Abstract Body (Do not enter title and authors here): Background
Patients with IBD exhibit elevated risk of cardiovascular and cerebrovascular events. While anti-inflammatory medications such as 5-amiosalicylic acids (5-ASA) and TNF-α antagonists are associated with reduced ischemic heart disease (IHD) risk, recent concerns about newer drugs like tofacitinib have been raised by the FDA. This study evaluates the cardiovascular and cerebrovascular risks associated with newer agents including tofacitinib, vedolizumab, ozanimod, and ustekinumab.
Goals
To assess and compare the risks of IHD, acute myocardial infarction (AMI), and cerebrovascular accidents/transient ischemic attacks (CVA/TIA) among patients treated with newer IBD agents versus those treated with traditional TNF-α antagonists.
Methods
This retrospective cohort study utilized the TriNetX network comprising over 60 health care organizations in the US. Eligible patients were those aged over 15, diagnosed with IBD following the FDA approval dates for each studied newer agents (tofacitinib, vedolizumab, ozanimod, and ustekinumab). We excluded patients with prior diagnoses of IHD, AMI, CVA/TIA, cardiomyopathies, heart failure, atrial fibrillation, or cerebral insults. A 1:1 propensity score-matching (PSM) method was employed to adjust for baseline characteristics. We matched IBD patients using all newer agents individually to IBD patients using TNF-α antagonists (Etanercept, Adalimumab, or Infliximab). Cox proportional hazard regressions were applied to compute the hazard ratios (HR) and 95% confidence intervals (CI) for IHD, AMI, and CVA/TIA events. Patients were followed-up until June 4, 2024 or the development of events, whichever came first.
Results
Patients treated with tofacitinib, vedolizumab, and ozanimod showed no significant increased risk of IHD, AMI, or CVA/TIA compared to TNF-α antagonist users. Notably, ustekinumab users demonstrated a decreased risk for these events. Detailed data were shown in Table 1.
Conclusion
Newer medications such as tofacitinib, ozanimod, and vedolizumab do not increase cardiovascular or cerebrovascular risks in IBD patients. Ustekinumab may offer protective benefits against such risks, indicating its potential utility in managing elevated cardiovascular risks among these patients.