AI Article Synopsis
- Belimumab is a monoclonal antibody effective in treating systemic lupus erythematosus (SLE), available in both intravenous and subcutaneous forms, prompting a study to develop a reliable method for measuring its levels in human serum.
- The study utilized a technique called nano-surface and molecular-orientation limited (nSMOL) proteolysis combined with liquid chromatography-tandem mass spectrometry (LC-MS/MS) for quantification, achieving a total assay time of 10 minutes with high accuracy and precision.
- Results revealed that belimumab concentrations were significantly higher in patients receiving subcutaneous administration compared to intravenous, and the developed method can enhance future research on belimumab's effectiveness and safety in SLE treatment
Article Abstract
Introduction: Belimumab is a monoclonal antibody against B cell activating factor (BLyS). This monoclonal antibody (mAb) has been shown to be effective in reducing disease activity in patients with systemic lupus erythematosus (SLE). Belimumab is available in two forms as a lyophilized powder for intravenous (IV) use, or single-dose syringe for subcutaneous (SC) use. The aim of this study was to develop and validate a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for quantitation of belimumab in human serum.
Material And Methods: All analyses relied on nano-surface and molecular-orientation limited (nSMOL) proteolysis coupled with LC-MS/MS. Quantifications was performed in multiple reactions monitoring (MRM) mode, and electrospray ionization was conducted in positive mode.
Results: Belimumab was quantified with signature peptide QAPGQGLEWMGGIPFGTAK and normalized using P14R. The total run time per assay was 10 min. Linearity was measured from 5 to 800 μg/mL (r² > 0.995). Accuracy and precision based on three quality control levels range from 11.2 - 9.51 % and 1.24 - 13.12 % respectively. The carryover was less than 7 %. In all, 87 patient samples were processed (65, IV; 22, SC). Mean concentration of belimumab was significantly higher for SC (93.0 ± 74.0 µg/mL) than for IV (67.4 ± 38.9 µg/mL) administration.
Conclusion: We have developed the first method of belimumab quantification combining LC-MS/MS and nSMOL proteolysis. It can be used for future clinical pharmacokinetic studies of belimumab and for investigating the relationship between belimumab concentration, efficacy, and toxicity in SLE patients.
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| http://dx.doi.org/10.1016/j.jpba.2023.115730 | DOI Listing |
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