Stelara shows favorable safety profile through 1-year of IBD treatment
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Data from six phase 2/3 studies showed that Stelara had a favorable safety profile through 1-year of treatment in Crohn’s disease and ulcerative colitis, according to research published in Inflammatory Bowel Diseases.
William J. Sandborn, MD, of the University of California, San Diego, and colleagues wrote that previous research — including in psoriatic disease — has demonstrated a good safety profile for the drug (ustekinumab, Janssen), but integrated analysis of combined patients with IBD, could help physicians make treatment choices.
“This increases the precision to detect safety signals compared with placebo for all events and increases identification of less frequent events,” they wrote. “Furthermore, because ustekinumab IBD indications uniquely employ intravenous induction, followed by subcutaneous maintenance dosing these integrated safety analyses of all IBD phase 2/3 studies also provide important data examining the possibility that these higher doses or the IBD population might have a different safety profile than the psoriatic diseases.”
Researchers pooled data from six ustekinumab phase 2/3 CD and UC studies and evaluated safety through 1 year. Patients received either placebo or induction and maintenance therapy with ustekinumab (n = 2,574).
Patients who received the drug had safety outcomes that were generally comparable to placebo, including number of patients with adverse events per 100 patient-years (118.32; 95% CI, 113.25-123.55 vs. 165.99; 95% CI, 155.81-176.67), serious adverse events (21.23; 95% CI, 19.12-23.51 vs. 27.5; 95% CI, 23.45-32.04), infections (64.32; 95% CI, 60.6-68.21 vs. 80.31; 95% CI, 73.28-87.84), serious infections (5.02; 95% CI, 4.02-6.19 vs. 5.53; 95% CI, 3.81-7.77), and malignancies excluding nonmelanoma skin cancer (0.4; 95% CI, 0.16-0.83 vs. 0.17; 95% CI, 0-0.93).
“This integrated analysis provides additional robust safety data for the use of ustekinumab in patients with IBD,” Sandborn and colleagues wrote. “These data are consistent with the established safety profile of ustekinumab across all approved indications and support a favorable benefit-risk profile of ustekinumab treatment in patients with IBD.”
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