Pharmacodynamic modelling and exposure-response assessment of inebilizumab in subjects with neuromyelitis optica spectrum disorders.

ABSTRACT:

Aims

Neuromyelitis optica spectrum disorders (NMOSD) is an autoantibody-mediated, B cell-driven disease. Inebilizumab is a humanized, affinity-optimized, afucosylated IgG1 κ monoclonal antibody that binds to the B-cell specific surface antigen CD19, resulting in rapid, profound and sustained depletion of circulating peripheral B cells in NMOSD subjects (pivotal study). The objective of this study was to conduct population modelling of B-cell response following inebilizumab treatment in adult subjects with NMOSD, and to assess the impact of drug exposure to outcome.

Methods

A haematopoietic transit model was developed to describe the joint effects of reducing influx from pro-B cells and accelerating CD20⁺  B-cell depletion in the blood by inebilizumab. Furthermore,

SUBMITTER: Yan L 

PROVIDER: S-EPMC9545531 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature