Stratification of antibody-positive subjects by antibody level reveals an impact of immunogenicity on pharmacokinetics

AAPS Journal

Volumn 15, Issue 1, 2013, Pages 30-40

  Zhou, Lei ^a   Hoofring, Sarah A ^a   Wu, Yu ^a   Vu, Thuy ^a   Ma, Peiming ^a   Swanson, Steven J ^a   Chirmule, Narendra ^a   Starcevic, Marta ^a  

^a AMGEN INC   (United States)

Author keywords

antidrug antibodies; immunogenicity; pharmacokinetics

Indexed keywords

AMG 317; DRUG ANTIBODY; MONOCLONAL ANTIBODY; UNCLASSIFIED DRUG;

ANTIBODY BLOOD LEVEL; ANTIBODY DETECTION; ANTIBODY RESPONSE; ARTICLE; ASTHMA; CONTROLLED STUDY; DOSE RESPONSE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISPOSITION; DRUG DOSE COMPARISON; DRUG ELIMINATION; HUMAN; IMMUNOGENICITY; MAJOR CLINICAL STUDY;

ANTIBODIES; ANTIBODIES, MONOCLONAL; HUMANS; PATIENT SATISFACTION;

EID: 84871949938     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-012-9408-8     Document Type: Article

References (35)

1. Shankar G, Pendley C, Stein KE. A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs. Nat Biotechnol. 2007;25(5):555-61. (Pubitemid 46834844)
2. Schellekens H. Factors influencing the immunogenicity of therapeutic proteins. Nephrol Dial Transplant. 2005;20 Suppl 6:vi3-9.
3. De Groot AS, Scott DW. Immunogenicity of protein therapeutics. Trends Immunol. 2007;28(11):482-90. (Pubitemid 350087812)
4. Nelson AL, Dhimolea E, Reichert JM. Development trends for human monoclonal antibody therapeutics. Nat Rev Drug Discov. 2010;9(10):767-74.
5. Getts DR, Getts MT, McCarthy DP, Chastain EM, Miller SD. Have we overestimated the benefit of human(ized) antibodies? MAbs. 2010;2(6):682-94.
6. Bender NK, Heilig CE, Droll B, Wohlgemuth J, Armbruster FP, Heilig B. Immunogenicity, efficacy and adverse events of adalimumab in RA patients. Rheumatol Int. 2007;27(3):269-74. (Pubitemid 46088257)
7. Furie R, Stohl W, Ginzler EM, Becker M, Mishra N, Chatham W, et al. Biologic activity and safety of belimumab, a neutralizing anti-B-lymphocyte stimulator (BLyS) monoclonal antibody: a phase I trial in patients with systemic lupus erythematosus. Arthritis Res Ther. 2008;10(5):R109.
8. Kay J, Rahman MU. Golimumab: a novel human anti-TNF-alpha monoclonal antibody for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. Core Evid. 2010;4:159-70.
9. Shankar G, Shores E, Wagner C, Mire-Sluis A. Scientific and regulatory considerations on the immunogenicity of biologics. Trends Biotechnol. 2006;24(6):274-80. (Pubitemid 43853075)
10. 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(1-2):1-16. (Pubitemid 38900899)
11. Koren E, Smith HW, Shores E, Shankar G, Finco-Kent D, Rup B, et al. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J Immunol Methods. 2008;333(1-2):1-9.
12. 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(5):1267-81.
13. 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(1-2):189-95. (Pubitemid 41262233)
14. Moxness M, Tatarewicz S, Weeraratne D, Murakami N, Wullner D, Mytych D, et al. Immunogenicity testing by electrochemiluminescent detection for antibodies directed against therapeutic human monoclonal antibodies. Clin Chem. 2005;51(10):1983-5. (Pubitemid 41368199)
15. 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(11):7467-72. (Pubitemid 46847475)
16. Murphy M, Jason-Moller L, Bruno J. Using Biacore to measure the binding kinetics of an antibody-antigen interaction. Curr Protoc Protein Sci. 2006;Chapter 19:Unit 19 4.
17. Gorovits B. Antidrug antibody assay validation: industry survey results. AAPS J. 2009;11(1):133-8.
18. Corren J, Busse W, Meltzer EO, Mansfield L, Bensch G, Fahrenholz J, et al. A randomized, controlled, phase 2 study of AMG 317, an IL-4Ralpha antagonist, in patients with asthma. Am J Respir Crit Care Med. 2009;181(8):788-96.
19. 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(10):2530-42.
20. US Department of Health and Human Services, FDA (CDER, CBER). Guidance for industry - assay development for immunogenicity testing of therapeutic proteins (draft). 2009. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM192750.pdf. Accessed 1 Oct 2012.
21. Gibiansky L, Gibiansky E, Kakkar T, Ma P. Approximations of the target-mediated drug disposition model and identifiability of model parameters. J Pharmacokinet Pharmacodyn. 2008;35(5):573-91.
22. Benson G, Auerswald G, Elezovic I, Lambert T, Ljung R, Morfini M, et al. Immune tolerance induction in patients with severe hemophilia with inhibitors: expert panel views and recommendations for clinical practice. Eur J Haematol. 2012;88(5):371-9.
23. Rehlaender BN, Cho MJ. Antibodies as carrier proteins. Pharm Res. 1998;15(11):1652-6. (Pubitemid 28524572)
24. van der Laken CJ, Voskuyl AE, Roos JC, Stigtervan Walsum M, de Groot ER, Wolbink G, et al. Imaging and serum analysis of immune complex formation of radiolabelled infliximab and anti-infliximab in responders and non-responders to therapy for rheumatoid arthritis. Ann Rheum Dis. 2007;66(2):253-6. (Pubitemid 46226064)
25. Shmagel KV, Chereshnev VA. Molecular bases of immune complex pathology. Biochemistry (Mosc). 2009;74(5):469-79.
26. Tabrizi M, Bornstein GG, Suria H. Biodistribution mechanisms of therapeutic monoclonal antibodies in health and disease. AAPS J. 2010;12(1):33-43.
27. 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(2):127-32.
28. Bartelds GM, Wijbrandts CA, Nurmohamed MT, Stapel S, Lems WF, Aarden L, et al. Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis. 2007;66(7):921-6. (Pubitemid 46999794)
29. Calabresi PA, Giovannoni G, Confavreux C, Galetta SL, Havrdova E, Hutchinson M, et al. The incidence and significance of anti-natalizumab antibodies: results from AFFIRM and SENTINEL. Neurology. 2007;69(14):1391-403. (Pubitemid 47511460)
30. Ternant D, Aubourg A, Magdelaine-Beuzelin C, Degenne D, Watier H, Picon L, et al. Infliximab pharmacokinetics in inflammatory bowel disease patients. Ther Drug Monit. 2008;30(4):523-9.
31. Dirks NL, Meibohm B. Population pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010;49(10):633-59.
32. Xu Z, Seitz K, Fasanmade A, Ford J, Williamson P, Xu W, et al. Population pharmacokinetics of infliximab in patients with ankylosing spondylitis. J Clin Pharmacol. 2008;48(6):681-95. (Pubitemid 351713154)
33. Fasanmade AA, Adedokun OJ, Ford J, Hernandez D, Johanns J, Hu C, et al. Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis. Eur J Clin Pharmacol. 2009;65(12):1211-28.
34. Zhu Y, Hu C, Lu M, Liao S, Marini JC, Yohrling J, et al. Population pharmacokinetic modeling of ustekinumab, a human monoclonal antibody targeting IL-12/23p40, in patients with moderate to severe plaque psoriasis. J Clin Pharmacol. 2009;49(2):162-75.
35. The common technical document for the registration of pharmaceuticals for human use. Efficacy-M4E (R1) clinical overview and clinical summary of module 2. Module 5: clinical study reports. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; 2002.