor antagonists and the risk of cardiovascular disease in patients with rheumatoid arthritis: a systematic literature review","volume":"50","author":"Westlake","year":"2011","journal-title":"Rheumatology (Oxford)"},{"key":"2026050317365583400_izaf302-B9","doi-asserted-by":"crossref","first-page":"316","DOI":"10.1056\/NEJMoa2109927","article-title":"Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis","volume":"386","author":"Ytterberg","year":"2022","journal-title":"N Engl J Med"},{"key":"2026050317365583400_izaf302-B10","doi-asserted-by":"crossref","first-page":"1400","DOI":"10.1136\/annrheumdis-2019-216761","article-title":"Incidence of venous and arterial thromboembolic events reported in the tofacitinib rheumatoid arthritis, psoriasis and psoriatic arthritis development programmes and from real-world data","volume":"79","author":"Mease","year":"2020","journal-title":"Ann Rheum Dis"},{"key":"2026050317365583400_izaf302-B11","doi-asserted-by":"crossref","first-page":"1068","DOI":"10.1111\/apt.15514","article-title":"Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme","volume":"50","author":"Sandborn","year":"2019","journal-title":"Aliment Pharmacol Ther"},{"key":"2026050317365583400_izaf302-B12","doi-asserted-by":"crossref","first-page":"1910","DOI":"10.1093\/ibd\/izae267","article-title":"Biologics and Oral Small Molecules Are Not Associated With Increased Major Adverse Cardiovascular Events or Venous Thromboembolism in Inflammatory Bowel Disease","volume":"31","author":"Qapaja","year":"2025","journal-title":"Inflamm Bowel Dis"},{"key":"2026050317365583400_izaf302-B13","doi-asserted-by":"crossref","first-page":"1541","DOI":"10.1016\/j.cgh.2018.11.035","article-title":"Safety of tofacitinib for treatment of ulcerative colitis, based on 4.4 years of data from global clinical trials","volume":"17","author":"Sandborn","year":"2019","journal-title":"Clin Gastroenterol Hepatol"},{"key":"2026050317365583400_izaf302-B14","doi-asserted-by":"crossref","first-page":"464","DOI":"10.1111\/apt.16712","article-title":"Safety and efficacy of tofacitinib for treatment of ulcerative colitis: final analysis of OCTAVE Open, an open-label, long-term extension study with up to 7.0 years of treatment","volume":"55","author":"Sandborn","year":"2022","journal-title":"Aliment Pharmacol Ther"},{"key":"2026050317365583400_izaf302-B15","doi-asserted-by":"crossref","first-page":"5206","DOI":"10.1007\/s10620-022-07404-z","article-title":"Comparative risk of thrombotic and cardiovascular events with tofacitinib and anti-TNF agents in patients with inflammatory bowel diseases","volume":"67","author":"Kochar","year":"2022","journal-title":"Dig Dis Sci"},{"key":"2026050317365583400_izaf302-B16","doi-asserted-by":"crossref","first-page":"1208","DOI":"10.1001\/jamadermatol.2020.2977","article-title":"Association between early severe cardiovascular events and the initiation of treatment with the anti-interleukin 12\/23p40 antibody ustekinumab","volume":"156","author":"Poizeau","year":"2020","journal-title":"JAMA Dermatol"},{"key":"2026050317365583400_izaf302-B17","doi-asserted-by":"crossref","first-page":"1525","DOI":"10.14309\/ajg.0000000000002676","article-title":"Rates of adverse events in patients with ulcerative colitis undergoing colectomy during treatment with tofacitinib vs biologics: a multicenter observational study","volume":"119","author":"Dragoni","year":"2024","journal-title":"Am J Gastroenterol"},{"key":"2026050317365583400_izaf302-B18","doi-asserted-by":"crossref","first-page":"1394","DOI":"10.1093\/ibd\/izaa289","article-title":"Tofacitinib treatment safety in moderate to severe ulcerative colitis: comparison of observational population cohort data from the IBM MarketScan\u00ae administrative claims database with tofacitinib trial data","volume":"27","author":"Curtis","year":"2021","journal-title":"Inflamm Bowel Dis"},{"key":"2026050317365583400_izaf302-B19","doi-asserted-by":"crossref","first-page":"1218","DOI":"10.1002\/art.42846","article-title":"Risk of venous thromboembolism with tofacitinib versus tumor necrosis factor inhibitors in cardiovascular risk-enriched rheumatoid arthritis patients","volume":"76","author":"Charles-Schoeman","year":"2024","journal-title":"Arthritis Rheumatol"},{"key":"2026050317365583400_izaf302-B20","doi-asserted-by":"crossref","first-page":"723","DOI":"10.1016\/j.crohns.2012.10.008","article-title":"Clinical presentation of venous thromboembolism in inflammatory bowel disease","volume":"7","author":"Papay","year":"2013","journal-title":"J Crohns Colitis"},{"key":"2026050317365583400_izaf302-B21","doi-asserted-by":"crossref","first-page":"1905","DOI":"10.1016\/j.cgh.2014.02.034","article-title":"Thromboprophylaxis is associated with reduced post-hospitalization venous thromboembolic events in patients with inflammatory bowel diseases","volume":"12","author":"Ananthakrishnan","year":"2014","journal-title":"Clin Gastroenterol Hepatol"},{"key":"2026050317365583400_izaf302-B22","doi-asserted-by":"crossref","first-page":"2374","DOI":"10.1016\/j.cgh.2018.11.062","article-title":"Concomitant use of aminosalicylates is not associated with improved outcomes in patients with ulcerative colitis escalated to vedolizumab","volume":"17","author":"Ma","year":"2019","journal-title":"Clin Gastroenterol Hepatol"},{"key":"2026050317365583400_izaf302-B23","doi-asserted-by":"crossref","first-page":"780","DOI":"10.1136\/gut.2010.221127","article-title":"Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial","volume":"60","author":"Reinisch","year":"2011","journal-title":"Gut"},{"key":"2026050317365583400_izaf302-B24","doi-asserted-by":"crossref","first-page":"1197","DOI":"10.1038\/s41395-018-0144-2","article-title":"No benefit of concomitant 5-aminosalicylates in patients with ulcerative colitis escalated to biologic therapy: pooled analysis of individual participant data from clinical trials","volume":"113","author":"Singh","year":"2018","journal-title":"Am J Gastroenterol"},{"key":"2026050317365583400_izaf302-B25","doi-asserted-by":"crossref","first-page":"977","DOI":"10.1136\/gutjnl-2018-317021","article-title":"Stopping 5-aminosalicylates in patients with ulcerative colitis starting biologic therapy does not increase the risk of adverse clinical outcomes: analysis of two nationwide population-based cohorts","volume":"68","author":"Ungaro","year":"2019","journal-title":"Gut"},{"key":"2026050317365583400_izaf302-B26","doi-asserted-by":"crossref","first-page":"1152","DOI":"10.1016\/j.cgh.2019.08.012","article-title":"Stopping mesalamine therapy in patients with crohn\u2019s disease starting biologic therapy does not increase risk of adverse outcomes","volume":"18","author":"Ungaro","year":"2020","journal-title":"Clin Gastroenterol Hepatol"},{"key":"2026050317365583400_izaf302-B27","doi-asserted-by":"crossref","first-page":"1949","DOI":"10.1093\/ecco-jcc\/jjad113","article-title":"Impact of concomitant 5-aminosalicylic acid therapy on vedolizumab efficacy and safety in inflammatory bowel disease: post hoc analyses of clinical trial data","volume":"17","author":"Ungaro","year":"2023","journal-title":"J Crohns Colitis"},{"key":"2026050317365583400_izaf302-B28","doi-asserted-by":"crossref","first-page":"108","DOI":"10.1111\/jgh.16786","article-title":"Evaluating the effects of 5-aminosalicylic acid on tofacitinib treatment in ulcerative colitis","volume":"40","author":"Nishida","year":"2025","journal-title":"J Gastroenterol Hepatol"},{"key":"2026050317365583400_izaf302-B29","doi-asserted-by":"crossref","first-page":"2373","DOI":"10.1093\/ibd\/izaf001","article-title":"Impact of 5-aminosalicylic acid on ustekinumab in inflammatory bowel disease: a retrospective medical claims analysis","volume":"31","author":"Nishida","year":"2025","journal-title":"Inflamm Bowel Dis"},{"key":"2026050317365583400_izaf302-B30","doi-asserted-by":"crossref","first-page":"2036","DOI":"10.1093\/ibd\/izaf088","article-title":"Lack of efficacy of concomitant 5-aminosalicylic acid with vedolizumab in inflammatory bowel disease: a large-scale administrative database analysis","volume":"31","author":"Nishida","year":"2025","journal-title":"Inflamm Bowel Dis"},{"key":"2026050317365583400_izaf302-B31","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1159\/000547093","article-title":"Does 5-aminosalicylic acid prevent colorectal cancer in tumour necrosis factor: treated ulcerative colitis? A real-world study","author":"Nishida","year":"2025","journal-title":"Digestion"},{"key":"2026050317365583400_izaf302-B32","doi-asserted-by":"crossref","first-page":"584","DOI":"10.1016\/j.dld.2024.09.005","article-title":"Incidence and risk factors for thromboembolic events in pediatric-onset inflammatory bowel disease: A French population-based study","volume":"57","author":"Richard","year":"2025","journal-title":"Dig Liver Dis"},{"key":"2026050317365583400_izaf302-B33","doi-asserted-by":"crossref","first-page":"1169","DOI":"10.1046\/j.1365-2036.2000.00824.x","article-title":"Inhibition of platelet activation by 5-aminosalicylic acid in inflammatory bowel disease","volume":"14","author":"Carty","year":"2000","journal-title":"Aliment Pharmacol Ther"}],"container-title":["Inflammatory Bowel Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ibdjournal\/article-pdf\/32\/5\/904\/65799979\/izaf302.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ibdjournal\/article-pdf\/32\/5\/904\/65799979\/izaf302.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,3]],"date-time":"2026-05-03T21:37:05Z","timestamp":1777844225000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ibdjournal\/article\/32\/5\/904\/8373792"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,8]]},"references-count":33,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2025,12,8]]},"published-print":{"date-parts":[[2026,5,1]]}},"URL":"https:\/\/doi.org\/10.1093\/ibd\/izaf302","relation":{},"ISSN":["1078-0998","1536-4844"],"issn-type":[{"value":"1078-0998","type":"print"},{"value":"1536-4844","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,5]]},"published":{"date-parts":[[2025,12,8]]}}}