Development, Validation and Application of the Dried Blood Spot Analysis Method for the Determination of Ustekinumab in Patients with Inflammatory Bowel Disease.

ABSTRACT: Background: Ustekinumab (UST) is a monoclonal antibody (mAb) used in the treatment of inflammatory bowel disease (IBD). Elevated serum concentrations are typically associated with improved therapeutic outcomes, and therapeutic drug monitoring (TDM) is a useful tool for guiding mAbs treatment. This study aimed to develop a dried blood spot (DBS) method for TDM of UST in patients with IBD. Methods: The commercial enzyme-linked immunosorbent assay for plasma samples was optimized for DBS samples and subsequently validated according to international guidelines for classical and DBS-specific validation parameters. It was then applied to analyze serum and DBS samples obtained from venous and capillary blood of IBD patients undergoing UST therapy. Results: The method was line

SUBMITTER: Mingas PD 

PROVIDER: S-EPMC12472599 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature