LC-MS/MS method for the quantitation of serum tocilizumab in rheumatoid arthritis patients using rapid tryptic digestion without IgG purification

Mihara, 2005, Tocilizumab inhibits signal transduction mediated by both mIL-6R and sIL-6R, but not by the receptors of other members of IL-6 cytokine family, Int. Immunopharm., 5, 1731, 10.1016/j.intimp.2005.05.010 Hashizume, 2015, Tocilizumab, a humanized anti-IL-6R antibody, as an emerging therapeutic option for rheumatoid arthritis: Molecular and cellular mechanistic insights, Int. Rev. Immunol., 34, 265, 10.3109/08830185.2014.938325 Okuda, 2008, Review of tocilizumab in the treatment of rheumatoid arthritis, Biologics, 2, 75 Benucci, 2016, Correlations between immunogenicity, drug levels, and disease activity in an Italian cohort of rheumatoid arthritis patients treated with tocilizumab, Biologics, 10, 53 Arad, 2019, Association of serum tocilizumab trough concentrations with clinical disease activity index scores in adult patients with rheumatoid arthritis, J. Rheumatol., 46, 1577, 10.3899/jrheum.181431 Willrich, 2015, Quantitation of infliximab using clonotypic peptides and selective reaction monitoring by LC-MS/MS, Int. Immunopharm., 28, 513, 10.1016/j.intimp.2015.07.007 Willeman, 2019, A multiplex liquid chromatography tandem mass spectrometry method for the quantification of seven therapeutic monoclonal antibodies: Application for adalimumab therapeutic drug monitoring in patients with Crohn's disease, Anal. Chim. Acta, 1067, 63, 10.1016/j.aca.2019.03.033 Iwamoto, 2019, Multiplexed monitoring of therapeutic antibodies for inflammatory diseases using Fab-selective proteolysis nSMOL coupled with LC-MS, J. Immunol. Methods, 472, 44, 10.1016/j.jim.2019.06.014 Truffot, 2021, Variability of rituximab and tocilizumab trough concentrations in patients with rheumatoid arthritis, Fundam. Clin. Pharmacol., 35, 1090, 10.1111/fcp.12662 Rivera-Burgos, 2013, Disparities between immobilized enzyme and solution based digestion of transferrin with trypsin, J. Separ. Sci., 36, 454, 10.1002/jssc.201200740 Regnier, 2014, Accelerating trypsin digestion: The immobilized enzyme reactor, Bioanalysis, 6, 2685, 10.4155/bio.14.216 Shibata, 2017, Simple and rapid LC-MS/MS method for the absolute determination of cetuximab in human serum using an immobilized trypsin, J. Pharm. Biomed. Anal., 146, 266, 10.1016/j.jpba.2017.08.012 Iwamoto, 2019, Acceleration of nano-surface and molecular-orientation limited (nSMOL) proteolysis with acidified reduction pretreatment for quantification of Tocilizumab, J. Pharm. Biomed. Anal., 164, 467, 10.1016/j.jpba.2018.11.019 Shida, 2018, LC-MS/MS method for denosumab quantitation in human serum with rapid protein digestion using immobilized trypsin, Bioanalysis, 10, 1501, 10.4155/bio-2018-0161 Ogata, 2015, Longterm safety and efficacy of subcutaneous tocilizumab monotherapy: Results from the 2-year open-label extension of the MUSASHI study, J. Rheumatol., 42, 799, 10.3899/jrheum.140665 Kneepkens, 2017, Serum tocilizumab trough concentration can be used to monitor systemic IL-6 receptor blockade in patients with rheumatoid arthritis: A prospective observational cohort study, Scand. J. Rheumatol., 46, 87, 10.1080/03009742.2016.1183039 Abe, 2020, Quantitative LC-MS/MS method for nivolumab in human serum using IgG purification and immobilized tryptic digestion, Anal. Methods, 12, 54, 10.1039/C9AY02087J The International ImMunoGeneTics Information System®, IMGT/3Dstructure-DB and IMGT/2Dstructure-DB version 4.12.2. https://www.imgt.org. (Accessed 25 July 2019). U.S. Food and Drug Administration. Guidance for Industry Bioanalytical Method Validation. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioanalytical-method-validation-guidance-industry#search=%E2%80%99GuidanceforIndustryBioanalyticalMethodValidation. (Accessed 18 October 2021). Hirano, 2011, Suitability of chemiluminescent enzyme immunoassay for the measurement of blood tacrolimus concentrations in rheumatoid arthritis, Clin. Biochem., 44, 397, 10.1016/j.clinbiochem.2010.12.020 van den Broek, 2013, Bioanalytical LC-MS/MS of protein-based biopharmaceuticals, J. Chromatogr. B Anal. Technol. Biomed. Life Sci., 929, 161, 10.1016/j.jchromb.2013.04.030 Fekete, 2012, New trends in reversed-phase liquid chromatographic separations of therapeutic peptides and proteins: Theory and applications, J. Pharm. Biomed. Anal., 69, 9, 10.1016/j.jpba.2012.03.024 Ogata, 2014, Phase III study of the efficacy and safety of subcutaneous versus intravenous tocilizumab monotherapy in patients with rheumatoid arthritis, Arthritis Care Res., 66, 344, 10.1002/acr.22110 Todoroki, 2018, Current mass spectrometric tools for the bioanalyses of therapeutic monoclonal antibodies and antibody-drug conjugates, Anal. Sci., 34, 397, 10.2116/analsci.17R003 Tetik, 2010, Determination of oxidant stress in plasma of rheumatoid arthritis and primary osteoarthritis patients, Indian J. Biochem. Biophys., 47, 353 Anyasor, 2014, Anti-inflammatory and antioxidant activities of Costus afer Ker Gawl. hexane leaf fraction in arthritic rat models, J. Ethnopharmacol., 155, 543, 10.1016/j.jep.2014.05.057