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Sunday Poster Session

Category: IBD

P0827 - Risk of Myocardial Infarction, Stroke, and Thromboembolic Events in Patients With Ulcerative Colitis Treated With Tofacitinib Compared to Biologic Treatments in the United States

Sunday, October 27, 2024
3:30 PM – 7:00 PM ET
Location: Exhibit Hall E
David T.. Rubin, MD, FACG1, Stefan Schreiber, MD2, Silvio Danese, MD3, Laurent Peyrin-Biroulet, MD, PhD4, Milena Gianfrancesco, PhD, MPH5, Arif Soonasra, PharmD6, Sarah Sidhu, MD5, Ivana Vranic, MD7, Ahmed Shelbaya, MD5, David Gruben, PhD8, Jeffrey Curtis, MD9, Miguel D Regueiro, MD10, Marla C. Dubinsky, MD11
1University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL; 2University Hospital, Kiel, Schleswig-Holstein, Germany; 3IRCCS San Raffaele Scientific Institute, Milan, Lombardia, Italy; 4INFINY Institute, FHU-CURE, INSERM NGERE, Nancy University Hospital, Vandœuvre-lès-Nancy, Lorraine, France; McGill University Health Centre, Montreal, QC, Canada, Nancy, Lorraine, France; 5Pfizer Inc., New York, NY; 6Pfizer Inc., Collegeville, PA; 7Pfizer Inc., Walton Oaks, England, United Kingdom; 8Pfizer Inc., Groton, CT; 9University of Alabama at Birmingham, Birmingham, AL; 10Cleveland Clinic, Cleveland, OH; 11Icahn School of Medicine at Mount Sinai, New York, NY

Introduction: There is limited information on safety events observed for tofacitinib using real-world data that includes an active comparator. In this analysis, we examined the risk of myocardial infarction or stroke (MI-S) and thromboembolic events (TE) among patients (pts) with ulcerative colitis (UC) initiating tofacitinib or biologics, using data from an adjudicated United States (US) medical and pharmacy claims database (Komodo Health).

Methods: Patients with UC initiating a new treatment with tofacitinib, ustekinumab, vedolizumab, or TNFi from 31 May 2018–30 September 2022 were selected. Stabilized inverse probability treatment weights (sIPTW) were calculated using 17 covariates in the main analysis to examine the risk of MI-S and TE, and an additional 53 in a sensitivity analysis to control for additional comorbidities, UC-related measures, and health care utilization variables. Cox proportional hazards models with sIPTW were used to calculate hazard ratios (HRs) and bootstrapping to calculate 95% confidence intervals (CIs). Sub-analyses restricted to individuals with no prior history of MI-S or TE.

Results: UC pts initiating new treatment were included: n=5,171 tofacitinib; n=10,424 ustekinumab; n=17,129 vedolizumab; n=29,872 TNFi. Mean age at index date was 43.1 (+ 15.1) years, and mean follow-up 359.2 (+ 323.7) days. A greater proportion of pts initiating tofacitinib had used >3 prior biologics (14.8%) compared to ustekinumab (6.8%), vedolizumab (1.4%), and TNFi (1.6%).

Based on a total of 113 MI-S and 166 TE events, the incidence rates of MI-S and TE per 100 person-years were 0.13 (95% CI 0.05, 0.28) and 0.17 (95% CI 0.07, 0.34) for tofacitinib; 0.17 (95% CI 0.10, 0.27) and 0.16 (95% CI 0.09, 0.26) for ustekinumab; 0.17 (95% CI 0.12, 0.24) and 0.23 (95% CI 0.17, 0.31) for vedolizumab; and 0.19 (95% CI 0.15, 0.25) and 0.33 (95% CI 0.27, 0.40) for TNFi, respectively. In analyses restricted to pts with no history of MI-S or TE or adjusting for 70 total covariates, there were no significant differences in risk of developing MI-S or TE between treatment groups (Table).

Discussion: In this large US-based claims analysis adjusting for many covariates, there were no significant differences in risk of developing MI-S or TE among pts with UC initiating tofacitinib compared to biologics. These findings are important for the consideration of treatment options and discussions of risks/benefits for UC pts.


Note: The table for this abstract can be viewed in the ePoster Gallery section of the ACG 2024 ePoster Site or in The American Journal of Gastroenterology's abstract supplement issue, both of which will be available starting October 27, 2024.


Disclosures:
David Rubin: AbbVie – Consultant. AltruBio – Consultant. Apex – Consultant. Avalo Therapeutics – Consultant. Bausch Health – Consultant. Bristol Myers Squibb – Consultant. Buhlmann Diagnostics Corp – Consultant. Celgene – Consultant. ClostraBio – Consultant. Connect BioPharma – Consultant. Cornerstones Health – Board of Directors. Crohn's & Colitis Foundation – Board of Trustees. Douglas Therapeutics – Consultant. Eli Lilly – Consultant. InDex Pharmaceuticals – Consultant. Intouch Group – Consultant. Iterative Health – Consultant. Janssen Pharmaceuticals – Consultant. Odyssey Thera – Consultant. Pfizer – Consultant. Prometheus Biosciences – Consultant. Samsung Neurologica – Consultant. Takeda – Consultant, Grant/Research Support.
Stefan Schreiber: AbbVie – Consultant, Personal fees, Speakers Bureau. Amgen – Personal fees. Arena Pharmaceuticals – Consultant, Personal fees, Speakers Bureau. Biogen – Consultant, Personal fees, Speakers Bureau. Bristol Myers Squibb – Consultant, Personal fees, Speakers Bureau. Celgene – Consultant, Personal fees, Speakers Bureau. Celltrion – Consultant, Personal fees, Speakers Bureau. Eli Lilly and Company – Personal fees. Falk – Consultant, Personal fees, Speakers Bureau. Ferring Pharmaceuticals – Personal fees. Fresenius – Consultant, Personal fees, Speakers Bureau. Galapagos – Personal fees. Gilead – Consultant, Personal fees. Hikma Pharmaceuticals – Advisory Committee/Board Member, Consultant. I-MAB – Consultant, Personal fees. Janssen – Consultant, Personal fees, Speakers Bureau. Morphic – Personal fees. MSD – Consultant, Personal fees, Speakers Bureau. Mylan – Consultant, Personal fees. Novartis – Personal fees. Pfizer Inc – Consultant, Personal fees, Speakers Bureau. Protagonist – Consultant, Personal fees. Provention Bio – Consultant, Personal fees. Roche – Personal fees. Sandoz/Hexal – Personal fees. Shire – Personal fees. Takeda – Consultant, Personal fees, Speakers Bureau. Theravance Biopharma – Consultant, Personal fees. Ventyx – Consultant, Personal fees.
Silvio Danese: Abbvie – Consultant, Lecture Fees. Alimentiv – Consultant. Allergan – Consultant. Amgen – Consultant, Lecture Fees. Applied Molecular Transport – Consultant. AstraZeneca – Consultant. Athos Therapeutics – Consultant. Biogen – Consultant. Boehringer Ingelheim – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant. Celltrion – Consultant. Dr Falk Pharma – Consultant. Eli Lilly and Company – Consultant. Enthera – Consultant. Ferring Pharmaceuticals Inc – Consultant, Lecture Fees. Gilead – Consultant, Lecture Fees. Hospira – Consultant. Inotrem – Consultant. Janssen – Consultant, Lecture Fees. Johnson & Johnson – Consultant. Morphic – Consultant. MSD – Consultant. Mundipharma – Consultant. Mylan – Consultant, Lecture Fees. Pfizer – Consultant, Lecture Fees. Roche – Consultant. Sandoz – Consultant. Sublimity Therapeutics – Consultant. Takeda – Consultant, Lecture Fees. Teladoc Health – Consultant. TiGenix – Consultant. UCB Inc. – Consultant. Vial – Consultant. Vifor – Consultant.
Laurent Peyrin-Biroulet: AbbVie – Grant/Research Support, Personal fees. Allergan – Personal Fees. Alma Bio Therapeutics – Personal Fees. Amgen – Personal Fees. Applied Molecular Transport – Personal Fees. Arena – Personal Fees. Biogen – Personal Fees. Boehringer Ingelheim – Personal Fees. Bristol Myers Squibb – Personal Fees. Celgene – Personal Fees. Celltrion – Personal Fees. CTMA – Stock Options. Enterome – Personal Fees. Enthera – Personal Fees. Ferring – Personal Fees. Fresenius Kabi – Personal Fees. Genentech – Personal Fees. Gilead – Personal Fees. Hikma – Personal Fees. InDex Pharmaceuticals – Personal Fees. Janssen – Personal Fees. Lilly – Personal Fees. MSD – Grant/Research Support, Personal Fees. Mylan – Personal Fees. Nestlé – Personal Fees. Norgine – Personal Fees. Oppilan Pharma – Personal Fees. OSE Immunotherapeutics – Personal Fees. Pfizer Inc – Personal Fees. Pharmacosmos – Fees. Samsung Bioepis – Personal Fees. Sandoz – Personal Fees. Sterna – Personal Fees. Sublimity Therapeutics – Personal Fees. Takeda – Grant/Research Support, Personal Fees. Tillotts – Personal Fees. Vifor – Personal Fees.
Milena Gianfrancesco: Pfizer Inc – Employee, Stock Options.
Arif Soonasra: Pfizer Inc – Employee, Stock Options.
Sarah Sidhu: Pfizer Inc – Employee, Stock Options.
Ivana Vranic: Pfizer Inc – Employee, Stock Options.
Ahmed Shelbaya: Pfizer Inc – Employee, Stock Options.
David Gruben: Pfizer Inc – Employee, Stock Options.
Jeffrey Curtis: Pfizer Inc – Consultant, Grant/Research Support.
Miguel D Regueiro: AbbVie – Advisory Committee/Board Member, Consultant, Speakers Bureau.
Marla Dubinsky: AbbVie – Consultant. Abivax – Consultant. Arena – Consultant. AstraZeneca – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant. Eli Lilly – Consultant. Genentech – Consultant. Gilead – Consultant. Janssen – Consultant. Pfizer Inc – Consultant. Prometheus Labs – Consultant. Takeda – Consultant.


David T.. Rubin, MD, FACG1, Stefan Schreiber, MD2, Silvio Danese, MD3, Laurent Peyrin-Biroulet, MD, PhD4, Milena Gianfrancesco, PhD, MPH5, Arif Soonasra, PharmD6, Sarah Sidhu, MD5, Ivana Vranic, MD7, Ahmed Shelbaya, MD5, David Gruben, PhD8, Jeffrey Curtis, MD9, Miguel D Regueiro, MD10, Marla C. Dubinsky, MD11. P0827 - Risk of Myocardial Infarction, Stroke, and Thromboembolic Events in Patients With Ulcerative Colitis Treated With Tofacitinib Compared to Biologic Treatments in the United States, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.