P-105 The Effect of Vedolizumab on Extraintestinal Manifestations in Patients with Crohnʼs Disease in GEMINI 2
Notice bibliographique
Résumé
Vedolizumab (VDZ) is a gut-selective α4β7 integrin antagonist with demonstrated efficacy and safety in patients with moderately to severely active Crohn's disease (CD).1 In post hoc analyses of data from the double-blind (DB) placebo (PBO)-controlled GEMINI 2 study (NCT00783692), we investigated the effect of VDZ on extraintestinal manifestations (EIMs) in the subpopulation of patients who had EIMs at baseline. Patients received DB PBO, DB VDZ, or open-label VDZ induction. At week 6, VDZ responders were re-randomized to DB PBO (VDZ/PBO) or VDZ every 8 weeks (Q8W) or every 4 weeks (Q4W) for the 46-week maintenance phase. VDZ nonresponders continued on VDZ Q4W and patients who received PBO continued on PBO (PBO/PBO). EIMs were evaluated post hoc from the CD Activity Index (CDAI) complications component. Patients with EIMs were defined as those with (1) any CDAI complication, (2) CDAI complications excluding anal disease-related complications (ie, arthritis/arthralgia, iritis/uveitis, erythema nodosum, pyoderma gangrenosum, aphthous stomatitis, or fever >37.8°C during the past week), (3) any anal disease-related complication (abscess, anal fissure, anal fistula, or other fistula), and (4) arthritis/arthralgia. Kaplan-Meier (KM) estimates for the time to resolution of EIMs were evaluated in patients with baseline EIMs from the PBO/PBO population and all patients receiving VDZ during maintenance (ie, week 6 responders and nonresponders combined). Resolution of EIMs was defined as absence of CDAI complications at each post-baseline study visit until week 52; patients who discontinued the study were counted as not resolved. Hazard ratios (HRs) were calculated over 52 weeks. In total, 494 combined VDZ and 107 PBO/PBO patients had EIM(s) at baseline. KM estimates for resolution of any EIM with VDZ were 13% at week 26 and 32% at week 52 (versus 4% and 23% with PBO, respectively); the HR was 1.4 (95% CI, 0.7–2.79). When excluding anal disease-related complications, KM estimates with VDZ were 18% at week 26 and 43% at week 52 (versus 6% and 23% with PBO, respectively); the HR was 1.87 (95% CI, 0.96–3.64). For resolution of anal disease-related complications, KM estimates with VDZ were 10% at week 26 and 22% at week 52 (versus 6% and 25% with PBO, respectively); the HR was 0.8 (95% CI, 0.18–3.49). KM estimates for resolution of arthritis/arthralgia with VDZ were 19% at week 26 and 42% at week 52 (versus 7% and 26% with PBO, respectively); the HR was 1.84 (95% CI, 0.91–3.71). This post hoc analysis did not show statistically significant benefit of vedolizumab over placebo for the treatment of EIMs in CD. However, within the limitations of the data collection and the fact that the study was not powered to assess EIMs, there was a trend toward benefit. Further study is needed regarding which patients may benefit.
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) | 0,001 | 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 | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 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 ».