A place of intravenous immunoglobulins in current clinical practice: Privigen is a novel 10% immunoglobulin

Abstract

Intravenous immunoglobulins (IVIGs) were initially designed to treat patients with primary immunodeficiencies (PID). Due to the multidirectional effect of IVIGs on the immune system, a range of nosological entities, in which these agents are successfully administered, is steadily expanding. As of now, IVIGs are successfully used in neurology, rheumatology, hematology, and oncology and they are essential drugs for many patients. In spite of the long experience with IVIGs, their mechanism of action remains unclear, numerous investigations for their clinical introduction are being continued. Therefore, there is a growing need to increase the production of the drugs, which gives rise to the emergence of novel medications, which differ in their composition and manufacture technologies, on the pharmacological market. The 10% intravenous immunoglobulin privigen, the safety and efficacy of which has been proven in foreign practice, is a novel drug on the Russian market.

References

  1. Anderson D, Ali K, Blanchette V, Brouwers M, Couban S, Radmoor P, Huebsch L, Hume H, McLeod A, Meyer R, Moltzan C, Nahirniak S, Nantel S, Pineo G, and Rock G. Guidelines on the Use of Intravenous Immune Globulin for Hematologic Conditions. Transfusion Med Rev. 2007;21(2) Suppl 1:S9-S56. doi: 10.1016/j.tmrv.2007.01.001.
  2. Кондратенко И.В., Заплатников А.Л., Бологов А.А. Внутривенные иммуноглобулины: что и когда? (Лекция). Детская больница. 2010;4:56-60. http://www.rdkb.ru/files/file217.pdf
  3. Привиджен. Монография по продукту
  4. Донюш Е. Использование внутривенных иммуноглобулинов в клинической практике. Вопросы современной педиатрии. 2011;2(10):49-63.
  5. Латышева Т. Внутривенные иммуноглобулины (ВВИГ, IVIG) в клинической практике. Пособие для врачей. Экон-Информ; 2009.
  6. Райнер X. Бергер, Стефания М., Боде-Бергер, Юрген Ц., Фролих. Иммуноглобулины для внутривенного введения. Medizinischeklinic. 1995;9:520-526.
  7. Аллергология и иммунология. Национальное руководство, краткое издание. Под ред. Хаитова Р.М., Ильиной Н.И. М.: ГЭОТАР-медиа; 2013.
  8. Kaveri SV, Maddur MS, Hegde P, Lacroix-Desmazes S, Bayry J. Intravenous immunoglobulins in immunodeficiencies: more than mere replacement therapy. Clin Exp Immunol. 2011;164 Suppl 2:2-5. doi: 10.1111/j.1365-2249.2011.04387.x.
  9. Латышева Е.А., Латышева Т.В. Применение внутривенных иммуноглобулинов в клинической практике. Педиатрическая фармакология. 2013;1(10):26-30. doi: 10.15690/pf.v10i1.586.
  10. Clinical Guidelines for immunoglobulin use. Second edition update. Department of Health. July 2011 http://www.ivig.nhs.uk/documents/dh_129666.pdf
  11. AAAAI Position Paper: Use of IGIV — January 2005 http://www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Practice%20and%20Parameters/IGIV-2005.pdf
  12. Compagno N, Malipiero G, Cinetto F, Agostini C. Immunoglobulin Replacement Therapy in Secondary Hypogammaglobulinemia. Front Immunol. 2014;5:626. doi: 10.3389/fimmu.2014.00626.
  13. Elovaara А, Apostolski S, van Doorn P, Gilhus NE, Hietaharju A, Honkaniemi J, van Schaik IN, Scolding N, Soelberg Sørensen P, Udd B. EFNS guidelines for the use of intravenous immunoglobulin in treatment of neurological diseases. Eur J Neurol. 2008;15:893-908. doi: 10.1111/j.1468-1331.2008.02246.x.
  14. Mulhearn B, Bruce IN. Indications for IVIG in Rheumatic Diseases. Rheumatology. 2015;54(3):383-391. doi: 10.1093/rheumatology/keu429.
  15. Spycher MO, Kronthaler U, Dickneite G. Investigation of potential neurological effects of stabilizers used in immunoglobulin products for intravenous use: comparison of L-proline and glycine. Presented at the American College of Allergy, Asthma and Immunology, Dallas, Texas, USA, November 8ollege of Allergy, Asthma
  16. Centers for Disease Control and Prevention (CDC). Renal insufficiency and failure associated with immune globulin intravenous therapy — United States, 1985—1998. Morb Mortal Weekly Rep. 1999;48(24):518-518i.
  17. Spycher MO, Bolli R, Hodler G, Gennari K, Hubsch A, Spath P, Schnorf J. Well-tolerated liquid intravenous immunoglobulin G preparations (IVIGs) have a low immunoglobulin G dimer (IgG-dimer) content. J Autoimmun. 1999;96(Suppl. 1):96.
  18. Инструкция по применению лекарственного препарата для медицинского применения Привиджен. Государственный реестр лекарственных средств: http://grls.rosminzdrav.ru/Grls_View_v2.aspx?idReg=84899&t= .
  19. Stein MR, Nelson RP, Church JA, Wasserman RL, Borte M, Vermylen C, Bichler J, for the IgPro10 in PID study group. Safety and efficacy of Privigen, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies. J Clin Imunol. 2009;29(1):137-144. doi: 10.1007/s10875-008-9231-2.
  20. Church JA, Leibl H, Stein MR, Melamed IR, Rubinstein A, Schneider LC, Wasserman RL, Pavlova BG, Birthistle K, Mancini M, Fritsch S, Patrone L, Moore-Perry K, Ehrlich HJ; US-PID-IGIV 10% Study Group 10. Efficacy, safety and tolerability of a new 10% liquid intravenous immune globulin [IGIV 10%] in patients with primary immunodeficiency. J Clin Immunol. 2006;26(4):388-395. doi: 10.1007/s10875-006-9025-3.
  21. Hoffmann R, Lotichius P, Pfruender D. Efficacy and tolerability of polyvalent intravenous immunoglobulin (IVIG) PrivigenR — a multicenter noninterventional study. J Allergy Clin Immunol. 2010;125(2):AB141. doi: 10.1016/j.jaci.2009.12.554.
  22. Robak T, Salama A, Kovaleva L, Vyhovska YI, Davies S, Mazzucconi MG, Zenker O, Kiessling P, for the International PrivigenR in ITP Study Group. Efficacy and safety of PrivigenR, a novel liquid intravenous immunoglobulin formulation, in adolescent and adult patients with chronic immune thrombocytopenic purpura. Hematology. 2009;14(4):227-236. doi: 10.1179/102453309x439773.
  23. Leger J, De Bleecker J, Sommer C, Robberecht W, Saarela M, Kamienowski J, Stelmasiak Z, Mielke O, Tackenberg B, Shebl A, Bauhofer A, Zenker O, Merkies I. Efficacy and safety of Privigen in patients with inflammatory demyelinating polyneuropathy: a prospective, single-arm, open-label Phase III study (the PRIMA study). J Peripheral Nervous System. 2013;18(2):130-140. doi: 10.1111/jns5.12017.
  24. Siani B., Willimann K., Wymann S. et al. Isoagglutinin reduction in human immunoglobulin products by donor screening. Biol Ther 2014;4:15–26.
  25. Hubsch A., EI Menyawi I., Siani B. et al. Isoagglutinin depletion in human immunoglobulin products: donor screening or a specific immunoaffininty chromatography step. Poster presented at the 16th Biennal Meeting of the European Society for Immunodeficiencies (ESID) 29.10–01.11.2014, Prague, Czech Republic

Statistics

Views

Abstract: 106

PDF (Russian): 38

Article Metrics

Metrics Loading ...

Refbacks

  • There are currently no refbacks.

Copyright (c) 2020 Latysheva T.V., Latysheva E.A., Martynova I.A.

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
 

Address of the Editorial Office:

  • Novij Zykovskij proezd, 3, 40, Moscow, 125167

Correspondence address:

  • Novoslobodskaya str 31c4., Moscow, 127005, Russian Federation

Managing Editor:

 

© 2018-2021 "Consilium Medicum" Publishing house


This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies