Efficacy of etrasimod at Week 52 among patients with clinical response at Week 12 compared with the overall ulcerative colitis population: post hoc analysis of the phase 3 ELEVATE UC 52 trial
Bibliographic record
Abstract
Introduction Etrasimod is an investigational, oral, once-daily, selective sphingosine 1-phosphate (S1P) 1,4,5 receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC). The phase 3 ELEVATE UC 52 trial (NCT03945188) comprised a 12-week (wk) induction period followed by a 40-wk maintenance period with a treat-through design (maintenance efficacy evaluated in all patients [pts] randomised from baseline), [ 1 ] in contrast with UC clinical trials using responder re-randomisation designs (maintenance efficacy only evaluated in pts with clinical response at induction period end).[ 2 ] Objectives This post hoc analysis reports efficacy at Wk52 in pts with clinical response at Wk12 (end of induction period) vs the overall population (including Wk12 non-responders). Methodology Here, pts with UC aged 16–80 years were randomised 2:1 to etrasimod 2 mg once daily or placebo (PBO). Achievement of clinical remission, clinical response, symptomatic remission, endoscopic improvement, corticosteroid-free clinical remission and endoscopic improvement-histologic remission at Wk52 was assessed in pts with baseline modified Mayo score (MMS) 5–9 who met clinical response criteria (≥2-point &≥30% decrease from baseline MMS &≥1-point decrease from baseline rectal bleeding subscore [RBS] or absolute RBS≤1) at Wk12. Results This analysis included 409 pts (etrasimod, n=274; PBO, n=135). At Wk12, 171/274 [62.4%] and 46/135 [34.1%] pts had clinical response with etrasimod and PBO, respectively (percentage difference [Δ]=28.3%; p <0.001). In this subgroup, a larger proportion of pts achieved clinical remission at Wk52 with etrasimod vs PBO (49.1% [n=84/171] vs 17.4% [n=8/46]; Δ=31.9%; p <0.001; [ Fig. 1 ]). Higher proportions of Wk12 clinical responders receiving etrasimod or PBO achieved clinical remission vs the overall population, with a numerically larger treatment effect (Wk52, Δ=31.9% vs Δ=25.4%; [ Fig. 1 ]). Generally similar results were observed for other efficacy endpoints at Wk52 ([ Figs. 1 ] [ 2 ]). Abb. 1 Abb. 2 Conclusion Among pts in ELEVATE UC 52 with Wk12 clinical response, proportions of pts receiving etrasimod or PBO achieving Wk52 efficacy outcomes were greater vs the overall population. These results help contextualise ELEVATE UC 52 efficacy results when considering other treatments that used responder re-randomisation designs. Publication History Article published online: 28 August 2023 © 2023. Thieme. All rights reserved. Georg Thieme Verlag Rüdigerstraße 14, 70469 Stuttgart, Germany
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.008 | 0.005 |
| Meta-epidemiology (narrow) | 0.002 | 0.000 |
| Meta-epidemiology (broad) | 0.004 | 0.004 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".