Impact of Adalimumab therapy after 12 Weeks in patients with Crohnʼs Disease who were nonresponders at week 4
Notice bibliographique
Résumé
Adalimumab, a fully human antibody targeting tumor necrosis factor, is approved for treatment of adults with moderate to severe Crohn's disease (CD). In clinical trials, 52-58% of patients responded to adalimumab by Week 41,2; however, some patients require additional time to respond. Additional data on the length of an adequate trial of adalimumab may benefit physicians when making treatment decisions. This analysis assessed the efficacy of adalimumab by Week 12 among patients who did not respond after 4 weeks using data from 2 clinical trials: the Crohn's Trial of the Fully Human Antibody Adalimumab for Remission Maintenance (CHARM) and the open-label extension (OLE) of the Gauging Adalimumab Efficacy in Infliximab Nonresponders (GAIN) study. In CHARM, following a 4-week induction period in which all patients received OL adalimumab 80 mg/40 mg at Weeks 0/2, patients were randomized to placebo, adalimumab 40 mg every other week (eow), or adalimumab 40 mg weekly. In GAIN, patients who failed infliximab were randomized to adalimumab 160 mg/80 mg or placebo induction at Weeks 0/2. After 4 weeks, patients could enroll in an OLE study in which they received adalimumab 40 mg eow. Remission (CD Activity Index [CDAI] <150) and clinical response (CR-70; defined as a decrease from baseline CDAI of greater than or equal to 70 points) rates by Week 12 were evaluated for CHARM patients who were randomized to blinded adalimumab 40 mg eow and did not achieve a CR-70 response at Week 4 and GAIN patients who received OL adalimumab 40 mg eow after being randomized to the blinded adalimumab 160-/80-mg induction dose and did not achieve a CR-70 response at Week 4. In CHARM, 260 patients were initially randomized to blinded adalimumab 40 mg eow. Among 88 patients who did not respond (CR-70) at Week 4, 60% achieved CR-70 and 28% achieved remission by Week 12. By Week 12, 82% and 57% of patients who were randomized to eow therapy (including Week-4 responders and nonresponders) achieved CR-70 and remission, respectively. In GAIN, 159 patients were initially randomized to adalimumab 160 mg/80 mg; 150 with nonmissing CDAI entered the OLE. Among 69 patients who did not respond (CR-70) at Week 4, 67% receiving OL adalimumab 40 mg eow achieved CR-70 and 25% achieved remission by Week 12. Combining responders and nonresponders (n = 150), most patients achieved CR-70 response (85%) and remission (45%) by Week 12. Most initial Week-4 nonresponders benefited from continued treatment with adalimumab 40 mg eow through Week 12, with almost two-thirds achieving CR-70 response and more than one-fourth achieving remission. When continuing adalimumab therapy for up to 12 weeks, incremental benefits in clinical response were demonstrated in patients not responding to initial induction dosing.
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 | 0,003 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,002 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 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) | 0,002 | 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 ».