Ustekinumab may trigger severe cardiovascular events in high-risk individuals
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Treatment of psoriatic conditions or Crohn’s disease with ustekinumab was associated with severe cardiovascular events in certain high-risk patients, according to a study.
Florence Poizeau, MD, and colleagues aimed to assess whether initiation of the interleukin-12/23p40 antibody ustekinumab would lead to severe cardiovascular events in patients with moderate to severe psoriasis, psoriatic arthritis and Crohn’s disease.
The case-time-control analysis included findings for 9,290 patients culled from the French national health insurance database; all individuals were exposed to ustekinumab between April 1, 2010, and Dec. 31, 2016.
The researchers classified patients based on their cardiovascular risk profile and evaluated outcomes based on a risk period of 6 months before the severe cardiovascular event as compared with a reference period for the 6 months before that.
A severe cardiovascular event was defined as acute coronary syndrome or stroke. The patient cohort was 52% men with a mean age of 43 years.
Results showed 179 severe cardiovascular events, including 65 cases of acute coronary syndrome, 68 cases of unstable angina and 46 cases of stroke.
High and low cardiovascular risk profiles were based on age, hypertension, dyslipidemia, tobacco use, diabetes status and obesity. Among patients with high cardiovascular risk, initiation of ustekinumab carried a statistically significant association with severe cardiovascular event occurrence (OR = 4.17; 95% CI, 1.19-14.59). No such association was reported for individuals with low cardiovascular risk (OR = 0.30; 95% CI, 0.03-3.13).
“In line with the current mechanistic models for atherosclerotic disease, the period after the initiation of anti-IL-12/23p40 may be associated with atherosclerotic plaque destabilization via the inhibition of helper T cell subtype 17,” Poizeau and colleagues wrote. “Although the study interpretation is limited by its observational design, these results suggest that caution may be needed in the prescription of ustekinumab to patients at high cardiovascular risk.”