Stelara-Associated Acute Coronary Syndrome, Stroke, and Unstable Angina Seen in Recent Stelara French Medical Study
Stelara (ustekinumab) was approved by the FDA in 2009, initially for Crohn's disease and psoriatic arthritis, then ulcerative colitis in October 2019 and psoriasis in July 2020. Now, despite these recent additional treatment indications, there is an emerging drug safety issue for Stelara. In particular, 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)].
Design, Setting, and Participants: This case-time-control study used data from the French national health insurance database, covering 66 million individuals, on all patients exposed to [Stelara (ustekinumab)] between April 1, 2010, and December 31, 2016, classified according to their cardiovascular risk level (high- and low-risk strata). The risk period was the 6 months before the SCE, defined as acute coronary syndrome or stroke, and the reference period was the 6 months before the risk period....
Results: Of the 9290 patients exposed to [Stelara (ustekinumab)] (4847 men [52%]; mean [SD] age, 43  years), 179 experienced SCEs (65 cases of acute coronary syndrome, 68 cases of unstable angina, and 46 cases of stroke). Among patients with a high cardiovascular risk, a statistically significant association between initiation of [Stelara (ustekinumab)] treatment and SCE occurrence was identified (odds ratio, 4.17; 95% CI, 1.19-14.59). Conversely, no statistically significant association was found among patients with a low cardiovascular risk (odds ratio, 0.30; 95% CI, 0.03-3.13).
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.
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Some commentary about this emerging 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":
Offering a U.S. clinician's perspective on the French study, Anthony Fernandez, MD, PhD, director of medical dermatology at the Cleveland Clinic, called the findings "unique and interesting with very robust odds ratios. These posttreatment associations have actually been a big area of research over the past decade but not with such defined time periods."
No significant increases in risk have been seen with other biologics, Dr. Fernandez added, 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."...
... "The data certainly support the need for further research in this area," he said in an interview, "and in the meantime this paper will probably make me extra cautious in using [Stelara (ustekinumab)] in those at significant risk."
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 emerging 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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