Efficacy and safety of etrasimod in patients with moderate to severe isolated proctitis compared with patients with more extensive disease: a subgroup analysis of the phase 3 ELEVATE UC 52 and ELEVATE UC 12 trials
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). Although approximately 30% of patients (pts) with UC present with isolated proctitis, [ 1 ] most phase 3 trials of systemic UC therapies exclude this subgroup. Objectives This post hoc analysis of pts with UC enrolled in the ELEVATE UC trials assessed the efficacy and safety of etrasimod in pts with isolated proctitis vs those with more extensive disease (proctosigmoiditis/left-sided colitis/pancolitis). Methodology In the phase 3 ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 (NCT03996369) trials, pts (aged 16–80 years) with moderately to severely active UC were randomised 2:1 to etrasimod 2 mg once daily or placebo (PBO). ELEVATE UC 52 comprised a 12-week (wk) induction period followed by a 40-wk maintenance period with a treat-through design. ELEVATE UC 12 comprised a 12-wk induction period. Both trials allowed inclusion of pts with isolated proctitis (<10 cm rectal involvement; centrally read) provided they met all other eligibility criteria. Pre-defined clinical endpoints were assessed in pts with isolated proctitis in a pooled cohort from both studies and in a subgroup of pts with more extensive disease (data from individual studies). Safety was assessed up to Wk 52. Result In ELEVATE UC 52 and ELEVATE UC 12, 289 and 238 pts received etrasimod, and 144 and 116 pts received PBO, respectively. [ 2 ] This analysis included 64 pts (etrasimod, N=42; PBO, N=22) at Wk 12 and 36 pts (etrasimod, N=27; PBO, N=9) at Wk 52 with isolated proctitis. Proportions of pts with isolated proctitis achieving clinical remission and clinical response at Wks 12 and 52, and corticosteroid-free remission at Wk 52 were generally greater in pts receiving etrasimod vs PBO ([ Fig. 1 ]). Efficacy findings were similar in pts with isolated proctitis vs those with more extensive disease ([ Fig. 1 ]). Safety in pts with isolated proctitis was similar to the overall trial population. [ 2 ] Abb. 1 Conclusion Etrasimod was effective for induction and maintenance of clinical remission in pts with UC and isolated proctitis. Efficacy and safety of etrasimod in pts with isolated proctitis were similar to those with more extensive disease in the ELEVATE UC trials. [ 2 ] 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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
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".