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Label-free quantification of anti-TNF-alpha in patients treated with adalimumab using an optical biosensor

dc.contributor.authorBustos Cruz, Rosa Helena
dc.contributor.authorZapata, Carlos
dc.contributor.authorEsteban Mancera, Efraín Arsenio
dc.contributor.authorGarcía Casallas, Julio César
dc.contributor.authorJáuregui, Edwin
dc.contributor.authorJaimes Fernández, Diego Alejandro
dc.date.accessioned2019-02-08T13:22:25Z
dc.date.available2019-02-08T13:22:25Z
dc.date.issued2018-02-21
dc.identifier.urihttp://hdl.handle.net/10818/34885
dc.description20 páginases_CO
dc.description.abstractThis study describes the development of a immunosensory label-free quantification methodology based on surface plasmon resonance (SPR) and its applicability in measuring/evaluating therapeutic drug monitoring (TDM) of anti-TNF-alpha monoclonal antibody (adalimumab) in rheumatoid arthritis (RA) patients. The experimental parameters evaluated in this study were immobilising ligands by pre-concentration assays, sensor surface regeneration, ascertaining the method’s sensitivity and correlating the results from quantifying plasma samples by ELISA immunoassay. The results showed that SPR immunosensory detection provided a precise, sensitive strategy, along with real-time determination, for quantifying adalimumab, having great potential for clinical routine regarding TDMes_CO
dc.language.isoenges_CO
dc.publisherUniversidad de La Sabanaes_CO
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.sourceUniversidad de La Sabana
dc.sourceIntellectum Repositorio Universidad de La Sabana
dc.subjectAdalimumabes_CO
dc.subjectMedicamentos -- Efectos fisiológicoses_CO
dc.titleLabel-free quantification of anti-TNF-alpha in patients treated with adalimumab using an optical biosensores_CO
dc.typebachelorThesises_CO
dc.publisher.programEspecialización en Farmacología Clínica
dc.publisher.departmentFacultad de Medicina
dc.identifier.local268174
dc.identifier.localTE09520
dc.rights.accessRightsrestrictedAccess
dc.creator.degreeEspecialista en Farmacología Clínica
dcterms.referencesFeagan, B. G.; Choquette, D.; Ghosh, S.; Gladman, D. D.; Ho, V.; Meibohm, B.; Zou, G.; Xu, Z.; Shankar, G.; Sealey, D. C.; Russell, A. S., The challenge of indication extrapolation for infliximab biosimilars. Biologicals. 2014, 42, 177-83.eng
dcterms.referencesBendtzen, K.; Svenson, M., Enzyme Immunoassas and Radioimmunoassays for Quantification of Anti-TNF Biopharmaceuticals and Anti-Drug Antibodies. In Detection and Quantifi cation of Antibodies to Biopharmaceuticals, John Wiley & Sons, I., Ed. 2011.eng
dcterms.referencesEuropean Medicines Agency, Guideline on Immunogenicity assesment of biotechnology-derived therapeutic proteins. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/10/WC500 385 194507.pdf. 2015.eng
dcterms.referencesUS Food and Drug Administration Biosimilars Guidelines. (13 386 th Oct 2017),eng
dcterms.referencesWHO, W. H. O., Guidelines for Evaluation of Similar Biotherapeutic Products (SBPs). http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB _22APRIL2010.pdf. 2009.eng
dcterms.referencesTernant, D.; Paintaud, G., Pharmacokinetics and concentration-effect relationships of therapeutic monoclonal antibodies and fusion proteins. Expert Opin Biol Ther. 2005, 5 Suppl 1, S37-47.eng
dcterms.referencesKaneko, Y.; Takeuchi, T., Targeted antibody therapy and relevant novel biomarkers for precision medicine for rheumatoid arthritis. Int Immunol. 2017.eng
dcterms.referencesSchmier, J.; Ogden, K.; Nickman, N.; Halpern, M. T.; Cifaldi, M.; Ganguli, A.; Bao, Y.; Garg, V., Costs of Providing Infusion Therapy for Rheumatoid Arthritis in a Hospital-based Infusion Center Setting. Clin Ther. 2017, 39, 1600-1617.eng
dcterms.referencesEinodshofer, M. T.; Duren, L. N., Cost Management through Care Management, Part 2: The Importance of Managing Specialty Drug Utilization in the Medical Benefit. Am Health Drug Benefits. 2012, 5, 359-64eng
dcterms.referencesBatticciotto, A.; Ravasio, R.; Riva, M.; Sarzi-Puttini, P., Efficacy and Treatment Costs of Monotherapy with bDMARDs in the Treatment of Rheumatoid Arthritis in Patients Intolerant to or Inappropriate to Continue Treatment with Methotrexate. Adv Ther. 2016, 33, 1360-73eng
dcterms.referencesWong, U.; Cross, R. K., Primary and secondary nonresponse to infliximab: mechanisms and countermeasures. Expert Opin Drug Metab Toxicol. 2017, 13, 1039-1046eng
dcterms.referencesOrdas, I.; Mould, D. R.; Feagan, B. G.; Sandborn, W. J., Anti-TNF monoclonal antibodies in inflammatory bowel disease: pharmacokinetics-based dosing paradigms. Clin Pharmacol Ther. 2012, 91, 635-46.eng
dcterms.referencesKamath, A. V., Translational pharmacokinetics and pharmacodynamics of monoclonal antibodies. Drug Discov Today Technol. 2016, 21-22, 75-83eng
dcterms.referencesDeng, R.; Jin, F.; Prabhu, S.; Iyer, S., Monoclonal antibodies: what are the pharmacokinetic and pharmacodynamic considerations for drug development? Expert Opin Drug Metab Toxicol. 2012, 8, 141-60.eng
dcterms.referencesLobo, E. D.; Hansen, R. J.; Balthasar, J. P., Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci. 2004, 93, 2645-68.eng
dcterms.referencesWang, W.; Wang, E. Q.; Balthasar, J. P., Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther. 2008, 84, 548-58.eng
dcterms.referencesYanai, H.; Lichtenstein, L.; Assa, A.; Mazor, Y.; Weiss, B.; Levine, A.; Ron, Y.; Kopylov, U.; Bujanover, Y.; Rosenbach, Y.; Ungar, B.; Eliakim, R.; Chowers, Y.; Shamir, R.; Fraser, G.; Dotan, 419 I.; Ben-Horin, S., Levels of drug and antidrug antibodies are associated with outcome of interventions after loss of response to infliximab or adalimumab. Clin Gastroenterol Hepatol. 2015, 421 13, 522-530 e2.eng
dcterms.referencesvan Schie, K. A.; Wolbink, G. J.; Rispens, T., Cross-reactive and pre-existing antibodies to therapeutic antibodies--Effects on treatment and immunogenicity. MAbs. 2015, 7, 662-71.eng
dcterms.referencesKrishna, M.; Nadler, S. G., Immunogenicity to Biotherapeutics - The Role of Anti-drug Immune Complexes. Front Immunol. 2016, 7, 21.eng
dcterms.referencesJani, M.; Isaacs, J. D.; Morgan, A. W.; Wilson, A. G.; Plant, D.; Hyrich, K. L.; Chinoy, H.; Barton, A.; Braggss, High frequency of antidrug antibodies and association of random drug levels with efficacy in certolizumab pegol-treated patients with rheumatoid arthritis: results from the BRAGGSS cohort. Ann Rheum Dis. 2017, 76, 208-213.eng
dcterms.referencesVincent, F. B.; Morand, E. F.; Murphy, K.; Mackay, F.; Mariette, X.; Marcelli, C., Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflammatory diseases: a real issue, a clinical perspective. Annals of the rheumatic diseases. 2013, 72, 165-78.eng
dcterms.referencesWolbink, G. J.; Vis, M.; Lems, W.; Voskuyl, A. E.; de Groot, E.; Nurmohamed, M. T.; Stapel, S.; ak, P. P.; Aarden, L.; Dijkmans, B., Development of antiinfliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis. Arthritis Rheum. 2006, 54, 711-5.eng
dcterms.referencesPrado, M. S.; Bendtzen, K.; Andrade, L. E. C., Biological anti-TNF drugs: immunogenicity underlying treatment failure and adverse events. Expert Opin Drug Metab Toxicol. 2017, 13, 985- 995.eng
dcterms.referencesBartelds, G. M.; Krieckaert, C. L.; Nurmohamed, M. T.; van Schouwenburg, P. A.; Lems, W. F.; Twisk, J. W.; Dijkmans, B. A.; Aarden, L.; Wolbink, G. J., Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA. 2011, 305, 1460-8.eng
dcterms.referencesSeitz, K.; Zhou, H., Pharmacokinetic drug-drug interaction potentials for therapeutic monoclonal antibodies: reality check. Journal of clinical pharmacology. 2007, 47, 1104-18.eng
dcterms.referencesDarwish, M.; Burke, J. M.; Hellriegel, E.; Robertson, P., Jr.; Phillips, L.; Ludwig, E.; Munteanu, M. C.; Bond, M., An evaluation of the potential for drug-drug interactions between bendamustine and rituximab in indolent non-Hodgkin lymphoma and mantle cell lymphoma. Cancer Chemother Pharmacol. 2014, 73, 1119-27.eng
dcterms.referencesZhou, H.; Sharma, A., Therapeutic protein-drug interactions: plausible mechanisms and assessment strategies. Expert opinion on drug metabolism & toxicology. 2016, 1-9.eng
dcterms.referencesMatucci, A.; Nencini, F.; Pratesi, S.; Maggi, E.; Vultaggio, A., An overview on safety of monoclonal antibodies. Curr Opin Allergy Clin Immunol. 2016, 16, 576-581eng
dcterms.referencesDoessegger, L.; Banholzer, M. L., Clinical development methodology for infusion-related reactions with monoclonal antibodies. Clin Transl Immunology. 2015, 4, e39.eng
dcterms.referencesVultaggio, A.; Maggi, E.; Matucci, A., Immediate adverse reactions to biologicals: from pathogenic mechanisms to prophylactic management. Curr Opin Allergy Clin Immunol. 2011, 11, 458 262-8.eng
dcterms.referencesHansel, T. T.; Kropshofer, H.; Singer, T.; Mitchell, J. A.; George, A. J., The safety and side effects of monoclonal antibodies. Nat Rev Drug Discov. 2010, 9, 325-38.eng
dcterms.referencesVultaggio, A.; Matucci, A.; Nencini, F.; Pratesi, S.; Parronchi, P.; Rossi, O.; Romagnani, S.; Maggi, E., Anti-infliximab IgE and non-IgE antibodies and induction of infusion-related severe anaphylactic reactions. Allergy. 2010, 65, 657-61.eng
dcterms.referencesSuntharalingam, G.; Perry, M. R.; Ward, S.; Brett, S. J.; Castello-Cortes, A.; Brunner, M. D.; Panoskaltsis, N., Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med. 2006, 355, 1018-28.eng
dcterms.referencesWing, M., Monoclonal antibody first dose cytokine release syndromes-mechanisms and prediction. J Immunotoxicol. 2008, 5, 11-5.eng
dcterms.referencesWilliams, M.; Khalid, T.; Hughes, S.; Bonney, D.; Wynn, R., Rituximab-induced Cytokine Storm in the Absence of Overt Lymphoproliferative Disease. J Pediatr Hematol Oncol. 2016, 38, e29-31.eng
dcterms.referencesSeymour, H. E.; Worsley, A.; Smith, J. M.; Thomas, S. H., Anti-TNF agents for rheumatoid arthritis. Br J Clin Pharmacol. 2001, 51, 201-8.eng
dcterms.referencesCaminati, M.; Senna, G.; Stefanizzi, G.; Bellamoli, R.; Longhi, S.; Chieco-Bianchi, F.; Guarnieri, G.; Tognella, S.; Olivieri, M.; Micheletto, C.; Festi, G.; Bertocco, E.; Mazza, M.; Rossi, A.; Vianello, A.; 475 North East Omalizumab Network study, g., Drop-out rate among patients treated with omalizumab for severe asthma: Literature review and real-life experience. BMC Pulm Med. 2016, 16, 128.eng
dcterms.referencesNowatzke, W. L.; Rogers, K.; Wells, E.; Bowsher, R. R.; Ray, C.; Unger, S., Unique challenges of providing bioanalytical support for biological therapeutic pharmacokinetic programs. Bioanalysis. 2011, 3, 509-21.eng
dcterms.referencesvan Bezooijen, J. S.; Koch, B. C.; van Doorn, M. B.; Prens, E. P.; van Gelder, T.; Schreurs, M. W., Comparison of Three Assays to Quantify Infliximab, Adalimumab, and Etanercept Serum Concentrations. Ther Drug Monit. 2016, 38, 432-8.eng
dcterms.referencesFreeman, K.; Connock, M.; Auguste, P.; Taylor-Phillips, S.; Mistry, H.; Shyangdan, D.; Court, R.; Arasaradnam, R.; Sutcliffe, P.; Clarke, A., Clinical effectiveness and cost-effectiveness of use of therapeutic monitoring of tumour necrosis factor alpha (TNF-alpha) inhibitors [LISA487 TRACKER(R) enzyme-linked immunosorbent assay (ELISA) kits, TNF-alpha-Blocker ELISA kits and Promonitor(R) ELISA kits] versus standard care in patients with Crohn's disease: systematic reviews and economic modelling. Health Technol Assess. 2016, 20, 1-288.eng
dcterms.referencesChellaraj, V.; Cicero, K.; Abuarjah, K.; Lundberg, L.; Desai, H.; Gadkari, S.; Hantash, J.; Scott, G.; Beaver, C., Comparison Between Two UV ELISA Kits and an Electrochemiluminescence ELISA Method for the Quantification of HUMIRA® (Adalimumab) in Human Serum. http://www.inventivhealthclinical.com/497801ee-21a9-4235-91b1-2d3c9e279b38/download.htm. 2012eng
dcterms.referencesBendtzen, K.; Geborek, P.; Svenson, M.; Larsson, L.; Kapetanovic, M. C.; Saxne, T., Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab. Arthritis and rheumatism. 2006, 54, 3782- 9.eng
dcterms.referencesSvenson, M.; Geborek, P.; Saxne, T.; Bendtzen, K., Monitoring patients treated with anti-TNF500 alpha biopharmaceuticals: assessing serum infliximab and anti-infliximab antibodies. Rheumatology (Oxford). 2007, 46, 1828-34eng
dcterms.referencesRadstake, T. R.; Svenson, M.; Eijsbouts, A. M.; van den Hoogen, F. H.; Enevold, C.; van Riel, P. L.; Bendtzen, K., Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis. Ann Rheum Dis. 2009, 68, 1739-45.eng
dcterms.referencesMoberg, A.; Lager, A.; Hamalainen, M. D.; Jarhede, T., Increased sensitivity of SPR assays in plasma through efficient parallel assay optimization. Journal of pharmaceutical and biomedical analysis. 2013, 78-79, 224-32.eng
dcterms.referencesSwanson, S.; Mytych, D., The use of Surface Plasmon Resonance for the Detection and Characterization of Antibodies. In Detection and Quantifi cation of Antibodies to Biopharmaceuticals, John Wiley & Sons, I., Ed. 2011.eng
dcterms.referencesMire-Sluis, A. R.; Barrett, Y. C.; Devanarayan, V.; Koren, E.; Liu, H.; Maia, M.; Parish, T.; Scott, G.; Shankar, G.; Shores, E.; Swanson, S. J.; Taniguchi, G.; Wierda, D.; Zuckerman, L. A., Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods. 2004, 289, 1-16.eng
dcterms.referencesBhalla, N.; Jolly, P.; Formisano, N.; Estrela, P., Introduction to biosensors. Essays Biochem. 2016, 60, 1-8.eng
dcterms.referencesDamborsky, P.; Svitel, J.; Katrlik, J., Optical biosensors. Essays Biochem. 2016, 60, 91-100eng
dcterms.referencesPatel, S.; Nanda, R.; Sahoo, S.; Mohapatra, E., Biosensors in Health Care: The Milestones Achieved in Their Development towards Lab-on-Chip-Analysis. Biochem Res Int. 2016, 2016, 3130469.eng
dcterms.referencesNguyen, H. H.; Park, J.; Kang, S.; Kim, M., Surface plasmon resonance: a versatile technique for biosensor applications. Sensors (Basel). 2015, 15, 10481-510.eng
dcterms.referencesGutierrez-Gallego, R.; Bosch, J.; Such-Sanmartin, G.; Segura, J., Surface plasmon resonance immuno assays - A perspective. Growth Horm IGF Res. 2009, 19, 388-98eng
dcterms.referencesMalmborg, A. C.; Michaelsson, A.; Ohlin, M.; Jansson, B.; Borrebaeck, C. A., Real time analysis of antibody-antigen reaction kinetics. Scand J Immunol. 1992, 35, 643-50.eng
dcterms.referencesMytych, D. T.; La, S.; Barger, T.; Ferbas, J.; Swanson, S. J., The development and validation of a sensitive, dual-flow cell, SPR-based biosensor immunoassay for the detection, semi-quantitation, and characterization of antibodies to darbepoetin alpha and epoetin alpha in human serum. J Pharm Biomed Anal. 2009, 49, 415-26.eng
dcterms.referencesWadhwa, M.; Bird, C.; Dilger, P.; Gaines-Das, R.; Thorpe, R., Strategies for detection, measurement and characterization of unwanted antibodies induced by therapeutic biologicals. J Immunol Methods. 2003, 278, 1-17.eng
dcterms.referencesCenters for Medicare & Medicaid Services, Clinical Laboratory Improvement Amendments (CLIA). https://www.cms.gov/Regulations-and536 Guidance/Legislation/CLIA/index.html?redirect=/CLIA. 2017eng
dcterms.referencesAndersson, K.; Areskoug, D.; Hardenborg, E., Exploring buffer space for molecular interactions. J Mol Recognit. 1999, 12, 310-5.eng
dcterms.referencesGE Healthcare, Biacore TM Assay Handbook. http://proteins.gelifesciences.com/~/media/protein-purification541 ib/documents/handbooks/biacore_assay_handbook.pdf?la=en. 2012eng
dcterms.referencesLundström, I., Real-time biospecific interaction analysis. Biosensors and Bioelectronics. 1994, 9, 725- 736.eng
dcterms.referencesUSP, Development and Design of Biological Assays. USP 35 - NF 30:162. 2010, 1-36eng
dcterms.referencesSanquin, Adalimumab Level Elisa M 1885. https://www.sanquin.nl/repository/reagentia/ifu/Product_flyer_Adalimumab_ELISA_kit.pdf. 2015.eng
dcterms.referencesBian, S.; Stappen, T. V.; Baert, F.; Compernolle, G.; Brouwers, E.; Tops, S.; Vries, A.; Rispens, T.; Lammertyn, J.; Vermeire, S.; Gils, A., Generation and characterization of a unique panel of anti550 adalimumab specific antibodies and their application in therapeutic drug monitoring assays. J Pharm Biomed Anal. 2016, 125, 62-7.eng
dcterms.referencesvan der Neut Kolfschoten, M.; Schuurman, J.; Losen, M.; Bleeker, W. K.; Martinez-Martinez, P.; Vermeulen, E.; den Bleker, T. H.; Wiegman, L.; Vink, T.; Aarden, L. A.; De Baets, M. H.; van de Winkel, J. G.; Aalberse, R. C.; Parren, P. W., Anti-inflammatory activity of human IgG4 antibodies by dynamic Fab arm exchange. Science. 2007, 317, 1554-7eng
dcterms.referencesLu, J.; Van Stappen, T.; Spasic, D.; Delport, F.; Vermeire, S.; Gils, A.; Lammertyn, J., Fiber optic SPR platform for fast and sensitive infliximab detection in serum of inflammatory bowel disease patients. Biosens Bioelectron. 2016, 79, 173-9.eng
dcterms.referencesBian, S.; Lu, J.; Delport, F.; Vermeire, S.; Spasic, D.; Lammertyn, J.; Gils, A., Development and validation of an optical biosensor for rapid monitoring of adalimumab in serum of patients with Crohn's disease. Drug Test Anal. 2017.eng
dcterms.referencesTrilling, A. K.; Beekwilder, J.; Zuilhof, H., Antibody orientation on biosensor surfaces: a minireview. Analyst. 2013, 138, 1619-27eng
dcterms.referencesReal-Fernandez, F.; Cimaz, R.; Rossi, G.; Simonini, G.; Giani, T.; Pagnini, I.; Papini, A. M.; Rovero, P., Surface plasmon resonance-based methodology for anti-adalimumab antibody identification and kinetic characterization. Anal Bioanal Chem. 2015, 407, 7477-85.eng
dcterms.referencesMarquart, J. A., Surface Plasmon Resonance and Biomolecular Interaction Analysis Theory and Practice. 2013.eng
dcterms.referencesTam, Y. J.; Zeenathul, N. A.; Rezaei, M. A.; Mustafa, N. H.; Azmi, M. L. M.; Bahaman, A. R.; Lo, 570 S. C.; Tan, J. S.; Hani, H.; Rasedee, A., Wide dynamic range of surface-plasmon-resonance-based assay for hepatitis B surface antigen antibody optimal detection in comparison with ELISA. Biotechnol Appl Biochem. 2017, 64, 735-744.eng
dcterms.referencesSchmitz, E. M.; van de Kerkhof, D.; Hamann, D.; van Dongen, J. L.; Kuijper, P. H.; Brunsveld, L.; Scharnhorst, V.; Broeren, M. A., Therapeutic drug monitoring of infliximab: performance evaluation of three commercial ELISA kits. Clin Chem Lab Med. 2016, 54, 1211-9.eng


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