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Tremfya (Guselkumab) & Signal Identification

Basic Details
Status
Complete
Last Updated
Tuesday, June 17, 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

Guselkumab 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, or moderately to severely active ulcerative colitis. The FDA initiated two studies in Sentinel using tree-based scan statistics to support safety signal identification for guselkumab. A self-controlled risk interval study and an active comparator study using another interleukin-23 inhibitor, risankizumab-rzaa, as the comparator product were conducted. 

The goal of the studies was to monitor non-pregnancy and non-cancer outcomes among new users of guselkumab. The FDA determined the statistical alerts generated by these analyses did not warrant further evaluation or action. Overall, the studies did not identify any new safety concerns for guselkumab in this sample of real-world adult patients.     

Analytic Code Link(s) (2)
Outcome Monitoring Following Guselkumab Use: An Active Comparator Signal Identification Analysis Outcome Monitoring Following Guselkumab Use: A Self-Controlled Risk Interval Signal Identification Analysis
Result(s) (2)
Outcome Monitoring Following Guselkumab Use: An Active Comparator Signal Identification Analysis Outcome Monitoring Following Guselkumab Use: A Self-Controlled Risk Interval Signal Identification Analysis