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Serious Infection Following Ustekinumab Use in Patients with Crohn’s Disease: An Inverse Probability of Treatment Weighting Analysis

    Basic Details
    Date Posted
    In progress
    Medical Product
    Health Outcome(s)
    serious infection

    This analysis estimated the risk of serious infection in patients with Crohn’s disease treated with ustekinumab compared to patients with Crohn’s disease treated with non-ustekinumab biologics (i.e., infliximab, adalimumab, and vedolizumab) in the Sentinel Distributed Database (SDD). The study period includes data from October 1, 2016 to June 30, 2023.

    This analysis consists of two parts, Part 1 (v01) and 2 (v03), where Part 2 (v03) represents the final analysis for this study. This analysis includes updates to the selection and censoring criteria for the non-ustekinumab biologics group compared to the original report (Part 1 [v01]). The v01 analytic package was distributed to six Sentinel Data Partners on December 18, 2023. The v03 analytic package was distributed on April 22, 2024 but was run on the dataset retained from v01.

    The analytic packages associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

    Additional Details
    FDA Center
    Time Period
    October 1, 2016 – June 30, 2023
    Analysis Type
    Retrospective Inferential
    Population / Cohort
    Individuals 18 years of age and older with Crohn’s disease
    Data Sources
    Sentinel Distributed Database (SDD)