Pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy
| Autor: | Theresa Yuraszeck, Michael A. Tortorici, Billie L. Durn, Hans-Peter Hartung, Orell Mielke, Vera Bril, Ivo N. van Schaik, David R. Cornblath, Marc Pfister, Gen Sobue, Ingemar S. J. Merkies, Xuewen Ma, Michaela Praus, John-Philip Lawo, Richard A. Lewis, Petra M. Jauslin |
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| Přispěvatelé: | RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Klinische Neurowetenschappen |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Adult
Male medicine.medical_specialty Injections Subcutaneous Population SUBCUTANEOUS IMMUNOGLOBULIN Chronic inflammatory demyelinating polyneuropathy RM1-950 Placebo Models Biological Gastroenterology Drug Administration Schedule Article Young Adult Pharmacokinetics Internal medicine medicine Humans Immunologic Factors Pharmacology (medical) Dosing education Aged Randomized Controlled Trials as Topic Aged 80 and over education.field_of_study biology business.industry Research Articles Middle Aged medicine.disease Pharmacometrics Treatment Outcome Polyradiculoneuropathy Chronic Inflammatory Demyelinating Immunoglobulin G Modeling and Simulation Pharmacodynamics biology.protein Female Therapeutics. Pharmacology Antibody business |
| Zdroj: | CPT: Pharmacometrics and Systems Pharmacology, 10(8), 839-850. Wiley CPT: Pharmacometrics & Systems Pharmacology CPT: Pharmacometrics & Systems Pharmacology, Vol 10, Iss 8, Pp 839-850 (2021) |
| ISSN: | 2163-8306 |
| DOI: | 10.1002/psp4.12647 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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