P352 Assessment of the use of therapeutic drug monitoring of Adalimumab during maintenance therapy in children with inflammatory bowel disease
Notice bibliographique
Résumé
Background: Adalimumab (ADA) is effective in the induction and maintenance of remission in pediatric Crohn's disease (CD). Pharmacokinetics analysis of the IMAgINE-1 study demonstrated that a higher ADA concentration is associated with greater rates of remission. Data remains scarce in terms of which level is predictive of clinical remission in pediatric patients. Moreover, few study, have established the rate of anti-adalimumab antibody (AAA) in this population. Methods: Aims: To review our experience with therapeutic drug monitoring (TDM) in children with CD and Ulcerative colitis (UC) treated with ADA. The primary objective was to assess the serum levels of ADA in children aged 5–18 years during maintenance. We also aim to 1) establish the rate of AAA in our population and 2) correlate the levels of ADA with clinical response. Methods: This was a single-center retrospective cohort study. Patients were included if they had at least one serum level of ADA/AAA drawn between June 2014 and November 2016. ADA and AAA analysis were performed in a central lab using a classic ELISA technique. We collected biochemical inflammatory markers drawn the same day or, if missing, at a maximum of two weeks prior to the ADA level. The physician global assessment (PGA) was also recorded if it was done within 4 weeks of the ADA level. Results: In our database, we identified 95 patients treated with ADA during the study period. Fifty-eight (61%) had at least 1 ADA level drawn (47 with CD, 9 patients with UC and 2 with Indeterminate colitis (IBD-U)). The 2 patients with IBD-U were excluded. Eleven CD patients (19%) had not received infliximab prior to initiating ADA. We collected 97 ADA levels (84% in CD). The overall median ADA level was 12 ug/mL, with a median dose of 0.74 mg/Kg/ injection and at a median frequency of every 14 days. Four patients, all with CD, developed AAA (7.14%). A weekly administration was associated with a higher drug level (14.8 vs 10.1ug/mL, p-value 0.0011). A PGA of remission was linked to 47 (55.3%) levels. An ADA level above 10 correlated with remission according to PGA with a sensitivity of 76% and a specificity of 47.4% (p-value 0.0205). AAA and previous infliximab exposure correlated with a lower in ADA level (p=0.0016 and 0.0448 respectively). Combination therapy improved ADA levels in all patients, but more significantly in patients previously exposed to infliximab (p=0.0369). Conclusions: ADA measurement is a useful tool in monitoring therapy in children with CD or UC. Aiming for levels above 10 ug/mL could be a target, as it correlates with clinical remission. Combination therapy helps to improve ADA levels. Prospective studies are required to better assess the role of TDM with ADA therapy.
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 | 0,001 | 0,007 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,001 | 0,002 |
| 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 | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 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 ».