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Interstitial Lung Disease (ILD) in Patients with Inflammatory Bowel Disease (IBD) and Following Vedolizumab or Natalizumab Initiation: A Descriptive Analysis

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    natalizumab
    vedolizumab
    Health Outcome(s)
    interstitial lung disease
    Description

    The goals of this analysis were to estimate rates of interstitial lung disease (ILD) among patients with inflammatory bowel disease (IBD) and among patients with IBD who initiated vedolizumab or natalizumab in the Sentinel Distributed Database (SDD). Patients with evidence of Crohn’s disease or ulcerative colitis were also examined as separate populations. The study period includes data from January 1, 2006 to April 30, 2023. We distributed this request to six Sentinel Data Partners on October 12, 2023.

    The analytic package 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
    CDER
    Time Period
    January 1, 2006 – April 30, 2023
    Analysis Type
    Descriptive
    Population / Cohort
    Individuals 18 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)