THE EVALUATION OF IMMUNOGENIC POTENTIAL OF VARIOUS MEDICATIONS OF INSULIN

Abstract

The article presents a review of publications implemented with the purpose to characterize immunogenic potential of medications of insulin: from preparations of animal origin to modern genetically engineered products. The review is presented concerning regulative requirements regulating control of insulin products safety. It is established that during evaluation of safety of insulin products the main attention is focused on issues of immunogenicity. The analysis of publications from open access in information database MEDLINE (Pubmed) was carried out, permitting to characterize immunogenic potential of insulin preparations. On balance, the review included 17 articles according the results of selection. It is established that information about immunogenic potential of insulin products is contradictory enough that can be determined by both characteristics of studies and technological particularities of production of medicinal insulin products. The modern preparations of analogs of insulin are in general comparative by their safety characteristics with medicinal preparations of human genetically engineered insulin. Among analogs of insulin the most immunogenic potential is specific to aspart and glargin. The cases of development of cross-reactive antibodies between various medicinal preparations of insulin are observed.

Keywords

human genetically engineered insulin / analogs of insulin / bio-similar medicinal preparations of insulin / immunogenicity / safety

References

[1] World Health Organization. Global Diabetes Report. 2015. Available at: http://apps.who.int/iris/bitstream/10665/204871/1/9789241565257_eng.pdf

[2] International Diabetes Federation. Diabetes Atlas. 2015. Available at: http://www.diabetesatlas.org/

[3] Всемирная организация здравоохранения. Российская Федерация. Статистические данные. Available at: http://www.who.int/countries/rus/ru/

[4] Филиппова А.В., Чжао В., Колбин А.С. Клиническая разработка биосимилярных продуктов инсулина и его аналогов: современный этап развития. Российский медицинский журнал. 2017; 23(5): 269-74

[5] Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2001L0083:20110721:EN:PDF

[6] European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations II: Biological medicinal products. 2016. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/08/WC500211728.pdf

[7] European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 2006. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf

[8] Rosenfeld L. Insulin: discovery and controversy. Clin. Chem. 2002; 48(12): 2270-88.

[9] Drugs@FDA: FDA Approved Drug Products. Company Ely Lilly Humulin NDA 018780. 1982. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018780

[10] Company Ely Lilly and Humalog NDA 020563. 1997. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020563a_s003_071697.pdf

[11] Novo Nordisk Inc Novolog NDA 020986. 2000. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/ 020986Orig1s061.pdf

[12] US Sanofi Aventis. Apidra NDA 021629. 2004. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-629_Apidra.cfm

[13] US Sanofi Aventis Glargin NDA 021081. 2000. Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM327015.pdf

[14] Novo Nordisk Inc Detemir NDA 021878. 2005. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021878s000_Levemir TOC.cfm

[15] Novo Nordisk Inc Degludec NDA 203314. 2015. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203313and203314Orig1s000TOC.cfm

[16] European Medicines Agency. Guideline on Immunogenicity assessment of 7 biotechnology-derived therapeutic proteins. 2015. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/10/WC500194507.pdf

[17] Ebbers H., Al-Temimi E., Moors E.H., Mantel-Teeuwisse A.K., Schellekens H., Leufkens H.G. Differences between post-authorization adverse drug reactions of biopharmaceuticals and small molecules. BioDrugs. 2013; 27(2): 167-74.

[18] Fineberg S.E., Kawabata T.T., Finco-Kent D., Fountaine R.J., Finch G.L., Krasner A.S. Immunological Responses to Exogenous Insulin. Endocr. Rev. 2007; 27 (6): 625-52.

[19] Reewes W.G., Kelly U. Insulin antibodies induced by bovine insulin therapy. Clin. Exp. Immunol. 1982; 50: 163-70.

[20] Devlin J.G. Evidence for the existence of an IgM immunoglobulin to insulin. Ir. J. Med. Sci. 1966; 6(491): 507-10.

[21] Faulk W.P., Karam J.H., Fudenberg H.H. Human anti-insulin antibodies. J. Immunol. 1971; 106(4): 1112-6.

[22] Reisman R.E., Wicher K., Arbesman C.E. Immunotherapy with antigen E. J. Allergy. 1969; 44(2): 82-95.

[23] Patterson R., O’Rourke J., Roberts M., Suszko I. Immunologic reactions against insulin. I. IgG anti-insulin and insulin resistance. J. Immunol. 1973; 110(4): 1126-34.

[24] Radermecker R.P., Scheen A.J. Allergy reactions to insulin: effects of continuous insulin infusion and insulin analogues. Diabetes Metab. Res. Rev. 2007; 23(5): 348-55.

[25] Radermecker R.P., Renard E., Scheen A.J. Circulating insulin antibodies: influence of continuous subcutaneous or intraperitoneal insulin infusion, and impact on glucose control. Diabetes Metab. Res. Rev. 2009; 25(6): 491-501.

[26] Dixon K., Exon P.D., Hughes H.R. Insulin antibodies in the etiology of labile diabetes. Lancet. 1972; 1(7746): 343-7.

[27] Bliss M. The Discovery of Insulin. Chicago: University of Chicago Press; 1982.

[28] Chance R., Root M., Galloway J. The immunogenicity of insulin preparations. Acta Endocrinol. Suppl. (Copenh). 1976; 205: 185-98.

[29] Himanshu M., Bhat S.B., Ramchandran S., Bhat K.G., Kumar P.K. Immunogenicity of human and bovine insulin in type 1 diabetes mellitus patients. Diabetes Technol. Ther. 2008; 10(4): 305-9.

[30] Ho L.T., Lam H.C., Wu M.S., Kwok C.F., Jap T.S., Tang K.T., et al. A twelve month double-blind randomized study of the efficacy and immunogenicity of human and porcine insulins in non-insulin-dependent diabetics. Zhonghua Yi Xue Za Zhi (Taipei). 1991; 47(5): 313-9.

[31] Lahtela J.T., Knip M., Paul R., Antonen J., Salmi J. Severe antibody-mediated human insulin resistance: successful treatment with the insulin analog lispro. A case report. Diabetes Care. 1997; 20(1): 71-3.

[32] Pettitt D.J., Ospina P., Howard C., Zisser H., Jovanovic L. Efficacy, safety and lack of immunogenicity of insulin aspart compared with regular human insulin for women with gestational diabetes mellitus. Diabet. Med. 2007; 24(10): 1129-35.

[33] Raskin P., Guthrie R.A., Leiter L., Riis A., Jovanovic L. Use of insulin aspart, a fast-acting insulin analog, as the mealtime insulin in the management of patients with type 1 diabetes. Diabetes Care. 2000; 23(5): 583-8.

[34] Davidson J., Vexiau P., Cucinotta D., Vaz J., Kawamori R. Biphasic insulin aspart 30: literature review of adverse events associated with treatment. Clin. Ther. 2005; 27(Suppl. B): S75-88.

[35] Hermansen K., Madsbad S., Perrild H., Kristensen A., Axelsen M. Comparison of the soluble basal insulin analog insulin detemir with NPH insulin: a randomized open crossover trial in type 1 diabetic subjects on basal-bolus therapy. Diabetes Care. 2001; 24(2): 296-301.

[36] Thalange N., Bereket A., Jensen L.B., Hiort L.C., Peterkova V. Development of Insulin Detemir/Insulin Aspart Cross- Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2-16 Years. Diabetes Ther. 2016; 7(4): 713-24.

[37] Hattori N., Duhita M.R., Mukai A., Matsueda M., Shimatsu A. Development of insulin antibodies and changes in titers over a long-term period in patients with type 2 diabetes. Clin. Chim. Acta. 2014; 433: 135-8.

[38] Chance R., Root M., Galloway J. The immunogenicity of insulin preparations. Acta Endocrinol. Suppl. (Copenh). 1976; 205: 185-98.

[39] Ilag L., Deeg M., Costigan T., Hollander P., Blevins T.C., Edelman S.V., et al. Evaluation of immunogenicity of LY2963016 insulin glargine compared with Lantus(R) insulin glargine in patients with type 1 or type 2 diabetes mellitus. Diabetes Obes. Metab. 2016; 18(2): 159-68.

[40] Hadjiyianni I., Dahl D., Lacaya L.B., Pollom R.K., Chang C.L., Ilag L.L. Efficacy and safety of LY2963016 insulin glargine in patients with type 1 and type 2 diabetes previously treated with insulin glargine. Diabetes Obes. Metab. 2016; 18(4): 425-9.

RIGHTS & PERMISSIONS

Eco-Vector