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Utilization of Guselkumab, Risankizumab, Tildrakizumab, and Brodalumab: Second Descriptive Analysis

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    brodalumab
    guselkumab
    risankizumab
    tildrakizumab
    Description

    In this report we examined counts of individuals and total available follow-up time for users of guselkumab, risankizumab, and tildrakizumab with plaque psoriasis and users of brodalumab in the Sentinel Distributed Database (SDD). This is the second report of an ongoing plan to monitor uptake of these drugs until sufficient follow-up time accrues among treated patients. We will then conduct propensity-score-matched analyses examining non-Hodgkin lymphoma in users of guselkumab, risankizumab, and tildrakizumab versus users of a comparator drug, as well as serious infection, acute myocardial infarction and stroke, and inpatient neutropenia in users of brodalumab versus users of a comparator drug.

    • The first monitoring analysis for guselkumab, risankizumab, and tildrakizumab can be found here.
    • The first monitoring analysis for brodalumab can be found here.

    The study period includes data from February 15, 2017 to February 28, 2022. We distributed this request to six Sentinel Data Partners on August 16, 2022.

    Additional Details
    FDA Center
    CDER
    Time Period
    February 15, 2017 – February 28, 2022
    Analysis Type
    Descriptive
    Population / Cohort
    Individuals 18 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)