Epitope characterization of pre-existing and developing antibodies to an aglycosylated monoclonal antibody therapeutic of G1m17,1 allotype

Journal of Immunological Methods

Volumn 382, Issue 1-2, 2012, Pages 93-100

  Tatarewicz, Suzanna M ^a   Juan, Gloria ^a   Swanson, Steven J ^a   Moxness, Michael S ^a  

^a AMGEN INC   (United States)

Author keywords

Anti therapeutic antibody; G1m allotype; Immunoassay; Immunoglobulin haplotype; Monoclonal antibody therapeutic immunogenicity

Indexed keywords

EPITOPE; HUMAN MONOCLONAL ANTIBODY; IMMUNOGLOBULIN G1 ANTIBODY; NEUTRALIZING ANTIBODY; THERAPEUTIC AGLYCOSYLATED IGG1 MONOCLONAL ANTIBODY; UNCLASSIFIED DRUG;

ADULT; ALLERGIC REACTION; ALLOTYPE; ANTIBODY BLOOD LEVEL; ANTIGEN BINDING; ARTICLE; CHEMOLUMINESCENCE; CLINICAL TRIAL; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; ELECTROIMMUNOASSAY; FACE ERYTHEMA; FEMALE; G1M ALLOTYPE; GENE LINKAGE DISEQUILIBRIUM; GLYCOSYLATION; HUMAN; HYPOTENSION; IMMUNE RESPONSE; IMMUNIZATION; IMMUNOGENICITY; INCIDENCE; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; SINGLE DRUG DOSE; URTICARIA;

ANTIBODIES; ANTIBODIES, MONOCLONAL; CLINICAL TRIALS, PHASE I AS TOPIC; DOUBLE-BLIND METHOD; EPITOPES; GLYCOSYLATION; HUMANS; IMMUNOGLOBULIN ALLOTYPES; IMMUNOGLOBULIN G; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84863597134     PISSN: 00221759     EISSN: 18727905     Source Type: Journal    
DOI: 10.1016/j.jim.2012.05.009     Document Type: Article

References (23)

1. Allen J.C., Kunkel H.G. Antibodies to genetic types of gamma globulin after multiple transfusions. Science 1963, 139:418.
2. Bech-Hansen N.T., Linsley P.S., Cox D.W. Restriction fragment length polymorphisms associated with immunoglobulin Cγ, genes reveal linkage disequilibrium and genomic organization. Proc. Natl. Acad. Sci. 1983, 80:6952.
3. Bosques C.J., Collins B.E., Meador J.W., Sarvaiya H., Murphy J.L., DelloRusso G., Bulik D.A., Hsu I.H., Washburn N., Sipsey S.F., Myette J.R., Raman R., Shriver Z., Sasisekharan R., Venkataraman G. Chinese hamster ovary cells can produce galactose-α-1,3-galactose antigens on proteins. Nat. Biotechnol. 2010, 28:1153.
4. Burtis C.A., Ashwood E.R. Tietz Textbook of Clinical Chemistry. A Division of Harcourt Brace and Company 1986, 2194. W.B. Saunders and Company, Philadelphia, PA. 2nd ed.
5. Chung C.H., Mirakhur B., Chan E., Le Q.T., Berlin J., Morse M., Murphy B.A., Satinover S.M., Hosen J., Mauro D., Slebos R.J., Zhou Q., Gold D., Hatley T., Hicklin D.J., Platts-Mills T.A.E. Cetuximab-induced anaphylaxis and IgE specific for galactose-α-1,3-galactose. N. Engl. J. Med. 2008, 358(11):1109.
6. Dugoujon J.M., Hazout S., Loirat F., Mourrieras B., Crouau-Roy B.B., Sanchez-Mazas A. GM haplotype diversity of 82 populations over the world suggests a centrifugal model of human migrations. Am. J. Phys. Anthropol. 2004, 125:175.
7. Goetze A.M., Zhang Z., Liu L., Jacobsen F.W., Flynn G.C. Rapid LC-MS screening for IgG Fc modifications and allelic variants in blood. Mol. Immunol. 2011, 49:338.
8. Grillberger L., Kreil T.R., Nasr S., Reiter M. Emerging trends in plasma-free manufacturing of recombinant protein therapeutics expressed in mammalian cells. Biotechnol. J. 2009, 4:186.
9. Grubb R., Grubb A., Kjellen L., Lycke E., Aman P. Rheumatoid arthritis - a gene transfer disease. Exp. Clin. Immunogenet. 1999, 16(1):1.
10. Jefferis R., Lefranc M.P. Human immunoglobulin allotypes - possible implications for immunogenicity. MAbs 2009, 1(4):1.
11. Jenkins N., Murphy L., Tyther R. Post-translational modifications of recombinant proteins: significance for biopharmaceuticals. Mol. Biotechnol. 2008, 39:113.
12. Jerne D. Antibody suppression and antiallotype antibodies. II. Interference of circulating antiallotype antibodies with prophylactic treatment against Rh sensitization. Scand. J. Immunol. 1976, 5:1085.
13. Lefranc M.P., Lefranc G. Gm allotypes and Gm haplotypes. IMGT®, the international ImMunoGeneTics information system® 2012, http://www.imgt.org/IMGTrepertoire/Proteins/allotypes/human/IGH/IGHC (founder and director: Marie-Paule Lefranc, Montpellier, France) (accessed 25.02.12).
14. Magdelaine-Beuzelin C., Vermeire S., Goodall M., Baert F., Noman M., van Assche G., Ohresser M., Degenne D., Dugoujon J.M., Jefferis R., Rutgeerts P., Lefranc M.P., Waitier H. IgG1 heavy chain-coding gene polymorphism (G1m allotypes) and development of antibodies-to-infliximab. Pharmacogenet. Genomics 2009, 19:383.
15. Moudgil K.D., Durai M. Infection and Autoimmunity 2004, 19. Elsevier B.V., Amsterdam, The Netherlands. 1st ed. Y. Shoenfeld, N.R. Rose (Eds.).
16. Moxness M., Tatarewicz S., Weeraratne D., Murakami N., Wullner D., Mytych D., Jawa V., Koren E., Swanson S.J. Immunogenicity testing by electrochemiluminescent detection for antibodies directed against therapeutic human monoclonal antibodies. Clin. Chem. 2005, 51(10):1983.
17. Oxelius V.A., Eibl M.M. Different Gm allotype amounts in human intravenous immunoglobulin (IVIG) preparations; survival of foreign Gm allotypes in immunodeficient patients. Clin. Exp. Immunol. 1996, 106:203.
18. Ramos-Casals M., Brito-Zeron P., Munoz S., Soria N., Galiana D., Bertolaccini L., Cuadrado M.J., Khamashta M.A. Autoimmune diseases induced by TNF-targeted therapies. Medicine 2007, 86(4):242.
19. Rispens T., de Vrieze H., de Groot E., Wouters D., Stapel S., Wolbink G.J., Aarden L.A. Antibodies to constant domains of therapeutic monoclonal antibodies: anti-hinge antibodies in immunogenicity testing. J. Immunol. Methods 2011, 375(1-2):93.
20. Steinberg A.G., Cook C.E. The Distribution of the Human Immunoglobulin Allotypes 1981, Oxford University Press, Oxford.
21. Walsh G., Jefferis R. Post-translational modifications in the context of therapeutic proteins. Nat. Biotechnol. 2006, 24:1241.
22. Walter M.A., Cox D.W. Nonuniform linkage disequilibrium within a 1,500-kb region of the human immunoglobulin heavy-chain complex. Am. J. Hum. Genet. 1991, 49:917.
23. Wilson J.A., Steinberg A.G. Antibodies to gamma globulin in the serum of children and adults. Transfusion 1965, 5(6):516.