Details
This analysis performed signal identification for guselkumab by monitoring non-pregnancy and non-cancer outcomes among new users of guselkumab in the Sentinel Distributed Database (SDD).
We conducted this signal identification (SI) assessment using a self-controlled risk interval design to identify incident outcomes and temporal clusters of incident outcomes following initiation of treatment with guselkumab in Tree-Only Scan and Tree-Temporal Scan analyses.
We distributed this request to 13 Sentinel Data Partners on September 10, 2024. The study period included data from July 13, 2017 through the latest available data, i.e., April 30, 2024.
This is a supplemental analysis to the active comparator analysis, which used an active comparator study design with guselkumab as the exposure of interest and risankizumab as the active comparator.
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.