P451 Efficacy and safety of tofacitinib in the treatment of patients with active, moderate to severe, Ulcerative Colitis: a systematic review and meta-analysis
Notice bibliographique
Résumé
Abstract Background To perform a systematic review and meta-analysis to discuss the efficacy and safety of tofacitinib in patients with moderate to severe ulcerative colitis (UC). Methods We searched PubMed, Scopus, Web of Science, in addition to Cochrane Central, until May 2020 using relevant keywords. We included randomized controlled trials (RCTs) in addition to cohort studies that compared tofacitinib oral treatment versus placebo in patients with active UC, with a moderate to severe degree. Quality of included RCTs was assessed by the Cochrane risk of bias assessment tool, whereas the Newcastle-Ottawa scale was applied to assess for bias sources in included cohort studies. Data were pooled, after being extracted, from eligible articles in the review manager software, or the open meta-analyst software. Dichotomous outcomes were pooled as risk ratios (RR) under the fixed effect model, while continuous outcomes were pooled as standardized mean difference (SMD) under the random-effects model. Results pooling data from seven RCTs and four cohort studies, 2728 patients, showed that tofacitinib therapy was superior to placebo in inducing a clinical response in UC patients after eight weeks (p = 0.0001) and 26 weeks, in a proportion 0.4 of patients who took tofacitinib 10 mg BID. Additionally, tofacitinib treatment was associated with significantly higher events of clinical remission of UC, after eight weeks (RR= 3.12, 95% CI [2.34, 4.16], p < 0.0001). Likewise, endoscopic, deep, in addition to symptomatic remission rates were higher in the tofacitinib group, compared to the group of placebo (p ≤ 0.008). Most of the drug-related adverse events were comparable between tofacitinib and placebo groups. However, tofacitinib treatment was associated with fewer serious adverse events (RR= 0.68, 95% CI [0.48, 0.98], p = 0.04); adverse events that led to drug discontinuation (RR= 0.53, 95% CI [0.39, 0.73], p< 0.0001); and worsening of UC (RR= 0.48, 95% CI [0.38, 0.61], p < 0.00001). On the other hand, the placebo group had fewer overall infections (p = 0.002); and elevation in laboratory parameters, including LDL cholesterol, total cholesterol, and triglycerides. Conclusion Our systematic review and meta-analysis showed that, in patients with active moderate to severe UC, tofacitinib treatment was superior to placebo in inducing clinical response and remission, with less adverse reactions. Additionally, treatment with tofacitinib showed beneficial quality of life and survival benefits for UC patients. Future clinical trials should study the effect of higher doses of tofacitinib in larger RCTs, with longer follow up periods.
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 | 0,019 | 0,044 |
| Méta-épidémiologie (sens strict) | 0,003 | 0,002 |
| Méta-épidémiologie (sens large) | 0,020 | 0,035 |
| Bibliométrie | 0,012 | 0,011 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,005 | 0,002 |
| Science ouverte | 0,002 | 0,002 |
| Intégrité de la recherche | 0,002 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,004 | 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 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 ».