P038 Comparing the Efficacy and Safety of Subcutaneous Vedolizumab Versus Adalimumab for the Treatment of Ulcerative Colitis: A Network Meta-Analysis
Notice bibliographique
Résumé
BACKGROUND: Vedolizumab (VDZ), a gut-selective monoclonal α4β7 integrin antibody, is approved for the treatment of moderately to severely active ulcerative colitis (UC) and Crohn’s disease. Intravenous (IV) VDZ was recently shown to be superior to subcutaneous (SC) adalimumab (ADA) in VARSITY (1), the first head-to-head randomized controlled trial (RCT) of biological therapies in UC. No comparative efficacy or safety data versus ADA exist for VDZ SC, a new formulation in development (2). To generate estimates of the comparative efficacy and safety of VDZ SC versus ADA, we conducted a network meta-analysis (NMA) of RCTs. METHODS: The NMA was conducted using results from a targeted literature review that identified RCTs of both VDZ and ADA: GEMINI 1, VISIBLE 1, ULTRA-2, and VARSITY. In the former two trials, responders were rerandomized at the end of induction, whilst the latter two trials were treat-through designs. To adequately analyze these trials in one network of evidence, efficacy outcomes were assessed conditionally upon response at start of maintenance. For treat-through studies, this was response at 6/8 weeks. Efficacy outcomes in the maintenance period were response and remission at 52/54 weeks. Safety outcomes were overall adverse events (AEs), serious AEs (SAEs), overall infections, serious infections, and AEs leading to discontinuation as reported at 52 weeks. Odds ratios (OR) with 95% credible intervals (CrI) were estimated using probit and binomial NMA models. ADA SC 40 mg Q2W, VDZ IV 300 mg Q4W, and VDZ IV 300 mg Q8W were all compared against VDZ SC 108 mg Q2W (reference group). RESULTS: ADA had lower rates for maintenance of response and remission relative to VDZ SC, but this was not statistically significant (ORs with 95% Crl: 0.60 [0.33, 1.08] and 0.59 [0.33, 1.09], respectively). Although overall AEs were significantly higher with ADA compared with VDZ SC (OR 2.02 [1.04, 3.89]), other safety outcomes were similar: overall infections, OR 1.86 (0.94, 3.77); serious AEs, OR 1.41 (0.54, 3.75); serious infections, OR 0.39 (0.05, 2.73); AEs leading to discontinuation, OR 2.58 (0.80, 9.44). As expected, VDZ IV had similar maintenance efficacy and safety outcomes relative to VDZ SC. CONCLUSION(S): Results from this indirect treatment comparison suggest that VDZ SC may achieve higher rates of maintenance response and remission among responders at start of maintenance than ADA and is associated with a lower risk of overall AEs. In the absence of a head-to-head trial between VDZ SC and ADA SC, these findings support a favorable benefit-risk profile of VDZ SC in UC.
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 | 0,025 | 0,040 |
| Méta-épidémiologie (sens strict) | 0,004 | 0,002 |
| Méta-épidémiologie (sens large) | 0,014 | 0,053 |
| Bibliométrie | 0,004 | 0,005 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,003 | 0,002 |
| Science ouverte | 0,003 | 0,002 |
| Intégrité de la recherche | 0,003 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,007 | 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 ».