(146) Use of Immunomodulators/Biologics is protective against Major Adverse Cardiovascular Events in Medicare patients with Inflammatory Bowel Disease over use of 5-ASA alone.

Background: Emerging evidence indicates that patients with Inflammatory Bowel Disease (IBD) exhibit a higher incidence of major cardiovascular events (MACE), which may be attributed to inflammation, endothelial dysfunction, and use of certain therapeutic regimens. Immunomodulators and biologics, used in managing IBD, may play a role in modulating this risk due to their protective effect on inflammatory pathways.

Objectives: The objective of this study is to assess the MACE risk in Medicare beneficiaries diagnosed with IBD on immunomodulators or biologics in comparison to those treated with 5-aminosalicylic acid (5-ASA) alone.

Methods: We identified an IBD patient cohort from a 15% Medicare claims sample between January 1, 2011, and December 31, 2020. Cohort entry was marked by the first prescription of IM/B or 5-ASA. The primary outcome was time to MACE-related ER/inpatient visit. Follow-up extended to the occurrence of the outcome, study's administrative end, or up to 3 years, whichever came first. Propensity score matching at a 1:3 ratio was conducted to balance demographic characteristics, clinical comorbidities, and medication use between groups. Cox Proportional Hazards models estimated hazard ratios (HRs) and 95% confidence intervals (CIs) for MACE risk with IM/B versus 5-ASA use in IBD patients, adjusting for confounders. An intention-to-treat analysis approach was applied.

Results: After PS matching, the majority of baseline characteristics were balanced in their respective cohort. Yet, rheumatoid arthritis, bipolar disorder, alcohol disorder, hypertension and tobacco use were unbalanced. The analysis reveals that the use of IM/B is associated with a protective effect in reducing the risk of MACE among patients with IBD when compared to the use of 5-ASA. The adjusted hazard ratio for MACE in IM users versus 5-ASA users was 0.92 (95% CI: 0.77-1.12), and the use of B is associated with a decrease on MACE (HR: 0.71, 95% CI: 0.40-1.26).

Conclusions: This study suggests a potential protective effect of immunomodulators and/or biologics against MACE events in Medicare beneficiaries with IBD, compared to 5-aminosalicylic acid treatment. The findings highlight the importance of the timely management of inflammation management in IBD with IM/B when their use is warranted. The future study may need to better balance the disease severity.