P-066 YI Randomized Clinical Trial for Clinical Response Evaluation in Crohnʼs Disease
Notice bibliographique
Résumé
The introduction of biological therapy was a milestone in the treatment of Crohn's Disease (CD). Biological therapy promotes mucosal healing and decrease rates of hospitalizations and surgeries. In the current literature there are no prospective clinical trials comparing the clinical efficacy of Infliximab (IFX) versus adalimumab (ADA) in CD. The purpose of this study was to compare the efficacy of IFX versus ADA on clinical response and improvement of quality of life in patients with CD. A prospective and longitudinal study was carried out in patients with CD treated with anti-TNF agents. Patients with biologic therapy indication were randomized to receive either IFX or ADA and were evaluated at weeks 0, 14, 30 and 54 of treatment. The Crohn's Disease Activity Index (CDAI) was used to assess the clinical response of CD patients. We considered patients to be in long-term clinical remission if the CDAI was less than 150 through week 54 from the start of anti-TNF treatment. The inflammatory bowel disease questionnaire (IBDQ) was used to measure the health-related quality of life (HRQoL). Clinical data were evaluated as age, gender, disease duration, smoking and laboratory tests such as hemoglobin, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and albumin. Statistical analysis: descriptive analysis, ANOVA with repeated measures considering the interaction drug × time, then the adjusted Tukey's multiple comparison test. Sixteen individuals were included in this study, 10 female, 11 Caucasians and 6 smokers, the mean age was 37 (±12.5) years and a mean of 4.9 (±5.7) years of disease duration. They had the following characteristics determined by the Montreal classification: A1 (6.25%), A2 (75%) and A3 (18.75%); L1 (25%), L2 (31.25%) and L3 (43.75%); B1 (18.75%), B2 (50%), B3 (25%) and B2/B3 (6.25%). Mean of CDAI of 187.7 (±117.1) points, hemoglobin average of 11.9 (SD: 2.6) g/dL, ESR of 35.1 (SD: 27.7) mm/h, CRP of 2.5 (SD: 2.0) mg/dL, and albumin of 3.4 (SD: 0.8) g/dL. Nine of them received Adalimumab and 7 received Infliximab. Thirteen (86, 67%) experienced clinical response during follow-up (8 received ADA (88.9%) and 5 received IFX (83.3%); P = 1.0. Two (12.5%) patients underwent hospitalization and surgery, one from each group (P = 1.0), with no death in both groups. Only 8 patients completed 30 weeks and 4 patients have completed 54 weeks of treatment. There was an improvement in quality of life during follow-up for both treatment groups (P = 1.0). In ADA group, 62.5% of patients presented good/excellent quality of life at week 0 and 100% at week 54. In IFX group the percentage of patients with good/excellent quality of life increased from 14.3% to 100%. There was clinical response and improvement of quality of life of patients with CD treated with Biological Therapy. There was no difference between IFX and ADA group.
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 | 0,002 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,002 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,021 | 0,002 |
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 ».