Immunomodulators, Biologics, and 5-ASA for Inflammatory Bowel Disease and Major Adverse Cardiovascular Events in...

Patients with inflammatory bowel disease (IBD) are at increased risk of major adverse cardiovascular events (MACE), driven by chronic inflammation, endothelial dysfunction, and use of certain therapeutic regimens. Whether different IBD treatments mitigate this risk remains unclear.

To examine the association of the use of immunomodulators or biologics vs 5-aminosalicylic acid (5-ASA) with risk of MACE among older patients with IBD.

This comparative effectiveness study was conducted among a 15% Medicare claims sample of patients with IBD aged 65 years or older was identified, with entry defined by the first prescription of immunomodulators, biologics, or 5-ASA between January 1, 2012, and December 31, 2020. Follow-up extended to the outcome, switch or discontinuation of study drug, the study's administrative end, or up to 3 years, whichever occurred first. Propensity score matching at a 1:3 ratio balanced demographics, comorbidities, and medication use between groups. Data analyses were conducted between January and September 2025.

Exposures were use of immunomodulators or biologics compared with 5-ASA, identified using National Drug Codes and Healthcare Common Procedure Coding System procedure codes.

The primary outcome was time to the first emergency department or inpatient visit caused by a MACE, defined as myocardial infarction, stroke, or all-cause mortality. Hazard ratios (HRs) and 95% CIs for MACE risk with immunomodulators or biologics vs 5-ASA were estimated using Cox proportional hazards models.

A total of 16 387 patients (mean [SD] age, 74.73 [6.79] years; 9861 [60.18%] female) were included in the analysis. In the immunomodulators vs 5-ASA and biologics vs 5-ASA cohort, the mean (SD) ages were 74.05 (6.43) years and 73.68 (6.01) years, respectively, after matching. Both cohorts had more female participants (2580 [58.85%] and 1780 [58.09%], respectively). Baseline comorbidities were mostly balanced between groups. Compared with 5-ASA, there was no statistically significant difference in the risk of MACE for immunomodulators (HR, 0.84 [95% CI, 0.61-1.17]) or biologics (HR, 0.86 [95% CI, 0.59-1.24]), although point estimates were below 1.

In this comparative effectiveness study of Medicare beneficiaries with IBD, there was no statistically significant difference in MACE risk between those who used immunomodulators or biologics vs 5-ASA.