Prospective study to characterize adalimumab exposure in pediatric patients with rheumatic diseases.
Drug exposure
Heterogeneity
Pharmacodynamics
Pharmacokinetics
Target concentration
Therapeutic drug monitoring
bDMARDs
Journal
Pediatric rheumatology online journal
ISSN: 1546-0096
Titre abrégé: Pediatr Rheumatol Online J
Pays: England
ID NLM: 101248897
Informations de publication
Date de publication:
02 Jan 2024
02 Jan 2024
Historique:
received:
30
08
2023
accepted:
15
11
2023
medline:
4
1
2024
pubmed:
4
1
2024
entrez:
3
1
2024
Statut:
epublish
Résumé
In pediatric rheumatic diseases (PRD), adalimumab is dosed using fixed weight-based bands irrespective of methotrexate co-treatment, disease activity (DA) or other factors that might influence adalimumab pharmacokinetics (PK). In rheumatoid arthritis (RA) adalimumab exposure between 2-8 mg/L is associated with clinical response. PRD data on adalimumab is scarce. Therefore, this study aimed to analyze adalimumab PK and its variability in PRD treated with/without methotrexate. A two-center prospective study in PRD patients aged 2-18 years treated with adalimumab and methotrexate (G Twenty-eight patients (14 per group), diagnosed with juvenile idiopathic arthritis (71.4%), non-infectious uveitis (25%) or chronic recurrent multifocal osteomyelitis (3.6%) completed the study. G This study revealed a high heterogeneity in adalimumab exposure in PRD. Adalimumab exposure tended to be higher with methotrexate co-treatment compared to adalimumab monotherapy although differences were not statistically significant. Most children showed adalimumab exposure exceeding those reported for RA with clinical response, particularly with methotrexate co-treatment. This highlights the need of further investigations to establish model-based personalized treatment strategies in PRD to avoid under- and overexposure. NCT04042792 , registered 02.08.2019.
Sections du résumé
BACKGROUND
BACKGROUND
In pediatric rheumatic diseases (PRD), adalimumab is dosed using fixed weight-based bands irrespective of methotrexate co-treatment, disease activity (DA) or other factors that might influence adalimumab pharmacokinetics (PK). In rheumatoid arthritis (RA) adalimumab exposure between 2-8 mg/L is associated with clinical response. PRD data on adalimumab is scarce. Therefore, this study aimed to analyze adalimumab PK and its variability in PRD treated with/without methotrexate.
METHODS
METHODS
A two-center prospective study in PRD patients aged 2-18 years treated with adalimumab and methotrexate (G
RESULTS
RESULTS
Twenty-eight patients (14 per group), diagnosed with juvenile idiopathic arthritis (71.4%), non-infectious uveitis (25%) or chronic recurrent multifocal osteomyelitis (3.6%) completed the study. G
CONCLUSION
CONCLUSIONS
This study revealed a high heterogeneity in adalimumab exposure in PRD. Adalimumab exposure tended to be higher with methotrexate co-treatment compared to adalimumab monotherapy although differences were not statistically significant. Most children showed adalimumab exposure exceeding those reported for RA with clinical response, particularly with methotrexate co-treatment. This highlights the need of further investigations to establish model-based personalized treatment strategies in PRD to avoid under- and overexposure.
TRIAL REGISTRATION
BACKGROUND
NCT04042792 , registered 02.08.2019.
Identifiants
pubmed: 38167019
doi: 10.1186/s12969-023-00930-8
pii: 10.1186/s12969-023-00930-8
doi:
Banques de données
ClinicalTrials.gov
['NCT04042792']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
5Informations de copyright
© 2023. The Author(s).
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