Dosing optimization of rituximab for primary membranous nephropathy by population pharmacokinetic and pharmacodynamic study.

ABSTRACT: Primary membranous nephropathy (PMN) is the most common cause for adult nephrotic syndrome. Rituximab has demonstrated promising clinical efficacy by random controlled trials and the off-label use is widely adopted in PMN. However, the standard dosage is borrowed from B cell lymphoma treatment with far more antigens and is oversaturated for PMN treatment, accompanied with additional safety risk and unnecessary medical cost. More than 15% serious adverse events were observed under standard dosage and low dose therapies were explored recently. Dose optimization by clinical trials is extremely time- and cost-consuming and can be significantly accelerated with the aid of model-informed drug development. Here, we aim to establish the first population pharmacokinetic and pharmacodynamic (PPK/PD)

SUBMITTER: Liang H 

PROVIDER: S-EPMC11002205 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature