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
Bibliographic record
Abstract
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.
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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 | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".