Dose, exposure, and treatment regimen of intravenous immunoglobulin G in multifocal motor neuropathy

Bibliographic Details
Title: Dose, exposure, and treatment regimen of intravenous immunoglobulin G in multifocal motor neuropathy
Authors: Zhaoyang Li, Stefan Roepcke, Ryan Franke, Leman Yel
Source: Frontiers in Neurology, Vol 15 (2024)
Publisher Information: Frontiers Media S.A., 2024.
Publication Year: 2024
Collection: LCC:Neurology. Diseases of the nervous system
Subject Terms: intravenous immunoglobulin, multifocal motor neuropathy, immunoglobulin, population pharmacokinetic modeling, dose-exposure relationship, Neurology. Diseases of the nervous system, RC346-429
More Details: IntroductionIntravenous immunoglobulin (IVIG) is the only approved treatment for multifocal motor neuropathy (MMN), a rare, chronic, immune-mediated demyelinating neuropathy. There is a significant gap in understanding of the role of serum immunoglobulin G (IgG) levels in the efficacy of IVIG in affected patients. We aimed to characterize the interplay between dose and exposure of IVIG and the effects of patient factors on individual variabilities.MethodsSerum IgG trough concentration data from a phase 3, randomized, double-blind, placebo-controlled, crossover trial of IVIG 10% in 44 patients with MMN (NCT00666263) were analyzed using fit-for-purpose population PK modeling. Patient factors were tested as covariates, and IgG PK profiles following various dosing regimens were simulated.ResultsSerum IgG levels, with significant inter-patient variability, correlated with dose and treatment interruptions at the individual patient level. Simulated data for various dosing regimens (0.4–2 g/kg once every 1–4 weeks [Q1–4W]) revealed that more frequent dosing provided more stable IgG levels than less frequent dosing, and dose splitting over multiple days had no significant effects on PK.DiscussionIn patients with MMN, stable dosing and consistent serum IgG levels are crucial to avoid negative responses owing to treatment interruptions. Dosing intervals more frequent than Q4W may alleviate periodic symptom deterioration. Dose splitting potentially offers flexibility for patients requiring large volumes of IVIG without negatively affecting serum IgG PK, while maintaining treatment efficacy. Variability in serum IgG levels between patients suggests that individualizing IVIG treatment regimens and target IgG levels may play a key role in managing MMN.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 1664-2295
Relation: https://www.frontiersin.org/articles/10.3389/fneur.2024.1478419/full; https://doaj.org/toc/1664-2295
DOI: 10.3389/fneur.2024.1478419
Access URL: https://doaj.org/article/14cb03d93729418393dd4776a8b554e8
Accession Number: edsdoj.14cb03d93729418393dd4776a8b554e8
Database: Directory of Open Access Journals
More Details
ISSN:16642295
DOI:10.3389/fneur.2024.1478419
Published in:Frontiers in Neurology
Language:English