Population pharmacokinetic simulation of varied Immune Globulin Subcutaneous (Human), 20% solution (Ig20Gly) loading and maintenance dosing regimens in immunoglobulin-naïve patients with primary immunodeficiency diseases
| Autor: | Todd Dumas, Seth Berry, Barbara McCoy, Zhaoyang Li, Leman Yel |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Injections Subcutaneous Primary Immunodeficiency Diseases Immunology Population Gastroenterology Loading dose Models Biological Immunoglobulin G Drug Administration Schedule Young Adult Pharmacokinetics Internal medicine medicine Immunology and Allergy Humans Immunologic Factors Computer Simulation Dosing education Child Pharmacology education.field_of_study biology business.industry medicine.disease Biological Variation Population Child Preschool biology.protein Primary immunodeficiency Trough level Female Antibody business |
| Zdroj: | International immunopharmacology. 100 |
| ISSN: | 1878-1705 |
| Popis: | BACKGROUND The pharmacokinetics of Ig20Gly, a 20% subcutaneous immunoglobulin (IG) therapy, is well characterized in IG-experienced patients with primary immunodeficiency diseases (PID). Data from IG-naive patients are limited. OBJECTIVE Simulate serum total immunoglobulin G (IgG) pharmacokinetic profiles in IG-naive patients with PID for different Ig20Gly initiation and maintenance dosing regimens. METHODS A population pharmacokinetic model developed with data from pivotal phase 2/3 trials of weekly Ig20Gly in PID (NCT01412385, NCT01218438) was used to simulate pharmacokinetic profiles of IgG in various scenarios with 400- or 800-mg/kg total loading doses (administered as split doses over 1-2 weeks) and corresponding 100- or 200-mg/kg weekly maintenance doses, respectively. Endogenous baseline IgG levels (1.5, 2.0, 4.0, 6.0 g/L) were evaluated for each scenario; time to putative therapeutic target IgG trough level (7 g/L) was determined. RESULTS Serum IgG levels reached steady-state by approximately Week 12 for all scenarios and baseline endogenous IgG levels. Time to target trough level generally occurred sooner with 1-week versus 2-week loading schemes. Endogenous baseline IgG levels |
| Databáze: | OpenAIRE |
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