S863 Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Bio-naïve Patients With Late Crohn’s Disease: Results from the EVOLVE Expansion Study
Notice bibliographique
Résumé
Introduction: Real-world data comparing the clinical effectiveness and safety of vedolizumab (VDZ) and ustekinumab (UST) in patients (pts) with late Crohn’s Disease (CD, with a disease duration ≥2 years) is limited. Methods: EVOLVE Expansion (NCT05056441) was a multicenter, observational, retrospective medical chart review study in Australia, Belgium, and Switzerland from 2016 to 2021 in which biologic-naïve pts with CD (≥18 years old) initiated first-line biologic treatment with VDZ or UST were included. In this analysis, we assessed treatment outcomes in CD patients with late treatment commencement with biologics (disease duration >2 years). Data collected were from treatment initiation to chart abstraction, death, treatment discontinuation or loss to follow-up, whichever came first. The Kaplan Meier method was used to estimate cumulative rates of clinical response, remission, mucosal healing, and treatment persistence over 36 months. Serious adverse events (SAEs), serious infections (SIs), CD exacerbations and CD-related hospitalizations and surgeries were also evaluated. Baseline demographic and clinical characteristics across treatment groups were balanced using inverse probability weighting (IPW). Results: A total of 203 patients initiating late treatment with VDZ and 168 with UST were included. 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 82.1%, UST 86.7%; P=0.49), clinical remission (VDZ 89.9%, UST 91.6%; P=0.98) and mucosal healing (VDZ 90.5%, UST 88.2%, P=0.36). Treatment persistence was significantly higher with UST (VDZ 70.2%, UST 76.8%; P=0.03). There were no significant differences in the risk of safety outcomes: SAEs (hazard ratio [HR]=1.07; CI 0.56-2.04; P=0.83), SIs (HR=6.93; CI 0.71-67.28; P=0.10), CD exacerbations (HR=1.07; CI 0.70-1.61; P=0.76), CD-related surgeries (HR=0.87; CI 0.49-1.56; P=0.64) or CD-related hospitalizations (HR=1.48; CI 0.63-3.50; P=0. 37). Conclusion: In CD pts with late initiation of treatment with a biologic, there were no significant differences between the VDZ and UST cohorts for clinical response, clinical remission, or mucosal healing. The probability of treatment persistence was greater in pts treated with UST. The risks of CD-related surgeries, hospitalizations, and SIs were similar between cohorts. Table 1. - Baseline Charactersitics Unweighted Weighted Baseline Characteristics VDZN=203 USTN=168 P-value VDZN=185 USTN=186 Std Diff after IPW Age (years), mean ± SD 50.3±16.2 47.9±15.5 0.1593 49.5±15.9 50.2±15.9 0.0416 Male, n (%) 100 (49.3) 90 (53.6) 0.4084 94 (50.6) 93 (49.8) 0.0083 Disease duration (years), median (min, max) 10.3 (2.0, 52.6) 12.1 (2.1, 46.0) 0.3395 10.5 (2.0-52.6) 10.1 (2.1-46.0) 0.0206 CD location 0.0179 Colonic with/without upper GI disease, n (%) 53 (26.1) 26 (15.5) 37 (20.1) 40 (21.7) 0.0201 Ileal with/without upper GI disease, n (%) 87 (42.9) 75 (44.6) 68 (36.8) 75 (40.6) 0.0309 Ileocolonic with/without upper GI disease, n (%) 57 (28.1) 57 (33.9) 65 (35.4) 53 (28.5) 0.0029 Disease behavior 0.0625 Non-stricturing, non-penetrating, n (%) 124 (61.1) 86 (51.2) 116 (62.5) 92 (49.4) 0.0400 Penetrating, n (%) 9 (4.4) 18 (10.7) 15 (8.2) 20 (10.5) 0.0061 Stricturing, n (%) 61 (30.0) 58 (34.5) 33 (17.7) 47 (25.2) 0.0200 Disease severity 0.4837 Normal, n (%) 23 (11.3) 12 (7.1) 21 (11.1) 17 (9.1) Mild, n (%) 33 (16.3) 33 (19.6) 31 (16.9) 33 (17.6) 0.0053 Moderate, n (%) 108 (53.2) 96 (57.1) 98 (53.2) 110 (59.4) 0.0130 Severe, n (%) 16 (7.9) 9 (5.4) 14 (4.5) 12 (6.5) 0.0045 Active fistula* at index Yes, n (%) 24 (11.7) 29 (17.3) 0.1361 22 (11.8) 27 (14.3) 0.0023 Prior CD-related surgeries before treatment initiation Yes, n (%) 53 (25.7) 52 (31.0) 0.3025 54 (29.3) 57 (30.9) 0.0345 CD-related hospitalizations in previous 12 months Yes, n (%) 22 (10.8) 30 (17.9) 0.0525 25 (13.7) 25 (13.5) 0.0025 *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 | 0,007 | 0,008 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,002 |
| 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 ».