P039 Integrating Maintenance Efficacy and Safety of Vedolizumab and Other Advanced Therapies for the Treatment of Ulcerative Colitis: A Network Meta-Analysis
Notice bibliographique
Résumé
BACKGROUND: Comparative efficacy and safety data for therapeutic options in ulcerative colitis (UC) are lacking. Intravenous (IV) vedolizumab (VDZ) was recently shown to be superior to subcutaneous (SC) adalimumab (ADA) in VARSITY, the first head-to-head randomized controlled trial (RCT) of biologic therapies in UC. The objective of this study is to provide estimates of the efficacy and safety of other biologic therapies and tofacitinib (TOFA) relative to VDZ IV, by means of a network meta-analysis (NMA). METHODS: Relevant RCTs of VDZ (IV and SC), ADA, infliximab (IFX), golimumab (GOL), ustekinumab (UST), and tofacitinib (TOFA) were identified through a targeted literature review. Efficacy outcomes in the maintenance period were remission and response at 52/54 weeks. Differences in study design (treat-through vs re-randomized) across the relevant RCTs were accounted for by assessing efficacy outcomes conditional on response at start of maintenance. For treat-through studies, this was response at 6/8 weeks. Safety outcomes were overall adverse events (AEs), serious AEs (SAEs), overall infections, serious infections, and AEs leading to discontinuation as reported at 52/54 weeks. Odds ratios (ORs) with 95% credible intervals (CrIs) were estimated using probit and binomial NMA models, with results presented with VDZ IV 300 mg Q8W as the reference group. Analyses were conducted for the overall study population, as well as separately for the anti-tumor necrosis factor (TNF)–naïve and –experienced populations. RESULTS: Sixteen RCTs evaluating 13 therapies were included in the NMAs. Connected networks could be created for all three populations in the maintenance (10 trials) period. In the overall population, relative to VDZ 300 mg Q8W, ADA 40 mg, GOL 50 mg, and UST 90 mg Q12W had significantly lower rates for maintenance of response (OR: 0.62 [95% CrI 0.45, 0.86], 0.54 [95% CrI 0.31, 0.94], 0.58 [95% CrI 0.34, 0.98], respectively) and maintenance of remission (OR: 0.62 [95% CrI 0.45, 0.86], 0.54 [95% CrI 0.30, 0.94], 0.58 [95% CrI 0.34, 0.98], respectively). All other treatments had similar maintenance of efficacy to VDZ 300 mg Q8W. For safety outcomes, GOL had significantly higher rates of overall AEs (GOL 100 mg OR: 2.17 [95% CrI 1.18, 4.00]; GOL 50 mg OR: 1.90 [95% CrI 1.02, 3.54]) relative to VDZ 300 mg Q8W. Both GOL 100 mg (OR: 1.84 [95% CrI 1.07, 3.18]) and TOFA 10 mg (OR: 2.03 [95% CrI 1.19, 3.55]) had significantly higher rates of infections, while UST 90 mg Q12W had significantly lower rates of infections (OR: 0.58 [95% CrI 0.33, 0.98]) relative to VDZ 300 mg Q8W. GOL 100 mg also had significantly higher rates of discontinuation due to AEs (OR: 3.43 [95% CrI 1.18, 10.22]). ADA 40 mg, IFX 10 mg/kg, and IFX 5 mg/kg were similar to VDZ 300 mg Q8W across all safety outcomes. CONCLUSION(S): Results from this NMA based on RCTs indicate a favorable benefit-risk profile for VDZ 300 mg Q8W compared with other advanced therapeutic options available for 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 | 0,026 | 0,039 |
| Méta-épidémiologie (sens strict) | 0,003 | 0,001 |
| Méta-épidémiologie (sens large) | 0,011 | 0,057 |
| Bibliométrie | 0,005 | 0,007 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,004 | 0,002 |
| Science ouverte | 0,003 | 0,002 |
| Intégrité de la recherche | 0,002 | 0,003 |
| 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 ».