Evaluation of Hydroxychloroquine Blood Concentrations and Effects in Childhood-Onset Systemic Lupus Erythematosus.

hydroxychloroquine pharmacodynamics pharmacokinetics systemic lupus erythematosus

Journal

Pharmaceuticals (Basel, Switzerland)
ISSN: 1424-8247
Titre abrégé: Pharmaceuticals (Basel)
Pays: Switzerland
ID NLM: 101238453

Informations de publication

Date de publication:
17 Mar 2021
Historique:
received: 15 02 2021
revised: 08 03 2021
accepted: 12 03 2021
entrez: 3 4 2021
pubmed: 4 4 2021
medline: 4 4 2021
Statut: epublish

Résumé

Hydroxychloroquine (HCQ) is an antimalarial agent given to patients with systemic lupus erythematosus (SLE) as first-line therapy. It alleviates childhood-onset systemic lupus erythematosus cSLE skin and musculoskeletal disease, decreasing disease activity and flares. HCQ concentration-effect relationships in children remains unknown. This study aimed to investigate the pharmacokinetics of HCQ and possible concentration-effect relationships. HCQ blood concentrations and effects were obtained during clinical follow-up on different occasions. cSLE flares were defined using the SLE Disease Activity Index (SLEDAI); flare was denoted by a SLEDAI score > 6. Blood concentration was measured using high-performance liquid chromatography with fluorometric detection. Statistical analysis was performed using a nonlinear mixed-effect approach with the Monolix software. A total of 168 blood samples were obtained from 55 pediatric patients. HCQ apparent blood clearance (CL/F) was dependent on patients' bodyweight and platelet count. Patients with active cSLE had a lower mean blood HCQ concentration compared with inactive cSLE patients (536 ± 294 vs. 758 ± 490 ng/mL, We developed the first HCQ blood concentration-effect relationship for cSLE associated with active or non-active disease status. A prospective randomized study is necessary to confirm these results.

Sections du résumé

BACKGROUND BACKGROUND
Hydroxychloroquine (HCQ) is an antimalarial agent given to patients with systemic lupus erythematosus (SLE) as first-line therapy. It alleviates childhood-onset systemic lupus erythematosus cSLE skin and musculoskeletal disease, decreasing disease activity and flares. HCQ concentration-effect relationships in children remains unknown. This study aimed to investigate the pharmacokinetics of HCQ and possible concentration-effect relationships.
METHODS METHODS
HCQ blood concentrations and effects were obtained during clinical follow-up on different occasions. cSLE flares were defined using the SLE Disease Activity Index (SLEDAI); flare was denoted by a SLEDAI score > 6. Blood concentration was measured using high-performance liquid chromatography with fluorometric detection. Statistical analysis was performed using a nonlinear mixed-effect approach with the Monolix software.
RESULTS RESULTS
A total of 168 blood samples were obtained from 55 pediatric patients. HCQ apparent blood clearance (CL/F) was dependent on patients' bodyweight and platelet count. Patients with active cSLE had a lower mean blood HCQ concentration compared with inactive cSLE patients (536 ± 294 vs. 758 ± 490 ng/mL,
CONCLUSION CONCLUSIONS
We developed the first HCQ blood concentration-effect relationship for cSLE associated with active or non-active disease status. A prospective randomized study is necessary to confirm these results.

Identifiants

pubmed: 33802811
pii: ph14030273
doi: 10.3390/ph14030273
pmc: PMC8002378
pii:
doi:

Types de publication

Journal Article

Langues

eng

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Auteurs

Noël Zahr (N)

Clinical Investigation Center, Department of Pharmacology, INSERM, CIC-1901, UMR ICAN 1166, Pitié-Salpêtrière Hospital, Sorbonne Université, AP-HP, F-75013 Paris, France.

Saik Urien (S)

Department of Pediatric and Perinatal Pharmacology, Necker Hospital, Université de Paris, AP-HP, F-75015 Paris, France.

Christian Funck-Brentano (C)

Clinical Investigation Center, Department of Pharmacology, INSERM, CIC-1901, UMR ICAN 1166, Pitié-Salpêtrière Hospital, Sorbonne Université, AP-HP, F-75013 Paris, France.

Hélène Vantomme (H)

Clinical Investigation Center, Department of Pharmacology, INSERM, CIC-1901, UMR ICAN 1166, Pitié-Salpêtrière Hospital, Sorbonne Université, AP-HP, F-75013 Paris, France.

Nicolas Garcelon (N)

Data Science Platform, INSERM UMR 1163, Imagine Institute, Université de Paris, AP-HP, F-75015 Paris, France.

Isabelle Melki (I)

Infectious Disease and Internal Medicine Reference Center for Rheumatic, AutoImmune and Systemic Diseases in Children (RAISE), Department of General Pediatrics, Robert Debré Hospital, Nord-Université de Paris, AP-HP, F-75019 Paris, France.

Margaux Boistault (M)

Reference Center MARHEA, Department of Pediatric Nephrology, Imagine Institute, INSERM U1163, Necker Hospital, Université de Paris, AP-HP, F-75015 Paris, France.

Olivia Boyer (O)

Reference Center MARHEA, Department of Pediatric Nephrology, Imagine Institute, INSERM U1163, Necker Hospital, Université de Paris, AP-HP, F-75015 Paris, France.

Brigitte Bader-Meunier (B)

Department of Pediatric Immunology, Hematology and Rheumatology, INSERM U1163, Imagine Institute, Necker Hospital, Université de Paris, AP-HP, F-75015 Paris, France.

Classifications MeSH