Therapeutic drug monitoring of CT-P13: a comparison of four different immunoassays.

ABSTRACT:

Background

The commercialization of CT-P13, an infliximab (IFX) biosimilar, has the potential to decrease health-related costs and enhance access to biological therapies. This study aimed to address the accuracy and inter-assay agreement of the CT-P13 quantification using four different assays initially developed to assess IFX.

Methods

The four different methods, one in-house method and three commercially available kits, were used to quantify exogenously-spiked samples and the sera from 185 inflammatory bowel disease (IBD) patients on CT-P13 therapy.

Results

The quantification of the spiked samples unveiled a consistent and accurate behaviour of three of the tested methods, with average percentage recoveries of 90%, 102% and 109%. Results from the clinical samples dem

SUBMITTER: Afonso J 

PROVIDER: S-EPMC5598811 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature