DOP021 Long-term effectiveness and safety of vedolizumab in patients with Crohn's disease: 5-year cumulative exposure of GEMINI 2 completers rolling into the GEMINI open-label extension study
Notice bibliographique
Résumé
Background: Vedolizumab (VDZ), a humanised monoclonal antibody that targets α4β7 integrin, is approved for moderately to severely active Crohn's disease (CD) and ulcerative colitis. The GEMINI open-label extension (OLE) trial is an ongoing study investigating the long-term safety of VDZ (NCT00790933). Here we report the 5-year exploratory analyses of effectiveness and safety in patients (pts) with CD who had completed GEMINI 2 [1] and were enrolled in GEMINI OLE. Methods: Analyses included pts who had responded to VDZ induction at Week (Wk) 6 and received VDZ maintenance (every 8 or 4 wks; data were combined) to Wk 52 of GEMINI 2, followed by VDZ every 4 wks in GEMINI OLE. Pts with 248 wks of cumulative VDZ treatment (data were collected from 22 May 2009 to 21 May 2015) were assessed for clinical response (decrease in Harvey–Bradshaw Index [HBI] of ≥3 points from baseline [BL]), clinical remission (HBI ≤4) and health-related quality of life (HRQoL), including IBD Questionnaire (IBDQ) and Euro Quality of Life-5D visual analogue scale (EQ-5D VAS). Safety was also assessed. Results: Of 308 pts in GEMINI 2 who responded to VDZ induction at Wk 6 and received VDZ in maintenance, 146 (47%) completed VDZ maintenance and were enrolled in GEMINI OLE (anti-TNFα-naïve n=81; anti-TNFα failure n=57). At the time of this analysis, 61 pts had completed 248 wks of cumulative VDZ treatment, 58 had discontinued (n=11 [19%] due to lack of continued benefit) and 27 are ongoing (have not yet reached 248 wks of treatment). Of pts with data at Wk 248 (n=61), 95% had clinical response and 89% were in remission (Table). HRQoL improvements were observed at Wk 248, with mean change from BL IBDQ and EQ-5D-VAS scores of 59.4 and 29.8, respectively. In the safety population, 134 pts had adverse events (AEs); 15 discontinued due to AEs. Serious AEs were reported in 41 pts (in 3 pts these were drug-related; 8 pts discontinued as a consequence of serious AEs). One death (not drug-related; motor accident) was reported. Table 1. Effectiveness outcomes in patients with CD and cumulative VDZ exposure for up to 248 wks Conclusions: Long-term VDZ therapy (∼5 years) was associated with clinical benefits including clinical response, clinical remission and HRQoL improvements in pts with moderately to severely active CD who responded at Wk 6, completed GEMINI 2 and enrolled in OLE. Long-term VDZ therapy was associated with no unanticipated AEs, and the safety profile was consistent with that previously observed in a 3-year interim analysis of the OLE study. References: [1] Sandborn WJ, Feagan BG, Rutgeerts P, et al., (2013), Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease, N Engl J Med, 711–21
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 distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 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 tête enseignante, 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 ».