Details
This analysis performed signal identification using a self-controlled risk interval design to identify incident outcomes and temporal clusters of incident outcomes following initiation of treatment with dupilumab in TreeScan and Tree Temporal Scan analyses. We identified all valid episodes of new use of dupilumab among those aged 12 years or older at the time of treatment initiation and screened for the occurrence of incident health outcomes of interest (HOIs) during pertinent risk and control windows.
We distributed this request to 14 Sentinel Data Partners on December 22, 2023 including 100% fee for service Medicare and All State Medicaid. This report includes data aggregated from 13 Data Partners to prevent potential overlap in Medicaid patient populations between two Data Partners for one year in the query period. The cohort selection period was from March 1, 2017 through up to June 30, 2023.
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.