S849 Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Bio-Naïve Patients With Complex Crohn’s Disease: Results From the EVOLVE Expansion Study
Notice bibliographique
Résumé
Introduction: Effectiveness of Crohn’s disease (CD) treatment (Tx) may vary per CD complexity. This analysis compared real-world clinical effectiveness and safety of vedolizumab (VDZ) and ustekinumab (UST) in bio-naïve patients (pts) with complex CD. Methods: Multicenter, observational, retrospective EVOLVE Expansion chart review study (NCT05056441) included bio-naïve pts with CD (≥ 18 years old) who initiated VDZ or UST in Australia, Belgium, or Switzerland from 2016 to 2021. A subgroup analysis analyzed outcomes in pts with complex CD (defined as at least 1 of: active fistula at Tx initiation and/or any prior CD-related surgeries during disease duration and/or CD-related hospitalizations in 12 months before Tx initiation). Data were collected from Tx initiation to the first of: chart abstraction initiation, Tx discontinuation, death, or loss to follow-up. Cumulative rates of clinical response, clinical remission, mucosal healing (all assessed using published algorithms1) and Tx persistence over 36 months of Tx were estimated in time-to-event analysis using Kaplan-Meier method. Safety was evaluated as serious adverse events (SAEs) and serious infections (SIs); healthcare resource utilization (HCRU) was evaluated as CD exacerbations, CD-related hospitalizations, and CD-related surgeries. Inverse probability of treatment weighting (IPTW) was used to balance baseline characteristics between cohorts. P< 0.05 denoted statistical significance. Results: In total, 198 pts (VDZ 103, UST 95) with complex CD were included in this analysis. Baseline characteristics between groups were similar after IPTW (Table 1). During 36 months of Tx, pts from VDZ and UST cohorts had similar rates of clinical response (VDZ 76.4%, UST 80.2%; P=0.47), clinical remission (VDZ 79.9%, UST 83.1%; P=0.40), mucosal healing (VDZ 92.6%, UST 78.7%; P=0.05), and Tx persistence (VDZ 73.1%, UST 70.0%; P=0.81). There were no significant differences in the risk of SAEs (HR=0.84; 95% CI, 0.38-1.85; P=0.66), CD exacerbations (HR=0.89; 95% CI, 0.49-1.65; P=0.72), CD-related surgeries (HR=3.39; 95% CI, 0.97-11.84; P=0.06), and CD-related hospitalizations (HR=0.81; 95% CI, 0.42-1.57; P=0.53) during 36 months. Conclusion: In a real-world clinical setting, pts with complex CD had similar cumulative rates of clinical response, clinical remission, mucosal healing, and Tx persistence as well as similar risk of SAEs and HCRU outcomes between VDZ and UST cohorts during 36 months. Reference: 1. Bressler B, et al. J Crohns Colitis. 2021;15(10):1694-1706. Table 1. - Baseline characteristics of bio-naïve patients with complex CD initiating first-line biologic treatment with vedolizumab or ustekinumab Unweighted Weighted Baseline characteristic VDZ n=103 UST n=95 P value* VDZ n=101 UST n=97 Std Diff after IPTW Age, mean±SD, y 51.3±17.3 47.6±16.6 0.13 50.6±17.0 50.4±16.8 0.015 Male, n (%) 56 (54.4) 51 (53.7) 0.92 53 (52.6) 51 (52.2) 0.008 Smoking status, n (%) 0.56 0.169 Current 22 (21.4) 15 (15.8) 40 (39.4) 36 (36.9) Former 23 (22.3) 27 (28.4) 24 (24.3) 29 (30.1) Never 43 (41.7) 36 (37.9) 21 (21.2) 15 (15.7) Disease duration Median (min, max), y 6.2 (0.0, 52.6) 9.2 (0.0, 46.0) 0.81 9.7 (1.4–22) 8.5 (1.0–22) 0.060 CD location at Tx initiation, n (%) 0.41 Colonic with/without upper GI disease 19 (18.4) 9 (9.5) 14 (14.2) 10 (9.8) 0.028 Ileal with/without upper GI disease 52 (50.5) 49 (51.6) 43 (43.1) 43 (43.9) 0.012 Ileocolonic with/without upper GI disease 28 (27.2) 31 (32.6) 35 (34.8) 32 (32.4) 0.040 Disease behavior at Tx initiation, n (%) 0.62 0.016 Non-stricturing, non-penetrating 56 (54.4) 43 (45.3) 46 (46.1) 40 (41.3) Penetrating 12 (11.7) 15 (15.8) 16 (15.7) 16 (16.7) Stricturing 30 (29.1) 32 (33.7) 26 (25.7) 23 (23.8) Disease severity at Tx initiation, n (%) 0.60 Normal 12 (11.7) 9 (9.5) 10 (10.4) 11 (11.2) Mild 20 (19.4) 26 (27.4) 20 (20.1) 29 (29.7) Moderate 50 (48.5) 44 (46.3) 50 (49.8) 41 (42.6) 0.027 Severe 11 (10.7) 6 (6.3) 9 (8.6) 7 (6.9) 0.022 Fistula† prior to Tx initiation, n (%) 30 (29.1) 24 (25.3) 0.54 27 (26.4) 27 (27.3) 0.040 CD-related surgeries since CD diagnosis, n (%) 71 (68.9) 63 (66.3) 0.69 72 (71.6) 68 (69.9) 0.038 CD-related hospitalizations in the 12 months prior to Tx initiation, n (%) 53 (51.5) 54 (56.8) 0.45 53 (53.0) 51 (52.6) 0.008 *Unadjusted P values are reported.†Enterocutaneous, perianal, rectovaginal, other, or unknown.CD, Crohn’s disease; GI, gastrointestinal; IPTW, inverse probability of treatment weighting; Std Diff, standardized difference; Tx, treatment; UST, ustekinumab; VDZ, vedolizumab; y, years.
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 | 0,006 | 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 ».