Ustekinumab May Be Associated With SCE in High Cardiovascular Risk Patients

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The association of ustekinumab therapy initiation and increased risk for severe cardiovascular events was assessed.

Ustekinumab treatment may incite severe cardiovascular events (SCEs) in patients with high cardiovascular risk, according to study results published in JAMA Dermatology.

Studies have shown a potential risk for SCEs within the first few months after initiating anti-IL-12/23p40 antibody treatment, but the association of ustekinumab and SCE occurrence has not yet been determined. To evaluate whether the initiation of ustekinumab treatment is associated with an increased risk for SCEs, French national health insurance data from 9290 patients (48% women) were analyzed. Patients who had at least 1 reimbursement for ustekinumab were included. SCEs that occurred 2 or more years after the patient’s most recent SCE were considered.

A total of 98 patients (37% women) experienced an SCE that resulted in admission to the intensive care unit (odds ratio [OR], 2.41; 95% CI, 0.83-7.01). A significantly increased risk for SCE in the first 6 months after ustekinumab initiation was observed for those with high cardiovascular risk (OR, 4.17; 95% CI, 1.19-14.59). Patients with 2 or more cardiovascular risk factors or a history of SCE were considered high risk.

Limitations to this study include the inability to include mortality outside the hospital due to lack of data. In addition, cardiovascular risk factors are often underreported in hospital discharge coding and therefore may not be accurately represented in this study.

The results of this study indicated to the investigators that patients considered at high cardiovascular risk were significantly more likely to experience acute coronary syndrome or stroke within the first 6 months of ustekinumab treatment initiation. The cardiovascular health of a patient may be important to take into account when considering ustekinumab treatment.

Disclosure: Several of the study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures. 


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. [published online September 9, 2020]. JAMA Dermatol. doi:10.1001/jamadermatol.2020.2977