Stelara, Entyvio have ‘comparable’ cardiovascular safety profiles in older adults with IBD
Key takeaways:
- No significant differences were observed between Stelara and Entyvio in the 3-year risk for a composite of major adverse cardiovascular events.
- Stelara was linked with lower risk for all-cause mortality.
SAN FRANCISCO — Although Stelara and Entyvio demonstrated similar cardiovascular safety profiles among older patients with inflammatory bowel disease, Stelara was associated with reduced all-cause mortality risk over 3 years, data showed.
“There are several studies indicating that incidence and prevalence of IBD, along with associated health care codes, is rising more rapidly in older adults than in younger individuals,” Emily Shu-Yen Chan, MD, MSc, an internal medicine resident at Louis A. Weiss Memorial Hospital in Chicago, said at Crohn’s & Colitis Congress. “However, despite this trend, there is a lack of evidence-based guidelines specifically tailored to older adults who make up less than 5% in most IBD trials.
“Furthermore, older adults with IBD often experienced high rates of hospitalizations, serious infections and cardiovascular complications due to aging and chronic inflammation,” she added.
In a population-based cohort study, Chan and colleagues used deidentified electronic health record data from TriNetX to compare the risk for major adverse cardiovascular events among patients with IBD aged 50 years and older treated with Stelara (ustekinumab, Janssen) vs. Entyvio (vedolizumab, Takeda Pharmaceuticals).
The researchers enrolled 2,286 ustekinumab-treated patients with ulcerative colitis, who were propensity-score matched 1:1 with vedolizumab-treated patients with UC, as well as 3,862 ustekinumab-treated patients with Crohn’s disease, who were similarly matched with vedolizumab-treated patients with CD.
The primary outcome was a composite of major adverse cardiovascular events (MACE), including ischemic and hemorrhagic stroke, acute myocardial infarction, non-ST elevated myocardial infarction, unstable angina and cardiac revascularization procedures. Secondary outcomes included venous thromboembolism (VTE), acute heart failure exacerbation and all-cause mortality.
After 3 years of follow-up, both CD and UC patients treated with ustekinumab had a lower cumulative risk for all-cause mortality than those treated with vedolizumab (CD: 112 vs. 150 events; adjusted HR = 0.77; 95% CI, 0.603-0.983 and UC: 56 vs. 113 events; aHR = 0.536; 95% CI, 0.389-0.738).
Among only UC patients, treatment with ustekinumab also was associated with reduced risk for cardiac revascularization procedures (66 vs. 99 events; aHR = 0.703; 95% CI, 0.515-0.961) and VTE (97 vs. 133 events; aHR = 0.769; 95% CI, 0.592-0.999).
Between ustekinumab and vedolizumab groups, there was no significant difference in the risk for a composite of MACE (CD: 407 vs. 449 events; aHR = 0.919; 95% CI, 0.803-1.05 and UC: 235 vs. 278 events; aHR = 0.884; 95% CI, 0.743-1.052).
“While ustekinumab and vedolizumab have comparable cardiovascular safety profiles in terms of MACE, ustekinumab may offer additional benefits in reducing mortality risk in both UC and CD patients and also in lowering VTE risk in UC patients over 3-year follow up,” Chan said. “Clinicians should consider cardiovascular risk when prescribing biologics.”
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Chan ESY, et al. Comparative risk of major adverse cardiovascular events with vedolizumab vs. ustekinumab in older adults with inflammatory bowel disease: A propensity-matched cohort analysis. Presented at: Crohn’s & Colitis Congress; Feb. 6-8, 2025; San Francisco.
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