Etrasimod for the symptomatic relief of ulcerative colitis: a post-hoc analysis from the ELEVATE UC clinical programme.

Abstract

Objective: Bothersome ulcerative colitis (UC) symptoms include stool frequency (SF), rectal bleeding (RB), abdominal pain and bowel urgency; symptomatic relief is a key treatment goal. Etrasimod is an oral, once-daily (QD), selective sphingosine 1-phosphate_1,4,5 receptor modulator for the treatment of moderately to severely active UC. We assessed outcomes related to symptomatic relief among patients with moderately to severely active UC in the phase III ELEVATE UC clinical programme.

Methods: In both ELEVATE UC 52 and ELEVATE UC 12, adults were randomly assigned (2:1) to etrasimod 2 mg QD or placebo. Symptomatic remission, symptomatic response, complete symptomatic remission, SF and RB were evaluated at each trial visit. Bowel urgency and abdominal pain were also assessed (weeks 12 and 52).

Results: Significantly more patients receiving etrasimod were in symptomatic remission and symptomatic response at weeks 12 and 52 versus placebo (all p<0.001). Improvements from baseline in RB and SF subscores were significantly greater in those receiving etrasimod versus placebo from weeks 2 (ELEVATE UC 12) and 4 (ELEVATE UC 52). Similarly, a significantly greater number of patients in the etrasimod versus placebo group were in complete symptomatic remission. At weeks 12 and 52, the number of patients achieving clinically meaningful improvements in bowel urgency, bowel urgency remission and abdominal pain remission was significantly greater for etrasimod versus placebo (all p<0.05).

Conclusion: Etrasimod was efficacious in improving symptoms of UC from week 2; improvements were maintained through week 52.

Trial registration number: ClinicalTrials.gov: NCT03945188; NCT03996369.