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IL-12/23 Inhibitor May Trigger Serious CV Events in High-Risk Patients

Findings from a recent study suggested ustekinumab may trigger serious cardiovascular events (SCEs) among patients with high cardiovascular risk.

“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,” the researchers wrote.

They performed a case-time-control study using data from the French national health insurance database to assess the association between ustekinumab and SCEs. Patients exposed to ustekinumab between April 1, 2010, and December 31, 2016, were included in the analysis and stratified as either high or low cardiovascular risk. The researchers defined the risk period as 6 months before SCEs and the reference period as 6 months before the risk period, as well as calculated the odds ratios (ORs) of SCEs after initiating ustekinumab.

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Among the 9290 patients treated with ustekinumab within the study period, 179 experienced SCEs. Among SCEs, 65 cases were acute coronary syndrome, 68 cases were unstable angina, and 46 cases were stroke.

The researchers found a statistically significant association between the initiation of ustekinumab and SCEs among patients with high cardiovascular risk (OR, 4.17; 95% CI, 1.19-14.59). However, they did not find a statistically significant association among patients with low cardiovascular risk (OR, 0.30; 95% CI, 0.03-3.13).

“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,” the researchers concluded.


Poizeau F, Nowak E, Kerbrat S, et al. Association between early severe cardiovascular events and the initiation of treatment with the anti-interleukin 12/23p40 antibody ustekinumab. JAMA Dermatol. Published online September 9, 2020. doi:10.1001/jamadermatol.2020.2977

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