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Ustekinumab and Comparator Treatment Utilization and Pneumonia Outcomes in Patients with Crohn's Disease or Ulcerative Colitis: An Updated Descriptive Analysis

    Basic Details
    Date Posted
    Medical Product
    Health Outcome(s)
    pneumonia (Chron's disease)
    pneumonia (ulcerative colitis)

    In this report, we identified patients with Crohn’s disease or ulcerative colitis in the Sentinel Distributed Database (SDD) and examined their uptake of ustekinumab, as well as rates of pneumonia among patients using comparator treatments (infliximab, adalimumab, or vedolizumab). This is the second report of an ongoing plan to monitor uptake of ustekinumab until sufficient treated person-time accrues to conduct a propensity-score-matched analysis 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 February 28, 2022. We distributed this request to six Sentinel Data Partners on August 19, 2022.

    Additional Details
    FDA Center
    Time Period
    October 1, 2016 – February 28, 2022
    Analysis Type
    Population / Cohort
    Individuals 18 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)