OP09 Histological remission and mucosal healing in a randomised, placebo-controlled, Phase 2 study of etrasimod in patients with moderately to severely active ulcerative colitis
Bibliographic record
Abstract
Etrasimod (APD334), an oral, selective sphingosine-1-phosphate receptor modulator, was evaluated in the randomised, double-blind, placebo-controlled, parallel-group, Phase 2 OASIS study (ClinicalTrials.gov identifier: NCT02447302) in patients with moderately to severely active ulcerative colitis (UC). Etrasimod demonstrated dose-dependent improvements in clinical response, clinical remission, and endoscopic appearance and decreased circulating lymphocytes. Here, we describe histological remission and mucosal healing results at Week 12. Patients were randomised to receive once-daily etrasimod 1 mg (n = 52) or 2 mg (n = 50), with no dose titration, or placebo (n = 54). At baseline and Week 12, endoscopic severity was assessed by sigmoidoscopy with central readings using the Mayo endoscopic subscore. Biopsies were taken, and histology results were scored by a blinded central pathologist using the Geboes index. Prespecified endpoint definitions were endoscopic improvement (Mayo endoscopic subscore of 0 or 1); histological improvement (Geboes score <3.1); and histological remission (Geboes score <2.0). Mucosal healing (a post hoc analysis) was defined as both endoscopic improvement and histological remission. Differences between groups were estimated using the Mantel–Haenszel analysis adjusted for current corticosteroid use at baseline and prior anti-tumour necrosis factor α use. Of 156 patients randomised, 90% completed the study. Etrasimod 2 mg, compared with placebo, resulted in significantly more patients who achieved endoscopic improvement (43.2% vs. 16.3%, respectively; p = 0.003), histological improvement (31.7% vs. 10.2%; p = 0.006), and histological remission (19.5% vs. 6.1%; p = 0.027) at Week 12 (Table). Mucosal healing was seen in 19.5% and 4.1% of patients treated with etrasimod 2 mg and placebo, respectively (p = 0.010). More patients receiving etrasimod 1 mg also achieved each endpoint compared with placebo; however, results did not reach statistical significance. Etrasimod 2 mg induced significantly higher rates of endoscopic improvement, histological improvement and remission, and mucosal healing in patients with moderately to severely active UC when compared with placebo. Mucosal healing may prove to be an achievable and objective measure of drug efficacy in UC induction studies. Abstract OP09 – Table. Endoscopic, histological, mucosal measures at Week 12.
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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) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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".