Ustekinumab for the Treatment of Crohn’s Disease
Notice bibliographique
Résumé
Introduction: Ustekinumab is a humanized immunoglobulin G monoclonal antibody that targets the shared p40 subunit of interleukin IL-12 and IL-23. It demonstrated promises in phase 2 trials for induction and maintenance therapy of anti-TNF resistant Crohn’s Disease (CD). In this study we sought to present our experience with subcutaneous ustekinumab in anti TNF resistant CD patients in a tertiary referral center. Methods: We performed a retrospective chart review of patients who were prescribed ustekinumab for treatment of CD between January 2010 and May 2014. Demographic, clinical, and treatment data were obtained. Primary end points were clinical response and remission which were defined as 3 points decline in Harvey-Bradshaw score from baseline and HBI less than 5 at week 8 respectively. Secondary outcomes were clinical response and maintenance of remission at 6 months. We also reviewed ancillary outcome such as modified short inflammatory bowel disease questionnaire (SIBDQ), mucosal healing, and serious adverse events. Results: The demographic characteristics of the patients were as follows: 14 (74%) female; 17 (90%) white; 2 (10%) Hispanic; mean age 36±16.7; and BMI 24±6.2. The disease characteristics based on Montreal classification were as follows: location 100% ileocolonic; disease phenotype: penetrating (B3)-90%; stricturing (B2)-10%. Twelve patients (63%) had perianal involvement, 4 (21%) had ileostomy, and 18 (94%) were steroid refractory. Previous treatment included one anti TNF failure in 5 patients (26%) and >1 anti TNF failure in 14 (74%). Three (15%), 9 (47%) and 5 (26.3%) failed concomitant methotrexate, 6 MP and imuran therapy respectively. Three patients were excluded as they just started therapy. All patients received ustekinumab 90 mg subcutaneous at week 0, 2, 8 as induction therapy. The maintenance dose was 90 mg subcutaneous every 8 weeks. Follow-up data was available for 16 and 11 patients at week 8 and 6 months respectively. Conclusion: Clinical response and remission were achieved in 13 out of 16 (81%) and 9 out of 16 (56%) patients at 8 weeks. In 6 months 7 out of 11 (63%) patients maintained their clinical response and 5 (45%) remained in clinical remission. Eleven out of 16 (69%) patients had SIBDQ improvement at week 8. Of 11 patients who had data available at 6 months, 8 (72%) had SIBDQ>35. Two out of 5 patients achieved mucosal healing at either 8 week or 6 months. Of 10 patients who had repeat imaging either at 8 weeks or 6 months, 4 showed improvement and 6 remained unchanged. None of our patients developed serious adverse events. In this cohort of patients with anti-TNF resistant CD, ustekinumab use resulted in clinical response in 81% and remission in 56% of patients with majority maintaining clinical response and remission up to 6 months of follow-up. Disclosure - Dr. Sarah Glover - Advisory Committee: Abbvie, Grant/Research Support: Biogen, Bristol Myers Squibb, Celgene, Elan, Janssen, Pfizer and UCB.
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 | 0,000 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,005 | 0,001 |
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 ».