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Pharmacokinetics of Prednisolone at Steady State in Young Patients With Systemic Lupus Erythematosus on Prednisone Therapy: An Open-Label, Single-Dose Study

Abstract Background Current prednisone dosing in the treatment of young patients with childhood-onset systemic lupus erythematosus (cSLE) is largely based on achieving balance between therapeutic efficacy and toxicity, with weight-based dosing a common clinical practice. Despite the widespread use o... Full description

Journal Title: Clinical therapeutics 2011, Vol.33 (10), p.1524-1536
Main Author: Sagcal-Gironella, Anna Carmela P., MD
Other Authors: Sherwin, Catherine M.T., PhD , Tirona, Rommel G., PhD , Rieder, Michael J., MD, PhD , Brunner, Hermine I., MD , Vinks, Alexander A., PharmD, PhD
Format: Electronic Article Electronic Article
Language: English
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Quelle: Alma/SFX Local Collection
Publisher: Bridgewater, NJ: EM Inc USA
ID: ISSN: 0149-2918
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title: Pharmacokinetics of Prednisolone at Steady State in Young Patients With Systemic Lupus Erythematosus on Prednisone Therapy: An Open-Label, Single-Dose Study
format: Article
creator:
  • Sagcal-Gironella, Anna Carmela P., MD
  • Sherwin, Catherine M.T., PhD
  • Tirona, Rommel G., PhD
  • Rieder, Michael J., MD, PhD
  • Brunner, Hermine I., MD
  • Vinks, Alexander A., PharmD, PhD
subjects:
  • Adolescent
  • Adult
  • Autoimmune diseases
  • Biological and medical sciences
  • Care and treatment
  • Child
  • Children & youth
  • Chromatography, High Pressure Liquid
  • Corticosteroids
  • Dosage and administration
  • Dose-Response Relationship, Drug
  • Drug therapy
  • Female
  • Glucocorticoids - pharmacokinetics
  • Glucocorticoids - therapeutic use
  • Humans
  • Internal Medicine
  • Lupus
  • Lupus Erythematosus, Systemic - blood
  • Lupus Erythematosus, Systemic - diagnosis
  • Lupus Erythematosus, Systemic - drug therapy
  • Male
  • Medical colleges
  • Medical Education
  • Medical research
  • Medical sciences
  • Medicine, Experimental
  • pediatric SLE
  • pharmacokinetics
  • Pharmacology. Drug treatments
  • Prednisolone
  • Prednisolone - blood
  • Prednisolone - pharmacokinetics
  • Prednisone
  • Prednisone - pharmacokinetics
  • Prednisone - therapeutic use
  • Prodrugs - pharmacokinetics
  • Prodrugs - therapeutic use
  • Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis
  • Severity of Illness Index
  • Steroids
  • Systemic lupus erythematosus
  • Tandem Mass Spectrometry
  • Young Adult
ispartof: Clinical therapeutics, 2011, Vol.33 (10), p.1524-1536
description: Abstract Background Current prednisone dosing in the treatment of young patients with childhood-onset systemic lupus erythematosus (cSLE) is largely based on achieving balance between therapeutic efficacy and toxicity, with weight-based dosing a common clinical practice. Despite the widespread use of prednisone, few attempts have been made to improve its clinical dosing regimen, and response to prednisone therapy remains variable. Objective The purpose of this study was to characterize the pharmacokinetic (PK) properties of prednisolone, the metabolite of the prodrug prednisone, in cSLE patients and explore the relationship between PK properties and cSLE disease activity. Methods Blood samples were taken 1 hour before the morning prednisone dose and at 20, 40, 60, and 90 minutes, and 2, 3, 4, 6, and 9 hours from 8 patients (ages 12–28 years) after an 8-hour fast. The mean weight-adjusted daily prednisone dose, stable for at least 30 days pre-study, was 0.29 mg/kg/d. PK analysis of prednisolone was performed using noncompartmental analysis with WinNonlin. cSLE disease activity was measured using the British Isles Lupus Assessment Group index and Systemic Lupus Erythematosus Disease Activity Index. Results Mean total prednisolone AUC0–9 , prednisone CL/F at steady state, and half-life were 1094 (range, 467–2404) ng/h/mL, 11 (range, 6.7–13.7) L/hr, and 2.6 (range, 1.3–3.9) hours. Mean total prednisolone AUC0–9 normalized to prednisone dose by weight was 4361 (range, 1136–9580) ng/h/mL/mg/kg. Mean total prednisolone Cmax normalized to prednisone dose by weight was 1097 (range, 301–2211) ng/mL/mg/kg at 1.84 (range, 0.48–4) hours (Tmax ). Patients on prednisone had interindividual variability in prednisolone AUC0–9 (61% CV) and dose-adjusted AUC0–9 (58% CV). Conclusions Interindividual variability in systemic exposure to prednisolone in cSLE patients was observed.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0149-2918
fulltext: fulltext
issn:
  • 0149-2918
  • 1879-114X
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titlePharmacokinetics of Prednisolone at Steady State in Young Patients With Systemic Lupus Erythematosus on Prednisone Therapy: An Open-Label, Single-Dose Study
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creatorSagcal-Gironella, Anna Carmela P., MD ; Sherwin, Catherine M.T., PhD ; Tirona, Rommel G., PhD ; Rieder, Michael J., MD, PhD ; Brunner, Hermine I., MD ; Vinks, Alexander A., PharmD, PhD
creatorcontribSagcal-Gironella, Anna Carmela P., MD ; Sherwin, Catherine M.T., PhD ; Tirona, Rommel G., PhD ; Rieder, Michael J., MD, PhD ; Brunner, Hermine I., MD ; Vinks, Alexander A., PharmD, PhD
descriptionAbstract Background Current prednisone dosing in the treatment of young patients with childhood-onset systemic lupus erythematosus (cSLE) is largely based on achieving balance between therapeutic efficacy and toxicity, with weight-based dosing a common clinical practice. Despite the widespread use of prednisone, few attempts have been made to improve its clinical dosing regimen, and response to prednisone therapy remains variable. Objective The purpose of this study was to characterize the pharmacokinetic (PK) properties of prednisolone, the metabolite of the prodrug prednisone, in cSLE patients and explore the relationship between PK properties and cSLE disease activity. Methods Blood samples were taken 1 hour before the morning prednisone dose and at 20, 40, 60, and 90 minutes, and 2, 3, 4, 6, and 9 hours from 8 patients (ages 12–28 years) after an 8-hour fast. The mean weight-adjusted daily prednisone dose, stable for at least 30 days pre-study, was 0.29 mg/kg/d. PK analysis of prednisolone was performed using noncompartmental analysis with WinNonlin. cSLE disease activity was measured using the British Isles Lupus Assessment Group index and Systemic Lupus Erythematosus Disease Activity Index. Results Mean total prednisolone AUC0–9 , prednisone CL/F at steady state, and half-life were 1094 (range, 467–2404) ng/h/mL, 11 (range, 6.7–13.7) L/hr, and 2.6 (range, 1.3–3.9) hours. Mean total prednisolone AUC0–9 normalized to prednisone dose by weight was 4361 (range, 1136–9580) ng/h/mL/mg/kg. Mean total prednisolone Cmax normalized to prednisone dose by weight was 1097 (range, 301–2211) ng/mL/mg/kg at 1.84 (range, 0.48–4) hours (Tmax ). Patients on prednisone had interindividual variability in prednisolone AUC0–9 (61% CV) and dose-adjusted AUC0–9 (58% CV). Conclusions Interindividual variability in systemic exposure to prednisolone in cSLE patients was observed.
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1EISSN: 1879-114X
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3PMID: 21982386
languageeng
publisherBridgewater, NJ: EM Inc USA
subjectAdolescent ; Adult ; Autoimmune diseases ; Biological and medical sciences ; Care and treatment ; Child ; Children & youth ; Chromatography, High Pressure Liquid ; Corticosteroids ; Dosage and administration ; Dose-Response Relationship, Drug ; Drug therapy ; Female ; Glucocorticoids - pharmacokinetics ; Glucocorticoids - therapeutic use ; Humans ; Internal Medicine ; Lupus ; Lupus Erythematosus, Systemic - blood ; Lupus Erythematosus, Systemic - diagnosis ; Lupus Erythematosus, Systemic - drug therapy ; Male ; Medical colleges ; Medical Education ; Medical research ; Medical sciences ; Medicine, Experimental ; pediatric SLE ; pharmacokinetics ; Pharmacology. Drug treatments ; Prednisolone ; Prednisolone - blood ; Prednisolone - pharmacokinetics ; Prednisone ; Prednisone - pharmacokinetics ; Prednisone - therapeutic use ; Prodrugs - pharmacokinetics ; Prodrugs - therapeutic use ; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis ; Severity of Illness Index ; Steroids ; Systemic lupus erythematosus ; Tandem Mass Spectrometry ; Young Adult
ispartofClinical therapeutics, 2011, Vol.33 (10), p.1524-1536
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1Sherwin, Catherine M.T., PhD
2Tirona, Rommel G., PhD
3Rieder, Michael J., MD, PhD
4Brunner, Hermine I., MD
5Vinks, Alexander A., PharmD, PhD
title
0Pharmacokinetics of Prednisolone at Steady State in Young Patients With Systemic Lupus Erythematosus on Prednisone Therapy: An Open-Label, Single-Dose Study
1Clinical therapeutics
addtitleClin Ther
descriptionAbstract Background Current prednisone dosing in the treatment of young patients with childhood-onset systemic lupus erythematosus (cSLE) is largely based on achieving balance between therapeutic efficacy and toxicity, with weight-based dosing a common clinical practice. Despite the widespread use of prednisone, few attempts have been made to improve its clinical dosing regimen, and response to prednisone therapy remains variable. Objective The purpose of this study was to characterize the pharmacokinetic (PK) properties of prednisolone, the metabolite of the prodrug prednisone, in cSLE patients and explore the relationship between PK properties and cSLE disease activity. Methods Blood samples were taken 1 hour before the morning prednisone dose and at 20, 40, 60, and 90 minutes, and 2, 3, 4, 6, and 9 hours from 8 patients (ages 12–28 years) after an 8-hour fast. The mean weight-adjusted daily prednisone dose, stable for at least 30 days pre-study, was 0.29 mg/kg/d. PK analysis of prednisolone was performed using noncompartmental analysis with WinNonlin. cSLE disease activity was measured using the British Isles Lupus Assessment Group index and Systemic Lupus Erythematosus Disease Activity Index. Results Mean total prednisolone AUC0–9 , prednisone CL/F at steady state, and half-life were 1094 (range, 467–2404) ng/h/mL, 11 (range, 6.7–13.7) L/hr, and 2.6 (range, 1.3–3.9) hours. Mean total prednisolone AUC0–9 normalized to prednisone dose by weight was 4361 (range, 1136–9580) ng/h/mL/mg/kg. Mean total prednisolone Cmax normalized to prednisone dose by weight was 1097 (range, 301–2211) ng/mL/mg/kg at 1.84 (range, 0.48–4) hours (Tmax ). Patients on prednisone had interindividual variability in prednisolone AUC0–9 (61% CV) and dose-adjusted AUC0–9 (58% CV). Conclusions Interindividual variability in systemic exposure to prednisolone in cSLE patients was observed.
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24Medical research
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27pediatric SLE
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32Prednisolone - pharmacokinetics
33Prednisone
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38Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis
39Severity of Illness Index
40Steroids
41Systemic lupus erythematosus
42Tandem Mass Spectrometry
43Young Adult
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titlePharmacokinetics of Prednisolone at Steady State in Young Patients With Systemic Lupus Erythematosus on Prednisone Therapy: An Open-Label, Single-Dose Study
authorSagcal-Gironella, Anna Carmela P., MD ; Sherwin, Catherine M.T., PhD ; Tirona, Rommel G., PhD ; Rieder, Michael J., MD, PhD ; Brunner, Hermine I., MD ; Vinks, Alexander A., PharmD, PhD
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13Glucocorticoids - pharmacokinetics
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abstractAbstract Background Current prednisone dosing in the treatment of young patients with childhood-onset systemic lupus erythematosus (cSLE) is largely based on achieving balance between therapeutic efficacy and toxicity, with weight-based dosing a common clinical practice. Despite the widespread use of prednisone, few attempts have been made to improve its clinical dosing regimen, and response to prednisone therapy remains variable. Objective The purpose of this study was to characterize the pharmacokinetic (PK) properties of prednisolone, the metabolite of the prodrug prednisone, in cSLE patients and explore the relationship between PK properties and cSLE disease activity. Methods Blood samples were taken 1 hour before the morning prednisone dose and at 20, 40, 60, and 90 minutes, and 2, 3, 4, 6, and 9 hours from 8 patients (ages 12–28 years) after an 8-hour fast. The mean weight-adjusted daily prednisone dose, stable for at least 30 days pre-study, was 0.29 mg/kg/d. PK analysis of prednisolone was performed using noncompartmental analysis with WinNonlin. cSLE disease activity was measured using the British Isles Lupus Assessment Group index and Systemic Lupus Erythematosus Disease Activity Index. Results Mean total prednisolone AUC0–9 , prednisone CL/F at steady state, and half-life were 1094 (range, 467–2404) ng/h/mL, 11 (range, 6.7–13.7) L/hr, and 2.6 (range, 1.3–3.9) hours. Mean total prednisolone AUC0–9 normalized to prednisone dose by weight was 4361 (range, 1136–9580) ng/h/mL/mg/kg. Mean total prednisolone Cmax normalized to prednisone dose by weight was 1097 (range, 301–2211) ng/mL/mg/kg at 1.84 (range, 0.48–4) hours (Tmax ). Patients on prednisone had interindividual variability in prednisolone AUC0–9 (61% CV) and dose-adjusted AUC0–9 (58% CV). Conclusions Interindividual variability in systemic exposure to prednisolone in cSLE patients was observed.
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