A126 REAL WORLD CLINICAL EFFICACY OF LOW DOSE USTEKINUMAB INDUCTION IN CROHN’S PATIENTS REFRACTORY TO ANTI-TNF THERAPY
Notice bibliographique
Résumé
Patients with moderate to severe Crohn’s disease refractory or intolerant to steroids, immunomodulators and anti-TNF therapy currently have few options for medical management outside of clinical trials. Ustekinumab, a monoclonal antibody, which inhibits interleukins 12 and 23 is currently being used safely and effectively to treat patients with psoriasis and recent studies suggest that it may be of value in treating moderate to severe Crohn’s disease in patients both naive and refractory to anti-TNF therapy. Currently the intravenous formulation of ustekinumab used in these studies is unavailable for use outside of clinical trials. The aim of this study was to examine the clinical efficacy of subcutaneously (sc) loaded ustekinumab in patients with moderate to severe Crohn’s disease who had failed at least one anti-TNF agent. All patients given a loading dose of ustekinumab 270 mg sc over two weeks were included in this retrospective analysis. Baseline demographic data was collected. The primary outcome was the proportion of patients who achieved a Harvey-Bradshaw Index (HBI) </= 3 and who remained on ustekinumab at six months of therapy post loading dose, without requiring a change in ustekinumab dose nor the addition of any new agents to treat their Crohn’s disease. Secondary outcome measures included the number of patients with serious adverse effects, the proportion of patents judged as improved (reduction of their HBI but not meeting the target of 3 or less) and the proportion of patients with a HBI </=3 regardless of whether or not their Crohn’s medications were increased. 47 patients were started on sc ustekinumab, among which 30 (64%) were females. The age of patients ranged from 24 to 74 years old with a mean of 46.1 years of age. Twenty eight (60%) had failed two anti-TNF agents while the remainder had failed only one. The mean HBI at drug initiation was 9.7 (range 5 to 16). All patients were still on ustekinumab at six months with 2 patients (4 %) every 12 weeks, 43 patients (92%) every 8 weeks, 1 patient (2%) every 6 weeks, and 1 patient (2%) every 4 weeks). At six month follow up 24/47 patients (51%) had an improvement in HBI of at least 3 points and 10/47 (21%) met the primary outcome measure of HBI 3 or less. No serious adverse events (ie. infection, systemic allergic reactions or malignancies) were observed. Loading doses of ustekinumab 270 mg sc administered over a two week period followed by maintenance doses at 4 or 12 week intervals appear to be clinically efficacious in the treatment of patients with moderate to severe Crohn’s disease refractory to anti-TNF therapy. With further experience it will be determined whether higher loading and maintenance doses given either sc or intravenously will further improve the rates of response and remission. None
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 | 0,004 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| 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 | 0,001 |
| 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 ».