For older adults with inflammatory bowel disease (IBD), there was no significant difference in the risk of major cardiovascular adverse events (MACE) for those taking ustekinumab (Stelara) versus vedolizumab (Entyvio), according to a propensity-matched cohort analysis.
Over a 3-year period, MACE occurred in 10.3% of patients taking ustekinumab and 12.2% of patients taking vedolizumab for those with ulcerative colitis (adjusted HR 0.88, 95% CI 0.74-1.05), and in 10.5% and 11.6%, respectively, for those with Crohn’s disease (aHR 0.92, 95% CI 0.80-1.05), reported Emily Shu-Yen Chan, MD, MSc, of the Louis A. Weiss Memorial Hospital in Chicago, during the Crohn’s and Colitis Congress.
Of note, ustekinumab was associated with a lower cumulative risk of all-cause mortality for patients with both ulcerative colitis and Crohn’s, Chan said.
Rates of all-cause mortality were 2.5% in the ustekinumab group and 4.9% in the vedolizumab group for ulcerative colitis patients (aHR 0.54, 95% CI 0.39-0.74) and 2.9% and 3.9%, respectively, in the Crohn’s group (aHR 0.77, 95% CI 0.60-0.98).
Venous thromboembolism (VTE) rates in ulcerative colitis patients were 4.2% with ustekinumab and 5.8% with vedolizumab (aHR 0.77, 95% CI 0.59-0.999), and rates of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) were also significantly different (2.9% vs 4.3%, respectively; aHR 0.70, 95% CI 0.52-0.96).
Rates of VTE, PCI, and CABG were not significantly different for Crohn’s patients.
“Our findings suggest that while ustekinumab and vedolizumab have comparable cardiovascular safety profiles in terms of MACE, ustekinumab may offer additional benefits in reducing mortality risks in both ulcerative colitis and Crohn’s disease patients and also in lowering VTE risks in ulcerative colitis patients over 3 years of follow-up,” Chan said. “Clinicians should consider cardiovascular risks when prescribing biologics.”
Though ustekinumab and vedolizumab are both recognized as having favorable safety profiles in patients with IBD, there is less evidence for their safety in older adults, who make up less than 5% of participants in IBD clinical trials, Chan noted.
“We have this vision that vedolizumab is one of our safer medicines, for good reason, but it looks like, for older adults, maybe ustekinumab might be equally safe,” Jonathan Moses, MD, of the Center for Pediatric Inflammatory Bowel Disease and Celiac Disease at Stanford Medicine Children’s Health in Palo Alto, California, told MedPage Today after attending the presentation. “These large health databases are a little messy sometimes with the confounders, but it is an interesting finding that needs to be followed up on.”
For this study, Chan’s team analyzed records from the TriNetX database, containing more than 113 million patients from 67 large healthcare organizations, for all patients ages 50 and older who took ustekinumab or vedolizumab for IBD from 2015 to 2024.
They used propensity score matching to match 2,286 patients taking ustekinumab with 2,286 patients taking vedolizumab for ulcerative colitis, and 3,862 patients taking ustekinumab to 3,862 patients taking vedolizumab for Crohn’s disease. They looked for cardiovascular events based on ICD-10 codes starting 30 days after beginning the medication through 3 years.
The primary outcome was a composite of MACE that included ischemic and hemorrhagic stroke, acute and non-ST-segment elevation myocardial infarction, unstable angina, and cardiac revascularization procedures. Secondary outcomes included VTE, acute heart failure exacerbation, and all-cause mortality.
The researchers adjusted their analyses for age, sex, race, ethnicity, comorbidities, body mass index, nicotine dependence, medication use, prior surgery (colectomy, enterectomy, and proctectomy), type of ulcerative colitis or Crohn’s disease, and labs that included inflammatory markers, lipid profiles, HbA1c, and albumin.
The study was limited by the potential for residual confounding and the lack of endoscopic or histologic data.
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Disclosures
Chan had no disclosures.
Moses reported medical advising for PSI.
Primary Source
Crohn’s and Colitis Congress
Source Reference: Chan ESY, et al “Comparative risk of major adverse cardiovascular events with ustekinumab vs vedolizumab in older adults with inflammatory bowel disease: a propensity-matched cohort analysis” CCC 2025.
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