Drug interference in immunogenicity assays depends on valency

被引：19

作者：

Rispens, Theo ^{[1
,2
]}

Hart, Margreet H. ^{[1
,2
]}

Ooijevaar-de Heer, Pleuni ^{[1
,2
]}

van Leeuwen, Astrid ^{[3
]}

Vennegoor, Anke ^{[4
]}

Killestein, Joep ^{[4
]}

Wolbink, Gerrit-Jan ^{[1
,2
]}

van der Kleij, Desiree ^{[3
]}

机构：

[1] Sanquin Res, Dept Immunopathol, NL-1066 CX Amsterdam, Netherlands

[2] Univ Amsterdam, Acad Med Ctr, Landsteiner Lab, NL-1012 WX Amsterdam, Netherlands

[3] Sanquin Diagnost Serv, Amsterdam, Netherlands

[4] Vrije Univ Amsterdam Med Ctr, Dept Neurol, Amsterdam, Netherlands

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2013年 / 85卷

关键词：

Natalizumab; Certolizumab; Anti-drug antibody (ADA); Bispecific antibody; Drug interference; ANTI-NATALIZUMAB ANTIBODIES; LONG-TERM TREATMENT; RHEUMATOID-ARTHRITIS; CLINICAL-RESPONSE; ADALIMUMAB; SERUM; EFFICACY; INFLIXIMAB; ELISA;

D O I：

10.1016/j.jpba.2013.07.022

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

Direct comparison of immunogenicity data is hampered by differential drug interference in different assay formats. In this paper we identify a drug-related factor that influences the extent of drug interference. We systematically investigated the influence of drug valency of different antibody-derived biologicals on the drug interference, using mono- and bivalent formats of adalimumab as a model system. Our results indicate that compared to regular bivalent antibodies, antibody-derived drugs that are monovalent result in less drug interference. Two real-life examples were examined: natalizumab, an IgG4 antibody that becomes effectively monovalent in vivo due to Fab arm exchange, and certolizumab pegol, a pegylated Fab fragment. For both drugs it was demonstrated that drug interference is less pronounced in an antigen-binding test compared to similar assays for other therapeutic antibodies. When comparing immunogenicity data obtained for different biologicals this phenomenon should be taken into account. (C) 2013 Elsevier B.V. All rights reserved.

引用

页码：179 / 185

页数：7

共 34 条

[1] Report of the ECCO pathogenesis workshop on anti-TNF therapy failures in inflammatory bowel diseases: Definitions, frequency and pharmacological aspects [J].

Allez, Matthieu ;

Karmiris, Konstantinos ;

Louis, Edouard ;

Van Assche, Gert ;

Ben-Horin, Shomron ;

Klein, Amir ;

Van der Woude, Janneke ;

Baert, Filip ;

Eliakim, Rami ;

Katsanos, Konstantinos ;

Brynskov, Jorn ;

Steinwurz, Flavio ;

Danese, Silvio ;

Vermeire, Severine ;

Teillaud, Jean-Luc ;

Lemann, Marc ;

Chowers, Yehuda .

JOURNAL OF CROHNS & COLITIS, 2010, 4 (04) :355-366

[2] Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease [J].

Baert, F ;

Noman, M ;

Vermeire, S ;

Van Assche, G ;

D'Haens, G ;

Carbonez, A ;

Rutgeerts, P .

NEW ENGLAND JOURNAL OF MEDICINE, 2003, 348 (07) :601-608

[3] Anti-infliximab and anti-adalimumab antibodies in relation to response to adalimumab in infliximab switchers and anti-tumour necrosis factor naive patients: a cohort study [J].

Bartelds, G. M. ;

Wijbrandts, C. A. ;

Nurmohamed, M. T. ;

Stapel, S. ;

Lems, W. F. ;

Aarden, L. ;

Dijkmans, B. A. C. ;

Tak, P. P. ;

Wolbink, G. J. .

ANNALS OF THE RHEUMATIC DISEASES, 2010, 69 (05) :817-821

[4] Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis [J].

Bartelds, Geertje M. ;

Wijbrandts, Carla A. ;

Nurmohamed, Michael T. ;

Stapel, Steven ;

Lems, Willem F. ;

Aarden, Lucien ;

Dijkmans, Ben A. C. ;

Tak, Paul Peter ;

Wolbink, Gerrit Jan .

ANNALS OF THE RHEUMATIC DISEASES, 2007, 66 (07) :921-926

[5] Development of Antidrug Antibodies Against Adalimumab and Association With Disease Activity and Treatment Failure During Long-term Follow-up [J].

Bartelds, Geertje M. ;

Krieckaert, Charlotte L. M. ;

Nurmohamed, Michael T. ;

van Schouwenburg, Pauline A. ;

Lems, Willem F. ;

Twisk, Jos W. R. ;

Dijkmans, A. C. ;

Aarden, Lucien ;

Wolbink, Gerrit Jan .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2011, 305 (14) :1460-1468

[6] Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor α inhibitor infliximab [J].

Bendtzen, Klaus ;

Geborek, Pierre ;

Svenson, Morten ;

Larsson, Lotta ;

Kapetanovic, Meliha C. ;

Saxne, Tore .

ARTHRITIS AND RHEUMATISM, 2006, 54 (12) :3782-3789

[7] An affinity capture elution (ACE) assay for detection of anti-drug antibody to monoclonal antibody therapeutics in the presence of high levels of drug [J].

Bourdage, James S. ;

Cook, Carolyn A. ;

Farrington, Daphne L. ;

Chain, Jana S. ;

Konrad, Robert J. .

JOURNAL OF IMMUNOLOGICAL METHODS, 2007, 327 (1-2) :10-17

[8] The incidence and significance of anti-natalizumab antibodies -: Results from AFFIRM and SENTINEL [J].

Calabresi, P. A. ;

Giovannoni, G. ;

Confavreux, C. ;

Galetta, S. L. ;

Havrdova, E. ;

Hutchinson, M. ;

Kappos, L. ;

Miller, D. H. ;

O'Connor, P. W. ;

Phillips, J. T. ;

Polman, C. H. ;

Radue, E. -W. ;

Rudick, R. A. ;

Stuart, W. H. ;

Lublin, F. D. ;

Wajgt, A. ;

Weinstock-Guttman, B. ;

Wynn, D. R. ;

Lynn, F. ;

Panzara, M. A. ;

Macdonell, R. ;

Hughes, A. ;

Taylor, I. ;

Lee, Y. C. ;

Ma, H. ;

King, J. ;

Kilpatrick, T. ;

Butzkueven, H. ;

Marriott, M. ;

Pollard, J. ;

Spring, P. ;

Spies, J. ;

Barnett, M. ;

Dehaene, I. ;

Vanopdenbosch, L. ;

D'Hooghe, M. ;

Van Zandijcke, M. ;

Derijck, O. ;

Seeldrayers, P. ;

Jacquy, J. ;

Piette, T. ;

De Cock, C. ;

Medaer, R. ;

Soors, P. ;

Vanroose, E. ;

Vanderhoven, L. ;

Nagels, G. ;

Dubois, B. ;

Deville, M. -C. ;

D'Haene, R. .

NEUROLOGY, 2007, 69 (14) :1391-1403

[9] Efficacy of a novel PEGylated humanized anti-TNF fragment (CDP870) in patients with rheumatoid arthritis: a phase II double-blinded, randomized, dose-escalating trial [J].

Choy, EHS ;

Hazleman, B ;

Smith, M ;

Moss, K ;

Lisi, L ;

Scott, DGI ;

Patel, J ;

Sopwith, M ;

Isenberg, DA .

RHEUMATOLOGY, 2002, 41 (10) :1133-1137

[10]

Garces S., 2012, ANN RHEUMATIC DIS

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