학술논문
Pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy.
Document Type
Academic Journal
Author
Tortorici MA; CSL Behring, King of Prussia, Pennsylvania, USA.; Yuraszeck T; CSL Behring, King of Prussia, Pennsylvania, USA.; Cornblath D; Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.; Bril V; Ellen and Martin Prosserman Centre for Neuromuscular Diseases, Division of Neurology, Department of Medicine, University Health Network, University of Toronto, Toronto, Canada.; Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.; Hartung HP; Department of Neurology, UKD and Center for Neurology and Neuropsychiatry, LVR Klinikum, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.; Brain and Mind Centre, University of Sydney, Sydney, Australia.; Medical University of Vienna, Vienna, Austria.; Sobue G; Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan.; Lewis RA; Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, California, USA.; Merkies ISJ; Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.; Curaçao Medical Center, Willemstad, Curaçao.; Lawo JP; CSL Behring, Marburg, Germany.; Praus M; CSL Behring, Marburg, Germany.; Durn BL; CSL Behring, King of Prussia, Pennsylvania, USA.; Mielke O; CSL Behring, Marburg, Germany.; Ma X; CSL Behring, King of Prussia, Pennsylvania, USA.; Jauslin P; Certara, Princeton, New Jersey, USA.; Pfister M; University of Basel, Basel, Switzerland.; van Schaik IN; Department of Neurology, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, The Netherlands.; Spaarne Gasthuis, Haarlem, The Netherlands.
Source
Publisher: Wiley Country of Publication: United States NLM ID: 101580011 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2163-8306 (Electronic) Linking ISSN: 21638306 NLM ISO Abbreviation: CPT Pharmacometrics Syst Pharmacol Subsets: MEDLINE
Subject
Language
English
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 (E max ) 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.
(© 2021 CSL Behring. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics.)
(© 2021 CSL Behring. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics.)