Immunogenicity of biopharmaceuticals: An example from erythropoietin

BioPharm International

Volumn 18, Issue 8, 2005, Pages 36-52

  Van Regenmortel, Marc H V ^a   Boven, Katia ^b   Bader, Fred ^c  

^a UNIVERSITÉ DE STRASBOURG   (France)

^b JOHNSON AND JOHNSON   (United States)

^c Chain LLC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ERYTHROPOIETIN; IMMUNOLOGICAL ADJUVANT; RECOMBINANT BLOOD CLOTTING FACTOR 8; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT HUMAN INSULIN; RECOMBINANT PROTEIN;

AMINO ACID SEQUENCE; ANEMIA; BIOTECHNOLOGY; DIABETES MELLITUS; DOSE RESPONSE; DRUG EFFECT; DRUG FORMULATION; DRUG MANUFACTURE; HEMOPHILIA A; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; IMMUNOLOGICAL TOLERANCE; INSULIN TREATMENT; PATENT; REVIEW;

EID: 24644461614     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (52)

1. Abbas AK, Lichtman AH. Cellular and Molecular Immunology, 5th edition. Saunders: Philadelphia; 2003.
2. Evens RP, Sindelar RD. Biotechnology products in the pipeline. In: Crommelin DJA, Sindelar RD (Ed.). Pharmaceutical Biotechnology, 2nd edition. London: Francis & Taylor; 2002. p. 389-406.
3. Porter S. Human immune response to recombinant human proteins. J. Pharm. Sci. 2001; 90:1-11.
4. Schernthaner G. Immunogenicity and allergenic potential of animal and human insulins. Diabetes Care. 1993; 16:155-165.
5. Laricchia-Robbio L, Moscato S, Genua A, et al. Naturally occurring and therapy-induced antibodies to human granulocyte colony-stimulating factor (G-CSF) in human serum. J. Cell Physiol. 1997; 173:219-226.
6. Oberg K, Aim G, Magnusson A, et al. Treatment of malignant carcinoid tumors with recombinant interferon alfa-2b: development of neutralizing interferon antibodies and possible loss of antitumor activity. J. Natl. Cancer Inst. 1989; 81:531-535.
7. Olsen E, Duvic M, Frankel a, et al. Pivotal phase III trial of two dose levels of denileukin diftitox for the treatment of cutaneous T-cell lymphoma. J. Clin. Oncol. 2001; 19:376-388.
8. Rosenschein U, Lenz R, Radnay J, et al. Streptokinase immunogenicity in thrombolytic therapy for acute myocardial infarction. Isr. J. Med. Sci. 1991; 27:541-545.
9. Vanderschueren SM, Stassen JM, Collen D. On the immunogenicity of recombinant staphylokinase in patients and in animal models. Thromb. Haemost. 1994; 72:297-301.
10. Grauer A, Ziegler R, Raue F. Clinical significance of antibodies against calcitonin. Exp. Clin. Endocrinol. Diabetes. 1995; 103:345-351.
11. Jacquemin MG, Saint-Remy JM. Factor VIII immunogenicity. Haemophilia 1998; 4:552-557.
12. Giannelli G, Antonelli G, Fera G, et al. Biological and clinical significance of neutralizing and binding antibodies to interferon-alpha (IFN-alpha) during therapy for chronic hepatitis C. Clin. Exp. Immunol. 1994; 97:4-9.
13. Prümmer O. Treatment-induced antibodies to interleukin-2. Biotherapy 1997; 10:15-24.
14. Blumenfeld Z, Frisch L, Conn PM. Gonadotropin-releasing hormone (GnRH) antibodies formation in hypogonadotropic azoospermic men treated with pulsatile GnRH-diagnosis and possible alternative treatment. Fertil. Steril. 1988; 50:622-629.
15. Claustrat B, David L, Faure A, Francois R. Development of anti-human chorionic gonadotropin antibodies in patients with hypogonadotropic hypogonadism. A study of four patients. J. Clin. Endocrinol. Metab. 1983; 57:1041-1047.
16. Ragnhammar P, Wadhwa M. Neutralizing antibodies to granulocyte-macrophage colony stimulating factor (GM-CSF) in carcinoma patients following GM-CSF combination therapy. Med. Oncol. 1996; 13:161-166.
17. Zipkin, I. Amgen lays MGDF to rest. BioCentury 1998 Sept.
18. Casadevall N, Dupuy E, Molho-Sabatier P, Tobelem G, Varet B, Mayeux P. Autoantibodies against erythropoietin in a patient with pure red-cell aplasia. New Engl. J. Med. 1996; 334:630-633.
19. Casadevall N, Nataf J, Viron B, Kolta A, Kiladjian JJ, Martin-Dupont P, et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. New Engl. J. Med. 2002; 346:469-475.
20. Bergrem H, Danielson BG, Eckardt KU, Kurtz A, Stridsberg M. A case of antierythropoietin antibodies following recombinant human erythropoietin treatment. In: Bauer C, Koch KM, Scigalla P, Wieczorek L (Ed.). Erythropoietin: molecular physiology and clinical application. New York: Marcel Dekker; 1993. pp.266-275.
21. Prabhakar SS, Muhlfelder T. Antibodies to recombinant human erythropoietin causing pure red cell aplasia. Clin. Nephrol. 1997; 47:331-335.
22. Peces R, de la Torre M, Alcazar R, Urra JM. Antibodies against recombinant human erythropoietin in a patient with erythropoietin-resistant anemia. New Engl. J. Med. 1996; 335:523-524.
23. Eckardt KU, Casadevall N. Pure red-cell aplasia due to anti-erythropoietin antibodies. Nephrol. Dial. Transplant. 2003; 18:865-869.
24. Johnson & Johnson. Press release. Summary of PRCA case reports: update on our company's effort to reduce case reports of pure red cell aplasia. October 10, 2003. Available at: www.jnj.com/news/jnj_news/1021024_095632.htm. Accessed November 2004.
25. Bennett C, Luminari S, Nissenson A, et al: Pure red-cell aplasia and recombinant epoetin therapy - a follow-up report from the research on adverse drug events and reports project. New Engl. J. Med. 2004; 351:1403-1408.
26. Krüger A, Schröer W, Röhrs F, Vescio G. PRCA in a patient treated with epoetin beta. Nephrol. Dial. Transplant. 2003; 18:1033-1034.
27. Casadevall N. Antibodies against rHuEPO: native and recombinant. Nephrol. Dial. Transplant. 2002; 17 Suppl 5:42-47.
28. Storring PL, Tiplady RJ, Gaines Das RE, Stenning BE, Lamikanra A, Rafferty B, et al. Epoetin alfa and beta differ in their erythropoietin isoform compositions and biological properties. Br. J. Haematol. 1998; 100:79-89.
29. Heavner G. Personal communication. 2003 May.
30. Bachmann MF, Zinkernagel RM. The influence of virus structure on antibody responses and virus serotype formation. Immunol. Today. 1996; 17:553-558.
31. Chackerian B, Lenz P, Lowy DR, Schiller JT. Determinants of autoantibody induction by conjugated papillomavirus virus-like particles. J. Immunol. 2002; 169:6120-6126.
32. Hochuli E. Interferon immunogenicity: technical evaluation of interferon-alpha 2a. J. Interferon Cytokine Res. 1997; 17:S15-S21.
33. Moore WV, Leppert P. Role of aggregated human growth hormone (hGH) in development of antibodies to hGH. J. Clin. Endocrinol. Metab. 1980; 51:691-697.
34. Hermeling S, Schellekens H, Crommelin DJ, Jiskoot W. Micelle-associated protein in epoetin formulations: a risk factor for immunogenicity? Pharm. Res. 2003; 20:1903-1907.
35. Schellekens H. Immunogenicity of biopharmaceuticals: why proteins should be treated with respect. Eur. J. Hosp. Pharm. 2003; 8:76-81.
36. Kerwin B, Deechongkit S, Park S, Kim J, Burnett H. Effects of polysorbates 20 and 80 on the structure and stability of darbepoetin alfa and epoetin alfa. European Renal Association-European Dialysis and Transplant Association (ERA-EDTA). 17 May 2004: 321.
37. Sharma B, Lisi P, Ryan M, Bader F. Technical investigations into the potential cause of the increased incidence of epoetin-associated pure red cell aplasia. Eur. J. Hosp. Pharm. 2004; 10:86-91.
38. Ho T, Griffin J. Guillain-Barre syndrome. Curr. Opin. Neurol. 1999; 12:389-394.
39. Phelps RG, Rees AJ. The HLA complex in Goodpasture's disease: a model for analyzing susceptibility to autoimmunity. Kidney Int. 1999; 56:1638-1653.
40. Skibeli V, Nissen-Lie G, Torjesen P. Sugar profiling proves that human serum erythropoietin differs from recombinant human erythropoietin. Blood 2001; 98:3626-3634.
41. Wadhwa M, Skog AL, Bird C, et al. Immunogenicity of granulocyte- macrophage colony-stimulating factor (GM-CSF) products in patients undergoing combination therapy with GM-CSF. Clin. Cancer Res. 1999; 5:1353-1361.
42. Antonelli G, Simeoni E, Currenti M, et al. Interferon antibodies in patients with infectious diseases. Anti-interferon antibodies. Biotherapy 1997; 10:7-14.
43. van Oss CJ, Singer JM, Gillman CF. The influence of particulate carriers and of mineral oil in adjuvants on the antibody response in rabbits to human gamma globulin. Immunol. Commun. 1976; 5:181-188.
44. Naim JO, Lanzafame RJ. The adjuvant effect of silicone-gel on antibody formation in rats. Immunol. Invest. 1993; 22:151-161.
45. Naim JO, Lanzafame RJ, van Oss CJ. The effect of silicone-gel on the immune response. J. Biomater. Sci. Polymer Ed. 1995; 7:123-132.
46. Naim JO, Ippolito KML, Lanzafame RJ, van Oss CJ. Induction of type II collagen arthritis in the DA rat using silicone gels and oils as adjuvant. J. Autoimmun. 1995; 8:751-761.
47. Naim JO, Ippolito KML, Lanzafame RJ. The effect of molecular weight and gel preparation on humoral adjuvancy of silicone oils and silicone gels. Immunol. Invest. 1995; 24:537-547.
48. Boven K, Stryker S, Knight J et al. The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes. Kidney Int. 2005; in press.
49. Frasier SD. Human pituitary growth hormone (hGH) therapy in growth hormone deficiency. Endocr. Rev. 1983; 4:155-170.
50. Johnson & Johnson. Press release. Intravenous administration required when using EPREX®/ERYPO® (epoetin alfa in chronic renal failure patients. Subcutaneous administration still available for oncology and other patients. December 2, 2002. Available at: www.jnj.com/news/jnj_news/ 20021202_143150.htm. Accessed November 2004.
51. Erythropoitin concentrated solution. Pharmeuropa 14.1. 2002 January:94-9.
52. Casadevall N. Personal communication. 2003 August.