Pharmacokinetic Modeling and Simulation of Biweekly Subcutaneous Immunoglobulin Dosing in Primary Immunodeficiency

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Cornelia B. Landersdorfer, PhD; Martin Bexon, MD; Jonathan Edelman, MD; Mikhail Rojavin, PhD; Carl M.J. Kirkpatrick, PhD; Jianfeng Lu, PhD; Marc Pfister, MD; Jagdev Sidhu, PhD

Table of Contents

Postgraduate Medicine:

Volume 125 No. 6

Category:

Clinical Features

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DOI: 10.3810/pgm.2013.11.2712
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.

Keywords: subcutaneous immunoglobulin; IgPro20; population pharmacokinetics; biweekly dosing; primary immunodeficiency