Efficacy and safety of etrasimod as a first-line advanced treatment following 5-aminosalicylic acid and/or thiopurines: data from the ELEVATE UC 52 and ELEVATE UC 12 phase 3 clinical trials
Bibliographic record
Abstract
Introduction: 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). Objectives: We assessed etrasimod efficacy and safety in biologic/Janus kinase inhibitor (JAKi)-naïve patients (pts) who previously took 5-aminosalicylic acid (5-ASA) and/or thiopurines in the ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 (NCT03996369) phase 3 trials. [ 1 ] Methodology: Pts received etrasimod 2 mg once daily or placebo (PBO). Pts in this post hoc analysis were naïve to biologic and/or JAKi treatments and included regardless of prior/concomitant corticosteroids (CS). Pts in Cohort A were previously or currently taking 5-ASA, but naïve to prior thiopurines; pts in Cohort B were thiopurine-experienced with/without prior/concomitant 5-ASA. Efficacy endpoints included clinical remission and endoscopic improvement (Weeks [Wks] 12 and 52), CS-free remission and sustained clinical remission (Wk 52) and symptomatic response (Wks 2, 4, 8 and 12). Data up to Wk 12 were pooled; Wk 52 data were from ELEVATE UC 52. Safety was assessed up to 52 wks. Result: In Cohort A, 135 and 62 pts received etrasimod and PBO, respectively; more pts in the etrasimod vs PBO arm achieved clinical remission (Wks 12 and 52), endoscopic improvement (Wks 12 and 52), CS-free remission (Wk 52) and sustained clinical remission (Wk 52; all p <0.05; [ Fig. 1a ]). In Cohort B, 69 and 35 pts received etrasimod and PBO, respectively; significantly more pts in the etrasimod vs PBO arm achieved clinical remission and endoscopic improvement (Wk 12) and sustained remission (Wk 52; all p <0.05; Fig. 1b). Numerical differences were seen for the other endpoints assessed. In both cohorts, numerical differences in the etrasimod vs PBO arm in pts achieving symptomatic response started at Wk 2. In both cohorts, safety findings were consistent with the overall population, with no increases in incidence rates of serious adverse events or serious infections in etrasimod vs PBO. Fig. 1 Conclusion: These results further characterise the efficacy and safety of etrasimod as a first-line advanced treatment after conventional 5-ASA and/or thiopurine therapy, and are consistent with previous results in biologic/JAKi-naïve pts. Limitations included post hoc analysis and a small sample size. Publication History Article published online: 26 September 2024 © 2024. Thieme. All rights reserved. Georg Thieme Verlag KG 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 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.002 | 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".