Vedolizumab Demonstrates Early Symptomatic Improvement in Ulcerative Colitis: A GEMINI 1 Post hoc Analysis
Notice bibliographique
Résumé
Introduction: Vedolizumab (VDZ) achieves long term clinical remission and mucosal healing in patients (pts) with moderately to severely active ulcerative colitis (UC).1 Relief of rectal bleeding (RB) and stool frequency (SF) remain important treatment goals for pts and key indicators of remission for physicians. We aimed to characterize early symptomatic response with VDZ, specifically evaluating the timing of RB and SF improvement. Methods: We assessed symptomatic improvement with VDZ through post hoc analysis of GEMINI 1 data. Pts with active UC were randomized to receive double-blind placebo (PBO) or VDZ at weeks (wks) 0 and 2 during the 6-wk induction phase. Mayo clinic SF subscores (SFS) and RB subscore (RBS) were evaluated at 0, 2, 4, and 6 wks. Mean subscores and mean percent change from baseline (BL) were reported for the overall population and in those who were tumor necrosis factor antagonist (anti-TNF) naïve. The percentages of pts who reached SFS ≤1 and/or RBS of 0 were also determined. Results: In anti-TNF-naïve pts, greater percentage decreases in mean SFS from BL were observed with VDZ than with PBO, reaching statistical significance at wks 4 and 6 as suggested by the non-overlapping 95% confidence intervals (Fig. 1). The same trends were observed in the overall population without reaching statistical significance. Similarly, a numerically greater percentage decrease from BL in RBS was observed with VDZ than with PBO, reaching statistical significance at wk 6 in both anti-TNF-naïve and overall populations (Fig. 2). Significantly larger percentages of pts overall achieved SFS ≤1 or RBS of 0 with VDZ than with PBO at wk 6 and as early as wk 2 among the anti-TNF-naïve population (Table). A composite of SFS ≤1 and RBS of 0 was achieved in a significantly greater percentage of pts with VDZ than PBO at all time points (Table).Figure: Percent change from baseline in stool frequency subscore *Data points represent adjusted percentage change from BL mean, where adjustment is for BL value and treatment. Error bars represent standard error and values in parentheses are 95% CI. Patients with BL SFS=0 were excluded from this analysis. Of note, the number of patients varies per study population at weeks 2, 4 and 6 and is reported below the x-axis. Abbreviations: anti-TNF, tumor necrosis factor antagonist; BL, baseline; CI, confidence interval; PBO, placebo; pts, patients; SFS, stool frequency subscore; VDZ, vedolizumab.Figure: Percent change from baseline in rectal bleeding subscore *Data points represent adjusted percentage change from BL mean, where adjustment is for BL value and treatment. Error bars represent standard error and values in parentheses represent 95% CI. Patients with BL RBS=0 were excluded from this analysis. Of note, the number of patients varies per study population at weeks 2, 4 and 6 and is reported below the x-axis. Abbreviations: anti-TNF, tumor necrosis factor antagonist; BL, baseline; CI, confidence interval; PBO, placebo; pts, patients; RBS, rectal bleeding subscore; VDZ, vedolizumab.Table: Table. Proportion of patients who achieved SFS ≤1, RBS = 0, or bothConclusion: Symptomatic improvements were achieved with VDZ as early as wk 2, with greater differences from PBO observed in anti-TNF-naïve pts. These results highlight the rapid onset of VDZ in UC; however, assessing efficacy at wk 14 and beyond for those who exhibit a more gradual response should be used to inform clinical practice.
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 | 0,008 | 0,006 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,002 |
| Bibliométrie | 0,001 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,001 |
| 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 ».