Practical application of acid dissociation in monitoring patients treated with adalimumab

Rheumatology International

Volumn 34, Issue 12, 2014, Pages 1701-1708

  Llinares Tello, Francisca ^a   Rosas Gómez de Salazar, José ^a   Senabre Gallego, José Miguel ^a   Santos Soler, Gregorio ^a   Santos Ramírez, Carlos ^b   Salas Heredia, Esteban ^a   Barber Vallés, Xavier ^c   Molina García, Juan ^a  

^a Marina Baixa Hospital   (Spain)

^b Hospital Marina Salud   (Spain)

^c MIGUEL HERNÁNDEZ UNIVERSITY   (Spain)

Author keywords

Adalimumab; Anti adalimumab antibodies; Anti TNF drugs; ELISA; Therapeutic drug monitoring

Indexed keywords

ADALIMUMAB; ANTIBODY; ANTIINFLAMMATORY AGENT; BIOLOGICAL MARKER; MONOCLONAL ANTIBODY;

ADOLESCENT; ADULT; AGED; ARTHRITIS, RHEUMATOID; BLOOD; DRUG MONITORING; DRUG TOLERANCE; ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; IMMUNOLOGY; MIDDLE AGED; PH; PREDICTIVE VALUE; PROCEDURES; REPRODUCIBILITY; RETROSPECTIVE STUDY; SPONDYLITIS, ANKYLOSING;

ADOLESCENT; ADULT; AGED; ANTI-INFLAMMATORY AGENTS; ANTIBODIES; ANTIBODIES, MONOCLONAL, HUMANIZED; ARTHRITIS, RHEUMATOID; BIOLOGICAL MARKERS; DRUG MONITORING; DRUG TOLERANCE; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; HYDROGEN-ION CONCENTRATION; MIDDLE AGED; PREDICTIVE VALUE OF TESTS; REPRODUCIBILITY OF RESULTS; RETROSPECTIVE STUDIES; SPONDYLITIS, ANKYLOSING;

EID: 84939889640     PISSN: 01728172     EISSN: 1437160X     Source Type: Journal    
DOI: 10.1007/s00296-014-3032-0     Document Type: Article

References (43)

1. Lee JW, Kelley M, King LE, Yang J, Salimi-Moosavi H, Tang MT et al (2011) Bioanalytical approaches to quantify “total” and “free” therapeutic antibodies and their targets: technical challenges and PK/PD applications over the course of drug development. AAPS J 13:99–110
2. Mok CC, van der Kleij D, Wolbink GJ (2013) Drug levels, anti-drug antibodies, and clinical efficacy of the anti-TNFα biologics in rheumatic diseases. Clin Rheumatol 32:1429–1435
3. Pascual-Salcedo D, Plasencia C, Ramiro S, Nuño L, Bonilla G, Nagore D et al (2011) Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis. Rheumatology 50:1445–1452
4. Krieckaert CLM, Bartelds GM, Lems WF, Wolbink GJ (2010) The effect of immunomodulators on the immunogenicity of TNF-blocking therapeutic monoclonal antibodies: a review. Arthritis Res Ther 12:217–222
5. Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M et al (2004) 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
6. Koren E, Smith HW, Shores E, Shankar G, Finco-Kent D, Rup B et al (2008) Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J Immunol Methods 333:1–9
7. Radstake TR, Svenson M, Eijsbouts AM, van den Hoogen FH, Enevold C, van Riel PL et al (2009) Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis. Ann Rheum Dis 68:1739–1745
8. Bartelds GM, Wijbrandts CA, Nurmohamed MT, Stapel S, Lems WF, Aarden L et al (2007) Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis 66:921–926
9. Bartelds GM, Krieckaert CL, Nurmohamed MT, van Schouwenburg PA, Lems WF, Twisk JW et al (2011) Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA 305:1460–1468
10. de Vries MK, Brouwer E, van der Horst-Bruinsma IE, Spoorenberg A, van Denderen JC, Jamnitski A et al (2009) Decreased clinical response to adalimumab in ankylosing spondylitis is associated with antibody formation. Ann Rheum Dis 68:1787–1788
11. Lecluse LL, Driessen RJ, Spuls PI, de Jong EM, Stapel SO, van Doorn MB et al (2010) Extent and clinical consequences of antibody formation against adalimumab in patients with plaque psoriasis. Arch Dermatol 146:127–132
12. Jamnitski A, Bartelds GM, Nurmohamed MT, van Schouwenburg PA, van Schaardenburg D, Stapel SO et al (2011) The presence or absence of antibodies to infliximab or adalimumab determines the outcome of switching to etanercept. Ann Rheum Dis 70:284–288
13. Wolbink GJ, Aarden LA, Dijkmans BA (2009) Dealing with immunogenicity of biologicals: assessment and clinical relevance. Curr Opin Rheumatol 21:211–215
14. Hart MH, de Vrieze H, Wouters D, Wolbink GJ, Killestein J, de Groot ER et al (2011) Differential effect of drug interference in immunogenicity assays. J Immunol Methods 372:196–203
15. van Schouwenburg PA, Bartelds GM, Hart MH, Aarden L, Wolbink GJ, Wouters D (2010) 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 362:82–88
16. van Schouwenburg PA, van de Stadt LA, de Jong RN, van Buren EEL, Kruithof S, de Groot E et al (2013) Adalimumab elicits a restricted anti-idiotypic antibody response in autoimmune patients resulting in functional neutralisation. Ann Rheum Dis 72:104–109
17. van Schouwenburg PA, Krieckaert CL, Rispens T, Aarden L, Wolbink GJ, Wouters D (2013) Long-term measurement of anti-adalimumab using pH-shift-anti-idiotype antigen binding test shows predictive value and transient antibody formation. Ann Rheum Dis 72:1680–1686
18. Bourdage JS, Cook CA, Farrington DL, Chain JS, Konrad RJ (2007) 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 Immunol Methods 327:10–17
19. Lofgren JA, Wala I, Koren E, Swanson SW, Jing S (2006) Detection of neutralizing anti-therapeutic protein antibodies in serum or plasma samples containing high levels of the therapeutic protein. J Immunol Methods 308:101–108
20. Patton A, Mullenix MC, Swanson SJ, Koren E (2005) An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen. J Immunol Methods 304:189–195
21. Schmidt E, Hennig K, Mengede C, Zillikens D, Kromminga A (2009) Immunogenicity of rituximab in patients with severe pemphigus. Clin Immunol 132:334–341
22. Sickert D, Kroeger K, Zickler C, Chokote E, Winkler B, Grenet JM et al (2008) Improvement of drug tolerance in immunogenicity testing by acid treatment on Biacore. J Immunol Methods 334:29–36
23. Shankar G, Shores E, Wagner C, Mire-Sluis AR (2006) Scientific and regulatory considerations on the immunogenicity of biologics. Trends Biotechnol 24:274–280
24. Mikulskis A, Yeung D, Subramanyam M, Amaravadi L (2011) Solution ELISA as a platform of choice for development of robust, drug tolerant immunogenicity assays in support of drug development. J Immunol Methods 365:38–49
25. Butterfield AM, Chain JS, Ackermann BL, Konrad RJ (2010) Comparison of assay formats for drug-tolerant immunogenicity testing. Bioanalysis 2:1961–1969
26. Smith HW, Butterfield A, Sun D (2007) 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. Regul Toxicol Pharmacol 49:230–237
27. Zhong ZD, Dinnogen S, Hokom M, Ray C, Weinreich D, Swanson SJ et al (2010) Identification and inhibition of drug target interference in immunogenicity assays. J Immunol Methods 355:21–28
28. Quinn TC, Kline R, Moss MW, Livingston RA, Hutton N (1993) Acid dissociation of immune complexes improves diagnostic utility of p24 antigen detection in perinatally acquired human immunodeficiency virus infection. J Infect Dis 167:1193–1196
29. Jayarao KS, Faulk WP, Karam JH, Grodsky GM, Forsham PH (1973) Measurement of immune complexes in insulin-treated diabetics. J Immunol Methods 3:337–345
30. Roch AM, Delcros JG, Ripoll JP, Thomas V, Richard J, Quash G (1990) A novel covalent enzyme-linked immunoassay (CELIA) for simultaneously measuring free and immune complex-bound antibodies of defined specificity: I. Application to naturally occurring antipolyamine antibodies in human sera. J Immunol Methods 133:1–11
31. Fineberg NS, Fineberg ES, Anderson JH, Birkett MA, Gibson RG, Hufferd S (1996) Immunologic effects of insulin lispro [Lys (B28), Pro (B29) human insulin] in IDDM and NIDDM patients previously treated with insulin. Diabetes 45:1750–1754
32. Dixon K (1974) Measurement of antibodies to insulin in serum. Clin Chem 20:1275–1281
33. Llinares Tello F, Rosas Gómez de Salazar J, Senabre Gallego JM, Santos Soler G, Santos Ramírez C, Salas Heredia E et al (2012) Analytical and clinical evaluation of a new immunoassay for therapeutic drug monitoring of infliximab and adalimumab. Clin Chem Lab Med 50:1845–1847
34. Llinares Tello F, Rosas J, de la Torre I, Valor L, Barber X, Senabre JM et al (2014) Comparative study of both versions of an immunoassay commercialized for therapeutic drug monitoring of adalimumab in rheumatoid arthritis. Reumatol Clín 10:105–108
35. Ruiz-Argüello B, Ruiz del Agua A, Torres N, Monasterio A, Martínez A, Nagore D (2013) Comparison study of two commercially available methods for the determination of infliximab, adalimumab, etanercept and anti-drug antibody levels. Clin Chem Lab Med 51:e287–e289
36. Rosas J, Llinares F, de la Torre I, Valor L, Barber X, Santos-Ramírez C et al (2013) Clinical usefulness of serum level of adalimumab in patients with rheumatoid arthritis. Ann Rheum Dis 72(Suppl3):333
37. Wang Y, Fang L, Zhou L, Wang J, Ahn H (2012) A Survey of applications of biological products for drug interference of immunogenicity assays. Pharm Res 29:3384–3392
38. Gorovits B (2009) Antidrug antibody assay validation: industry survey results. AAPS J 11:133–138
39. den Broeder AA, van der Maas A, van den Bemt BJF (2010) Dose de-escalation strategies and role of therapeutic drug monitoring of biologics in RA. Rheumatology 49:1801–1803
40. Bendtzen K (2012) Anti-TNF-α biotherapies: perspectives for evidence-based personalized medicine. Immunotherapy 4:1167–1179
41. Garcês S, Demengeot J, Benito-García E (2013) The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis. Ann Rheum Dis 72:1947–1955
42. Vincent FB, Morand EF, Murphy K, Mackay F, Mariette X, Marcelli C (2013) Antidrug antibodies to tumour necrosis factor-specific neutralising agents in chronic inflammatory diseases: a real issue, a clinical perspective. Ann Rheum Dis 72:165–178
43. Chen DY, Chen YM, Tsai WC, Tseng JC, Chen YH, Hsieh CW et al. (2014) Ann Rheum Dis. doi:10.1136/annrheumdis-2013-203893