DOP007 Change in Histological inflammation in patients with ulcerative colitis treated with vedolizumab: Results from the continuing VERDICT trial
Notice bibliographique
Résumé
Abstract Background Ulcerative colitis (UC) treatment targets include symptomatic, endoscopic, or histologic remission. The aim of the continuing VERDICT trial (NCT04259138) is to determine the optimal treatment target in patients with moderately-to-severely active UC.1,2 Patients follow treatment algorithms involving early introduction of vedolizumab (VDZ). In this analysis, we report changes in histology indices: Nancy index (NI), Robarts Histopathological index (RHI) and Geboes score from baseline to weeks 16, 32 and 48 in patients for whom histologic remission was included as a treatment target. Methods Patients received VDZ 300 mg IV, as per a treatment algorithm related to baseline UC treatment, until assigned treatment target was reached, with escalation steps between week 16,32 and 48, as indicated. Treatment target groups were as follows: Group 1 (corticosteroid-free [CSF] symptomatic remission), Group 2 (CSF symptomatic remission + CSF endoscopic remission), and Group 3 (CSF symptomatic remission + CSF endoscopic remission + CSF histologic remission, also termed disease clearance). CSF symptomatic remission was defined as Mayo rectal bleeding subscore=0, CSF endoscopic remission was defined as Mayo Endoscopic Score ≤1, and CSF histologic remission was defined as Geboes score<2B.0. For this analysis, we report the findings for Group 3, the only group with histologic remission included as a treatment target. Results At the interim data cutoff point for this analysis 672 patients were enrolled, with 265 patients in Group 3. Histologic scores improved by Week 16, with mean changes from baseline in NI of -1.4, and changes in RHI of -9.0. Histologic improvements continued to increase incrementally at Weeks 32 and 48 (Table). By Week 48, mean change from baseline in NI was -1.9 (Table). For RHI, mean change from baseline to Week 48 was -12.2. For both NI and RHI, mean change from baseline to Week 48 was greater in bionaïve than bio-exposed patients (Table). Histologic remission assessments were similar for NI, RHI, and Geboes score, with 50% of patients achieving corticosteroid-free histologic remission at Week 16, and 66.7% at Week 48 (Figure). Conclusion Vedolizumab treatment was associated with rates of corticosteroid-free histologic remission that were evident as early as Week 16 and increased incrementally through to Week 48, when it reached two thirds. The magnitude of histologic improvement was similar for all three scoring methods. References 1. Jairath et al., 2024. Doi:10.1136/bmjgast-2023-001218 2. Jairath et al., 2024. Doi: 10.1093/ecco-jcc/jjad212.0051 Funding The VERDICT trial is a collaborative study between Alimentiv and Takeda. Acknowledgements We thank the patients who participated in the trial, their caregivers, and the study investigators and members of the VERDICT study team. Medical writing support was provided by Paul Hassan, PhD, of Envision Pharma Group, and was funded by Takeda.
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) | 0,000 | 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 | 0,001 | 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 ».