Details
This analysis performed signal identification for guselkumab by monitoring non-pregnancy and non-cancer outcomes among new users of guselkumab (exposure of interest) compared to new users of risankizumab (active comparator) in the Sentinel Distributed Database (SDD). We conducted a Type 2 analysis using the Cohort Identification and Descriptive Analysis (CIDA) module, version 13.0.1, with the Propensity Score Analysis (PSA) and Signal Identification (SI) modules.
The analysis used the aggregated data for the propensity score matched analytic cohorts returned from the Data Partners (DPs) as requested in another Sentinel analysis where risankizumab was the exposure of interest and guselkumab was the active comparator.
The cohort selection included data from April 23, 2019 through September 30, 2023. We distributed this request to 13 Sentinel Data Partners on March 11, 2024.
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.