Immunogenicity to therapeutic proteins: Impact on PK/PD and efficacy

AAPS Journal

Volumn 14, Issue 2, 2012, Pages 296-302

  Chirmule, Narendra ^a   Jawa, Vibha ^a   Meibohm, Bernd ^b  

^a AMGEN INC   (United States)

^b UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

Author keywords

Antibody; Immunogenicity; Pharmacodynamics; Pharmacokinetics; Protein therapeutics

Indexed keywords

ADALIMUMAB; ALEMTUZUMAB; BETA INTERFERON; CETUXIMAB; DRUG ANTIBODY; DRUG METABOLITE; IMMUNOGLOBULIN; INFLIXIMAB; NATALIZUMAB; NEUTRALIZING ANTIBODY; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; OKT 3; POLYCLONAL ANTIBODY; PROTEIN DERIVATIVE; RECOMBINANT BLOOD CLOTTING FACTOR 8; RECOMBINANT BLOOD CLOTTING FACTOR 9; RECOMBINANT GLUCAN 1,4 ALPHA GLUCOSIDASE; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; RITUXIMAB;

ACCURACY; ANALYTIC METHOD; ANTIBODY DETECTION; ANTIBODY RESPONSE; ANTIBODY TITER; BIOASSAY; CROSS-SECTIONAL STUDY; DRUG CLEARANCE; DRUG DEGRADATION; DRUG DETERMINATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG MEGADOSE; DRUG TARGETING; DRUG TRANSFORMATION; HUMAN; IMMUNOASSAY; IMMUNOGENICITY; IMMUNOLOGICAL TOLERANCE; PHARMACODYNAMICS; PHARMACOKINETICS; PROTEIN MODIFICATION; QUANTITATIVE ANALYSIS; REVIEW;

ANIMALS; ANTIBODY FORMATION; BIOLOGICAL AGENTS; CLINICAL TRIALS AS TOPIC; HUMANS; IMMUNOGENETIC PHENOMENA; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; PROTEINS; TREATMENT OUTCOME;

EID: 84860710411     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-012-9340-y     Document Type: Review

References (45)

1. Meibohm B, Braeckman RA. Pharmacokinetics and pharmaco-dynamics of peptides and proteins. In: Crommelin DJA, Sindelar RD, Meibohm B, editors. Pharmaceutical biotechnology: concepts and applications. 3rd ed. New York: Informa Healthcare; 2007. p. 95-123.
2. Tang L, Persky AM, Hochhaus G, Meibohm B. Pharmacokinetic aspects of biotechnology products. J Pharm Sci. 2004;93:2184-204. (Pubitemid 39129617)
3. Dong JQ, Salinger DH, Endres CJ, Gibbs JP, Hsu CP, Stouch BJ, et al. Quantitative prediction of human pharmacokinetics for monoclonal antibodies: retrospective analysis of monkey as a single species for first-in-human prediction. Clin Pharmacokinet. 2011;50:131-42.
4. CHMP. Guideline of immunogenicity assessment of biotechnology-derived therapeutic proteins. London: EMEA Guidance Document; 2008.
5. Gupta S, Devanarayan V, Finco D, Gunn 3rd GR, Kirshner S, Richards S, et al. Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics. J Pharm Biomed Anal. 2011;55:878-88.
6. Shankar G, Devanarayan V, Amaravadi L, Barrett YC, Bowsher R, Finco-Kent D, et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J Pharm Biomed Anal. 2008;48:1267-81.
7. Jamnitski A, Bartelds GM, Nurmohamed MT, van Schouwenburg PA, van Schaardenburg D, Stapel SO, et al. The presence or absence of antibodies to infliximab or adalimumab determines the outcome of switching to etanercept. Ann Rheum Dis. 2011;70:284-8.
8. Lecluse LL, Driessen RJ, Spuls PI, de Jong EM, Stapel SO, van Doorn MB, et al. Extent and clinical consequences of antibody formation against adalimumab in patients with plaque psoriasis. Arch Dermatol. 2010;146:127-32.
9. Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M, et al. 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. (Pubitemid 38900899)
10. Barbosa MD, Vielmetter J, Chu S, Smith DD, Jacinto J. Clinical link between MHC class II haplotype and interferon-beta (IFN-beta) immunogenicity. Clin Immunol. 2006;118:42-50. (Pubitemid 43012045)
11. Carpenter J, et al. Meeting report on protein particles and immunogenicity of therapeutic proteins: filling the gaps in risk evaluation and mitigation. Biologicals. 2011;38:602-11.
12. Schellekens H. Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov. 2002;1:457-62. (Pubitemid 37361488)
13. Hansel TT, Kropshofer H, Singer T, Mitchell JA, George AJ. The safety and side effects of monoclonal antibodies. Nat Rev Drug Discov. 2010;9:325-38.
14. Rathore AS, Winkle H. Quality by design for biopharmaceuticals. Nat Biotechnol. 2009;27:26-34.
15. Bautista AC, Wullner D, Moxness M, Swanson SJ, Chirmule N, Jawa V. Impact of matrix-associated soluble factors on the specificity of the immunogenicity assessment. Bioanalysis. 2010;2:721-31.
16. Lee JW, Kelley M, King LE, Yang J, Salimi-Moosavi H, Tang MT, et al. 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. 2011;13:99-110.
17. Salimi-Moosavi H, Lee J, Desilva B, Doellgast G. Novel approaches using alkaline or acid/guanidine treatment to eliminate therapeutic antibody interference in the measurement of total target ligand. J Pharm Biomed Anal. 2009;51:1128-33.
18. Hall MP, Gegg C, Walker K, Spahr C, Ortiz R, Patel V, et al. Ligand-binding mass spectrometry to study biotransformation of fusion protein drugs and guide immunoassay development: strategic approach and application to peptibodies targeting the thrombopoietin receptor. AAPS J. 2010;12:576-85.
19. Liang M, Klakamp SL, Funelas C, Lu H, Lam B, Herl C, et al. Detection of high- and low-affinity antibodies against a human monoclonal antibody using various technology platforms. Assay Drug Dev Technol. 2007;5:655-62.
20. Lofgren JA, Dhandapani S, Pennucci JJ, Abbott CM, Mytych DT, Kaliyaperumal A, et al. Comparing ELISA and surface plasmon resonance for assessing clinical immunogenicity of panitumumab. J Immunol. 2007;178:7467-72. (Pubitemid 46847475)
21. Hay C, Recht M, Carcao M, Reipert B. Current and future approaches to inhibitor management and aversion. Semin Thromb Hemost. 2006;32 Suppl 2:15-21.
22. Swann PG, Tolnay M, Muthukkumar S, Shapiro MA, Rellahan BL, Clouse KA. Considerations for the development of therapeutic monoclonal antibodies. Curr Opin Immunol. 2008;20:493-9.
23. Thorpe R, Swanson SJ. Assays for detecting and diagnosing antibody-mediated pure red cell aplasia (PRCA): an assessment of available procedures. Nephrol Dial Transplant. 2005;20 Suppl 4:iv16-22. (Pubitemid 40711820)
24. Plotkin S, Orenstein W. Vaccines. Philadelphia: Saunders; 1999.
25. Buttel IC, Chamberlain P, Chowers Y, Ehmann F, Greinacher A, Jefferis R, et al. Taking immunogenicity assessment of therapeutic proteins to the next level. Biologicals. 2011;39: 100-9.
26. de Vries MK, Wolbink GJ, Stapel SO, de Groot ER, Dijkmans BA, Aarden LA, et al. Inefficacy of infliximab in ankylosing spondylitis is correlated with antibody formation. Ann Rheum Dis. 2007;66:133-4. (Pubitemid 46044875)
27. Bartelds GM, Krieckaert CL, Nurmohamed MT, van Schouwenburg PA, Lems WF, Twisk JW, et al. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA. 2011;305:1460-8.
28. Jawa V, Hokom M, Hu Z, El-Abaadi N, Zhuang Y, Berger D, et al. Assessment of immunogenicity of romiplostim in clinical studies with ITP subjects. Ann Hematol. 2010;89:S75-85.
29. Dirks NL, Meibohm B. Population pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010;49:633-59.
30. Keizer RJ, Huitema AD, Schellens JH, Beijnen JH. Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010;49:493-507.
31. Lanning DK, Knight KL. Somatic hypermutation: mutations 3′ of rabbit VDJ H-chain genes. J Immunol. 1997;159:4403-7. (Pubitemid 127470599)
32. Genzyme. Myozyme prescribing information. Cambridge: Genzyme; 2009.
33. Banugaria SG, Prater SN, Ng YK, Kobori JA, Finkel RS, Ladda RL, et al. The impact of antibodies on clinical outcomes in diseases treated with therapeutic protein: lessons learned from infantile Pompe disease. Genet Med. 2011;13: 729-36.
34. Mousavi SA, Sporstol M, Fladeby C, Kjeken R, Barois N, Berg T. Receptor-mediated endocytosis of immune complexes in rat liver sinusoidal endothelial cells is mediated by FcgammaRIIb2. Hepatology. 2007;46:871-84. (Pubitemid 47436133)
35. Montero-Julian FA, Klein B, Gautherot E, Brailly H. Pharma-cokinetic study of anti-interleukin-6 (IL-6) therapy with monoclonal antibodies: enhancement of IL-6 clearance by cocktails of anti-IL-6 antibodies. Blood. 1995;85:917-24.
36. Rehlaender BN, Cho MJ. Antibodies as carrier proteins. Pharm Res. 1998;15:1652-6. (Pubitemid 28524572)
37. Kakkar T, Sung C, Gibiansky L, Vu T, Narayanan A, Lin SL, et al. Population PK and IgE pharmacodynamic analysis of a fully human monoclonal antibody against IL4 receptor. Pharm Res. 2011;28:2530-42.
38. Tabrizi MA, Roskos LK. Preclinical and clinical safety of monoclonal antibodies. Drug Discov Today. 2007;12:540-7. (Pubitemid 47031663)
39. Baert F, Noman M, Vermeire S, Van Assche G, D'Haens G, Carbonez A, et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med. 2003;348:601-8. (Pubitemid 36204954)
40. Collins PW, Mathias M, Hanley J, Keeling D, Keenan R, Laffan M, et al. Rituximab and immune tolerance in severe hemophilia A: a consecutive national cohort. J Thromb Haemost. 2009;7:787-94.
41. Kishnani PS, Goldenberg PC, DeArmey SL, Heller J, Benjamin D, Young S, et al. Cross-reactive immunologic material status affects treatment outcomes in Pompe disease infants. Mol Genet Metab. 2010;99:26-33.
42. Millonig A, Rudzki D, Holzl M, Ehling R, Gneiss C, Kunz B, et al. High-dose intravenous interferon beta in patients with neutralizing antibodies (HINABS): a pilot study. Mult Scler. 2009;15:977-83.
43. Patton A, Mullenix MC, Swanson SJ, Koren E. An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen. J Immunol Methods. 2005;304:189-95. (Pubitemid 41262233)
44. Peng K, Siradze K, Quarmby V, Fischer SK. Clinical immuno-genicity specificity assessments: a platform evaluation. J Pharm Biomed Anal. 2011;54:629-35.
45. Quataert SA, Kirch CS, Wiedl LJ, Phipps DC, Strohmeyer S, Cimino CO, et al. Assignment of weight-based antibody units to a human antipneumococcal standard reference serum, lot 89-S. Clin Diagn Lab Immunol. 1995;2:590-7.