Etrasimod Real-World Experience in Ulcerative Colitis: A multicentre cohort study

Abstract

Background: Etrasimod is a novel oral selective sphingosine 1-phosphate receptor (S1PR) modulator recommended for induction and maintenance of remission in moderate-To-severe ulcerative colitis (UC). Safety considerations include potential cardiac conduction abnormalities warranting baseline electrocardiography (ECG). In addition, ophthalmologic assessment with optical coherence tomography (OCT) is recommended within 3 months of starting treatment. Real-world evidence of its safety and effectiveness remains limited. Method(s): A retrospective observational study was conducted across six tertiary centers. All patients with UC treated with etrasimod at each centre were included. Demographic data, cardiovascular and ophthalmologic assessments, adverse events, treatment persistence, disease activity indices (SCCAI, UCEIS) and faecal calprotectin at baseline, 3 and 6 months were collected. Result(s): 193 patients were included, with a median age of 38 years (IQR 29-49.5). 19.7% of patients had proctitis, 44.6% left-sided disease, 31.6% extensive UC, 1.0% IBD-U, and 3.1% unknown. 123 (63.7%) were advanced therapy (AT)-naive. Of those exposed to AT, the median (range) number of ATs was 2 (0-9). Baseline ECG was performed in 97.4% with six (3.1%) patients requiring first dose ambulatory cardiac monitoring. OCT was completed in 115/165 (69.7%) patients within three months of starting therapy. Adverse events were reported in 30 (15.5%) patients: headache (23.3%), lymphopaenia (16.6%, lymphocyte count =6 months of follow-up. Conclusion(s): This real-world study of etrasimod demonstrated a safety and efficacy profile consistent with data from the registration studies of etrasimod in UC, supporting its role in clinical practice. Ongoing, well curated real world datasets will enhance our understanding of this novel mechanism of action further.