DOP050 Target achievement after 48 weeks of vedolizumab treatment in patients with moderate to severe Ulcerative Colitis: An interim analysis from the VERDICT trial
Notice bibliographique
Résumé
Abstract Background The VERDICT study is a continuing, randomised controlled trial (NCT04259138)1-3 with a goal of determining the optimal treatment target for patients with moderate to severe ulcerative colitis (UC) by comparing 3 groups: Group 1 (corticosteroid-free [CSF] symptomatic remission); Group 2 (CSF symptomatic remission + CSF endoscopic remission); Group 3 (CSF symptomatic remission + CSF endoscopic remission + CSF histologic remission, also termed as disease clearance). This interim analysis reports target achievement up to week 48. Methods Following a treatment algorithm related to baseline UC treatment, vedolizumab (VDZ) 300 mg was administered intravenously until assigned treatment target was reached at week 48. CSF symptomatic remission was defined as Mayo rectal bleeding subscore=0, CSF endoscopic remission was defined as Mayo endoscopic score [MES]≤1, and CSF histologic remission was defined as Geboes score<2B.0. Patients reaching CSF remission are considered to maintain remission at future visits. Results As of 05SEP2024, 672 patients were enrolled with 185, 222, and 265 patients assigned to Groups 1, 2, and 3, respectively. Baseline age, disease duration, and proportion of patients with MES=3 were similar amongst groups. Concomitant corticosteroids were received by 43.2%, 40.1%, 50.6% of patients, respectively (median dose 25.5, 25.3, 23.8 mg) and baseline MES=3 was similar across all 3 groups (60.0%, 61.7%, 65.3%). Bionaïve patients comprised 71.9%, 77.5%, 83.4% of patients in Groups 1, 2, and 3, respectively. In patients with observed data and a week 32 visit, 80.7% (92/114), 63.0% (97/154), and 53.3% (113/212) achieved CSF remission at week 32. In patients with observed data and a week 48 visit, 90.3% (84/93), 77.3% (102/132), 67.2% (123/183) achieved CSF remission by week 48, with higher proportions in bionaïve (70.1%) compared to bio-exposed (50.0%) for Group 3 (Figure 1). In the intention-to-treat population, 49.7%, 43.7%, and 42.6% of patients, respectively, achieved CSF remission at week 32, with higher proportions in patients who were bionaïve (45.7%) compared to bio-exposed (27.3%) in Group 3. By week 48, 45.4% (84/185), 45.9% (102/222), and 46.4% (123/265) of patients achieved CSF remission, with higher proportions with bionaïve (49.8% [110/221]) versus bio-exposed (29.5% [13/44]) in Group 3. At time of analysis, 50.3%, 59.5%, 69.1% of randomised patients had completed the week 48 visit. Conclusion These interim week 48 results provide evidence of improvement from week 32 to 48 across all endpoints and continue to support the efficacy of VDZ in achieving the stringent endpoint of CSF disease clearance. 96-week follow-up for all patients in the trial will be complete March 2026. References 1Jairath V, Zou G, Wang Z, et al. Determining the optimal treatment target in patients with ulcerative colitis: rationale, design, protocol and interim analysis for the randomised controlled VERDICT trial. BMJ Open Gastroenterol. 2024;11:e001218. Doi:10.1136/bmjgast-2023-001218 2Jairath V, Zou G, Adsul S, et al. DOP11 Disease clearance after 16 weeks of treatment with vedolizumab in patients with moderate to severe Ulcerative Colitis: An interim analysis from the VERDICT trial. J Crohns Colitis. 2024;18 (Suppl 1):i92-i93. Doi: 10.1093/ecco-jcc/jjad212.0051 3Jairath V, Zou G, Adsul S, et al. PP0556 Target achievement after 32 weeks of vedolizumab treatment in patients with moderate to severe ulcerative colitis: An interim analysis from the VERDICT trial. UEG Week 2024 Poster Presentations. United European Gastroenterol J. 2024;12:665-1360. Doi: 10.1002/ueg2.12615
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 | 0,008 | 0,005 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,004 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,002 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 0,001 |
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 ».