Biologics, small molecules do not increase risk for major cardiac events, VTE in IBD
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Key takeaways:
- IBD patients on biologics had a lower risk for major cardiac events and venous thromboembolism vs. those not on biologics.
- Oral small molecules did not increase risk for cardiovascular events and VTE.
VANCOUVER, British Columbia — Patients with inflammatory bowel disease treated with biologics had lower risk for cardiovascular and thromboembolic events, and those on oral small molecules were not at increased risk, a presenter noted here.
“Patients with inflammatory bowel disease are known to have an increase in major adverse cardiovascular events such as coronary artery disease, myocardial infarction and stroke,” Miguel Regueiro, MD, chief of the Digestive Disease Institute at Cleveland Clinic, said during his presentation at the ACG Annual Scientific Meeting. “Similarly, we all know that patients with Crohn’s and ulcerative colitis, specifically, are at increased risk for [venous thromboembolism (VTE)] such as deep vein thrombosis and pulmonary embolism.”
He continued, “The reasons for this are not entirely clear, but it’s thought that chronic inflammation may affect endothelial dysfunction, and we certainly see this in our ulcerative colitis patients admitted to the hospital who have higher rates of VTE.”
Although effective in treating IBD, certain biologic and small-molecule therapies have been implicated in increasing the risk for major adverse cardiovascular events (MACE) and VTE. Seeking to investigate the rates of these conditions in IBD patients on advanced therapies, Regueiro and colleagues used the TriNetx multi-institutional database from January 2021 to June 2023 to identify adults on the biologics infliximab, adalimumab, golimumab, certolizumab, vedolizumab, natalizumab or ustekinumab (n = 67,607) or oral small molecule therapies tofacitinib, upadacitinib or ozanimod (n = 3,194).
Researchers compared them with IBD patients who did not receive these treatments and performed propensity-score matching for age, race, sex, cardiovascular risk factors and non-advanced therapy medications, including immunomodulators, 5-ASAs and steroids.
To determine causality, researchers waited at least 30 days after initiation of treatment to assess MACE and VTE.
According to results, patients on biologics had a lower risk for coronary artery disease (CAD; adjusted OR = 0.691; 95% CI, 0.66-0.724), myocardial infarction (MI; aOR = 0.662; 95% CI, 0.608-0.721), stroke (aOR = 0.71; 95% CI, 0.65e-0.771) and VTE (aOR = 0.848; 95% CI, 0.806-0.891).
“The adjusted odds ratio actually showed a decreased rate of MACE and VTE in the patients treated with biologics compared to those not on biologics,” Regueiro said. “Some of this may be driven by the fact that we’re decreasing inflammation, which may decrease VTE and MACE, but this study was not prepared to make that evaluation.”
Additionally, those who received small molecules did not have increased risk for CAD (aOR = 1.046; 95% CI, 0.823-1.328), MI (aOR = 1.039; 95% CI, 0.605-1.784), stroke (aOR = 0.868; 95% CI, 0.567-1.33) or VTE (aOR = 1.073; 95% CI, 0.827-1.392).
However, Regueiro noted the adjusted odds ratio did not demonstrate a significant difference in MACE or VTE between patients on small molecules and those not on the therapy.
“These data are consistent with some of the emerging long-term extension data from IBD clinical trials,” Regueiro said. “For those who treat and practice in inflammatory bowel disease, I think these data continue to support and affirm and, hopefully, comfort us that we are not at least seeing higher rates of DVT, PE and MACE.”
He added, “The main question that may be asked is, will the FDA change in any way the current indication, which requires a [tumor necrosis factor] before upadacitinib or tofacitinib. That remains to be seen.”
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Regueiro M, et al. Biologic and small molecule therapies are not associated with increased major adverse cardiovascular events (MACE) or VTE in IBD: A propensity matched cohort study. Presented at: ACG Annual Scientific Meeting; Oct. 20-25, 2023; Vancouver, British Columbia (hybrid meeting).
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