{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T08:14:33Z","timestamp":1793088873926,"version":"4.5.0"},"reference-count":27,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T00:00:00Z","timestamp":1785196800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>This analysis of insurer-complete administrative data and claims from a United States database (Komodo Health) assessed the risk of serious infections, myocardial infarction (MI), stroke, and venous thromboembolism (VTE) among patients with ulcerative colitis (UC) initiating tofacitinib or biologic treatments.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients with UC initiating treatment with tofacitinib, ustekinumab, vedolizumab, or tumor necrosis factor inhibitors (TNFis) from May 31, 2018, to September 30, 2022, were included. Stabilized inverse probability treatment weights (sIPTWs) were calculated and Cox proportional hazards models with sIPTWs were used to calculate hazard ratios; bootstrapping was used to calculate 95% CIs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In total, 5171, 10\u200a424, 17\u200a129, and 29\u200a872 patients initiated tofacitinib, ustekinumab, vedolizumab, and TNFis, respectively. The mean patient age at index was 43.1\u2009years and the mean follow-up was 359.2\u2009days. At baseline, a greater proportion of patients initiating tofacitinib vs biologics had used\u2009\u2265\u20092 prior biologics (46.3% vs 7.5%-33.7%, respectively). Incidence rates (IRs)\/100 patient-years (PY) of serious infections were 2.62, 2.73, 2.45, and 3.25 for tofacitinib, ustekinumab, vedolizumab, and TNFi, respectively. For MI\/stroke and VTE the IRs\/100 PY were, respectively, 0.13 and 0.17 for tofacitinib, 0.17 and 0.16 for ustekinumab, 0.17 and 0.23 for vedolizumab, and 0.19 and 0.33 for TNFi. There were no significant differences in the risk of developing serious infections, MI\/stroke, or VTE between treatments.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>No significant risk differences were observed among patients with UC initiating tofacitinib compared with biologics in a large US claims database. These findings add to evaluations of treatment risks vs benefits in patients with UC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>European Union post-authorization study (PAS) register number<\/jats:title>\n                    <jats:p>EUPAS103443.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ibd\/izag142","type":"journal-article","created":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T23:50:57Z","timestamp":1782863457000},"source":"Crossref","is-referenced-by-count":3,"title":["Risk of serious infection, myocardial infarction, stroke, and thromboembolic events in patients in the United States with ulcerative colitis treated with tofacitinib compared with biologic treatments"],"prefix":"10.1093","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5647-1723","authenticated-orcid":false,"given":"David T","family":"Rubin","sequence":"first","affiliation":[{"name":"University of Chicago Medicine Inflammatory Bowel Disease Center , Chicago, IL 60637,","place":["United States"]}],"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 Internal Medicine I, University Hospital Schleswig-Holstein, Kiel University , Kiel, 24105,","place":["Germany"]}],"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 Gastroenterology, CHRU Nancy, INSERM NGERE, Universit\u00e9 de Lorraine , Vand\u0153uvre-l\u00e8s-Nancy, 54000,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7341-1351","authenticated-orcid":false,"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Istituto Clinico Humanitas , Milan, 20089,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8351-4626","authenticated-orcid":false,"given":"Milena A","family":"Gianfrancesco","sequence":"additional","affiliation":[{"name":"Pfizer Inc , New York, NY 10001,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arif","family":"Soonasra","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Collegeville, PA 19426,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Sidhu","sequence":"additional","affiliation":[{"name":"Pfizer Inc , New York, NY 10001,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivana","family":"Vranic","sequence":"additional","affiliation":[{"name":"Pfizer Ltd , Tadworth, KT20 7NY,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmed","family":"Shelbaya","sequence":"additional","affiliation":[{"name":"Pfizer Inc , New York, NY 10001,","place":["United States"]},{"name":"Department of Epidemiology, Mailman School of Public Health , New York, NY 10032,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Gruben","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Groton, CT 06340,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuqin","family":"Wei","sequence":"additional","affiliation":[{"name":"Komodo Health, Inc , San Francisco, CA 94105,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin L","family":"Winthrop","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Oregon Health & Science University , Portland, OR 97239,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey R","family":"Curtis","sequence":"additional","affiliation":[{"name":"Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham , Birmingham, AL 35294,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel D","family":"Regueiro","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic , Cleveland, OH 44195,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marla C","family":"Dubinsky","sequence":"additional","affiliation":[{"name":"Susan and Leonard Feinstein IBD Center, Icahn School of Medicine at Mount Sinai , New York, NY 10029,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,7,28]]},"reference":[{"key":"2026072817374853100_izag142-B1","author":"U.S. Food and Drug Administration"},{"key":"2026072817374853100_izag142-B2","doi-asserted-by":"publisher","first-page":"5023","DOI":"10.1021\/jm401490p","article-title":"Discovery and development of Janus kinase (JAK) inhibitors for inflammatory diseases","volume":"57","author":"Clark","year":"2014","journal-title":"J Med Chem"},{"key":"2026072817374853100_izag142-B3","doi-asserted-by":"publisher","first-page":"1723","DOI":"10.1056\/NEJMoa1606910","article-title":"Tofacitinib as induction and maintenance therapy for ulcerative colitis","volume":"376","author":"Sandborn","year":"2017","journal-title":"N Engl J Med"},{"key":"2026072817374853100_izag142-B4","doi-asserted-by":"publisher","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":"2026072817374853100_izag142-B5","doi-asserted-by":"publisher","first-page":"901","DOI":"10.1136\/ard-2022-223715","article-title":"Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance","volume":"82","author":"Kristensen","year":"2023","journal-title":"Ann Rheum Dis"},{"key":"2026072817374853100_izag142-B6","doi-asserted-by":"publisher","first-page":"268","DOI":"10.1016\/j.dld.2019.10.003","article-title":"Real-world evidence of tofacitinib effectiveness and safety in patients with refractory ulcerative colitis","volume":"52","author":"Lair-Mehiri","year":"2020","journal-title":"Dig Liver Dis"},{"key":"2026072817374853100_izag142-B7","doi-asserted-by":"publisher","first-page":"622","DOI":"10.1007\/s10620-021-06990-8","article-title":"Inflammatory bowel disease patients who respond to treatment with anti-tumor necrosis factor agents demonstrate improvement in pre-treatment frailty","volume":"67","author":"Kochar","year":"2022","journal-title":"Dig Dis Sci"},{"key":"2026072817374853100_izag142-B8","doi-asserted-by":"publisher","first-page":"1385","DOI":"10.1093\/ecco-jcc\/jjaa075","article-title":"Real-world effectiveness of tofacitinib for moderate to severe ulcerative colitis: a multicentre UK experience","volume":"14","author":"Honap","year":"2020","journal-title":"J Crohns Colitis"},{"key":"2026072817374853100_izag142-B9","doi-asserted-by":"publisher","first-page":"1592","DOI":"10.1016\/j.cgh.2020.06.050","article-title":"Safety of tofacitinib in a real-world cohort of patients with ulcerative colitis","volume":"19","author":"Deepak","year":"2021","journal-title":"Clin Gastroenterol Hepatol"},{"key":"2026072817374853100_izag142-B10","doi-asserted-by":"publisher","first-page":"35","DOI":"10.1093\/ecco-jcc\/jjaa145","article-title":"Tofacitinib in ulcerative colitis: real-world evidence from the ENEIDA registry","volume":"15","author":"Chaparro","year":"2021","journal-title":"J Crohns Colitis"},{"key":"2026072817374853100_izag142-B11","doi-asserted-by":"publisher","first-page":"e1979","DOI":"10.1002\/hsr2.1979","article-title":"Private health insurance in the United States and Sweden: a comparative review","volume":"7","author":"Dave","year":"2024","journal-title":"Health Sci Rep"},{"key":"2026072817374853100_izag142-B12","author":"Cohen","year":"2024"},{"key":"2026072817374853100_izag142-B13","doi-asserted-by":"publisher","first-page":"339","DOI":"10.1093\/ibd\/izac097","article-title":"The risk of serious infections before and after anti-TNF therapy in inflammatory bowel disease: a retrospective cohort study","volume":"29","author":"Holmgren","year":"2023","journal-title":"Inflamm Bowel Dis"},{"key":"2026072817374853100_izag142-B14","doi-asserted-by":"publisher","first-page":"417","DOI":"10.18553\/jmcp.2020.26.4.417","article-title":"Incidence of serious infections and design of utilization and safety studies for biologic and biosimilar surveillance","volume":"26","author":"Zhang","year":"2020","journal-title":"J Manag Care Spec Pharm"},{"key":"2026072817374853100_izag142-B15","doi-asserted-by":"publisher","first-page":"e74","DOI":"10.1016\/j.cgh.2021.02.032","article-title":"Comparative risk of serious infections with tumor necrosis factor alpha antagonists vs vedolizumab in patients with inflammatory bowel diseases","volume":"20","author":"Singh","year":"2022","journal-title":"Clin Gastroenterol Hepatol"},{"key":"2026072817374853100_izag142-B16","doi-asserted-by":"publisher","first-page":"937","DOI":"10.1136\/gut.2010.228585","article-title":"Thromboembolic risk among Danish children and adults with inflammatory bowel diseases: a population-based nationwide study","volume":"60","author":"Kappelman","year":"2011","journal-title":"Gut"},{"key":"2026072817374853100_izag142-B17","doi-asserted-by":"publisher","first-page":"e1438","DOI":"10.1503\/cmaj.161485","article-title":"Comparative risk of incident venous thromboembolism in patients with inflammatory bowel disease initiating tumour necrosis factor-alpha inhibitors or nonbiologic agents: a cohort study","volume":"189","author":"Desai","year":"2017","journal-title":"CMAJ"},{"key":"2026072817374853100_izag142-B18","doi-asserted-by":"crossref","first-page":"430","DOI":"10.1055\/s-0037-1615600","article-title":"The incidence of deep venous thrombosis and pulmonary embolism among patients with inflammatory bowel disease: a population-based cohort study","volume":"85","author":"Bernstein","year":"2001","journal-title":"Thromb Haemost"},{"key":"2026072817374853100_izag142-B19","article-title":"Comparative risk of serious infections associated with treatment of inflammatory bowel disease","author":"Khan","year":"2025","journal-title":"Inflamm Bowel Dis"},{"key":"2026072817374853100_izag142-B20","doi-asserted-by":"publisher","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":"2026072817374853100_izag142-B21","doi-asserted-by":"publisher","first-page":"177","DOI":"10.1186\/s12876-022-02215-y","article-title":"Real-world characteristics, treatment experiences and corticosteroid utilisation of patients treated with tofacitinib for moderate to severe ulcerative colitis","volume":"22","author":"Chiorean","year":"2022","journal-title":"BMC Gastroenterol"},{"key":"2026072817374853100_izag142-B22","doi-asserted-by":"publisher","first-page":"3115","DOI":"10.1016\/j.cgh.2023.05.001","article-title":"Real-world experience with tofacitinib dose de-escalation in patients with moderate and severe ulcerative colitis","volume":"21","author":"Yu","year":"2023","journal-title":"Clin Gastroenterol Hepatol"},{"key":"2026072817374853100_izag142-B23","doi-asserted-by":"publisher","first-page":"798","DOI":"10.1136\/annrheumdis-2021-221915","article-title":"Tofacitinib and risk of cardiovascular outcomes: results from the Safety of TofAcitinib in Routine care patients with Rheumatoid Arthritis (STAR-RA) study","volume":"81","author":"Khosrow-Khavar","year":"2022","journal-title":"Ann Rheum Dis"},{"key":"2026072817374853100_izag142-B24","doi-asserted-by":"publisher","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":"2026072817374853100_izag142-B25","doi-asserted-by":"publisher","first-page":"96","DOI":"10.1186\/s12939-021-01436-z","article-title":"The convergence of racial and income disparities in health insurance coverage in the United States","volume":"20","author":"Lee","year":"2021","journal-title":"Int J Equity Health"},{"key":"2026072817374853100_izag142-B26","doi-asserted-by":"publisher","first-page":"e020428","DOI":"10.1161\/JAHA.120.020428","article-title":"Inpatient versus outpatient acute venous thromboembolism management: trends and postacute healthcare utilization from 2011 to 2018","volume":"10","author":"Lutsey","year":"2021","journal-title":"J Am Heart Assoc"},{"key":"2026072817374853100_izag142-B27","doi-asserted-by":"publisher","first-page":"1298","DOI":"10.7326\/M22-1460","article-title":"Good Publication Practice (GPP) guidelines for company-sponsored biomedical research: 2022 update","volume":"175","author":"DeTora","year":"2022","journal-title":"Ann Intern Med"}],"container-title":["Inflammatory Bowel Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ibdjournal\/advance-article-pdf\/doi\/10.1093\/ibd\/izag142\/70292891\/izag142.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ibdjournal\/advance-article-pdf\/doi\/10.1093\/ibd\/izag142\/70292891\/izag142.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T21:37:54Z","timestamp":1785274674000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ibdjournal\/advance-article\/doi\/10.1093\/ibd\/izag142\/8746265"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,28]]},"references-count":27,"URL":"https:\/\/doi.org\/10.1093\/ibd\/izag142","relation":{},"ISSN":["1078-0998","1536-4844"],"issn-type":[{"value":"1078-0998","type":"print"},{"value":"1536-4844","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,28]]},"article-number":"izag142"}}