S1145 Clinical Effectiveness and Safety of Vedolizumab in Patients With Crohn’s Disease in China: Results From a Real World Study
Notice bibliographique
Résumé
Introduction: Vedolizumab (VDZ) is a gut-selective antilymphocyte trafficking humanized monoclonal antibody that has demonstrated efficacy and safety for the treatment of moderate-to-severe Crohn’s Disease (CD) in global clinical trials. VDZ was conditionally approved in 2020 in China for the treatment of moderate to severe CD. The goal of this study was to evaluate the real-world clinical effectiveness and safety of VDZ in patients (pts) with CD in China. Methods: This was a multi-center, observational, retrospective medical chart review study in adult pts (≥18 years old) with active CD in China who initiated VDZ as any line of biologic treatment. Data were collected from VDZ 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 6, 18, and 30 months. Serious adverse events (SAEs), serious infections (SIs), CD exacerbations, and CD-related hospitalization and surgeries were also evaluated. Baseline demographic and clinical characteristics data were also collected. Results: In total, 131 Crohn’s disease pts who were treated with VDZ were included in the study. Baseline characteristics are shown in Table 1. Over 30 months, cumulative rates of clinical response and clinical remission were 69.6% and 46.8%, respectively and rates of mucosal healing and deep remission were 76.0% and 56.3%, respectively. The cumulative rate of treatment persistence over 30 months was 42.4%. The incidence rates per 100 patient-years was 4.73 (95% CI: 2.36, 9.45) for serious adverse events and 0.58 (95% CI: 0.08, 4.12) for serious infections. Incidence rates per 100 patient years for other outcomes were as follows: CD exacerbations 8.71 (95% CI: 5.16, 14.71), CD-related emergency department visits 1.17 (95% CI: 0.29, 4.66), and CD-related surgeries 5.49 (95% CI: 2.86, 10.55). Conclusion: VDZ is an effective and safe longer-term treatment in patients with CD in China. Results from this real-world study were consistent with results from previous global studies, supporting the effectiveness and safety of VDZ treatment across global regions. Acknowledgements: Medical writing support was provided by Paul Hassan, PhD, of Excel Scientific Solutions, and funded by Takeda. Table 1. - Baseline characteristics Baseline Characteristics VDZN=131 Age (years), mean ± SD 35.2±12.6 Male, n (%) 80 (61.1) Disease duration (years), mean ± SD 4.2(±4.2) CD location Colonic with/without upper GI disease, n (%) 21 (16.0) Ileal with/without upper GI disease, n (%) 16 (12.2) Ileocolonic with/without upper GI disease, n (%) 68 (51.9) Disease behavior Non-stricturing, non-penetrating, n (%) 36 (27.5) Stricturing, n (%) 45 (34.4) Penetrating, n (%) 23 (17.6) Disease severity Normal, n (%) 8 (6.1) Mild, n (%) 48 (36.6) Moderate, n (%) 43 (32.8) Severe, n (%) 8 (6.1) Active fistula* prior to index VDZ treatment initiation Yes, n (%) 54 (41.2) Prior CD-related surgeries before index VDZ treatment initiation Yes, n (%) 27 (20.6) CD-related hospitalizations 12 months before index VDZ treatment initiation** 77 (58.8) Prior non-biologic therapy before index VDZ treatment initiation 66 (50.4) Prior biologic therapy before index VDZ treatment initiation 53 (40.5) *Includes enterocutaneous, perianal, rectovaginal, other, and unknown.**Includes majority hospital visits to evaluate the CD signs and symptoms (97[71.3%]), acute CD flares (15 [11%]), surgery (10[7.4%]), among 136 hospital visits by 77 patients.CD, Crohn's disease; GI, gastrointestinal; Std Diff, standardized difference; VDZ, vedolizumab.
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 | 0,003 | 0,003 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 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 ».