OP09 Dose intensification of vedolizumab is not effective in inducing endoscopic response in Crohn’s disease patients with endoscopic primary non-response
Notice bibliographique
Résumé
Abstract Background Dose intensification of anti-α4β7 integrin vedolizumab (VDZ) in Crohn’s Disease (CD) patients with secondary loss of response has been reported to be effective. However, data on effectiveness of this intervention in primary non-responders is often inconsistent and retrospectively collected.1 Our aim was to investigate the effect of vedolizumab dose intensification in endoscopic non-responders after 26 weeks of standard dosing on both clinical and endoscopic remission at week 52. Methods In the LOVE-CD trial, early and late CD patients with moderate-severe disease activity (Crohn’s Disease Activity Index (CDAI) 220-450) and presence of ulcers at baseline endoscopy were treated with VDZ for 52 weeks.2 Early CD was defined as diagnosis <24 months and late CD as diagnosis >24 months and previous exposure to anti-TNF. All patients received standard doses of vedolizumab (300 mg at week 0,2 and 6 and further every 8 weeks with an additional dose at week 10 in case of clinical non-response) and underwent an endoscopy at week 0, 26 and 52. Corticosteroids were mandatorily tapered and had to be discontinued by week 26. Halfway the trial, after 130 patients (50%) had been included, the study protocol was amended by introducing dose intensification from 300 mg IV every 8 weeks to every 4 week in patients without endoscopic response (DSES-CD drop <50%) at week 26. The primary outcome was deep remission, defined as clinical (CDAI ≤150) and endoscopic remission (SES-CD ≤3) at week 52. Results In LOVE-CD, eighty-two patients (31.5%) were endoscopic non-responders at week 26 (44 prior to and 38 after the dose intensification amendment). Four patients in the dose intensification group were excluded from analysis due to missing week 52 endoscopy data. Apart from previous biological exposure (90.0% vs 73.5% in the dose intensification and standard dosing group, resp.), baseline characteristics were similar between the dose intensification and continued standard dosing groups (median SES-CD at baseline 11 (IQR 7-17) vs 13 (IQR 8-18) resp.). At week 52, the dose-intensified group had significantly higher VDZ serum concentrations at trough (mean 46.4 vs 16.3 ug/ml, p<0.001). However, there was no significant difference in endoscopic remission, clinical remission and deep remission rates at week 52 between the two groups (table 1). No significant differences in severe adverse events were observed between both groups (9.7% vs 13.6%, p=0.344). Conclusion In the LOVE-CD trial, dose intensification of vedolizumab in endoscopic non-responders with Crohn’s Disease after 6 months of standard dosing was not effective. References 1.Samaan, et al. (2019). Effectiveness of vedolizumab dose intensification to achieve inflammatory bowel disease control in cases of suboptimal response. Frontline gastroenterology, 11(3), 188-193. https://doi.org/10.1136/flgastro-2019-101259 2.D’Haens et al (2024). Vedolizumab treatment is more effective and safer in early versus late Crohn’s Disease: final results of the LOVE-CD trial. United European Gastroenterology Week, OP 2677.
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 | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 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 ».