P2161 - Long Term Risk of Venous Thromboembolism in Patients With Crohn's Disease Treated With Biologics or Immunomodulators

Maurice Facey, MD¹, Akash Khurana, MD², Syed Adil, MD¹, Ahmed Nadeem, MD³, Scott Martin, PhD¹, Preetika Sinh, MD⁴, Jeffry Katz, MD⁵, Vu Nguyen, MD⁵, Gregory Cooper, MD⁵, Miguel Regueiro, MD⁶, Emad Mansoor, MD^7
1University Hospitals Cleveland Medical Center, Cleveland, OH; ²Case Western Reserve University, University Hospitals, Cleveland, OH; ³Cleveland Clinic, Cleveland, OH; ⁴Medical College of Wisconsin, Milwaukee, WI; ⁵Case Western Reserve/UHCMC, Cleveland, OH; ⁶Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH; ⁷Case Western Reserve University / University Hospitals, Cleveland, OH

Introduction: Patients with Crohn’s Disease (CD) have an increased risk of venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). The pathogenesis of this association is thought to be multi-factorial and may be related to active gastrointestinal inflammation. We sought to evaluate the risk of incident VTE in CD in patients on biologics or immunomodulators.

Methods: We used a large health research network with data from 80 health care organizations, within the United States (TriNetX). Patients were included if they had CD (ICD-10 K50) and excluded if they had Ulcerative Colitis (ICD-10 K51), history of anticoagulant use, or history of VTE. Patients were divided into cohorts based on each specific sub-class of therapy (TNF inhibitors (TNFi), integrin antagonists, immunomodulators, IL-12/23 inhibitors) used in the treatment of CD and compared to those with CD not on these therapies. Within each cohort, we collected data on demographics, VTE risk factors as well as disease phenotypes (Table 1) and performed propensity score matching (PSM) to control for confounding. Primary outcome was new diagnoses of DVT and/or PE between 3 months to 5 years after starting a medication for CD. Odds ratio (OR) and 95% confidence interval (CI) were used to report associations for the propensity-matched cohorts.

Results: There were 123,167 patients with CD on biologics or immunomodulators: Anti-TNFs (n=51,811), Integrin receptor antagonists (n=11,659), IL-12/23 inhibitors (n=9,202) and Immunomodulators (n= 50,495) before PSM. After PSM, the groups were evenly matched without any statistically significant differences. Compared to patients with CD not on these therapies, the risk of DVT was significantly reduced in those treated with IL-12/23 inhibitors (OR 0.65, CI 0.44-0.95, p=0.03) and risk of PE was significantly reduced in those treated with TNF inhibitors (OR 0.72, CI 0.56-0.93, p=0.01). Aggregate risk of VTE (DVT or PE) was significantly reduced in those treated with IL-12/23 inhibitors (OR 0.70, CI 0.52-0.95, p=0.01) and TNF inhibitors (OR 0.84, CI 0.72-0.97, p=0.01). There were no significant differences in rates of DVT, PE or VTE for those treated with integrin antagonists and immunomodulators.

Discussion: The risk of VTE is significantly reduced in patients with CD treated with IL-12/23 inhibitors and TNF inhibitors. This supports the concept that control of inflammation reduces the VTE risk and that biologics and immunomodulators are not associated with DVT and PE.


Disclosures:


Maurice Facey, MD¹, Akash Khurana, MD², Syed Adil, MD¹, Ahmed Nadeem, MD³, Scott Martin, PhD¹, Preetika Sinh, MD⁴, Jeffry Katz, MD⁵, Vu Nguyen, MD⁵, Gregory Cooper, MD⁵, Miguel Regueiro, MD⁶, Emad Mansoor, MD⁷. P2161 - Long Term Risk of Venous Thromboembolism in Patients With Crohn's Disease Treated With Biologics or Immunomodulators, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.