Pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy

Abstract The two main objectives of this analysis were to (i) characterize the relationship between immunoglobulin (Ig) exposure and chronic inflammatory demyelinating polyneuropathy (CIDP) disease severity using data from 171 patients with CIDP who received either subcutaneous Ig (IgPro20; Hizentra...

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Autores principales:	Michael A. Tortorici, Theresa Yuraszeck, David Cornblath, Vera Bril, Hans‐Peter Hartung, Gen Sobue, Richard A. Lewis, Ingemar S. J. Merkies, John‐Philip Lawo, Michaela Praus, Billie L. Durn, Orell Mielke, Xuewen Ma, Petra Jauslin, Marc Pfister, Ivo N. vanSchaik, the PATH study group
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/864b1de80a0d49abab9c2cf35b4c5ae2
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spelling	oai:doaj.org-article:864b1de80a0d49abab9c2cf35b4c5ae22021-11-19T15:35:29ZPharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy2163-830610.1002/psp4.12647https://doaj.org/article/864b1de80a0d49abab9c2cf35b4c5ae22021-08-01T00:00:00Zhttps://doi.org/10.1002/psp4.12647https://doaj.org/toc/2163-8306Abstract The two main objectives of this analysis were to (i) characterize the relationship between immunoglobulin (Ig) exposure and chronic inflammatory demyelinating polyneuropathy (CIDP) disease severity using data from 171 patients with CIDP who received either subcutaneous Ig (IgPro20; Hizentra®) or placebo (PATH study), and to (ii) simulate and compare exposure coverage with various dosing approaches considering weekly dosing to be the reference dose. IgG pharmacokinetic (PK) parameters, including those from a previous population PK model, were used to predict individual IgG profile and exposure metrics. Treatment‐related changes in Inflammatory Neuropathy Cause and Treatment (INCAT) scores were best described by a maximum effect (Emax) model as a function of ΔIgG (total serum IgG at INCAT score assessment minus baseline IgG levels before intravenous Ig restabilization). Simulations indicate that flexible dosing from daily to biweekly (every other week) provide an exposure coverage equivalent to that of a weekly Ig dose.Michael A. TortoriciTheresa YuraszeckDavid CornblathVera BrilHans‐Peter HartungGen SobueRichard A. LewisIngemar S. J. MerkiesJohn‐Philip LawoMichaela PrausBillie L. DurnOrell MielkeXuewen MaPetra JauslinMarc PfisterIvo N. vanSchaikthe PATH study groupWileyarticleTherapeutics. PharmacologyRM1-950ENCPT: Pharmacometrics & Systems Pharmacology, Vol 10, Iss 8, Pp 839-850 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Therapeutics. Pharmacology RM1-950
spellingShingle	Therapeutics. Pharmacology RM1-950 Michael A. Tortorici Theresa Yuraszeck David Cornblath Vera Bril Hans‐Peter Hartung Gen Sobue Richard A. Lewis Ingemar S. J. Merkies John‐Philip Lawo Michaela Praus Billie L. Durn Orell Mielke Xuewen Ma Petra Jauslin Marc Pfister Ivo N. vanSchaik the PATH study group Pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy
description	Abstract The two main objectives of this analysis were to (i) characterize the relationship between immunoglobulin (Ig) exposure and chronic inflammatory demyelinating polyneuropathy (CIDP) disease severity using data from 171 patients with CIDP who received either subcutaneous Ig (IgPro20; Hizentra®) or placebo (PATH study), and to (ii) simulate and compare exposure coverage with various dosing approaches considering weekly dosing to be the reference dose. IgG pharmacokinetic (PK) parameters, including those from a previous population PK model, were used to predict individual IgG profile and exposure metrics. Treatment‐related changes in Inflammatory Neuropathy Cause and Treatment (INCAT) scores were best described by a maximum effect (Emax) model as a function of ΔIgG (total serum IgG at INCAT score assessment minus baseline IgG levels before intravenous Ig restabilization). Simulations indicate that flexible dosing from daily to biweekly (every other week) provide an exposure coverage equivalent to that of a weekly Ig dose.
format	article
author	Michael A. Tortorici Theresa Yuraszeck David Cornblath Vera Bril Hans‐Peter Hartung Gen Sobue Richard A. Lewis Ingemar S. J. Merkies John‐Philip Lawo Michaela Praus Billie L. Durn Orell Mielke Xuewen Ma Petra Jauslin Marc Pfister Ivo N. vanSchaik the PATH study group
author_facet	Michael A. Tortorici Theresa Yuraszeck David Cornblath Vera Bril Hans‐Peter Hartung Gen Sobue Richard A. Lewis Ingemar S. J. Merkies John‐Philip Lawo Michaela Praus Billie L. Durn Orell Mielke Xuewen Ma Petra Jauslin Marc Pfister Ivo N. vanSchaik the PATH study group
author_sort	Michael A. Tortorici
title	Pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy
title_short	Pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy
title_full	Pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy
title_fullStr	Pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy
title_full_unstemmed	Pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy
title_sort	pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/864b1de80a0d49abab9c2cf35b4c5ae2
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Pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy

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