Pharmacokinetic modeling and simulation of biweekly subcutaneous immunoglobulin dosing in primary immunodeficiency

Cornelia Barbara Landersdorfer, Martin Bexon, Jonathan Edelman, Mikhail Rojavin, Carl Michael James Kirkpatrick, Jianfeng Lu, Mark Pfister, Jagdev Sidhu

Research output: Contribution to journalArticleResearchpeer-review

22 Citations (Scopus)

Abstract

Replacement therapy with immunoglobulin G (IgG) given as intravenous or subcutaneous (SC) infusions is the standard treatment for patients with primary immunodeficiency. Due to the life-long need for replacement, increased flexibility in the administration and dosage regimens would improve patients quality of life. A population pharmacokinetic model that can predict plasma IgG concentrations for various routes, dosage regimens, and patient groups is a valuable tool to improve patient therapy. Such a model was developed based on IgG concentrations from 151 unique adult and pediatric patients who participated in 4 clinical trials of intravenous and SC IgG replacement therapy. Simulations predicted that the same total IgG dose, delivered SC, either in 1 biweekly dose (once every 2 weeks), or in 2 weekly doses, results in IgG peak and trough concentrations that remain within ? 10 of each other throughout the 14-day period. The developed population pharmacokinetic model predicted that biweekly SC Hizentra dosing offers a viable alternative to weekly SC therapy, allowing more flexible and optimized dosage regimens for patients with primary immunodeficiency.
Original languageEnglish
Pages (from-to)53 - 61
Number of pages9
JournalPostgraduate Medicine
Volume125
Issue number6
DOIs
Publication statusPublished - 2013

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