Immunogenicity of biological therapeutics: From assay to patient

Current Opinion in Rheumatology

Volumn 24, Issue 3, 2012, Pages 306-311

  Krieckaert, Charlotte ^a   Rispens, Theo ^b   Wolbink, Gertjan ^a,b  

^a Jan Van Breemen Research Institute/Reade   (Netherlands)

^b SANQUIN RESEARCH   (Netherlands)

Author keywords

assay techniques; biological therapies; clinical implications; immunogenicity; therapeutic drug monitoring

Indexed keywords

ADALIMUMAB; BIOLOGICAL PRODUCT; C REACTIVE PROTEIN; CETUXIMAB; DRUG ANTIBODY; ETANERCEPT; IMMUNOGLOBULIN F(AB')2 FRAGMENT; IMMUNOGLOBULIN G1; IMMUNOGLOBULIN G4; IMMUNOGLOBULIN M; INFLIXIMAB; METHOTREXATE; RECOMBINANT ERYTHROPOIETIN; TUMOR NECROSIS FACTOR;

ALGORITHM; ANAPHYLAXIS; ANKYLOSING SPONDYLITIS; ANTIBODY COMBINING SITE; ANTIBODY DETECTION; ANTIGEN ANTIBODY COMPLEX; ANTIGEN BINDING; BINDING AFFINITY; BIOLOGICAL THERAPY; CONFORMATIONAL TRANSITION; CROHN DISEASE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG INDUCED DISEASE; DRUG MONITORING; DRUG SAFETY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; ENZYME LINKED IMMUNOSORBENT ASSAY; ERYTHEMA; FALSE POSITIVE RESULT; HUMAN; HYPOTENSION; IMMUNE RESPONSE; IMMUNOASSAY; IMMUNOGENICITY; IMMUNOLOGICAL TOLERANCE; MONOTHERAPY; PATIENT DECISION MAKING; PERSONALIZED MEDICINE; PRIORITY JOURNAL; PURE RED CELL ANEMIA; RADIOIMMUNOASSAY; REVIEW; RHEUMATOID ARTHRITIS; SURVIVAL TIME; THROMBOEMBOLISM; TREATMENT RESPONSE;

BIOLOGICAL AGENTS; CONFOUNDING FACTORS (EPIDEMIOLOGY); DRUG MONITORING; HUMANS; IMMUNOASSAY; IMMUNOGLOBULINS; TREATMENT OUTCOME;

EID: 84859269587     PISSN: 10408711     EISSN: 15316963     Source Type: Journal    
DOI: 10.1097/BOR.0b013e3283521c4e     Document Type: Review

References (33)

1. Wolbink GJ, Aarden LA, Dijkmans BA. Dealing with immunogenicity of biologicals: assessment and clinical relevance. Curr Opin Rheumatol 2009; 21:211-215
2. Hart MH, de Vrieze H, Wouters D, et al. Differential effect of drug interference in immunogenicity assays. J Immunol Methods 2011; 372 (1-2):196-203.
3. Wadhwa M, Thorpe R. Unwanted immunogenicity: lessons learned and future challenges. Bioanalysis 2010; 2:1073-1084
4. Rispens T, Ooievaar-De Heer P, Vermeulen E, et al. Human IgG4 binds to IgG4 and conformationally altered IgG1 via Fc-Fc interactions. J Immunol 2009; 182:4275-4281
5. Rispens T, Leeuwen A, Vennegoor A, et al. Measurement of serum levels of natalizumab, an immunoglobulin G4 therapeutic monoclonal antibody. Anal Biochem 2011; 411:271-276
6. Zack DJ, Stempniak M, Wong AL, Weisbart RH. Localization of an Fc-binding reactivity to the constant region of human IgG4. Implications for the pathogenesis of rheumatoid arthritis. J Immunol 1995; 155:5057-5063
7. Tatarewicz S, Miller JM, Swanson SJ, Moxness MS. Rheumatoid factor interference in immunogenicity assays for human monoclonal antibody therapeutics. J Immunol Methods 2010; 357:10-16
8. Rispens T, de Vrieze H, de Groot E, et al. Antibodies to constant domains of therapeutic monoclonal antibodies: antihinge antibodies in immunogenicity testing. J Immunol Methods 2011; 375:93-99
9. van Schouwenburg PA, Bartelds GM, Hart MH, et al. 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 (1-2):82-88
10. Lofgren JA, Wala I, Koren E, et al. Detection of neutralizing antitherapeutic protein antibodies in serum or plasma samples containing high levels of the therapeutic protein. J Immunol Methods 2006; 308 (1-2): 101-108 (Pubitemid 43107958)
11. Bennett CL, Luminari S, Nissenson AR, et al. Pure red-cell aplasia and epoetin therapy. N Engl J Med 2004; 351:1403-1408 (Pubitemid 39288166)
12. Baert F, Noman M, Vermeire S, et al. Influence of immunogenicity on the longterm efficacy of infliximab in Crohn's disease. N Engl J Med 2003; 348:601-608 (Pubitemid 36204954)
13. van der Laken CJ, Voskuyl AE, Roos JC, et al. Imaging and serum analysis of immune complex formation of radiolabelled infliximab and antiinfliximab in responders and nonresponders to therapy for rheumatoid arthritis. Ann Rheum Dis 2007; 66:253-256 (Pubitemid 46226064)
14. Chung CH, Mirakhur B, Chan E, et al. Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose. N Engl J Med 2008; 358:1109-1117 (Pubitemid 351398485)
15. van Bueren JJ, Rispens T, Verploegen S, et al. Antigalactose-a-1,3- galactose IgE from allergic patients does not bind a-galactosylated glycans on intact therapeutic antibody Fc domains. Biotechnol 2011; 29:574-576; doi: 10.1038/nbt.1912
16. Korswagen LA, Bartelds GM, Krieckaert CL, et al. Venous and arterial thromboembolic events in adalimumab-treated patients with antiadalimumab antibodies: a case series and cohort study. Arthritis Rheum 2011; 63:877-883; doi: 10.1002/art.30209
17. Pascual-Salcedo D, Plasencia C, Ramiro S, et al. Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis. Rheumatology (Oxford) 2011; 50:1445-1452.
18. Ducourau E, Mulleman D, Paintaud G, et al. Antibodies toward infliximab are associated with low infliximab concentration at treatment initiation and poor infliximab maintenance in rheumatic diseases. Arthritis Res Ther 2011; 13:R105
19. van den Bemt BJ, den Broeder AA, Wolbink GJ, et al. Antiinfliximab antibodies are already detectable in most patients with rheumatoid arthritis halfway through an infusioncycle: an open-label pharmacokinetic cohort study. BMC Musculoskelet Disord 2011; 12:12.
20. Bartelds GM, Krieckaert CL, Nurmohamed MT, et al. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA 2011; 305:1460-1468.
21. Jamnitski A, Krieckaert CL, Nurmohamed MT, et al. Patients nonresponding to etanercept obtain lower etanercept concentrations compared with responding patients. Ann Rheum Dis 2012; 71:88-91.
22. Vermeire S, Noman M, Van Assche G, et al. Effectiveness of concomitant immunosuppressive therapy in suppressing the formation of antibodies to infliximab in Crohn's disease. Gut 2007; 56:1226-1231 (Pubitemid 47300423)
23. Krieckaert CL, Bartelds GM, Lems WF, Wolbink GJ. The effect of immunomodulators on the immunogenicity of TNF-blocking therapeutic monoclonal antibodies: a review. Arthritis Res Ther 2010; 12:217
24. Bendtzen K, Geborek P, Svenson M, et al. Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab. Arthritis Rheum 2006; 54:3782-3789 (Pubitemid 44955878)
25. Bartelds GM, de Groot E, Nurmohamed MT, et al. Surprising negative association between IgG1 allotype disparity and antiadalimumab formation: a cohort study. Arthritis Res Ther 2010; 12:R221
26. Bartelds GM, Wijbrandts CA, Nurmohamed MT, et al. Antiadalimumab antibodies in rheumatoid arthritis patients are associated with interleukin-10 gene polymorphisms. Arthritis Rheum 2009; 60:2541-2542
27. Colombel JF, Feagan BG, Sandborn WJ, et al. Therapeutic drug monitoring of biologics for inflammatory bowel disease. Inflamm Bowel Dis 2012; 18:349-358
28. Jamnitski A, Bartelds GM, Nurmohamed MT, et al. The presence or absence of antibodies to infliximab or adalimumab determines the outcome of switching to etanercept. Ann Rheum Dis 2011; 70:284-288
29. Bartelds GM, Wijbrandts CA, Nurmohamed MT, et al. Antiinfliximab and antiadalimumab antibodies in relation to response to adalimumab in infliximab switchers and antitumour necrosis factor naive patients: a cohort study. Ann Rheum Dis 2010; 69:817-821
30. Afif W, Loftus EV Jr, Faubion WA, et al. Clinical utility of measuring infliximab and human antichimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol 2010; 105:1133-1139.
31. Bendtzen K. Is there a need for immunopharmacologic guidance of antitumor necrosis factor therapies? Arthritis Rheum 2011; 63:867-870; doi: 10.1002/art.30207.
32. Yanai H, Hanauer SB. Assessing response and loss of response to biological therapies in IBD. Am J Gastroenterol 2011; 106:685-698
33. Blom M, Kievit W, Kuper HH, et al. Frequency and effectiveness of dose increase of adalimumab, etanercept, and infliximab in daily clinical practice. Arthritis Care Res (Hoboken) 2010; 62:1335-1341.