There is a new drug safety issue for Stelara. This time it is that Stelara-associated cardiovascular events were reported in a French medical study which, in turn, has resulted in some concern about the safety of Stelara.
The Stelara French study results were outlined in this medical journal article, “Association Between Early Severe Cardiovascular Events and the Initiation of Treatment With the Anti–Interleukin 12/23p40 Antibody Ustekinumab”, published online September 9, 2020, by JAMA Dermatology. From the Abstract from this article:
- Objective: To assess whether the initiation of [Stelara (ustekinumab)] treatment is associated with increased risk of [severe cardiovascular events (SCEs)].
- Conclusions and Relevance: This study suggests that the initiation of [Stelara (ustekinumab)] treatment may trigger SCEs among patients at high cardiovascular risk…. Although the study interpretation is limited by its observational design, these results suggest that caution may be needed in the prescription of [Stelara (ustekinumab)] to patients at high cardiovascular risk.
Some commentary about this new drug safety issue for Stelara can be found in a September 18, 2020, Medscape article, “Study Results Suggest Ustekinumab May Trigger Acute CV Events Early in Treatment”:
No significant increases in risk have been seen with other biologics, [according to Anthony Fernandez, MD, PhD, director of medical dermatology at the Cleveland Clinic], with the exception of briakinumab [(a human monoclonal antibody which is not FDA-approved)]. “But still, the current study does not definitively answer the question whether [Stelara (ustekinumab)] can trigger acute events within 6 months of treatment. There’s smoke, but we haven’t clearly seen a fire.”…
We point out that other medical experts who commented about this French medical study showing Stelara-associated cardiovascular events for the Medscape article were skeptical about the study’s findings and less concerned as regards the safety of Stelara.
Of course, we will continue to monitor this new drug safety issue for Stelara, watching for further medical research about Stelara-associated cardiovascular events and any regulatory actions related to the safety of Stelara.
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