Skip to main content

Outcome Monitoring Following Dupilumab Use: A Signal Identification Analysis

    Basic Details
    Date Posted
    In progress
    Medical Product

    This analysis performed signal identification for dupilumab by monitoring for the occurrence of incident non-pregnancy and non-cancer health outcomes and associated temporal clusters among new episodes of dupilumab use in the Sentinel Distributed Database (SDD).

    The cohort selection period is from March 1, 2017 to June 30, 2023. We distributed this request to 14 Sentinel Data Partners on December 22, 2023.

    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
    Time Period
    March 1, 2017 – June 30, 2023
    Analysis Type
    Signal Identification
    Population / Cohort
    Individuals 12 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)