S862 Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Bio-Naïve Patients With Early Crohn’s Disease: Results From the EVOLVE Expansion Study
Notice bibliographique
Résumé
Introduction: There is limited data comparing real-world clinical effectiveness and safety of vedolizumab (VDZ) and ustekinumab (UST) in patients (pts) with early Crohn’s Disease (CD, with a disease duration ≤2 years). Methods: EVOLVE Expansion (NCT05056441) was a multicenter, observational, retrospective medical chart review study in biologic-naïve pts with CD (≥18 years old) who initiated VDZ or UST treatment in Australia, Belgium, or Switzerland from 2016 to 2021. This analysis looked at treatment outcomes in patients with early treatment (disease duration ≤2 years) who initiated VDZ or UST as first-line biologic. Data were collected from treatment initiation to chart abstraction, treatment discontinuation, death, or loss to follow-up. Cumulative rates of clinical response, remission, mucosal healing, and treatment persistence were estimated using the Kaplan Meier method over 12, 24 and 36 months. Serious adverse events (SAEs), serious infections (SIs), CD exacerbations, and CD-related hospitalization and surgeries were also evaluated. Baseline demographic and clinical characteristics across treatment groups were balanced using inverse probability weighting (IPW). Results: There were 141 VDZ and 108 UST pts with early treatment. After IPW, both groups had similar baseline characteristics (Table 1). Over 36 months, cumulative rates were similar between VDZ- and UST-treated pts for clinical response (VDZ 80.8%, UST 79.0%; P=0.52) and clinical remission (VDZ 85.3%, UST 82.8%; P=0.52). Mucosal healing rates were significantly higher in VDZ- vs UST-treated pts (VDZ 92.5%, UST 87.0%, P=0.02). Treatment persistence (VDZ 64.6%, UST 76.7%; P=0.57) was not significantly different over 36 months. There were no significant differences in the risk of safety outcomes: SAEs (hazard ratio [HR]=1.23; CI 0.56-2.72; P=0.60), SIs (HR=6.57; CI 0.44-98.04; P=0.17), CD exacerbations (HR=1.07; CI 0.65-1.75; P=0.79), CD-related surgeries (HR=0.82; CI 0.38-1.76; P=0.61) or CD-related hospitalizations (HR=0.83; CI 0.35-1.95; P=0.67). Conclusion: In CD pts with early initiation of biologic treatment, rates of mucosal healing were significantly greater with VDZ vs UST. There were no significant differences between the VDZ and UST cohorts in clinical remission, clinical response, or treatment persistence. The probability of mucosal healing was significantly greater in pts treated with VDZ. The risk of CD-related hospitalization, surgeries, SAEs and SIs was similar between cohorts. Table 1. - Baseline Characteristics Unweighted Weighted Baseline Characteristics VDZN=141 USTN=108 P-value VDZN=126 USTN=123 Std Diff after IPW Age (years), mean ± SD 44.5±19.1 39.9±18.5 0.0567 42.9±18.5 43.0±19.0 0.0035 Male, n (%) 72 (51.1) 54 (50.0) 0.8678 66 (52.3) 61 (49.4) 0.0595 Disease duration (years), median (min, max) 0.5 (0.0, 2.0) 0.5 (0.0, 1.9) 0.7667 0.5 (0, 2.0) 0.4 (0, 1.9) 0.0501 CD location 0.0152 Colonic with/without upper GI disease, n (%) 28 (19.9) 11 (10.2) 21 (17.0) 13 (10.9) 0.0807 Ileal with/without upper GI disease, n (%) 71 (50.4) 60 (55.6) 69 (55.2) 64 (52.1) 0.0585 Ileocolonic with/without upper GI disease, n (%) 34 (24.1) 37 (34.3) 33 (26.3) 44 (35.6) 0.1115 Disease behavior 0.3313 0.0976 Non-stricturing, non-penetrating, n (%) 104 (73.8) 70 (64.8) 99 (78.7) 88 (71.7) Penetrating, n (%) 10 (7.1) 8 (7.4) 9 (7.0) 7 (6.0) Stricturing, n (%) 19 (13.5) 24 (22.2) 15 (11.8) 22 (17.7) Disease severity 0.0384 Normal, n (%) 10 (7.1) 10 (9.3) 9 (7.3) 13 (10.5) Mild, n (%) 40 (28.4) 13 (12.0) 40 (31.4) 17 (13.4) 0.1347 Moderate, n (%) 64 (45.4) 62 (57.4) 54 (43.0) 66 (53.2) 0.0885 Severe, n (%) 17 (12.1) 13 (12.0) 16 (12.4) 16 (12.7) 0.0914 Active fistula* at index Yes, n (%) 11 (7.8) 5 (4.6) 0.3118 8 (6.2) 6 (5.0) 0.0109 Prior CD-related surgeries before treatment initiation Yes, n (%) 18 (12.8) 11 (10.2) 0.5292 13 (10.3) 12 (9.9) 0.0525 CD-related hospitalizations in previous 12 months Yes, n (%) 30 (21.3) 24 (22.2) 0.8576 27 (21.3) 25 (20.1) 0.0120 *Includes enterocutaneous, perianal, rectovaginal, other, and unknown. CD, Crohn’s disease; GI, gastrointestinal; IPW, inverse probability weighting; NA, not available; Std Diff, standardized difference; UST, ustekinumab, VDZ, vedolizumab.
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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 | 0,006 | 0,006 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,001 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 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 ».