Etrasimod Corticosteroid-Free Efficacy, Impact of Concomitant Corticosteroids on Efficacy and Safety, and Corticosteroid-Sparing Effect in Ulcerative Colitis: Analyses of the ELEVATE UC Clinical Program.

BACKGROUND

Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). This post hoc analysis reports the efficacy and safety of etrasimod based on baseline corticosteroid (CS) use in the ELEVATE UC clinical program.

METHODS

Patients with UC received etrasimod 2 mg or placebo for up to 52 weeks. CS use was permitted; tapering was recommended from Week 12. Efficacy was assessed at Weeks 12 and 52 in ELEVATE UC 52, and Week 12 in ELEVATE UC 12, for patients in the CS and no-CS subgroups. CS-free efficacy at Week 52 was assessed in patients with baseline CS use.

RESULTS

In ELEVATE UC 52 and ELEVATE UC 12, 93 of 289 (32.2%) and 65 of 238 (27.3%) patients receiving etrasimod and 42 of 144 (29.2%) and 34 of 116 (29.3%) patients receiving placebo, respectively, had concomitant CS use at baseline. In the CS and no-CS subgroups, higher proportions of patients who received etrasimod vs placebo achieved clinical remission (p < 0.05) in ELEVATE UC 52 at Week 12 (CS: 32.3% vs 16.7%; no-CS: 26.0% vs 4.9%) and Week 52 (CS: 31.2% vs 9.5%; no-CS: 33.2% vs 6.9%). In the CS subgroup, significantly more patients receiving etrasimod achieved CS-free clinical remission at Week 52 (31.2% vs 7.1%) compared with those receiving placebo. No increases in infection rates were observed with baseline CS use. Safety was comparable between subgroups.

CONCLUSIONS

Etrasimod demonstrated efficacy in inducing and maintaining remission in both subgroups. CS-free remission was achieved in the CS subgroup. Safety was consistent, with no increase in infections.

CLINICAL TRIAL IDENTIFIERS

NCT03945188; NCT03996369.