PTH-065 Effect of vedolizumab treatment on extraintestinal manifestations in patients with crohn’s disease: a gemini 2 post hoc analysis
Notice bibliographique
Résumé
Introduction Reported rates of extraintestinal manifestations (EIMs) in patients (pts) with Crohn’s disease (CD) are 37%–55%.1,2 This post hoc exploratory analysis investigated the effect of vedolizumab (VDZ) treatment on existing and new EIMs in patients with CD enrolled in GEMINI 2 (NCT00783692). Method Outcomes were sustained resolution of existing EIMs (absence of symptoms, sustained to study end), worsening of existing EIMs and occurrence of new EIMs. For arthritis/arthralgia (ar/ar), Kaplan–Meier estimates were used to describe ‘time to sustained resolution’. A multivariate Cox regression adjusting for confounding factors was conducted. The effect of steroid tapering on new or worsening ar/ar was explored, using prednisone equivalent dose (≤30 mg) as a time-dependent covariate. Results Pts received VDZ (n=814), VDZ/placebo (VDZ/PLA: VDZ to Week 6, PLA Weeks 6–52; n=153) or PLA only (n=148). Rates of EIMs other than ar/ar were too low for further analysis. Predicted annual rates of sustained resolution of ar/ar were 51% (VDZ), 41% (VDZ/PLA) and 36% (PLA). VDZ pts were 32% more likely to achieve sustained resolution of ar/ar versus PLA pts, and 21% less likely to have a worsening/new occurrence (Table, both non-significant [NS]). In pts receiving corticosteroids (CS; n=530), adjustment for CS withdrawal resulted in an ~4% increased likelihood of new or worsening ar/ar in all groups (30 mg dose reduction hazard ratio [HR] 1.04 [95% CI: 0.67–1.60], NS). Hazard reduction for the VDZ groups versus PLA was similar (VDZ, 0.73 [95% CI: 0.44–1.22], NS; VDZ/PLA, 0.72 [95% CI: 0.37–1.39], NS). Conclusion In this post hoc exploratory analysis, there were trends for both a reduced incidence of new or worsening ar/ar and an increased rate of sustained resolution of ar/ar in pts receiving VDZ. CS tapering increased the probability of ar/ar in all groups. References . Lakatos L, et al. World J Gastroenterol2003;9:2300 . Zippi M, et al. World J Gastroenterol2014;20:17463 Disclosure of Interest B. Feagan Conflict with: Abbott/AbbVie, Amgen, Astra Zeneca, Bristol-Myers Squibb (BMS), Janssen Biotech (Centocor), JnJ/Janssen, Roche/Genentech, Millennium, Pfizer, Receptos, Santarus, Sanofi, Tillotts, UCB Pharma, Conflict with: Abbott/AbbVie, ActoGeniX, Akros, Albireo Pharma, Amgen, Astra Zeneca, Avaxia Biologics Inc., Avir Pharma, Axcan, Baxter Healthcare Corp., Biogen Idec, Boehringer-Ingelheim, Bristol-Myers Squibb, Calypso Biotech, Celgene, Elan/Biogen, enGene, Ferring Pharma, Roche/Genentech, gICare Pharma, Gilead, Given Imaging Inc., GSK, Ironwood Pharma, Janssen Biotech (Centocor), JnJ/Janssen, Kyowa Hakko Kirin Co Ltd., Lexicon, Lilly, Lycera BioTech, Merck, Mesoblast Pharma, Millennium, Nektar, Nestles, Novo Nordisk, Pfizer, Prometheus Therapeutics and Diagnostics, Protagonist, Receptos, Salix Pharma, Serono, Shire, Sigmoid Pharma, Synergy Pharma Inc., Takeda, Teva Pharma, TiGenix, Tillotts, UCB Pharma, Vertex Pharma, VHsquared Ltd., Warner Chilcott, Wyeth, Zealand, Zyngenia, Conflict with: Director of Robarts Clinical Trials Inc.; member of advisory boards Abbott/AbbVie, Amgen, Astra Zeneca, Avaxia Biologics Inc., Bristol-Myers Squibb, Celgene, Centocor Inc., Elan/Biogen, Ferring, JnJ/Janssen, Merck, Nestles, Novartis, Novo Nordisk, Pfizer, Prometheus Laboratories, Protagonist, Salix Pharma, Takeda, Teva, TiGenix, Tillotts Pharma AG, UCB Pharma, W Sandborn Conflict with: Janssen, AbbVie, Pfizer, Amgen, Genentech, Conflict with: Janssen, AbbVie, Pfizer, Amgen, Genentech, Takeda, Conflict with: Lecture fee(s): AbbVie, Takeda, J.-F. Colombel Conflict with: Intestinal Biotech Development, Genfit, Conflict with: AbbVie, Janssen and Janssen, Genentech, Takeda, Conflict with: AbbVie, Amgen, Boehringer-Ingelheim, Celgene Corporation, Celltrion, Enterome, Ferring, Genentech, Janssen and Janssen, Medimmune, Merck and Co., Pfizer, Protagonist, Second Genome, Seres, Takeda, Theradiag, Conflict with: Lecture fee(s): AbbVie, Ferring, Takeda, Shire, S O’Byrne Conflict with: Takeda Pharmaceuticals International AG, J Khalid Conflict with: Takeda Development Centre Europe Ltd, N Brayshaw Conflict with: Takeda Development Centre Europe Ltd, P Geransar Conflict with: Takeda Pharmaceuticals International AG, D Rubin Conflict with: AbbVie Inc., Bristol-Myers Squibb, Centocor/Janssen Pharmaceuticals, Inc., Cornerstones Health, Inc., Elan Pharmaceuticals, Emmi, Given Imaging, Ironwood, Lifecore Biomedical, LLC, Prometheus Pharmaceuticals, Santarus, Shire, Takeda-Millennium, Telsar Pharmaceuticals, UCB Pharma, Vertex Pharmaceuticals, Warner Chilcott
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 | 0,006 | 0,006 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,004 | 0,006 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,001 | 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) | 0,006 | 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 ».