P325 Integrating efficacy and safety of vedolizumab and other advanced therapies for the treatment of ulcerative colitis: Results from a network meta-analysis
Notice bibliographique
Résumé
Direct head-to-head comparisons of the efficacy and safety of advanced therapies for ulcerative colitis (UC) are limited. We performed a systematic literature review and indirect treatment comparison of randomised controlled trials (RCTs) of biologics and tofacitinib (TOFA) for UC. Medline, Embase, and Cochrane Library databases were searched from 1997 to July 2018 to identify RCTs of vedolizumab (VDZ), adalimumab (ADA), infliximab (IFX), golimumab (GOL) and TOFA. Efficacy outcomes were sustained response and remission at 1 y. Safety outcomes were overall adverse events (AEs), serious AEs (SAEs), overall infections, serious infections, and AEs leading to discontinuation as reported at 1 year. Odds ratios (OR) with 95% credible intervals (CrI) were estimated using network meta-analyses (NMA) and were transformed into number-needed-to-treat (NNT) and number-needed-to-harm (NNH) using the pooled placebo (PBO) estimates across all trials. Results are reported for the overall population and among bio-naïve patients. Data for sustained response and remission with TOFA for bio-naïve patients were not available. Six RCTs were included in the NMA. Overall, VDZ 300 mg Q8W had statistically significantly higher chances of sustained response and remission (OR: 2.20 [1.07–4.64] and 2.57 [1.09–6.13], respectively) compared with ADA. In bio-naïve patients, VDZ 300 mg q8w had numerically higher OR of both sustained response and remission compared with all other therapies; however, the results were not statistically significant (data not shown). Compared with PBO, the OR of SR was statistically significantly higher for all the interventions (Table 1). The lowest NNT for sustained remission was with TOFA in the overall population and with VDZ in bio-naïve patients. Similar trends were observed for SR. The risk of all the AEs (including SAEs) was numerically the lowest with VDZ, with NNH values closest to PBO (Table 2). Indirect treatment comparisons from this NMA suggested VDZ may achieve higher rates of both sustained response and sustained remission than comparator therapies in the overall study populations and was associated with lowest risk of AEs. These findings support the favourable benefit-risk profile of VDZ in UC, especially in bio-naïve patients. Head-head trials are required to confirm the findings. Table 1. Odds ratios and number-needed-to-treat for sustained remission with vedolizumab and other treatments for ulcerative colitis. Table 2. Odds ratios and number-needed-to-harm for safety outcomes with vedolizumab and other treatments for ulcerative colitis.
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 | 0,048 |
| Méta-épidémiologie (sens strict) | 0,004 | 0,001 |
| Méta-épidémiologie (sens large) | 0,013 | 0,051 |
| Bibliométrie | 0,007 | 0,007 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,005 | 0,002 |
| Science ouverte | 0,002 | 0,003 |
| Intégrité de la recherche | 0,002 | 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 ».