S712 Benefits of High versus Low Dose Upadacitinib as Maintenance Treatment in Ulcerative Colitis Patients Who Were Responders to 8-week Induction with Upadacitinib: Results From the U-ACHIEVE Phase 3 Maintenance Trial
Notice bibliographique
Résumé
Introduction: Evaluate the benefits of upadacitinib (UPA) 30mg (UPA30) vs 15mg (UPA15) once daily (QD) as maintenance treatment in patients (pts) with active ulcerative colitis (UC). Methods: This post-hoc analysis included pts with clinical response after 8 wks of induction (16-wk induction responders were excluded) with UPA 45mg QD who were enrolled in U-ACHIEVE maintenance trial and re-randomized 1:1:1 to UPA15, UPA30, or placebo (PBO) QD for 52 wks. Clinical remission per Partial Adapted Mayo score were evaluated in subgroups of pts with mild (Adapted Mayo score < 5), moderate (Adapted Mayo score 5 to ≤7), or severe (Adapted Mayo score >7) UC at wks 0 and 52 of maintenance. For each UPA dose, area under the curve (AUC) analysis on proportion of pts in clinical remission per Partial Adapted Mayo score at wks 0, 4, 8, 12, 20, 28, 36, 44 and 52 of maintenance was used to calculate the number of wks pts were in clinical remission. To assess these benefits in the non-elder population, analysis was replicated for UPA doses in pts < 65 years. Results: Data from 451 pts (UPA15, n=149; UPA30, n=148; PBO, n=154) were analyzed. At Wk 0 of maintenance, at least 91% of pts had mild disease and no pts had severe disease across treatment groups (Table). At the end of 52-wks maintenance, 19.7% more UPA30 pts were in lesser disease severity (10.5% and 9.2% more pts with mild and moderate disease, respectively) vs UPA15. Based on AUC analysis, PBO pts, UPA15 and UPA30 pts were in clinical remission for 15.8 (95% CI: 12.2, 19.5), 30.5 (95% CI: 26.4, 34.6), and 34.4 (95% CI: 30.5, 38.3) wks, respectively. UPA30 pts were in clinical remission for an additional 3.8 wks (26.9 days) over a year of maintenance vs UPA15. In pts < 65 years old (n=411), 26% more UPA30 pts were in lesser disease severity (14% and 12% more pts with mild and moderate disease, respectively) vs UPA15 and were in clinical remission for an additional 4.2 wks (29.3 days) over a year of maintenance vs UPA15. Conclusion: After 52-wks of maintenance treatment with UPA 30mg QD, pts had less severe disease and were in clinical remission for approximately 1 additional month/year vs pts treated with UPA 15mg QD indicating clinical benefit of high dose UPA as maintenance treatment in UC. Table 1. - Patients with mild, moderate, and severe UC at Weeks 0 and 52 and weeks in clinical remission Patients with mild, moderate, and severe UC at Weeks 0 and 52 and weeks in clinical remission Week 0 Week 52 a Weeks in Clinical Remission b n (%) N Mild Moderate Severe Mild Moderate Severe Mean (95% CI) PBO 149 137 (92.0) 12 (8.1) 0 34 (22.8) 70 (47.0) 45 (30.2) 15.8 (12.2, 19.5) UPA 15 mg 148 136 (91.9) 11 (7.4) 0 94 (63.5) 25 (16.9) 28 (18.9) 30.5 (26.4, 34.6) UPA 30 mg 154 141 (91.6) 13 (8.4) 0 114 (74.0) 24 (15.6) 15 (9.7) 34.4 (30.5, 38.3) aPatients with Adapted Mayo scores collected at or after initiation of UC-related rescue medications through the end of the maintenance study or who prematurely discontinued from the study were assumed to have Week 52 Adapted Mayo score return to baseline. Patients with missing data for reasons other than UC-related rescue medications or premature discontinuation were handled by last observation carried forward. Disease severity was defined by Adapted Mayo score: mild (Adapted Mayo < 5), moderate (Adapted Mayo 5 to ≤7), and severe (Adapted Mayo >7).bClinical remission was defined as Partial Adapted Mayo score ≤2 with no subscore >1.
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 | 0,002 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,002 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,002 |
| 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 ».