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Serious Infection Following Ustekinumab Use in Patients with Ulcerative Colitis: An Inverse Probability of Treatment Weighting Analysis

Basic Details
Date Posted
Status
In progress
Medical Product
ustekinumab
Health Outcome(s)
serious infection
Description

This analysis estimated the risk of serious infection in patients with ulcerative colitis treated with ustekinumab compared to patients with ulcerative colitis treated with non-ustekinumab biologics (i.e., infliximab, adalimumab, and vedolizumab) in the Sentinel Distributed Database (SDD). The study period includes data from November 1, 2019 to May 31, 2025. We distributed this request to six Sentinel Data Partners on January 6, 2026.

The analytic packages 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.

Deliverables (1)
Sentinel Analytic Package: Serious Infection Following Ustekinumab Use in Patients with Ulcerative Colitis: An Inverse Probability of Treatment Weighting Analysis
Additional Details
FDA Center
CDER
Time Period
November 1, 2019 – May 31, 2025
Analysis Type
Retrospective Inferential
Population / Cohort
Individuals 18 years of age and older with ulcerative colitis
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Study: Stelara (Ustekinumab) & Serious Infection
Serious Infection Algorithm Defined in "Serious Infection Following Ustekinumab Use in Patients with Ulcerative Colitis: An Inverse Probability of Treatment Weighting Analysis"