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), 3332 (UC advanced therapy), 1435 (UC trial-similar), and 160 795 (Non-UC) individuals were included. In the UC overall cohort, <11% of patients used advanced therapy. The UC overall cohort had significantly higher incidence rates (IRs) across most safety outcomes compared with the Non-UC cohort (highest: malignancy [excluding non-melanoma skin cancer] at 31.1 compared with 14.1 IRs per 1000 patient-years, respectively), regardless of age or oral corticosteroid use. Incidence rates of safety outcomes for the UC advanced therapy and UC trial-similar (also requiring prior advanced therapy use) cohorts were generally similar or lower than the UC overall cohort. The UC trial-similar and UC advanced therapy cohorts had generally comparable safety outcomes. Conclusions: These findings assist in understanding the background risks of safety events in patients with UC and suggest that the incidence of select safety outcomes is comparable between the ELEVATE UC trials and RWD.