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Volumn 2016, Issue , 2016, Pages

Understanding the Supersensitive Anti-Drug Antibody Assay: Unexpected High Anti-Drug Antibody Incidence and Its Clinical Relevance

Author keywords

[No Author keywords available]

Indexed keywords

DRUG ANTIBODY; HYBRID PROTEIN; MONOCLONAL ANTIBODY; ANTIBODY; BIOLOGICAL PRODUCT; DRUG;

EID: 84975317276     PISSN: 23148861     EISSN: 23147156     Source Type: Journal    
DOI: 10.1155/2016/3072586     Document Type: Review
Times cited : (64)

References (39)
  • 1
    • 84878550146 scopus 로고    scopus 로고
    • Evolution and emergence of therapeutic monoclonal antibodies what cardiologists need to know
    • I. N. Foltz, M. Karow, and S. M. Wasserman, "Evolution and emergence of therapeutic monoclonal antibodies what cardiologists need to know, " Circulation, vol. 127, no. 22, pp. 2222-2230, 2013.
    • (2013) Circulation , vol.127 , Issue.22 , pp. 2222-2230
    • Foltz, I.N.1    Karow, M.2    Wasserman, S.M.3
  • 2
    • 34249684926 scopus 로고    scopus 로고
    • Arisk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs
    • G. Shankar, C. Pendley, and K. E. Stein, "Arisk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs, " Nature Biotechnology, vol. 25, no. 5, pp. 555-561, 2007.
    • (2007) Nature Biotechnology , vol.25 , Issue.5 , pp. 555-561
    • Shankar, G.1    Pendley, C.2    Stein, K.E.3
  • 3
    • 84860710411 scopus 로고    scopus 로고
    • Immunogenicity to therapeutic proteins: Impact on PK/PD and efficacy
    • N. Chirmule, V. Jawa, and B. Meibohm, "Immunogenicity to therapeutic proteins: impact on PK/PD and efficacy, "The AAPS Journal, vol. 14, no. 2, pp. 296-302, 2012.
    • (2012) The AAPS Journal , vol.14 , Issue.2 , pp. 296-302
    • Chirmule, N.1    Jawa, V.2    Meibohm, B.3
  • 4
    • 33745728702 scopus 로고    scopus 로고
    • Current and future approaches to inhibitormanagement and aversion
    • C. Hay, M. Recht, M. Carcao, and B. Reipert, "Current and future approaches to inhibitormanagement and aversion, " Seminars in Thrombosis and Hemostasis, vol. 32, no. 2, pp. 15-21, 2006.
    • (2006) Seminars in Thrombosis and Hemostasis , vol.32 , Issue.2 , pp. 15-21
    • Hay, C.1    Recht, M.2    Carcao, M.3    Reipert, B.4
  • 6
    • 19044363558 scopus 로고    scopus 로고
    • Assays for detecting and diagnosing antibody-mediated pure red cell aplasia (PRCA): An assessment of available procedures
    • R. Thorpe and S. J. Swanson, "Assays for detecting and diagnosing antibody-mediated pure red cell aplasia (PRCA): an assessment of available procedures, " Nephrology Dialysis Transplantation, vol. 20, no. 4, pp. 16-22, 2005.
    • (2005) Nephrology Dialysis Transplantation , vol.20 , Issue.4 , pp. 16-22
    • Thorpe, R.1    Swanson, S.J.2
  • 7
    • 17644378667 scopus 로고    scopus 로고
    • Immunogenicity of engineered antibodies
    • W. Y. K. Hwang and J. Foote, "Immunogenicity of engineered antibodies, " Methods, vol. 36, no. 1, pp. 3-10, 2005.
    • (2005) Methods , vol.36 , Issue.1 , pp. 3-10
    • Hwang, W.Y.K.1    Foote, J.2
  • 8
    • 67349241946 scopus 로고    scopus 로고
    • Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies
    • R. Ponce, L. Abad, L. Amaravadi et al., "Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies, " Regulatory Toxicology and Pharmacology, vol. 54, no. 2, pp. 164-182, 2009.
    • (2009) Regulatory Toxicology and Pharmacology , vol.54 , Issue.2 , pp. 164-182
    • Ponce, R.1    Abad, L.2    Amaravadi, L.3
  • 9
    • 0142039654 scopus 로고    scopus 로고
    • Strategies for detection, measurement and characterization of unwanted antibodies induced by therapeutic biological
    • M. Wadhwaa, C. Birda, P. Dilgera, R. Gaines-Dasb, and R. Thorpea, "Strategies for detection, measurement and characterization of unwanted antibodies induced by therapeutic biological, " Journal of Immunological Methods, vol. 278, no. 1-2, pp. 1-17, 2003.
    • (2003) Journal of Immunological Methods , vol.278 , Issue.1-2 , pp. 1-17
    • Wadhwaa, M.1    Birda, C.2    Dilgera, P.3    Gaines-Dasb, R.4    Thorpea, R.5
  • 10
    • 0142066078 scopus 로고    scopus 로고
    • Immunogenicity: Concepts/issues/concerns
    • K. E. Stein, "Immunogenicity: concepts/issues/concerns, " Developments in Biologicals, vol. 109, pp. 15-23, 2002.
    • (2002) Developments in Biologicals , vol.109 , pp. 15-23
    • Stein, K.E.1
  • 11
    • 0037434552 scopus 로고    scopus 로고
    • Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease
    • F. Baert, M. Noman, S. Vermeire et al., "Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease, " The New England Journal of Medicine, vol. 348, no. 7, pp. 601-608, 2003.
    • (2003) The New England Journal of Medicine , vol.348 , Issue.7 , pp. 601-608
    • Baert, F.1    Noman, M.2    Vermeire, S.3
  • 12
    • 79953906254 scopus 로고    scopus 로고
    • Development of antidrug antibodies against Adalimumab and association with disease activity and treatment failure during long-term follow-up
    • G. M. Bartelds, C. L. M. Krieckaert, M. T. Nurmohamed et al., "Development of antidrug antibodies against Adalimumab and association with disease activity and treatment failure during long-term follow-up, " The Journal of the American Medical Association, vol. 305, no. 14, pp. 1460-1468, 2011.
    • (2011) The Journal of the American Medical Association , vol.305 , Issue.14 , pp. 1460-1468
    • Bartelds, G.M.1    Krieckaert, C.L.M.2    Nurmohamed, M.T.3
  • 13
    • 84890281406 scopus 로고    scopus 로고
    • Adverse events to monoclonal antibodies used for cancer therapy focus on hypersensitivity responses
    • B. A. Baldo, "Adverse events to monoclonal antibodies used for cancer therapy focus on hypersensitivity responses, " OncoImmunology, vol. 2, no. 10, article e26333, 2013.
    • (2013) OncoImmunology , vol.2 , Issue.10
    • Baldo, B.A.1
  • 14
    • 0038752054 scopus 로고    scopus 로고
    • Pure red-cell aplasia due to anti-erythropoietin antibodies
    • K.-U. Eckardt and N. Casadevall, "Pure red-cell aplasia due to anti-erythropoietin antibodies, " Nephrology Dialysis Transplantation, vol. 18, no. 5, pp. 865-869, 2003.
    • (2003) Nephrology Dialysis Transplantation , vol.18 , Issue.5 , pp. 865-869
    • Eckardt, K.-U.1    Casadevall, N.2
  • 15
    • 3142534409 scopus 로고    scopus 로고
    • Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
    • A. R. Mire-Sluis, Y. C. Barrett, V. Devanarayan et al., "Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products, " Journal of Immunological Methods, vol. 289, no. 1-2, pp. 1-16, 2004.
    • (2004) Journal of Immunological Methods , vol.289 , Issue.1-2 , pp. 1-16
    • Mire-Sluis, A.R.1    Barrett, Y.C.2    Devanarayan, V.3
  • 16
    • 58249116651 scopus 로고    scopus 로고
    • Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products
    • G. Shankar, V. Devanarayan, L. Amaravadi et al., "Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products, " Journal of Pharmaceutical and Biomedical Analysis, vol. 48, no. 5, pp. 1267-1281, 2008.
    • (2008) Journal of Pharmaceutical and Biomedical Analysis , vol.48 , Issue.5 , pp. 1267-1281
    • Shankar, G.1    Devanarayan, V.2    Amaravadi, L.3
  • 17
    • 84975242493 scopus 로고    scopus 로고
    • US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research, Draft Guidance for Industry. Assay Development for Immunogenicity Testing of Therapeutic Proteins
    • US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research, Draft Guidance for Industry. Assay Development for Immunogenicity Testing of Therapeutic Proteins, 2009, http://www. fda. gov/downloads/drugs/guidancecomplianceregulatoryinformation/ guidances/ucm338856. pdf.
    • (2009)
  • 18
    • 84921730324 scopus 로고    scopus 로고
    • US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research
    • US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research, "Guidance for industry, Immunogenicity assessment for therapeutic protein products, " 2014, http://www. fda. gov/downloads/%20drugs/guidancecomplianceregulatoryinformation/ guidances/ucm338856. pdf.
    • (2014) Guidance for Industry, Immunogenicity Assessment for Therapeutic Protein Products
  • 21
    • 84991706907 scopus 로고    scopus 로고
    • US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research
    • US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research, "Draft guidance for industry. Assay development and validation for immunogenicity testing of therapeutic proteins, Revision 1, " 2016, http://www. fda. gov/ucm/ groups/fdagov-public/@fdagov-drugs-gen/documents/document/ ucm192750. pdf.
    • (2016) Draft Guidance for Industry. Assay Development and Validation for Immunogenicity Testing of Therapeutic Proteins, Revision 1
  • 22
    • 84872057712 scopus 로고    scopus 로고
    • A survey of applications of biological products for drug interference of immunogenicity assays
    • Y.-M. C. Wang, L. Fang, L. Zhou, J. Wang, and H.-Y. Ahn, "A survey of applications of biological products for drug interference of immunogenicity assays, " Pharmaceutical Research, vol. 29, no. 12, pp. 3384-3392, 2012.
    • (2012) Pharmaceutical Research , vol.29 , Issue.12 , pp. 3384-3392
    • Wang, Y.-M.C.1    Fang, L.2    Zhou, L.3    Wang, J.4    Ahn, H.-Y.5
  • 23
    • 84975213969 scopus 로고    scopus 로고
    • AbbVie: Humira Insert, 2013, http://www. accessdata. fda. gov/ drugsatfda docs/label/2013/125057s310lbl. pdf.
    • (2013) AbbVie: Humira Insert
  • 24
    • 24344448252 scopus 로고    scopus 로고
    • An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen
    • A. Patton, M. C. Mullenix, S. J. Swanson, and E. Koren, "An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen, " Journal of Immunological Methods, vol. 304, no. 1-2, pp. 189-195, 2005.
    • (2005) Journal of Immunological Methods , vol.304 , Issue.1-2 , pp. 189-195
    • Patton, A.1    Mullenix, M.C.2    Swanson, S.J.3    Koren, E.4
  • 25
    • 36048943918 scopus 로고    scopus 로고
    • Detection of antibodies against therapeutic proteins in the presence of residual therapeutic protein using a solid-phase extraction with acid dissociation (SPEAD) sample treatment prior to ELISA
    • H. W. Smith, A. Butterfield, and D. Sun, "Detection of antibodies against therapeutic proteins in the presence of residual therapeutic protein using a solid-phase extraction with acid dissociation (SPEAD) sample treatment prior to ELISA, " Regulatory Toxicology and Pharmacology, vol. 49, no. 3, pp. 230-237, 2007.
    • (2007) Regulatory Toxicology and Pharmacology , vol.49 , Issue.3 , pp. 230-237
    • Smith, H.W.1    Butterfield, A.2    Sun, D.3
  • 30
    • 80052505451 scopus 로고    scopus 로고
    • Differential effect of drug interference in immunogenicity assays
    • M. H. Hart, H. de Vrieze, D. Wouters et al., "Differential effect of drug interference in immunogenicity assays, " Journal of Immunological Methods, vol. 372, no. 1-2, pp. 196-203, 2011.
    • (2011) Journal of Immunological Methods , vol.372 , Issue.1-2 , pp. 196-203
    • Hart, M.H.1    De Vrieze, H.2    Wouters, D.3
  • 31
    • 84900297592 scopus 로고    scopus 로고
    • Development of a method that eliminates falsepositive results due to nerve growth factor interference in the assessment of fulranumab immunogenicity
    • S. Dai, A. Schantz, A. Clements-Egan, M. Cannon, and G. Shankar, "Development of a method that eliminates falsepositive results due to nerve growth factor interference in the assessment of fulranumab immunogenicity, " AAPS Journal, vol. 16, no. 3, pp. 464-477, 2014.
    • (2014) AAPS Journal , vol.16 , Issue.3 , pp. 464-477
    • Dai, S.1    Schantz, A.2    Clements-Egan, A.3    Cannon, M.4    Shankar, G.5
  • 32
    • 84975212338 scopus 로고    scopus 로고
    • Overcome drug and soluble target interferences in immunogenicity sample analysis for antibody therapy
    • Reston, Va, USA
    • L. Zou, "Overcome drug and soluble target interferences in immunogenicity sample analysis for antibody therapy, " in Proceedings of the IBC's 16th Annual Immunogenicity for Biotherapeutics, Reston, Va, USA, 2015.
    • (2015) Proceedings of the IBC's 16th Annual Immunogenicity for Biotherapeutics
    • Zou, L.1
  • 33
    • 84903597970 scopus 로고    scopus 로고
    • Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations
    • G. Shankar, S. Arkin, L. Cocea et al., "Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations, " The AAPS Journal, vol. 16, no. 4, pp. 658-673, 2014.
    • (2014) The AAPS Journal , vol.16 , Issue.4 , pp. 658-673
    • Shankar, G.1    Arkin, S.2    Cocea, L.3
  • 34
    • 84949671505 scopus 로고    scopus 로고
    • 2015 White paper on recent issues in bioanalysis: Focus on new technologies and biomarkers (part 3-LBA, biomarkers and immunogenicity)
    • L. Amaravadi, A. Song, H. Myler et al., "2015 White paper on recent issues in bioanalysis: focus on new technologies and biomarkers (part 3-LBA, biomarkers and immunogenicity), " Bioanalysis, vol. 7, no. 24, pp. 3107-3124, 2015.
    • (2015) Bioanalysis , vol.7 , Issue.24 , pp. 3107-3124
    • Amaravadi, L.1    Song, A.2    Myler, H.3
  • 35
    • 84876530257 scopus 로고    scopus 로고
    • Clinical relevance of serum natalizumab concentration and antinatalizumab antibodies in multiple sclerosis
    • A. Vennegoor, T. Rispens, E. M. M. Strijbis et al., "Clinical relevance of serum natalizumab concentration and antinatalizumab antibodies in multiple sclerosis, " Multiple Sclerosis Journal, vol. 19, no. 5, pp. 593-600, 2013.
    • (2013) Multiple Sclerosis Journal , vol.19 , Issue.5 , pp. 593-600
    • Vennegoor, A.1    Rispens, T.2    Strijbis, E.M.M.3
  • 36
    • 34848816850 scopus 로고    scopus 로고
    • The incidence and significance of anti-natalizumab antibodies: Results from AFFIRM and SENTINEL
    • P. A. Calabresi, G. Giovannoni, C. Confavreux et al., "The incidence and significance of anti-natalizumab antibodies: results from AFFIRM and SENTINEL, " Neurology, vol. 69, no. 14, pp. 1391-1403, 2007.
    • (2007) Neurology , vol.69 , Issue.14 , pp. 1391-1403
    • Calabresi, P.A.1    Giovannoni, G.2    Confavreux, C.3
  • 37
    • 79953177025 scopus 로고    scopus 로고
    • Kinetics and incidence of anti-natalizumab antibodies in multiple sclerosis patients on treatment for 18 months
    • B. Oliver, O. Fernández, T. Orpez et al., "Kinetics and incidence of anti-natalizumab antibodies in multiple sclerosis patients on treatment for 18 months, " Multiple Sclerosis, vol. 17, no. 3, pp. 368-371, 2011.
    • (2011) Multiple Sclerosis , vol.17 , Issue.3 , pp. 368-371
    • Oliver, B.1    Fernández, O.2    Orpez, T.3
  • 38
    • 84860396489 scopus 로고    scopus 로고
    • Occurrence of antibodies against natalizumab in relapsing multiple sclerosis patients treated with natalizumab
    • P. S. Sørensen, P. E. Hyldgaard Jensen, A. Haghikia et al., "Occurrence of antibodies against natalizumab in relapsing multiple sclerosis patients treated with natalizumab, " Multiple Sclerosis Journal, vol. 17, no. 9, pp. 1074-1078, 2011.
    • (2011) Multiple Sclerosis Journal , vol.17 , Issue.9 , pp. 1074-1078
    • Sørensen, P.S.1    Hyldgaard Jensen, P.E.2    Haghikia, A.3
  • 39
    • 85052412514 scopus 로고    scopus 로고
    • Biogen Idec and élan, Tysabri Insert, 2013, http://www. fda. gov/ safety/medwatch/safetyinformation/%20safety-relateddruglabelingchanges% 20/ucm106674. htm.
    • (2013) Biogen Idec and élan, Tysabri Insert


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