S852 Long-Term Clinical and Endoscopic Outcomes in True North Week 52 Clinical Remitters Over 3 Years of Treatment With Ozanimod: An Interim Analysis of the True North Open-Label Extension Study
Notice bibliographique
Résumé
Introduction: Ozanimod (OZA), a selective sphingosine 1-phosphate receptor modulator, is approved for the treatment of moderately to severely active ulcerative colitis (UC) based on results from the phase 3 True North (TN) study, which demonstrated the efficacy and safety of OZA over 52 weeks. A subsequent post hoc analysis demonstrated the durability of OZA efficacy and favorable safety profile of OZA over 3 years during the ongoing TN OLE in patients with UC who achieved clinical response at TN Week (W) 52. Methods: The present interim analysis of the TN OLE expands the evaluation of TN W52 clinical responders to include those who achieved clinical remission at TN W52 (ie, clinical remitters) vs those who did not (ie, clinical nonremitters) before entering the TN OLE. Clinical remission, clinical response, endoscopic improvement, and corticosteroid (CS)–free remission were evaluated in TN W52 clinical remitters vs nonremitters at OLE W46 and OLE W94 using observed case (OC) and nonresponder imputation (NRI) analyses. Results: In all, 131 patients entered the OLE as TN W52 clinical responders on continuous OZA therapy; of these patients, 63% (83/131) were clinical remitters. All patients had received 146 weeks of continuous OZA treatment up to OLE W94 or discontinued treatment. TN baseline demographic and disease characteristics were generally similar between the 2 groups, but a lower incidence of prior tumor necrosis factor (TNF) inhibitor use was reported in clinical remitters (25.3% [21/83]) vs clinical nonremitters (43.8% [21/48]); prior non–anti-TNF biologic use was similar between groups. Compared with clinical nonremitters, more clinical remitters achieved the evaluated efficacy endpoints at OLE W46 and OLE W94 in the OC analysis (Table 1). A similar trend was observed in the NRI analysis. Durability of response for all efficacy endpoints was sustained from OLE W46 to OLE W94 in most clinical remitters and nonremitters, respectively: 68.5% (37/54) and 75.0% (12/16); clinical response: 75.0% (48/64) and 75.9% (22/29); endoscopic improvement: 66.1% (41/62) and 68.4% (13/19); and CS-free remission: 67.9% (36/53) and 80.0% (12/15). Conclusion: Most patients who achieved clinical remission after 1 year of OZA had sustained efficacy for an additional 2 years of continuous OZA treatment. These findings provide further evidence for the long-term durability of OZA treatment in patients with moderately to severely active UC. Table 1. - OZA efficacy at OLE W46 and OLE W94 in TN W52 clinical responders with or without clinical remission (OC analysis) Clinical remitters at TN W52 (n=83) Clinical nonremitters at TN W52 (n=48) OLE W46 OLE W94 OLE W46 OLE W94 Clinical remission,a % (n/N) 97.0 (64/66) 94.4 (51/54) 93.5 (29/31) 85.2 (23/27) Clinical response,b % (n/N) 81.8 (54/66) 75.9 (41/54) 51.6 (16/31) 55.6 (15/27) Endoscopic improvement,c % (n/N) 86.1 (62/72) 78.6 (44/56) 59.4 (19/32) 63.3 (19/30) CS-free remission,d % (n/N) 80.3 (53/66) 74.1 (40/54) 48.4 (15/31) 55.6 (15/27) Note: Denominators for the OC analyses were based on the numbers of patients who completed OLE W46 or OLE W94 and had data available for the endpoints in question.aClinical remission: RBS=0 point and SFS ≤1 point, a decrease of ≥1 point from the baseline SFS, and endoscopy subscore ≤1 point.bClinical response: reduction from baseline in the 9-point Mayo score (sum of the RBS, SFS, and endoscopy subscore) of ≥2 points and ≥35%, and a reduction from baseline in the RBS of ≥1 point or an absolute RBS of ≤1 point.cEndoscopic improvement: endoscopy subscore of ≤1.dCS-free remission: clinical remission while off CS for ≥12 weeks.RBS, rectal bleeding subscore; SFS, stool frequency subscore.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
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 | 0,006 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,002 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 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 ».