Stelara safe in older in patients with IBD
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In older patients with inflammatory bowel disease, adverse event rates were comparable between those treated with Stelara and those who received placebo, according to a recent analysis.
“All of us who take care of patients with IBD are taking care of patients who are getting older and we are confronted with having to make choices of different medications, including biologic therapy, in these patients with quite little data from clinical trials,” Maria T. Abreu, MD, from the Crohn’s and Colitis Center at the University of Miami Miller School of Medicine, said during a poster presentation at the ACG Annual Scientific Meeting.
To gain insight into this issue, Abreu and colleagues evaluated adverse event rates for patients aged 60 years or older in a pooled analysis of data from all phase 2 and 3 trials of Stelara (ustekinumab, Janssen) available for patients with Crohn’s disease, ulcerative colitis and psoriatic diseases.
Despite having more comorbidities than their younger counterparts, patients older than 60 years had rates of adverse events on ustekinumab that were similar to those younger than 60 years, according to the data. Additionally, patients who received placebo vs. ustekinumab consistently fared somewhat worse in terms of adverse events per 100 patient-years, Abreu noted.
“That included rates of infections, including serious infections,” Abreu said. “They were similar whether patients were receiving ustekinumab or placebo and whether patients were older or younger than 60, again suggesting the safety profile, at least with respect to infections, is very good in patients with ustekinumab.”
The researchers also assessed cancer risk by analyzing the rates of cancer in patients older than 60 years in these studies of ustekinumab and compared them with age-matched patients in the Surveillance, Epidemiology and End Results database.
“Again, what was seen is that, in fact, the rates of malignancy with patients on ustekinumab were very similar to the rates of malignancy in those patients who had never received ustekinumab and were matched for age,” Abreu said. “This study is reassuring that ustekinumab has an acceptable safety profile, and we can say to patients that are older than 60 that we now have sufficient data to conclude that this is a safe medication to use in that age group.”
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Abreu MT, et al. Safety of ustekinumab in older IBD patients (≥60 years): Pooled safety analysis through 5 years in CD and 2 years in UC and all approved indications. Presented at: ACG Annual Scientific Meeting; Oct. 22-27, 2021; Las Vegas (hybrid meeting).
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