Assessment and impact of age on the efficacy and safety among patients in the etrasimod ELEVATE UC clinvical programme
Bibliographic record
Abstract
Introduction: Etrasimod is an oral, once-daily (QD), selective sphingosine 1-phosphate (S1P) 1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). Age has been shown to impact treatment safety and efficacy in patients (pts) with inflammatory bowel disease. [ 1 ] Objectives: This post hoc analysis explored the impact of age on the safety and efficacy of etrasimod in pts with UC in the phase 3 ELEVATE UC clinical programme. Methodology: Data pooled from ELEVATE UC 52 (treat-through design comprising a 12-week (wk) induction period followed by a 40-wk maintenance period; NCT03945188) and ELEVATE UC 12 (12-wk induction; NCT03996369) were analysed in pts receiving etrasimod 2 mg QD and placebo. Proportions and incidence rates (IRs) per 100 pt-years from pooled data of treatment-emergent adverse events (TEAEs) and events of interest were stratified by age (<40 years, 40–59 years, ≥60 years) and analysed. Efficacy analyses were evaluated in pts with baseline Modified Mayo score 5–9 for the primary efficacy endpoint (clinical remission) and select secondary endpoints at Wk 12 (both trials) and Wk 52 (ELEVATE UC 52) stratified by age. Result: Of 787 pts in the ELEVATE UC programme, 420 (53.4%) were aged <40 years, 276 (35.1%) were aged 40–59 years and 91 (11.6%) were aged ≥60 years. The proportions and IRs of TEAEs and events of interest were mostly similar between age groups and treatment arms (Table). IRs of arthralgia, fatigue, hypertension and pyrexia were higher in older age groups, regardless of treatment arm. Serious adverse events (AEs) and AEs leading to treatment discontinuation were low and consistent across all age subgroups. Serious infections and infection events of interest were balanced across age groups and treatment arms. Regardless of age subgroup, significantly more pts treated with etrasimod vs placebo achieved the primary and select secondary efficacy endpoints at Wk 12 and Wk 52. Fig. 1 Conclusion: The safety profile of etrasimod 2 mg QD in the UC population was consistent across age groups, and with no new risks other than the estimated risks associated with increasing age. [ 2 ] Pts receiving etrasimod in the ELEVATE UC programme showed significant clinical benefit as assessed by clinical remission, symptomatic remission and endoscopic improvement compared with placebo, regardless of age. Fig. 2 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 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| 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".