| dc.contributor.author | Bustos Cruz, Rosa Helena | |
| dc.contributor.author | Zapata, Carlos | |
| dc.contributor.author | Esteban Mancera, Efraín Arsenio | |
| dc.contributor.author | García Casallas, Julio César | |
| dc.contributor.author | Jáuregui, Edwin | |
| dc.contributor.author | Jaimes Fernández, Diego Alejandro | |
| dc.date.accessioned | 2019-02-08T13:22:25Z | |
| dc.date.available | 2019-02-08T13:22:25Z | |
| dc.date.issued | 2018-02-21 | |
| dc.identifier.uri | http://hdl.handle.net/10818/34885 | |
| dc.description | 20 páginas | es_CO |
| dc.description.abstract | This 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 TDM | es_CO |
| dc.language.iso | eng | es_CO |
| dc.publisher | Universidad de La Sabana | es_CO |
| dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 International | * |
| dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
| dc.source | Universidad de La Sabana | |
| dc.source | Intellectum Repositorio Universidad de La Sabana | |
| dc.subject | Adalimumab | es_CO |
| dc.subject | Medicamentos -- Efectos fisiológicos | es_CO |
| dc.title | Label-free quantification of anti-TNF-alpha in patients treated with adalimumab using an optical biosensor | es_CO |
| dc.type | bachelorThesis | es_CO |
| dc.publisher.program | Especialización en Farmacología Clínica | |
| dc.publisher.department | Facultad de Medicina | |
| dc.rights.accessRights | restrictedAccess | |
| dc.creator.degree | Especialista en Farmacología Clínica | |
| dcterms.references | Feagan, 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.references | Bendtzen, 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.references | European 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.references | US Food and Drug Administration Biosimilars Guidelines. (13 386 th Oct 2017), | eng |
| dcterms.references | WHO, 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.references | Ternant, 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.references | Kaneko, Y.; Takeuchi, T., Targeted antibody therapy and relevant novel biomarkers for precision
medicine for rheumatoid arthritis. Int Immunol. 2017. | eng |
| dcterms.references | Schmier, 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.references | Einodshofer, 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, 359-64 | eng |
| dcterms.references | Batticciotto, 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, 1360-73 | eng |
| dcterms.references | Wong, U.; Cross, R. K., Primary and secondary nonresponse to infliximab: mechanisms and
countermeasures. Expert Opin Drug Metab Toxicol. 2017, 13, 1039-1046 | eng |
| dcterms.references | Ordas, 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.references | Kamath, A. V., Translational pharmacokinetics and pharmacodynamics of monoclonal
antibodies. Drug Discov Today Technol. 2016, 21-22, 75-83 | eng |
| dcterms.references | Deng, 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.references | Lobo, E. D.; Hansen, R. J.; Balthasar, J. P., Antibody pharmacokinetics and pharmacodynamics. J
Pharm Sci. 2004, 93, 2645-68. | eng |
| dcterms.references | Wang, W.; Wang, E. Q.; Balthasar, J. P., Monoclonal antibody pharmacokinetics and
pharmacodynamics. Clin Pharmacol Ther. 2008, 84, 548-58. | eng |
| dcterms.references | Yanai, 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.references | van 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.references | Krishna, M.; Nadler, S. G., Immunogenicity to Biotherapeutics - The Role of Anti-drug Immune
Complexes. Front Immunol. 2016, 7, 21. | eng |
| dcterms.references | Jani, 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.references | Vincent, 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.references | Wolbink, 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.references | Prado, 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.references | Bartelds, 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.references | Seitz, K.; Zhou, H., Pharmacokinetic drug-drug interaction potentials for therapeutic monoclonal
antibodies: reality check. Journal of clinical pharmacology. 2007, 47, 1104-18. | eng |
| dcterms.references | Darwish, 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.references | Zhou, H.; Sharma, A., Therapeutic protein-drug interactions: plausible mechanisms and
assessment strategies. Expert opinion on drug metabolism & toxicology. 2016, 1-9. | eng |
| dcterms.references | Matucci, A.; Nencini, F.; Pratesi, S.; Maggi, E.; Vultaggio, A., An overview on safety of
monoclonal antibodies. Curr Opin Allergy Clin Immunol. 2016, 16, 576-581 | eng |
| dcterms.references | Doessegger, L.; Banholzer, M. L., Clinical development methodology for infusion-related
reactions with monoclonal antibodies. Clin Transl Immunology. 2015, 4, e39. | eng |
| dcterms.references | Vultaggio, 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.references | Hansel, 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.references | Vultaggio, 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.references | Suntharalingam, 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.references | Wing, M., Monoclonal antibody first dose cytokine release syndromes-mechanisms and
prediction. J Immunotoxicol. 2008, 5, 11-5. | eng |
| dcterms.references | Williams, 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.references | Seymour, 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.references | Caminati, 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.references | Nowatzke, 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.references | van 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.references | Freeman, 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.references | Chellaraj, 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.
2012 | eng |
| dcterms.references | Bendtzen, 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.references | Svenson, 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, 1828-34 | eng |
| dcterms.references | Radstake, 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.references | Moberg, 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.references | Swanson, 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.references | Mire-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.references | Bhalla, N.; Jolly, P.; Formisano, N.; Estrela, P., Introduction to biosensors. Essays Biochem. 2016,
60, 1-8. | eng |
| dcterms.references | Damborsky, P.; Svitel, J.; Katrlik, J., Optical biosensors. Essays Biochem. 2016, 60, 91-100 | eng |
| dcterms.references | Patel, 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.references | Nguyen, 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.references | Gutierrez-Gallego, R.; Bosch, J.; Such-Sanmartin, G.; Segura, J., Surface plasmon resonance
immuno assays - A perspective. Growth Horm IGF Res. 2009, 19, 388-98 | eng |
| dcterms.references | Malmborg, 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.references | Mytych, 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.references | Wadhwa, 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.references | Centers for Medicare & Medicaid Services, Clinical Laboratory Improvement Amendments
(CLIA). https://www.cms.gov/Regulations-and536 Guidance/Legislation/CLIA/index.html?redirect=/CLIA. 2017 | eng |
| dcterms.references | Andersson, K.; Areskoug, D.; Hardenborg, E., Exploring buffer space for molecular interactions.
J Mol Recognit. 1999, 12, 310-5. | eng |
| dcterms.references | GE Healthcare, Biacore TM Assay Handbook.
http://proteins.gelifesciences.com/~/media/protein-purification541 ib/documents/handbooks/biacore_assay_handbook.pdf?la=en. 2012 | eng |
| dcterms.references | Lundström, I., Real-time biospecific interaction analysis. Biosensors and Bioelectronics. 1994, 9, 725-
736. | eng |
| dcterms.references | USP, Development and Design of Biological Assays. USP 35 - NF 30:162. 2010, 1-36 | eng |
| dcterms.references | Sanquin, Adalimumab Level Elisa M 1885.
https://www.sanquin.nl/repository/reagentia/ifu/Product_flyer_Adalimumab_ELISA_kit.pdf.
2015. | eng |
| dcterms.references | Bian, 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.references | van 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, 1554-7 | eng |
| dcterms.references | Lu, 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.references | Bian, 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.references | Trilling, A. K.; Beekwilder, J.; Zuilhof, H., Antibody orientation on biosensor surfaces: a
minireview. Analyst. 2013, 138, 1619-27 | eng |
| dcterms.references | Real-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.references | Marquart, J. A., Surface Plasmon Resonance and Biomolecular Interaction Analysis Theory and
Practice. 2013. | eng |
| dcterms.references | Tam, 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.references | Schmitz, 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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