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

Area of Science:

• Gastroenterology
• Pharmacovigilance
• Real-world evidence

Background:

• Approved therapies for ulcerative colitis (UC) include sphingosine 1-phosphate receptor modulators.
• Clinical trials may underestimate rare safety events due to non-representative populations.
• Real-world data (RWD) are crucial for a comprehensive safety assessment in UC.

Purpose of the Study:

• To investigate safety outcomes in patients with ulcerative colitis (UC) using real-world data (RWD).
• To compare safety profiles across different UC treatment cohorts and a non-UC cohort.
• To assess the generalizability of clinical trial safety findings to real-world UC populations.

Main Methods:

• Utilized Optum® de-identified Electronic Health Record data from January 2016 to December 2022.
• Analyzed four cohorts: UC overall, UC advanced therapy, UC trial-similar (ELEVATE UC criteria), and Non-UC.
• Compared incidence rates (IRs) of various safety outcomes across cohorts.

Main Results:

• Included over 32,000 UC patients and 160,000 Non-UC individuals.
• UC patients exhibited significantly higher IRs for most safety outcomes versus Non-UC individuals (e.g., malignancy).
• Safety outcomes in UC advanced therapy and UC trial-similar cohorts were generally similar to or lower than the overall UC cohort.

Conclusions:

• Findings provide insight into background safety risks in patients with UC.
• Incidence of select safety outcomes in the ELEVATE UC trials appears comparable to RWD.
• RWD complements clinical trial data for a more complete understanding of UC treatment safety.