Moscow experience of using etanercept biosimilar in patients with immune-inflammatory rheumatic diseases

Cover Page

Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription Access

Abstract

The growing demand for biological disease-modifying antirheumatic drugs (bDMARDs) and their high cost put a heavy burden on the healthcare budget, thereby limiting the availability of treatment for patients. The introduction of bDMARDs’ biosimilars into clinical practice has made it possible to expand the availability of therapy for a larger number of patients. Our analysis of the use of the biosimilar etanercept Erelzi® in 103 patients with rheumatoid arthritis showed that the drug is highly effective in the treatment of rheumatoid arthritis. It can be used both in bionaive patients with the ineffectiveness of basic therapy, and in the case of medical switching from other biologics (including tumor necrosis factor alpha inhibitors (iTNF)) and targeted synthetic basic anti-inflammatory drugs (tsDMARDs), as well as when non-medical switching is necessary. The biosimilar of etanercept Erelzi® has optimal cost of treatment course and the lowest cost-effectiveness value, which means that its use will not affect the budget and will make highly effective therapy available to more patients.

About the authors

Alena I. Zagrebneva

City Clinical Hospital No. 52 of the Moscow Health Department; Russian National Research Medical University named after N.I. Pirogov

Email: alrheumo@mail.ru
ORCID iD: 0000-0002-3235-1425

MD, Cand. Sci. (Med.)

Russian Federation, Moscow; Moscow

Elena N. Simonova

City Clinical Hospital No. 52 of the Moscow Health Department; Peoples’ Friendship University of Russia

Email: 4130524@mail.ru
ORCID iD: 0000-0002-8372-6995

MD

Russian Federation, Moscow; Moscow

Тatiana V. Mezenova

City Clinical Hospital No. 52 of the Moscow Health Department; Research Institute of Health Organization and Medical Management of the Moscow Health Department; Russian Medical Academy continuing Professional Education

Email: tmezenova@mail.ru
ORCID iD: 0000-0002-8035-6669
SPIN-code: 8684-3579

MD, Cand. Sci. (Med.)

Russian Federation, Moscow; Moscow; Moscow

Natalia B. Burmistrova

City Clinical Hospital No. 52 of the Moscow Health Department

Email: ANBurmistroba04@mail.ru
ORCID iD: 0000-0003-2366-0231

MD

Russian Federation, Moscow

Yuliya A. Gavrikova

City Clinical Hospital No. 52 of the Moscow Health Department; Research Institute of Health Organization and Medical Management of the Moscow Health Department

Author for correspondence.
Email: jgavrikovagkb52@gmail.com
ORCID iD: 0000-0001-8414-1545

MD

Russian Federation, Moscow; Moscow

Vladislav V. Dolgov

City Clinical Hospital No. 52 of the Moscow Health Department; Research Institute of Health Organization and Medical Management of the Moscow Health Department

Email: drdolgovvvv@gmail.com
ORCID iD: 0000-0001-8007-5499

MD

Russian Federation, Moscow; Moscow

Evgeniya O. Morozova

City Clinical Hospital No. 52 of the Moscow Health Department

Email: morozova15950@yandex.ru
ORCID iD: 0000-0001-9406-2488

MD

Russian Federation, Moscow

Zhaneta M. Kodzeva

City Clinical Hospital No. 52 of the Moscow Health Department

Email: zhaneta996@mail.ru
ORCID iD: 0000-0001-7983-6115

MD

Russian Federation, Moscow

Ksenia S. Sapogina

National Research University “Higher School of Economics”

Email: ksenia.grossssmann@gmail.com
ORCID iD: 0000-0002-0727-5176
Russian Federation, Moscow

Anastasia A. Fomina

Russian National Research Medical University named after N.I. Pirogov

Email: fomina.med@gmail.com
ORCID iD: 0000-0002-4463-5847
Russian Federation, Moscow

References

  1. Smolen J.S., Aletaha D., Bijlsma J.W. et al. Treating Rheumatoid Arthritis to Target: Recommendations of an International Task Force. Ann Rheum Dis. 2010;69(4):631–637. https://doi.org/10.1136/ard.2009.123919
  2. Федеральный закон "Об обращении лекарственных средств" от 12.04.2010 N 61-ФЗ
  3. EMA and European Commission (EC). Biosimilars in the EU: information guide for healthcare professionals. 2019. Available at https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide- healthcare-professionals_en.pdf; accessed Feb 5, 2020
  4. Weise M, Bielsky MC, De Smet K. et al. Biosimilars: what clinicians should know. Blood. 2012;120:5111 7. https://doi: 10.1182/blood-2012-04-425744
  5. Kay J. A 'wind of change' to biosimilars: the NOR-SWITCH trial and its extension. J Intern Med. 2019;285:693-5. https://doi: 10.1111/joim.12896
  6. Cohen, H.P., Lamanna, W.C., Schiestl, M. (2018). Totality of Evidence and the Role of Clinical Studies in Establishing Biosimilarity. In: Gutka, H., Yang, H., Kakar, S. (eds) Biosimilars. AAPS Advances in the Pharmaceutical Sciences Series, vol 34. Springer, Cham. https://doi.org/10.1007/978-3-319-99680-6_22
  7. European Commission (EC). Information guide for patients: what do I need to know about biosimilar medicines. 2017. Available at http://ec.europa.eu/DocsRoom/documents/20961; accessed Oct 24, 2017.
  8. McCamish M, Pakulski J, Sattler C, Woollett G. Toward interchangeable biologics. Clin Pharmacol Ther. 2015 Mar;97(3):215-7. https://doi: 10.1002/cpt.39.
  9. McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther. 2012;91:405-17. https://doi: 10.1038/clpt.2011.343
  10. Kurki P, et al. Interchangeability of biosimilars: a European perspective. BioDrugs. 2017;31:83-91.
  11. Macdonald JC, et al. Regulatory considerations in oncologic biosimilar drug development. MAbs. 2015;7:653-61.
  12. Christl L. FDA’s overview of the regulatory guidance for the development and approval of biosimilar products in the US. Available at https://www.fda.gov/media/90496/download; accessed Feb 1,2020.
  13. Дедов И. И., Шестакова М. В., Петеркова В. А. и соавт. Проект рекомендаций Российской ассоциации эндокринологов по применению биосимиляров инсулина. Сахарный диабет. – 2021. – Т. 24. – №. 1. – С. 76-79.
  14. Куликов А.Ю., Серпик В.Г., Лила А.М. Фармакоэкономическое обоснование переключения пациентов с ревматическими заболеваниями с оригинальных генно-инженерных биологических препаратов на биосимиляры в условиях системы здравоохранения России. Современная ревматология. 2022;16(3S):1-17. https://doi.org/10.14412/1996-7012-2022-2S-1-17
  15. Jaworski J, Matucci-Cerinic M, Schulze-Koops H. et al. Switch from reference etanercept to SDZ ETN, an etanercept biosimilar, does not impact efficacy, safety, and immunogenicity of etanercept in patients with moderate-to-severe rheumatoid arthritis: 48-week results from the phase III, randomized, double-blind EQUIRA study. Arthritis Res Ther. 2019 May 28;21(1):130. https://doi: 10.1186/s13075-019-1907-x.
  16. Griffits CEM, Thaci D, Gerdes S. et al. The EGALITY study: a confirmatory, randomized, double-blind study compating the efficacy, safety and immunogencity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol. 2017;176:928-38 https://doi: 10.1111/bjd.15152
  17. Jørgensen K, Olsen I, Goll G. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017 Jun 10;389(10086):2304-2316. https://doi: 10.1016/S0140-6736(17)30068-5
  18. Carballo N, Pérez García C, Grau S. et al. Real-world effectiveness and persistence of reference etanercept versus biosimilar etanercept GP2015 among rheumatoid arthritis patients: A cohort study. Front. Pharmacol. 13:980832. https://doi: 10.3389/fphar.2022.980832

Supplementary files

Supplementary Files
Action
1. JATS XML

Copyright (c) 2023 Eco-Vector



Согласие на обработку персональных данных

 

Используя сайт https://journals.rcsi.science, я (далее – «Пользователь» или «Субъект персональных данных») даю согласие на обработку персональных данных на этом сайте (текст Согласия) и на обработку персональных данных с помощью сервиса «Яндекс.Метрика» (текст Согласия).