S1470 Matching-Adjusted Indirect Comparison of Etrasimod Versus Ozanimod for Clinical Response and Remission Among Patients With Moderately to Severely Active Ulcerative Colitis
Notice bibliographique
Résumé
Introduction: Etrasimod (ETR) and ozanimod (OZN) are selective sphingosine 1-phosphate receptor modulators targeting the S1P1,4,5, and S1P 1,5 receptors, respectively, for the treatment of moderately to severely active ulcerative colitis (UC). While network meta-analyses have been conducted that included both ETR and OZN, differences in populations and trial designs can impact outcomes. The aim was to conduct matching-adjusted indirect comparisons (MAIC) between ETR and OZN to compare clinical response and remission after the induction period and among induction phase responders following the maintenance period. Methods: Data from phase 3 clinical trials of ETR and OZN that reported data on both induction and maintenance were included in the analyses, namely ELEVATE UC 52 and TRUE NORTH. Patients (pts) in ELEVATE UC 52 received 2mg ETR or placebo (PBO) throughout induction and maintenance, in a treat-through trial design, while pts in TRUE NORTH received 1mg equivalent dose of OZN or PBO during induction, OZN pts with clinical response after induction were further rerandomized to PBO or OZN for maintenance. A PBO anchored approach was used for induction results, while an unanchored approach was conducted for maintenance due to differences in the maintenance PBO arms resulting from the distinct trial designs. Patient level data from ELEVATE UC 52 were weighted using MAIC methodology to match the TRUE NORTH population. Pts were matched on age, sex, corticosteroid use, duration of UC, previous biologic exposure, modified Mayo Score, and presence of left-sided disease, all measured at baseline. Results: After MAIC weighting, matched characteristics were similar with standardized mean differences < 0.1. There were no significant differences between ETR and OZN after the induction period for the outcomes of clinical response and remission (Table 1). However, following the maintenance period, for both clinical response and remission among induction phase responders, a significantly greater proportion of ETR pts achieved clinical response and remission compared to OZN (relative risk 1.19 (95% CI, 1.06-1.31), P < 0.05 and 1.34 (95% CI, 1.11-1.55), P < 0.05 respectively) at 52 weeks. Conclusion: MAIC results suggest superiority of ETR over OZN in terms of clinical response and remission at the end of the maintenance period (52 weeks), while both treatments are similar after the induction period (10-12 weeks). Additional comparisons of other efficacy and safety outcomes will further facilitate treatment decisions. Table 1. - Summary of the data and results of the matching-adjusted indirect comparisons for the clinical response and remission outcome over induction and maintenance periods Treatments Number of patients with the outcome (prior to weighting) Number of patients in the arm (prior to weighting) Unadjusted relative risk (95% CI) (prior to weighting) Adjusted relative risk (95% CI) (post MAIC weighting) ESS Induction Clinical response Etrasimod 2 mg/PBO 171/46 274/135 0.99 (0.70, 1.41) P-value = 1 0.99 (0.77, 1.34) P-value = 1 360.114 Ozanimod 1 mg/PBO 205/56 429/216 Clinical remission Etrasimod 2 mg/PBO 74/10 274/135 1.19 (0.51, 2.77) P-value = 0.6968 1.37 (0.79, 3.25) P-value = 0.3875 360.114 Ozanimod 1 mg/PBO 79/13 429/216 Maintenance Clinical response among induction phase responders Etrasimod 2 mg 123 171 1.20 (1.04, 1.38) P-value = 0.011 1.19 (1.06, 1.31) P-value = 0.001 237.405 Ozanimod 1 mg 138 230 Clinical remission among induction phase responders Etrasimod 2 mg 84 171 1.33 (1.06, 1.67) P-value = 0.014 1.34 (1.11, 1.55) P-value = 0.001 237.405 Ozanimod 1 mg 85 230 PBO, placebo; CI, confidence interval; ESS, effective sample size.Analysis matched on age, sex, baseline corticosteroid use, duration of ulcerative colitis, biologic exposure, modified Mayo Score, and extent of left-sided disease.
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,007 | 0,013 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,010 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,007 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».