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Peer-Reviewed Publication
Inflamm Bowel Dis2026July 28, 2026Journal Article

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.

David T Rubin1, Stefan Schreiber2, Laurent Peyrin-Biroulet3, Silvio Danese4, Milena A Gianfrancesco5, Arif Soonasra6, Sarah Sidhu5, Ivana Vranic7, Ahmed Shelbaya5,8, David Gruben9, Yuqin Wei10, Kevin L Winthrop11, Jeffrey R Curtis12, Miguel D Regueiro13, Marla C Dubinsky14
1University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL 60637, United States.
2Department Internal Medicine I, University Hospital Schleswig-Holstein, Kiel University, Kiel, 24105, Germany.
3Department of Gastroenterology, CHRU Nancy, INSERM NGERE, Université de Lorraine, Vandœuvre-lès-Nancy, 54000, France.
4Division of Gastroenterology, Istituto Clinico Humanitas, Milan, 20089, Italy.
5Pfizer Inc, New York, NY 10001, United States.
6Pfizer Inc, Collegeville, PA 19426, United States.
7Pfizer Ltd, Tadworth, KT20 7NY, United Kingdom.
8Department of Epidemiology, Mailman School of Public Health, New York, NY 10032, United States.
9Pfizer Inc, Groton, CT 06340, United States.
10Komodo Health, Inc, San Francisco, CA 94105, United States.
11Division of Infectious Diseases, Oregon Health & Science University, Portland, OR 97239, United States.
12Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL 35294, United States.
13Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, OH 44195, United States.
14Susan and Leonard Feinstein IBD Center, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.

Abstract

BACKGROUND: 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. METHODS: Patients with UC initiating treatment with tofacitinib, ustekinuma…

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