Вопросы иммуногенности биологических препаратов: теория и практика
https://doi.org/10.14412/1996-7012-2009-527
Аннотация
Рассматривается чрезвычайно многогранная и важная для клинической практики проблема иммуногенности генно-инженерных биологических препаратов, ставших неотъемлемой частью терапии воспалительных ревматических заболеваний.
Литература
1. <div><p>Ревматология: национальное руководство. Под ред. Е.Л. Насонова, В.А. Насоновой. М.: ГЭОТАР-МЕДИА, 2008;720 с.</p><p>Насонов Е.Л. Фармакотерапия ревматоидного артрита - современные рекомендации. Врачъ 2007;1,1-4.</p><p>Насонов Е.Л. Ритуксимаб в лечении ревматических болезней. Науч-практич ревматол 2008; прил. 1:3-10.</p><p>Cheifetz A., Mayer L. Monoclonal Antibodies, Immunogenicity, and Associated Infusion Reactions. Mount Sinai J Med 2005;72(4):250-6.</p><p>Mirick G.R., Bradt B.M., Denardo S.J. et al. A review of human anti-globulin antibody (HAGA, HAMA, HACA, HAHA) responses to monoclonal antibodies. Not four letter words. Q J Nucl Med Mol Imaging 2004;48(4):251-7.</p><p>Waldmann T. Immunotherapy: past, present and future. Nature Medicine 2003;9:269-77.</p><p>Kimball J.A., Norman D.J., Shield C.F. et al. The OKT3 Antibody Response Study: a multicentre study of human anti-mouse antibody (HAMA) production following OKT3 use in solid organ transplantation. Transpl Immunol 1995;3(3):212-21.</p><p>Моисеенко В.М. Моноклональные антитела в лечении злокачественных опухолей. Практ онкол 2003;4(3):148-56.</p><p>Mascelli M.A., Zhou H., Sweet R. et al. Molecular, biologic, and pharmacokinetic properties of monoclonal antibodies: impact of these parameters on early clinical development. J Clin Pharmacol 2007;47(5):553-65.</p><p>Weiner L.M. Fully human therapeutic monoclonal antibodies. J Immunother 2006;29(1):1-9.</p><p>Maini R.N., Breedveld F.C., Kalden J.R. et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum 1998;41(9):1552-63.</p><p>Baert F., Noman M., Vermeire S. et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med 2003;348:601-8.</p><p>Anderson P.J. Tumor necrosis factor inhibitors: clinical implications of their different immunogenicity profiles. Semin Arthritis Rheum 2005;34(5 Suppl):19-22.</p><p>http://www.emea.europa.eu/pdfs/human/press/pus/444500en.pdf</p><p>http://www.gene.com/gene/ products/information/pdf/rituxan-prescribing.pdf</p><p>McLaughlin P., Grillo-Lopez A.J., Link B.K. et al. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol 1998;16:2825-33.</p><p>Piro L.D., White C.A., Grillo-Lоpez A.J. et al. Extended Rituximab (anti-CD20 monoclonal antibody) therapy for relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma. Ann Oncol 1999;10(6):655-61.</p><p>Looney R., Anolik J., Campbell D. et al. B Cell Depletion as a Novel Treatment for Systemic Lupus Erythematosus. Arthritis Rheum 2004;50(8):2580-9.</p><p>Albert D., Dunham J., Khan S. et al. Variability in the biological response to anti-CD20 B cell depletion in systemic lupus erythaematosus. Ann Rheum Dis 2008;67:1724-31.</p><p>http://www.emea.europa.eu/human- docs/PDFs/EPAR/humira/400803en6.pdf</p><p>Purcell R.T., Lockey R.F. Immunologic Responses to Therapeutic Biologic Agents. J Investig Allergol Clin Immunol 2008;18(5):335-42.</p><p>Van de Putte L.B., Atkins C., Malaise M. et al. Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed. Ann Rheum Dis 2004;63(5):508-16.</p><p>Bartelds G.M., Wijbrandts C.A., Nurmohamed M.T. 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.</p><p>Shankara G., Shores E., Wagner C. et al. Scientific and regulatory considerations on the immunogenicity of biologics. Trends Biotechnol 2006;24(6):274-80.</p><p>Насонов Е.Л. Эффективность и безопасность ингибиторов фактора некроза опухоли-а при ревматоидном артрите. РМЖ. 2008;16(24):1602-9.</p><p>Dore R.K., Mathews S., Schechtman J. et al. The immunogenicity, safety, and efficacy of etanercept liquid administered once weekly in patients with rheumatoid arthritis. Clin Exp Rheumatol 2007;25:40-6.</p><p>Wolbink G.J., Vis M., Lems W. et al. Development of antiirfliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis. Arthritis Rheum 2006;54(3):711-5.</p><p>Sidiropoulos P.I., Boumpas D.T. A significant number of patients receiving infliximab require dosing adjustments while some patients may indeed develop drug resistance. Ann Rheum Dis 2006;65:701-3.</p><p>Radstake T.R., Svenson M., Eijsbouts A.M. et al. Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis. Ann Rheum Dis 2008; Nov 19, doi:10.1136/ard.2008.092833.</p><p>Van der Bijl A.E., Breedveld F.C., Antoni C.E. et al. An open-label pilot study of the effectiveness of adalimumab in patients with rheumatoid arthritis and previous infliximab treatment: relationship to reasons for failure and anti-infliximab antibody status. Clin Rheumatol 2008;27(8):1021-8.</p><p>Van den Bemt B.J.F., Vos K., Den Broeder A. et al. A single course of rituximab does not abrogate anti-infliximab antibodies in patients with rheumatoid arthritis. Ann Rheum Dis 2008;67(Suppl. II):128.</p></div><br />
Рецензия
Для цитирования:
Karateyev DE. Вопросы иммуногенности биологических препаратов: теория и практика. Современная ревматология. 2009;3(1):67-72. https://doi.org/10.14412/1996-7012-2009-527
For citation:
Karateyev DE. The problems of THE immunogenicity of biologicals: theory and practice. Sovremennaya Revmatologiya=Modern Rheumatology Journal. 2009;3(1):67-72. (In Russ.) https://doi.org/10.14412/1996-7012-2009-527
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