DOP41 Achievement of corticosteroid-free clinical endpoints in subjects with ulcerative colitis: an analysis of the phase 3 ELEVATE UC 52 trial
Bibliographic record
Abstract
Abstract Background Achievement of corticosteroid (CS)-free remission is an important long-term outcome in ulcerative colitis (UC). Etrasimod is an investigational, once-daily, oral, selective sphingosine 1-phosphate receptor 1,4,5 (S1P1,4,5) modulator in development for the treatment of moderately to severely active UC. This analysis of the ELEVATE UC 52 trial reports on the achievement of CS-free clinical endpoints. Methods In ELEVATE UC 52 (NCT03945188), subjects (16-80 years) with moderately to severely active UC were randomised 2:1 to once-daily etrasimod 2 mg or placebo (PBO). ELEVATE UC 52 utilized a treat-through design comprising a 12-week induction period followed by a 40-week maintenance period. At study entry, subjects were permitted to receive concomitant treatment with CS (prednisone [≤20 mg/day], budesonide [≤9 mg/day], or equivalent]) provided they were on a stable dose 4 weeks prior to the screening endoscopy. Tapering of CS begun after the induction period. This analysis reports on achievement of CS-free (defined as no CS exposure in the 12 weeks immediately prior to week 52) clinical remission, CS-free endoscopic improvement, and CS-free symptomatic remission at week 52 in the ELEVATE UC 52 population, as well as CS-free clinical remission in pre-specified subgroups. Results In ELEVATE UC 52 a significantly greater proportion of etrasimod-treated subjects had CS-free clinical remission (32.1% [88/274] vs 6.7% [9/135]; P<0.001), CS-free endoscopic improvement (36.9% [101/274] vs 10.4% [14/135]; P<0.001), and CS-free symptomatic remission (43.4% [119/274] vs 18.5% [25/135]; P<0.001) at week 52 vs PBO (Figure 1). Subgroup analyses of CS-free clinical remission demonstrated efficacy across subgroups including previous exposure to a biologic/JAKi, number of previous biologics/JAKis (0, 1, or >1), disease severity at baseline (MMS 4-6 or 7-9), and extent of disease (proctitis, left-sided colitis/proctosigmoiditis, or pancolitis) (Figure 2A-D). There was a trend towards greater benefit in subjects who were biologic/JAKi naive and subjects who had been exposed to 0 or 1 vs >1 prior biologic/JAKi. Conclusion: In ELEVATE UC 52, a greater proportion of etrasimod-treated subjects achieved CS-free clinical remission, CS-free endoscopic improvement, and CS-free symptomatic remission at week 52 vs PBO. These results were also consistent for multiple disease-specific subgroups, including those with and without prior exposure to biologics/JAKis. Notably, all ELEVATE UC 52 subjects who were in clinical and symptomatic remission at week 52 were also in CS-free clinical and CS-free symptomatic remission.1 Reference: 1. Sandborn WJ, et al. Presented at: DDW 2022; May 24, 2022. Abstract 968a.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 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 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".