S1122 Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Bio-Naïve Patients With Non-Complicated Crohn’s Disease: Results From the EVOLVE Expansion Study
Notice bibliographique
Résumé
Introduction: Crohn’s disease (CD) complexity may affect treatment (Tx) outcomes. This analysis compared real-world clinical effectiveness and safety of vedolizumab (VDZ) and ustekinumab (UST) in bio-naïve patients with non-complicated CD. Methods: EVOLVE Expansion (NCT05056441) was a multicenter, observational, retrospective study analyzing medical charts of bio-naïve patients with CD aged ≥ 18 who initiated VDZ or UST (index) from 2016 to 2021 in Australia, Belgium, or Switzerland. Outcomes in pts with non-complicated CD (defined as no active fistula at index, no prior CD-related surgeries, and no CD-related hospitalizations in 12 months prior to index) were evaluated in a subgroup analysis. Data were collected from index to chart abstraction initiation, Tx discontinuation, death, or loss to follow-up, whichever was first. Time-to-event analyses for clinical outcomes (clinical response, clinical remission, and mucosal healing, assessed using published algorithms1) and Tx persistence during 36 months of Tx were conducted using Kaplan-Meier method. Safety (serious adverse events [SAEs], serious infections [SIs]) and healthcare resource utilization (HCRU; CD exacerbations, CD-related hospitalizations, CD-related surgeries) were also analyzed. Baseline characteristics between cohorts were balanced using inverse probability of treatment weighting (IPTW). Results: Overall, 425 pts (VDZ 244, UST 181) were included in this analysis. After IPTW, baseline characteristics were similar between groups (Table 1). During 36 months of Tx, weighted cumulative rates of clinical response (VDZ 85.0%, UST 85.6%; P=0.70), clinical remission (VDZ 93.3%, UST 91.3%, P=0.80), mucosal healing (VDZ 90.6%, UST 91.7%, P=0.14), and Tx persistence (VDZ 71.8%, UST 83.7%, P=0.07) were similar between both cohorts. During 36 months, risks of SAEs (HR=1.23; 95% CI, 0.62-2.46; P=0.55), SIs (HR=1.26; 95% CI 0.22-7.24; P=0.80), CD exacerbations (HR=1.09; 95% CI 0.74-1.61; P=0.66), CD-related surgeries (HR=1.11; 95% CI 0.47-2.62; P=0.82), and CD-related hospitalizations (HR=0.71; 95% CI 0.33-1.56; P=0.40) were similar between VDZ and UST cohorts. Conclusion: Over 36 months in a real-world clinical setting, cumulative rates of clinical response, clinical remission, mucosal healing, and Tx persistence, and rates of SAEs, SIs, and HCRU outcomes were not significantly different in patients with non-complicated CD who initiated VDZ or UST as a first-line biologic. Reference: 1. Bressler B, et al. J Crohns Colitis. 2021;15(10):1694-1706. Table 1. - Baseline characteristics of bio-naïve patients with non-complicated CD initiating first-line biologic treatment with vedolizumab or ustekinumab Unweighted Weighted Baseline characteristic VDZn=244 USTn=181 p value* VDZn=210 USTn=215 Std Diff after IPTW Age, mean±SD, y 46.5±17.6 43.3±17.3 0.06 45.7±16.6 45.7±18.1 0.001 Male, n (%) 118 (48.4) 93 (51.4) 0.54 102 (48.7) 100 (46.7) 0.040 Smoking status, n (%) 0.27 0.190 Current 46 (18.9) 31 (17.1) 113 (53.8) 123 (57.1) Former 50 (20.5) 25 (13.8) 43 (20.6) 30 (13.8) Never 128 (52.5) 108 (59.7) 36 (17.0) 43 (19.9) Disease duration, n with available data 242 181 Median (min, max), y 3.5 (0.0–46.0) 2.5 (0.0–40.0) 0.40 3.5 (0.0–46.0) 3.7 (0.0–40.0) 0.139 CD location at Tx initiation, n (%) 0.03 Colonic with/without upper GI disease 65 (26.6) 28 (15.5) 43 (20.4) 48 (22.3) 0.029 Ileal with/without upper GI disease 106 (43.4) 86 (47.5) 94 (44.7) 93 (43.1) 0.012 Ileocolonic with/without upper GI disease 63 (25.8) 63 (34.8) 68 (32.2) 68 (31.7) 0.020 Disease behavior at Tx initiation, n (%) 0.11 < 0.001 Non-stricturing, non-penetrating 174 (71.3) 113 (62.4) 161 (76.6) 145 (67.6) Penetrating 7 (2.9) 11 (6.1) 9 (4.1) 12 (5.7) Stricturing 51 (20.9) 50 (27.6) 29 (14.0) 40 (18.6) Disease severity at Tx initiation, n (%) 0.03 Normal 21 (8.6) 13 (7.2) 17 (8.3) 22 (20.1) Mild 55 (22.5) 20 (11.0) 51 (24.1) 21 (9.6) 0.002 Moderate 123 (50.4) 114 (63.0) 106 (50.5) 131 (60.8) 0.022 Severe 22 (9.0) 16 (8.8) 19 (9.2) 20 (9.5) 0.037 History of fistula† prior to Tx initiation, n (%) 5 (2.0) 10 (5.5) 0.05 4 (1.7) 11 (5.3) 0.196 *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 | 0,007 | 0,011 |
| 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 | 0,001 |
| 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 ».