Safety Outcomes in Patients With Ulcerative Colitis Using a Healthcare Administrative Database in the United States.

ABSTRACT:

Introduction

Several therapies, including sphingosine 1-phosphate receptor modulators, have been approved for ulcerative colitis (UC). Safety findings should be complemented with real-world data (RWD) as rare events may be underestimated in clinical trials due to populations not fully reflecting real-world practice.

Methods

We used RWD to investigate safety outcomes in 4 cohorts: (1) those receiving any UC treatment (UC overall), (2) those receiving advanced therapies (UC advanced therapy), (3) those meeting the selection criteria of the etrasimod ELEVATE UC clinical program (UC trial-similar), (4) individuals without UC (Non-UC). Data were extracted (1/2016-12/2022) from the Optum® de-identified Electronic Health Record data set.

Results

Data from 32 170 (UC overall)

SUBMITTER: Regueiro MD 

PROVIDER: S-EPMC12558580 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature