Validation of a sample pretreatment protocol to convert a drug-sensitive into a drug-tolerant anti-infliximab antibody immunoassay

Drug Testing and Analysis

Volumn 9, Issue 2, 2017, Pages 243-247

  Van Stappen, Thomas ^a   Brouwers, Els ^a   Vermeire, Séverine ^b   Gils, Ann ^a  

^a DEPARTMENT OF PHARMACEUTICAL AND PHARMACOLOGICAL SCIENCES   (Belgium)

^b UNIVERSITY HOSPITALS LEUVEN   (Belgium)

Author keywords

ELISA; immunogenicity; infliximab; therapeutic drug monitoring

Indexed keywords

ASSAYS; COPYRIGHTS; PATIENT MONITORING; PATIENT TREATMENT;

ELISA; IMMUNOGENICITY; INFLIXIMAB; META-ANALYSIS; PROTOCOL CANS; SAMPLE PRETREATMENT; SENSITIVE ASSAY; SERUM SAMPLES; THERAPEUTIC DRUG MONITORING; TREATMENT OPTIMIZATION;

ANTIBODIES;

INFLIXIMAB; ANTIBODY; ANTIRHEUMATIC AGENT;

ADULT; ARTICLE; CLINICAL ARTICLE; CLINICAL PROTOCOL; CONTROLLED STUDY; CROHN DISEASE; DRUG DOSE INTENSIFICATION; DRUG SENSITIVE IMMUNOASSAY; DRUG TOLERANCE; DRUG TOLERANT IMMUNOASSAY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMAN; IMMUNOASSAY; INFORMED CONSENT; LIMIT OF QUANTITATION; MALE; MEASUREMENT ACCURACY; MEASUREMENT PRECISION; PRETREATMENT PROTOCOL; PROCESS OPTIMIZATION; ULCERATIVE COLITIS; VALIDATION PROCESS; BLOOD; DRUG HYPERSENSITIVITY; DRUG MONITORING; IMMUNOLOGY; MIDDLE AGED; PROCEDURES; SENSITIVITY AND SPECIFICITY; VALIDATION STUDY;

ADULT; ANTIBODIES; ANTIRHEUMATIC AGENTS; DRUG HYPERSENSITIVITY; DRUG MONITORING; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMANS; INFLIXIMAB; MALE; MIDDLE AGED; SENSITIVITY AND SPECIFICITY;

EID: 84962521002     PISSN: 19427603     EISSN: 19427611     Source Type: Journal    
DOI: 10.1002/dta.1968     Document Type: Article

References (23)

1. European Medicines Agency: Remicade. European public assessment report. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000240/WC500050888.pdf [Accessed 20 February 2016].
2. European Medicines Agency: Humira. European public assessment report. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf [Accessed 20 February 2016].
3. E. Dreesen, A. Gils. Neutralisation of Soluble Tumor Necrosis Factor. In Anti-Tumor Necrosis Factor Therapy in Inflammatory Bowel Disease. (G. Rogler, H. Herfarth, T. Hibi, O. Haagen Nielsen). S. Karger AG, Switzerland, 2015, pp. 83–89.
4. K. Bendtzen, P. Geborek, M. Svenson, L. Larsson, M. C. Kapetanovic, T. Saxne. Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab. Arthritis Rheum. 2006, 54, 3782.
5. F. Baert, M. Noman, S. Vermeire, G. Van Assche, G. D'Haens, A. Carbonez, P. Rutgeerts. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N. Engl. J. Med. 2003, 348, 601.
6. C. Steenholdt, M. Svenson, K. Bendtzen, O. O. Thomsen, J. Brynskov, M. A. Ainsworth. Severe infusion reactions to infliximab: aetiology, immunogenicity and risk factors in patients with inflammatory bowel disease. Aliment. Pharmacol. Ther. 2011, 34, 51.
7. G. R. Lichtenstein, R. Panaccione, G. Mallarkey. Efficacy and safety of adalimumab in Crohn's disease. Therap. Adv. Gastroenterol. 2008, 1, 43.
8. S. Garces, J. Demengeot, E. Benito-Garcia. The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis. Ann. Rheum. Dis. 2013, 72, 1947.
9. N. Vande Casteele, A. Gils, S. Singh, L. Ohrmund, S. Hauenstein, P. Rutgeerts, S. Vermeire. Antibody response to infliximab and its impact on pharmacokinetics can be transient. Am. J. Gastroenterol. 2013, 108, 962.
10. M. Allez, K. Karmiris, E. Louis, G. Van Assche, S. Ben-Horin, A. Klein, J. Van der Woude, F. Baert, R. Eliakim, K. Katsanos, J. Brynskov, F. Steinwurz, S. Danese, S. Vermeire, J. L. Teillaud, M. Lemann, Y. Chowers. Report of the ECCO pathogenesis workshop on anti-TNF therapy failures in inflammatory bowel diseases: definitions, frequency and pharmacological aspects. J. Crohns Colitis. 2010, 4, 355.
11. P. A. van Schouwenburg, C. L. Krieckaert, T. Rispens, L. Aarden, G. J. Wolbink, D. Wouters. Long-term measurement of anti-adalimumab using pH-shift-anti-idiotype antigen binding test shows predictive value and transient antibody formation. Ann. Rheum. Dis. 2013, 72, 1680.
12. B. Ungar, Y. Chowers, M. Yavzori, O. Picard, E. Fudim, O. Har-Noy, U. Kopylov, R. Eliakim, S. Ben-Horin. The temporal evolution of antidrug antibodies in patients with inflammatory bowel disease treated with infliximab. Gut. 2014, 63, 1258.
13. T. Van Stappen, T. Billiet, N. Vande Casteele, G. Compernolle, E. Brouwers, S. Vermeire, A. Gils. An optimized anti-infliximab bridging enzyme-linked immunosorbent assay for harmonization of anti-infliximab antibody titers in patients with inflammatory bowel diseases. Inflamm. Bowel Dis. 2015, 21, 2172.
14. A. Gils, N. Vande Casteele, R. Poppe, M. Van de Wouwer, G. Compernolle, M. Peeters, E. Brouwers, S. Vermeire, N. Geukens, P. J. Declerck. Development of a universal anti-adalimumab antibody standard for interlaboratory harmonization. Ther. Drug Monit. 2014, 36, 669.
15. K. Bloem, A. van Leeuwen, G. Verbeek, M. T. Nurmohamed, G. J. Wolbink, D. van der Kleij, T. Rispens. 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.
16. T. Van Stappen, E. Brouwers, S. Tops, N. Geukens, S. Vermeire, P. J. Declerck, A. Gils. Generation of a highly specific monoclonal anti-infliximab antibody for harmonization of TNF-coated infliximab assays. Ther. Drug Monit. 2015, 37, 479.
17. S. S. Thomas, N. Borazan, N. Barroso, L. Duan, S. Taroumian, B. Kretzmann, R. Bardales, D. Elashoff, S. Vangala, D. E. Furst. Comparative immunogenicity of TNF inhibitors: impact on clinical efficacy and tolerability in the management of autoimmune diseases. A systematic review and meta-analysis. BioDrugs. 2015, 29, 241.
18. S. Vermeire, A. Gils. Value of drug level testing and antibody assays in optimising biological therapy. Frontline Gastroenterol. 2013, 4, 41.
19. N. Vande Casteele, M. Ferrante, G. Van Assche, V. Ballet, G. Compernolle, K. Van Steen, S. Simoens, P. Rutgeerts, A. Gils, S. Vermeire. Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease. Gastroenterol. 2015, 148, 1320.
20. C. Steenholdt, J. Brynskov, O. O. Thomsen, L. K. Munck, J. Fallingborg, L. A. Christensen, G. Pedersen, J. Kjeldsen, B. A. Jacobsen, A. S. Oxholm, J. Kjellberg, K. Bendtzen, M. A. Ainsworth. Individualised therapy is more cost-effective than dose intensification in patients with Crohn's disease who lose response to anti-TNF treatment: a randomised, controlled trial. Gut. 2013, 63, 919.
21. S. Ben-Horin, M. Yavzori, L. Katz, U. Kopylov, O. Picard, E. Fudim, D. Coscas, S. Bar-Meir, I. Goldstein, Y. Chowers. The immunogenic part of infliximab is the F(ab')2, but measuring antibodies to the intact infliximab molecule is more clinically useful. Gut. 2011, 60, 41.
22. P. A. van Schouwenburg, G. M. Bartelds, M. H. Hart, L. Aarden, G. J. Wolbink, D. Wouters. A novel method for the detection of antibodies to adalimumab in the presence of drug reveals "hidden" immunogenicity in rheumatoid arthritis patients. J. Immunol. Methods. 2010, 362, 82.
23. U. Kopylov, Y. Mazor, M. Yavzori, E. Fudim, L. Katz, D. Coscas, O. Picard, Y. Chowers, R. Eliakim, S. Ben-Horin. Clinical utility of antihuman lambda chain-based enzyme-linked immunosorbent assay (ELISA) versus double antigen ELISA for the detection of anti-infliximab antibodies. Inflamm. Bowel Dis. 2012, 18, 1628.