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Stelara (Ustekinumab) & Serious Infection

    Basic Details
    Status
    Ongoing
    Last Updated
    Friday, June 20, 2025
    Original Posting Date
    Health Outcome(s)
    serious infection (Crohn’s disease)
    serious infection (ulcerative colitis)
    Purpose
    Drug and Outcome Analysis
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Yes
    Study Summary

    The U.S. Food and Drug Administration (FDA) initiated this study in the Sentinel System to assess the risk of serious infection in patients with Crohn’s disease (CD) or ulcerative colitis (UC) during the use of ustekinumab (Stelara). The study was prompted by uncertainties that arose during the drug’s review regarding the magnitude or nature of risk posed by ustekinumab on immune function, as well as limited information available from clinical trials at the time. The primary goal of this analysis was to exclude two-fold or greater risk of serious infection in adult CD patients using ustekinumab when compared to adult CD patients using a biologic treatment other than ustekinumab.

    Sentinel estimated incidence at 44.1 and 51.6 patients with at least one serious infection or COVID-19 event per 1,000 patient-years of treatment with ustekinumab and comparator biologic, respectively. Sentinel estimated risk with hazard ratio (HR) 0.88 and 95% confidence interval (CI) 0.80-0.96. Based on these results, FDA determined that the safety information in ustekinumab labeling related to the risk of serious infection in patients with CD was adequate.

    FDA continues to evaluate the risk of serious infection in patients with UC following use of ustekinumab. Updates will be provided as information becomes available.