Pharmacometric Analysis Linking Immunoglobulin Exposure to Clinical Efficacy Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy

CSL Behring, King of Prussia, PA, USA. Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. 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. 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. Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan. Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA, USA. Department of Neurology, Maastricht University Medical Center, Maastricht, the Netherlands. Curaçao Medical Center, Willemstad, Curaçao. CSL Behring, Marburg. Princeton, NJ, USA. University of Basel, Basel, Switzerland. Department of Neurology, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam and Spaarne Gasthuis, Haarlem, the Netherlands.

CPT: pharmacometrics & systems pharmacology. 2021
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The two main objectives of this analysis were to (i) characterise 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 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 an E(max) model as a function of ΔIgG (total serum IgG at INCAT score assessment minus baseline IgG levels before intravenous Ig restabilisation). Simulations indicate that flexible dosing from daily to biweekly (every other week) provide an exposure coverage equivalent to that of a weekly Ig dose.
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Language : eng
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