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Serious Infection Following Ustekinumab Use in Patients with Crohn’s Disease or Ulcerative Colitis: A Descriptive Analysis

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    ustekinumab
    Health Outcome(s)
    serious infection (Crohn’s disease)
    serious infection (ulcerative colitis)
    Description

    In this report, we identified patients with Crohn’s disease or ulcerative colitis in the Sentinel Distributed Database and examined their uptake of ustekinumab, as well as rates of serious infection among patients using comparator treatments (infliximab, adalimumab, or vedolizumab). This is the first report of an ongoing plan to monitor uptake of ustekinumab until sufficient treated person-time accrues to conduct propensity-score-matched analyses of patients with either Crohn’s disease or ulcerative colitis, comparing rates of serious infection among patients initiating ustekinumab to rates among patients initiating comparator treatments.

    The study period includes data from October 1, 2016 to March 31, 2020. We distributed this request to seven Sentinel Data Partners on April 9, 2021.

    Additional Details
    FDA Center
    CDER
    Time Period
    October 1, 2016 - March 31, 2020
    Analysis Type
    Descriptive
    Population / Cohort
    Individuals 18 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)