OP014 Histological remission is predictive of improved clinical outcomes in patients with ulcerative colitis: results from the TOUCHSTONE open-label extension
Notice bibliographique
Résumé
Background: Histological remission (HR) has been reported as a positive prognostic indicator of clinical activity in ulcerative colitis (UC). The TOUCHSTONE open-label extension (OLE) is an opportunity to examine the impact of histologic remission on UC activity during a long-term evaluation of efficacy and safety of ozanimod 1 mg. TOUCHSTONE was a randomized, double-blind, placebo-controlled phase 2 trial designed to assess the efficacy and safety of ozanimod 0.5 mg and 1 mg versus placebo during induction and maintenance in patients with moderate to severe UC [1], and established that ozanimod induced and maintained clinical response, clinical remission (CR), endoscopic mucosal healing, and HR through weeks 8 and 32. Methods: A total of 197 patients were randomized (1:1:1) and treated with daily ozanimod at 0.5 mg, 1 mg, or placebo in TOUCHSTONE. Of the initial 197 patients randomized, 170 (86%) entered OLE and received daily ozanimod 1 mg, and 131 (77%) and 105 (62%) completed assessments at weeks 44 and 80. In this analysis, HR was defined as a Geboes score <2 and CR was defined as rectal bleeding score =0 and stool frequency score ≤1. Results: Of the patients who entered OLE, 27% showed histologic remission at the time of OLE entry and 34% were in CR. Clinical remission increased to 62% at OLE week 32, with 62%, and 55% in CR at OLE weeks 44 and 80. At OLE weeks 44 and 80, CR was seen in 83% and 80% of those in HR at OLE entry compared to 55% and 46% of those not in HR at OLE entry. The proportion of patients in CR increased throughout OLE while receiving 1 mg of ozanimod, regardless of prior treatment in the TOUCHSTONE study or HR status at OLE entry. The highest rates of CR were seen in patients in HR at OLE entry who had received ozanimod for 32 weeks prior to OLE entry, with CR rates at OLE weeks 4 and 8, with over 90% in CR. The lowest CR rates were seen in patients naïve to ozanimod and not in HR at OLE entry, with CR increasing from 13% at entry to 50% at OLE week 8, reaching a peak of 56% at OLE week 32. Overall, treatment with ozanimod for 32 to 36 weeks resulted in CR in 80% of patients. Most common adverse events seen in OLE were UC flare, back pain, URTI, anemia, and nasopharyngitis. Transient asymptomatic elevations in ALT or AST >3× ULN were seen in 3% of patients. Conclusions: Histological remission is predictive of CR in patients with UC receiving ozanimod 1 mg in OLE. All patients, whether naïve to or having received ozanimod in TOUCHSTONE, showed additional improvements in CR upon continued treatment with ozanimod 1 mg in OLE. Patients naïve to ozanimod had a rapid improvement in CR over the first 8 weeks of treatment with ozanimod 1 mg in OLE. References: [1] Sandborn WJ, Feagan BG, Wolf DC, et al. (2016), Ozanimod induction and maintenance treatment for ulcerative colitis. N Engl J Med, 1754–62
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 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| 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 | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,004 | 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 ».