OP010 Long term efficacy and safety of Ustekinumab for Crohn's disease: results from IM-UNITI long-term extension through 2 years
Notice bibliographique
Résumé
Background: Ustekinumab (UST) is a fully human IGG1 mAB to human IL 12/23p40 approved for treatment of moderate to severe active Crohn's disease (CD). The ongoing IM-UNITI long-term extension (LTE) evaluates efficacy & safety of subcutaneous (SC) UST through approximately 5 years of treatment, with results through wk96 reported herein. Methods: 1281 patients (pts) entered the maintenance study, including 397 UST induction responders in the primary population (randomized to SC placebo (PBO); n=133, UST 90mg q12w (q12w); n=132, or UST 90mg q8w (q8w); n=132). A one-time dose adjustment to 90mg q8w occurred in pts in the randomized group who met loss of response criteria between wks8 & 32. Non-randomized pts included: PBO induction responders who continued on PBO, non-responders to PBO induction who received a single UST 130mg IV dose then UST 90mg SC q12w if in clinical response at wk8, & non-responders to UST induction who received UST 90mg SC & if in clinical response at wk8 continued on UST 90 mg q8w. All pts completing wk44 were eligible to enter LTE continuing on the treatment they were on at wk44. This included 567 UST treated pts of which 237 were from the primary population. Pts receiving PBO were discontinued following the unblinding of the entire study, which occurred after the Week 44 DBL. Results: Table 1 presents analyses for randomized pts where pts with missing data or who discontinued are assumed not to be in response or remission at wk92, with 72.6% of q12w pts & 74.4% of q8w pts (non-dose adjusted) achieving remission at wk92. Based on observed data analyses, among randomized pts who continued to receive UST through wk96, 79.2% of q12w & 87.1% of q8w pts (non-dose adjusted) were in remission & 90.9% & 94.3% were in response at wk92, respectively. Among all UST treated pts who continued to receive UST through wk96, remission & response rates at wk92 were 70.7% & 84.7%. Safety events (per hundred subject years) were not higher among all UST treated pts compared to PBO from wk44 through wk96, including overall AE's (82.9 vs 91), SAE's (14.16 vs 18.2), & serious infections (3.73 vs 4.33), with 536.8 subject years of follow-up among UST treated pts & 115.4 subject years among PBO pts. Among all UST treated pts, there were 2 deaths (sudden death, asphyxia). There were two non-NMSC malignancies reported between wks44 & 96, a seminoma (UST) & a papillary thyroid cancer (PBO only). Conclusions: SC UST maintained clinical response & remission through two years. No new safety signals were observed.
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 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 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 ».