P209 Etrasimod improves quality of life in adults with moderate-to-severe ulcerative colitis

Introduction

Active ulcerative colitis (UC) can significantly impact quality of life (QOL). Etrasimod (ETR) is a once-daily, oral, selective sphingosine 1–phosphate receptor 1, 4, and 5 modulator that demonstrated efficacy in inducing response and remission in moderate-to-severe UC (Phase 2 OASIS trial; NCT02447302). Patients (pts) completing OASIS could enroll in an open-label extension (OLE; NCT02536404) and receive ETR 2mg for up to 34 additional weeks (wks). This post hoc analysis examined the effect of ETR on QOL in pts who participated in both OASIS/OLE.

Methods

In OASIS, adults (18-80 years) with moderate-to-severe UC (based on 3-component Mayo score) were randomized to once-daily ETR 2mg, ETR 1mg, or placebo (PBO). In OASIS/OLE, QOL was evaluated by the pt via the Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ contains 32 items across 4 dimensions (bowel/systemic symptoms; social/emotional function) with each item assessed on a 7-point scale (higher score indicates better QOL; ≥16-point improvement considered clinically meaningful). Data were collected at baseline, Wk 12, and end of treatment (EOT). Change from baseline in IBDQ score was evaluated based on randomized treatment in OASIS.

Results

109 pts were included in the Wk 12 analysis (ETR 2mg, n=30; ETR 1mg, n=38; PBO, n=41) and 107 in the EOT analysis (n=29, 38, 40, respectively). At Wk 12, the IBDQ score (mean±SD) increased by 37.2±40.4 points in the ETR 2mg group (P=0.07 vs PBO) and 30.9±34.4 points in the ETR 1mg group (P=0.63 vs PBO) vs 24.4±26.2 points in the PBO group. At EOT, the increase in IBDQ score noted in the ETR 2mg group at Wk 12 was maintained (37.8±44.9), while the IBDQ score further increased in the ETR 1mg and PBO groups once pts transitioned to ETR 2mg (40.3±43.5 and 41.7±50.3, respectively). At Wk 12, 73%, 61%, and 56% of pts in the ETR 2mg, ETR 1mg, and PBO group, respectively, achieved a clinically meaningful improvement in IBDQ score. At EOT, 71% achieved a clinically meaningful improvement.

Conclusions

These data suggest a trend toward improved QOL in adults with UC treated with ETR 2mg. Greater sample size is needed to confirm these results.