Lymphoma Risk following Guselkumab, Risankizumab, or Tildrakizumab Use: A Descriptive Analysis

    Basic Details
    Date Posted
    Tuesday, March 30, 2021
    Status
    Complete
    Medical Product
    guselkumab
    risankizumab
    tildrakizumab
    Health Outcome(s)
    lymphoma
    Description

    In this report we examined total available follow-up time of patients exposed to guselkumab, risankizumab, or tildrakizumab in the Sentinel Distributed Database (SDD). This is the first report of an ongoing plan to monitor uptake of these drugs until sufficient follow-up time accrues among treated patients to conduct a 1:1 propensity-score-matched analysis for non-Hodgkin lymphoma (NHL) in this cohort. We distributed this request to 16 Sentinel Data Partners on July 6, 2020. The study period included data from July 13, 2017 through December 31, 2019.

    Additional Details
    FDA Center
    CDER
    Time Period
    July 13, 2017 - December 31, 2019
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    Individuals 18 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)