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Outcome Monitoring Following Guselkumab Use: A Signal Identification and Self-Controlled Risk Interval Analysis

    Basic Details
    Date Posted
    Status
    In progress
    Medical Product
    guselkumab
    Description

    This analysis performed signal identification for guselkumab by monitoring non-pregnancy and non-cancer outcomes among new users of guselkumab in the Sentinel Distributed Database (SDD). 

    We conducted this signal identification (SI) assessment using a self-controlled risk interval design to identify incident outcomes and temporal clusters of incident outcomes following initiation of treatment with guselkumab in Tree-Only Scan and Tree-Temporal Scan analyses.

    We distributed this request to 13 Sentinel Data Partners on September 10, 2024. The study period included data from July 13, 2017 through the latest available data, i.e., April 30, 2024.

    This is a supplemental analysis to the active comparator analysis, which used an active comparator study design with guselkumab as the exposure of interest and risankizumab as the active comparator.

    Statistical alerts generated by this analysis do not on their own represent safety signals. Alerts are triaged in consideration of the study design, existing drug knowledge, therapeutic context, treated population, and potential public health impact. Alerts determined to be newly identified safety signals (NISS) follow the FDA’s Center for Drug Evaluation and Research manual of policies and procedures for NISS (MAPP 4121.3).

    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
    July 13, 2017 through the latest available data, i.e., April 30, 2024
    Analysis Type
    Signal Identification
    Population / Cohort
    Individuals aged 18 years or older without evidence of pregnancy or cancer
    Data Sources
    Sentinel Distributed Database (SDD)