Population pharmacokinetics of subcutaneous infliximab CT-P13 in Crohn's disease and ulcerative colitis.

ABSTRACT:

Background

Infliximab is a chimeric monoclonal antibody against tumour necrosis factor-alpha for the treatment of Crohn's disease (CD) and ulcerative colitis (UC). Recently, a subcutaneous formulation of CT-P13, an infliximab biosimilar, was approved for clinical use.

Aims

To characterise CT-P13 pharmacokinetics (PK) and its clinically relevant determinants after subcutaneous administration through population PK modelling.

Methods

Data from a two-part Phase I study with intravenous (5 mg/kg) and variable maintenance subcutaneous dosing of CT-P13 with frequent PK sampling in patients with CD or UC were used. Population PK analysis was conducted by non-linear mixed effects modelling. Covariates affecting PK parameters were chosen based on their clinical relevance (effec

SUBMITTER: Hanzel J 

PROVIDER: S-EPMC9292975 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature