Evolution of the understanding of psoriasis and therapeutic approaches used to manage such patients. BCD-085 is the first Russian genetically-engineered biological preparation for the treatment of patients suffering from psoriasis

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Abstract

This review paper discusses the systemic character of psoriasis. For medical specialists, it is of crucial importance to understand that psoriasis is not exclusively a skin disease; rather, it is pathogenetically connected with the development of a number of comorbid conditions. This fact has a practical significance in terms of choosing therapeutic strategies for managing patients with medium and severe dermatoses characterized by relapses and comorbid conditions. The long-term use of systemic medications in such cases, including genetically engineered biological ones, seems to be theoretically reasonable, since it facilitates control over the main clinical manifestations of the disease.

This paper presents information on the innovative Russian drug — BCD-085-inhibitor IL17 — and its effects on the key stages of psoriasis immunopathogenesis. The efficacy and safety of this drug for patients with moderate and severe psoriasis are discussed.

BCD-085 is found to exhibit a fast and high therapeutic response in terms of the PASI75, PASI90, PASI100 and sPGA indexes during the first 12 weeks of therapy. According to the available data, BCD-085 is characterized by a favourable safety profile and the absence of immunogenicity from the clinical standpoint.

About the authors

A. L. Bakulev

Saratov State Medical University named after V.I. Razumovsky, Ministry of Health of the Russian Federation

Author for correspondence.
Email: al_ba05@mail.ru

Andrey L. Bakulev — Dr. Sci. (Med.)., Prof., Head of Department, Department of Dermatovenerology and Cosmetology.

Bolshaya Kazachia str., 112, Saratov, 410012

Russian Federation

References

  1. Langley R. G. Exploring new concepts in the successful management of psoriasis. J Eur Acad Dermatol Venereol. 2012 Mar;26 Suppl 2:1-2.
  2. Кубанова А. А., Кубанов А. А., Знаменская Л. Ф., Чикин В.В., Бакулев А. Л., Хобейш М. М. и др. Псориаз. В кн.: Федеральные клинические рекомендации. Дерматовенерология, 2015: Болезни кожи. Инфекции, передаваемые половым путем. 5-е изд., перераб. и доп. М.: Деловой экспресс, 2016. С. 415-470.
  3. Bovenschen H. J., Vande Kerkhof P. C., Van Erp P. E. et al. Foxp3+ Regulatory T Cells of Psoriasis Patients Easily Differentiate into IL-17A-Producing Cells and Are Found in Lesional Skin. Journal of Investigative Dermatology. 2011;131:1853-1860. u
  4. Nestle F., Kaplan D. H., Barcer J. Psoriasis. N Engl J Med. 2009;361:496-509.
  5. Korn T., Bettelli E., Oukka M., Kuchroo V. K. IL-17 and Th17 Cells. Annu Rev Immunol. 2009;27:485-517.
  6. Pirro M., Stingeni L., Vaudo G., Mannarino M. R., Ministrini S., Vonella M. et al. Systemic inflammation and imbalance between endothelial injury and repair in patients with psoriasis are associated with preclinical atherosclerosis. Eur J PrevCardiol. 2015;Aug 22(8):1027-1035.
  7. Dauden E., Blasco A. J., Bonanad C., Botella R., Carrasco-sa J. M., Gonzalez-Parra E. et al. Position Statement for the Management of Comorbidities in Psoriasis. J Eur Acad Dermatol Venereol. 2018;Jul 10. doi: 10.1111/jdv.15177
  8. Dauden E., Castaneda S., Suarez C., Garcia-Campayo J., Blas-co A. J., Aguilar M. D. et al. Integrated approach to comorbidity in patients with psoriasis. Working Group on Psoriasis-associated Comorbidities. Actas Dermosifiliogr. 2012 Jan;103 Suppl 1:1-64.
  9. Dowlatshahi E. A., Wakkee M., Arends L. R., Nijsten T. The prevalence and odds of depressive symptoms and clinical depression in psoriasis patients: a systematic review and meta-analysis. J Invest Dermatol. 2014 Jun;134(6):1542-1551.
  10. Aleem D., Tohid H. Pro-inflammatory Cytokines, Biomarkers, Genetics and the Immune System: A Mechanistic Approach of Depression and Psoriasis. Rev Colomb Psiquiatr. 2018 Jul — Sep;47(3):177-186.
  11. Polic M. V., Miskulin M., Smolic M., Kralik K., Miskulin I., Berko-vic M. C. et al. Psoriasis Severity-A Risk Factor of Insulin Resistance Independent of Metabolic Syndrome. Int J Environ Res Public Health. 2018 Jul 13;15(7).
  12. Salunke A. S., Nagargoje M. V., Belgaumkar V. A., Tolat S. N., Chavan R.B. Association of Metabolic Syndrome in Chronic Plaque Psoriasis Patients and their Correlation with Disease Severity, Duration and Age: A Case Control Study from Western Maharashtra. J ClinDiagn Res. 2017 Aug;11(8):WC06-WC10.
  13. Бакулев А.Л. Стратегия «лечение до достижения цели» при псориазе. Актуальные вопросы устойчивости к биологической терапии. Вестник дерматологии и венерологии. 2016;(5):32-38.
  14. Mrowietz U., Kragballe K., Reich K. et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011 Jan;303(1):1-10.
  15. Mrowietz U. Implementing treatment goals for successful longterm management of psoriasis. J Eur Acad Dermatol Venereol. 2012 Mar;26 Suppl 2:12-20.
  16. Oji V., Luger T. A. The skin in psoriasis: assessment and challenges. Clin Exp Rheumatol. 2015 Sep-Oct;33(5 Suppl 93):S14-19.
  17. Strober B. E., Clay Cather J., Cohen D., Crowley J. J., Gordon K. B., Gottlieb A. B. et al. A Delphi Consensus Approach to Challenging Case Scenarios in Moderate-to-Severe Psoriasis: Part 1. Dermatol Ther (Heidelb). 2012 Dec;2(1):1. Epub 2012 Mar 17.
  18. Strober B. E., Clay Cather J., Cohen D., Crowley J. J., Gordon K. B., Gottlieb A. B. et al. A Delphi Consensus Approach to Challenging Case Scenarios in Moderate-to-Severe Psoriasis: Part. 2. Dermatol Ther (Heidelb). 2012 Dec;2(1):2. Epub 2012 Mar 30.
  19. Krueger G., Callis K. Potential of Tumor Necrosis Factor Inhibitors in Psoriasis and Psoriatic Arthritis. Arch Dermatol. 2004;140(2):218-225. doi: 10.1001/archderm.140.2.218
  20. Bovenschen H. J., Van de Kerkhof P. C., Van Erp P. E. et al. Foxp3+ Regulatory T Cells of Psoriasis Patients Easily Differentiate into IL-17A-Producing Cells and Are Found in Lesional Skin. Journal of Investigative Dermatology. 2011;131:1853-1860.
  21. Langley R. G., Elewski B. E., Lebwohl M. et al. Secukinumab in Plaque Psoriasis — Results of Two Phase 3 Trials. N Engl J Med. 2014;371:326-338.
  22. Gordon K. B., Blauvelt A., Papp K. A., Langley R. G., Luger T., Ohtsuki M. et al. Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2016 Jul 28;375(4):345-356.
  23. Griffiths C. E., Reich K., Lebwohl M., van de Kerkhof P., Paul C., Menter A. et al. Comparison ofixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015 Aug8;386(9993):541-551.
  24. Reich K., Pinter A., Lacour J. P., Ferrandiz C., Micali G., French L. E. et al. Comparison of ixekizumab with ustekinumab in moder-ate-to-severe psoriasis: 24-week results from IXORA-S, a phase III study. Br J Dermatol. 2017 Oct;177(4):1014-1023.
  25. Bilal J., Berlinberg A., Bhattacharjee S., Trost J., Riaz I. B., Kurtzman D. J. B. Asystematic review and meta-analysis of the efficacy and safety of the interleukin(IL)-12/23 and IL-17 inhibitors ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab and tildrakizumab for the treatment of moderate to severe plaquepsoriasis. J Dermatolog Treat. 2018 Mar 28:1-10.
  26. Lebwohl M., Strober B., Menter A., Gordon K., Weglowska J., Puig L. et al. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med. 2015 Oct;373(14):1318-1328.
  27. Инструкция по медицинскому применению лекарственного препарата Козэнтикс®, ЛП 003715-070716. http://grls.rosminzdrav.ru/
  28. www.accessdata.fda.gov/drugsatfda_docs/label/2017/125521s00 4lbl.pdf
  29. www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761032Orig1s000Lbl.pdf
  30. Kyntheum® Summary of Product Characteristics. https://www.ema. europa.eu/documents/product-information/kyntheum-epar-product-information_en.pdf
  31. Taltz® Summary of Product Characteristics. https://www.ema.europa.eu/documents/product-information/taltz-epar-product-information_en.pdf
  32. Strober B. et al. Clinical meaningfulness of complete skin clearance in psoriasis. Journal of the American Academy of Dermatology. 2016;75(1):77-82.e7.
  33. Armstrong A.W., Siegel M.P., Bagel J. et al. From the Medical Board of the National Psoriasis Foundation: Treatment targets for plaque psoriasis. Journal of the American Academy of Dermatology. Published online Nov. 28, 2016. doi: 10.1016/j.jaad.2016.10.017
  34. Nast A., Jacobs A., Rosumeck S., Werner R. Methods Report: European S3. Guidelines on the systemic treatment of psoriasis vulgaris — update 2015 — EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol. 2015;29:e1-e22. doi: 10.1111/jdv.13353
  35. Smith C. H. T., Jabbar-Lopez Z. K., MacMahon E. et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2017. Br J Dermatol. 2017;177:628-636. doi: 10.1111/bjd.15665
  36. Papp K. A. et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). The Lancet. 2008;371(9625):1675-1684.
  37. Reich K. et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicenter, double-blind trial. The Lancet. 2005;366(9494):1367-1374.
  38. Feldman S. R., Gordon K. B., Bala M., Evans R., Li S., Dooley L. T. et al. Infliximab treatment results in significant improvement in the quality of life of patients with severe psoriasis: a double-blind placebo-controlled trial. Br J Dermatol. 2005;152:954-960. doi: 10.1111/j.1365-2133.2005.06510.x
  39. Самцов А. В., Хайрутдинов В. Р., Бакулев А. Л., Кубанов А. А., Карамова А. Э., Артемьева А. В. и др. Эффективность и безопасность препарата BCD-085 — оригинального моноклонального антитела против интерлейкина-17 у пациентов со среднетяжелым и тяжелым вульгарным псориазом. Результаты II фазы международного многоцентрового сравнительного рандомизированного двойного слепого плацебо-контролируемого клинического исследования. Вестник дерматологии и венерологии. 2017;(5):52-63.
  40. Ekimova V., Ulitin A., Evdokimov S. et al. High Affinity Anti-IL-17A Monoclonal Antibody. Poster presentation. PEGS 2015. Unpublished data.
  41. Насонов Е. Л., Мазуров В. И., Усачева Ю. В., Черняева Е. В., Устюгов Ю. Ю., Улитин А. Б. и др. Разработки отечественных оригинальных генно-инженерных биологических препаратов для лечения иммуновоспалительных ревматических заболеваний. Научно-практическая ревматология. 2017;55(2):201-210.

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