Ocrelizumab in relapsing and primary progressive multiple sclerosis: Pharmacokinetic and pharmacodynamic analyses of OPERA I, OPERA II and ORATORIO.

ABSTRACT:

Aims

Ocrelizumab is a humanized monoclonal antibody that selectively targets CD20-positive B cells and is indicated for treatment of patients with relapsing forms of multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The pharmacokinetics and pharmacodynamics of ocrelizumab in patients with RMS or PPMS were assessed.

Methods

A population pharmacokinetic model was developed based on data from the Phase II study and the Phase III studies OPERA I and OPERA II in patients with RMS. Data from the ORATORIO Phase III study in patients with PPMS became available after model finalization and was used for external model evaluation.

Results

The ocrelizumab serum concentration vs time course was accurately described by a 2-compartment model with time-depend

SUBMITTER: Gibiansky E 

PROVIDER: S-EPMC8247316 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature