Using monoclonal antibodies as an international standard for the measurement of anti-adalimumab antibodies

Journal of Pharmaceutical and Biomedical Analysis

Volumn 120, Issue , 2016, Pages 198-201

  van Schouwenburg, Pauline A ^a,c   Kruithof, Simone ^a   Wolbink, Gertjan ^a,b   Wouters, Diana ^a   Rispens, Theo ^a  

^a ACADEMIC MEDICAL CENTER   (Netherlands)

^b Jan Van Breemen Research Institute   (Netherlands)

^c ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

Adalimumab; Anti drug antibodies; Anti idiotype Antibodies; Human monoclonal antibodies; Immunogenicity

Indexed keywords

ADALIMUMAB; ANTIIDIOTYPIC ANTIBODY; DRUG ANTIBODY; MONOCLONAL ANTIBODY; POLYCLONAL ANTIBODY; IMMUNOGLOBULIN G; PROTEIN BINDING;

ANTIBODY AFFINITY; ANTIGEN BINDING; ANTIGEN BINDING TEST; ARTICLE; CONTROLLED STUDY; ENZYME LINKED IMMUNOSORBENT ASSAY; PRIORITY JOURNAL; STANDARD; STANDARDIZATION; BLOOD; DOSE RESPONSE; HUMAN; PHYSIOLOGY; STANDARDS;

ADALIMUMAB; ANTIBODIES, ANTI-IDIOTYPIC; ANTIBODIES, MONOCLONAL; DOSE-RESPONSE RELATIONSHIP, DRUG; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; IMMUNOGLOBULIN G; PROTEIN BINDING; REFERENCE STANDARDS;

EID: 84952673844     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2015.12.040     Document Type: Article

References (10)

1. 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, 305:1460-1468.
2. Baert F., Noman M., Vermeire S., Van Assche G., D'Haens G., Carbonez A., Rutgeerts P. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N. Engl. J. Med. 2003, 348:601-608.
3. Wolbink G.J., Voskuyl A.E., Lems W.F., de Groot E., Nurmohamed M.T., Tak P.P., Dijkmans B.A., Aarden L. Relationship between serum trough infliximab levels, pretreatment C reactive protein levels, and clinical response to infliximab treatment in patients with rheumatoid arthritis. Ann. Rheum. Dis. 2005, 64:704-707.
4. Vande Casteele N., Buurman D.J., Sturkenboom M.G., Kleibeuker J.H., Vermeire S., Rispens T., van der Kleij D., Gils A., Dijkstra G. Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays. Aliment. Pharmacol. Ther. 2012, 36:765-771.
5. Steenholdt C., Bendtzen K., Brynskov J., Thomsen O.O., Ainsworth M.A. Clinical implications of measuring drug and anti-drug antibodies by different assays when optimizing infliximab treatment failure in Crohn's disease: post hoc analysis of a randomized controlled trial. Am. J. Gastroenterol. 2014, 109:1055-1064.
6. Gils A., Vande Casteele N., Poppe R., Van de Wouwer M., Compernolle G., Peeters M., Brouwers E., Vermeire S., Geukens N., Declerck P.J. Development of a universal anti-adalimumab antibody standard for interlaboratory harmonization. Ther. Drug Monit. 2014, 36:669-673.
7. van Schouwenburg P.A., Kruithof S., Votsmeier C., van Schie K., Hart M.H., de Jong R.N., van Buren E.E., van Ham M., Aarden L., Wolbink G., Wouters D., Rispens T. Functional analysis of the anti-adalimumab response using patient-derived monoclonal antibodies. J. Biol. Chem. 2014, 289:34482-34488.
8. van Schouwenburg P.A., van de Stadt L.A., de Jong R.N., van Buren E.E., Kruithof S., de Groot E., Hart M., van Ham S.M., Rispens T., Aarden L., Wolbink G.J., Wouters D. Adalimumab elicits a restricted anti-idiotypic antibody response in autoimmune patients resulting in functional neutralisation. Ann. Rheum. Dis. 2013, 72:104-109.
9. Bartelds G.M., Wijbrandts C.A., Nurmohamed M.T., Stapel S., Lems W.F., Aarden L., Dijkmans B.A., Tak P.P., Wolbink G.J. Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann. Rheum. Dis. 2007, 66:921-926.
10. Bloem K., van Leeuwen A., Verbeek G., Nurmohamed M.T., Wolbink G.J., van der Kleij D., Rispens T. Systematic comparison of drug-tolerant assays for anti-drug antibodies in a cohort of adalimumab-treated rheumatoid arthritis patients. J. Immunol. Methods 2015, 418:29-38.