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Interstitial Lung Disease (ILD) Rates in Patients with Inflammatory Bowel Disease (IBD) and Following IBD Advanced Therapy: A Descriptive Analysis

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    adalimumab
    certolizumab
    etrasimod
    golimumab
    infliximab
    mirikizumab
    ozanimod
    risankizumab
    tofacitinib
    upadacitinib
    ustekinumab
    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 IBD subtypes (Crohn's disease and ulcerative colitis) and among cohorts of IBD patients 1) without prior exposure to vedolizumab or natalizumab, 2) without prior exposure to vedolizumab or natalizumab but with prior exposure to other advanced IBD therapies, or 3) initiating other advanced IBD therapies in the Sentinel Distributed Database (SDD). The study period includes data from January 1, 2006 to April 30, 2023. We distributed this request to six Sentinel Data Partners on February 16, 2024.

    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)