Skip to main content

Skyrizi (Risankizumab-Rzaa) & Signal Identification

    Basic Details
    Status
    Complete
    Last Updated
    Tuesday, August 26, 2025
    Original Posting Date
    Health Outcome(s)
    signal identification
    Purpose
    Signal Identification
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    No
    Study Summary

    Risankizumab-rzaa is a monoclonal antibody and interleukin-23 inhibitor, currently approved for the treatment of adult patients with moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis. The FDA initiated two studies in Sentinel using tree-based scan statistics to support safety signal identification for risankizumab-rzaa. A self-controlled risk interval study and an active comparator study using another interleukin-23 inhibitor, guselkumab, as the comparator product were conducted.

    The goal of the studies was to monitor non-pregnancy and non-cancer outcomes among new users of risankizumab-rzaa. After evaluating the statistical alerts generated by this study in the context of other information, the FDA did not identify any new safety concerns and determined no further evaluation or action is warranted at this time. Statistical 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). Overall, the studies did not identify any new safety concerns for risankizumab-rzaa in this sample of real-world adult patients.