Evaluation of safety and efficacy of Hylan G-F 20 (Synvisc-One®) in patients with knee osteoarthritis in clinical practice

Cover Page
Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription or Fee Access

Abstract


Combined therapy of osteoarthritis (OA) includes intra-articular injections of hyaluronic acid. A prospective observational multicenter noncomparative study was conducted in compliance with routine clinical practice in patients with knee OA I–III stages in order to assess 1-year long-term safety and efficacy of Hylan G-F 20 (Synvisc-One®, one injection of 6 mL). Patients came for observation at 3, 6, and 12 months after intra-articular injection of Hylan G-F 20. The primary objective of the study was evaluation of pain severity while walking and rest by using the WOMAC VA3.1 (Western Ontario and McMaster Universities Osteoarthritis Index) scale after 26 and 52 weeks compared to baseline. Quality of life was measured by EQ-5D (EuroQuality of Life—five dimensions); patient’s general condition was measured by PTGA (Patient Global Assessment) and COGA (Clinical Observer Global Assessment). Results of the study were based on data of 121 patients (79.51% — women, 21.49% — men), mean age 62.97 ± 12.47 years. Positive clinical response was observed in 12 months (52 weeks) after Hylan GF-20 administration: pain severity versus baseline was decreased by 48.92% (p < 0.001) as per WOMAC A, stiffness in the joints versus baseline by 49.72% (p < 0.001) as per WOMAC B, difficulties in the daily life versus baseline by 41.54% (p < 0.001) as per WOMAC C. Seven adverse events were detected in five patients (4%), and one serious adverse event (cardiovascular abnormalities) was noticed during the entire study that was unrelated to the study drug. The extent of clinical response did not correlate with the stage of osteoarthritis. The quality of life was improved by 35.28% (p < 0.001) according to the questionnaire EQ-5D. The general condition of the patients was improved by 37.50% (p < 0.001) as per COGA and 42,86% (p < 0.001) as per PTGA. No patients were discontinued the study due to adverse event or any other reasons. Intra-articular injections of Hylan G-F 20 6 mL were associated with acceptable safety and efficacy, and the therapeutic effect was observed up to 52 weeks.


Full Text

Restricted Access

About the authors

Gennadiy V. Kuropatkin

Samara Hospital “Mother and Child – IDK”

Email: kuropatkin.gennady@gmail.com

Russian Federation, Samara

MD, Head of the Orthopedics Department

Ildar F. Ahtyamov

Kazan State Medical University

Author for correspondence.
Email: yalta60@mail.ru

Russian Federation, Kazan

MD, PhD, professor, Head of the Department of Traumatology, Orthopedics and Surgery of Extreme Conditions

Marina L. Stanislav

V.A. Nasonov Research Institute of Rheumatology

Email: marista@bk.ru

Russian Federation, Moscow

MD, PhD, Leading researcher

Vladimir A. Kushnir

Polyclinics No.3 of General Management Department of the President of the Russian Federation

Email: Drkushnir01@gmail.com

Russian Federation, Moscow

traumatologist

Igor G. Belenkiy

Pavlov University; Alexander Hospital

Email: Belenkiy.trauma@mail.ru

Russian Federation, Saint Petersburg

MD, PhD, Professor of the Department of Traumatology and Orthopedics; Head of the Department of Traumatology No.1 

Sergey S. Kopenkin

Pirogov Medical University

Email: Serko2001@mail.ru

Russian Federation, Moscow

MD, associate professor of the Department of Traumatology and Orthopedics and Military Surgery

Vartan O. Tamazyan

Central City Clinical Hospital

Email: vartantamazyan@yandex.ru

Russian Federation, Reutov

doctor

Natalya N. Vezikova

Petrozavodsk State Medical University

Email: Vezikov23@mail.ru

Russian Federation, Petrozavodsk

MD, PhD, Professor, Head of the Department of Hospital Therapy

Vasiliy V. Klyuchevskiy

Yaroslavl State Medical University

Email: Kluchevsky@inbox.ru

Russian Federation, Yaroslavl

MD, associate professor of the Department of Traumatology and Orthopedics

References

  1. Sen R., Hurley J.A. Ostheoarthritis. Treasure Island (FL): StatPearls Publishing; 2018 Jan, 26.
  2. Здравоохранение в России. 2015. Статистический сборник. Росстат, Москва, 2015. 174 с. [Zdravoohranenie v Rossii. 2015: Statistics revue. Rosstat. Moscow, 2015. 174 p. (In Russ.)]
  3. Алексеева Л.И., Зайцева Е.М. Перспективные направления терапии остеоартроза. Научно-практическая ревматология. 2014; 52(3): 247-250. [Alekseeva LI, Zayitseva EM. Perspective directions of therapy of osteoarthrosis. Nauchno-prakticheskaya revmatologia. 2014;52(3):247-250. (In Russ.)]
  4. Bruyere O, Cooper C, Pelletier J-P, et al. An Algorithm recommendation for the management of knee osteoarthritis in Europe and internationally: a report from a task force of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). Semin Arthritis Rheum. 2014;44(3):253-263. https://org.doi: 10.1016/j.semarthrit.2014.05.014.
  5. Денисов Л.Н., Цветкова Е.С., Голубев Г.Ш., и др. Алгоритм лечения остеоартрита коленного сустава Европейского общества по клиническим и экономическим аспектам остеопороза и остеоартрита (ESCEO) применим в российской клинической практике: совместное заключение ведущих российских специалистов и экспертов ESCEO по остеоартриту. Научно-практическая ревматология. 2016;54(6):641-653. [Denisov LN, Cvetkova ES, Golubev GSh, et al. The algorithm of treatment of osteoarthritis of a knee joint of the European society on clinical and economic aspects of osteoporosis and osteoarthritis (ESCEO) is applicable in the Russian clinical practice: joint conclusion of the leading Russian experts and experts of ESCEO in osteoarthritis. Nauchno-prakticheskaya revmatologia. 2014;52(3):247-250. (In Russ.)]
  6. Bruyère O, Cooper C, Pelletier J-P, et al. A consensus statement on the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) algorithm for the management of knee osteoarthritis-From evidence-based medicine to the real- life setting. Semin Arthritis Rheum. 2016;45(4 Suppl):S3-11.
  7. Bannuru RR, Vaysbrot EE, Sullivan MC, McAlindon TE. Relative efficacy of hyaluronic acid in comparison with NSAIDs for knee osteoarthritis: a systematic review and meta-analysis. Semin Arthritis Rheum. 2014;43(5):593-599.
  8. Migliore A, Bizzi E, De Lucia O, et al. Differences among Branded Hyaluronic Acids in Italy, Part 1: Data from In Vitro and Animal Studies and Instructions for Use. Clin Med Insights Arthritis Musculoskelet Disord. 2016;9:89-101.
  9. Bellamy N, et al. Viscosupplementation for the treatment of osteoarthritis of the knee (Review). The Cochrane Library. 2006;2.
  10. Bruyère O, Cooper C, Cutolo M, Reginster JY. International endorsement of the ESCEO algorithm for management of knee osteoarthritis in clinical practice. Semin Arthritis Rheum. 2017;47(2):e10.
  11. Хело М.Д., Ахтямов И.Ф., Абдуллах А.М., Саид Ф.М. Лечение гонартроза — современные тенденции и проблемные вопросы. Практическая медицина. 2018;16(7):48-53. [Helo MJ, Akhtiamov IF, Abdullah AM, Said FM. Treatment of arthrosis of the knee, current trends and issues. Practical Medicine. 2018;16(7)48-53. (In Russ.).]
  12. Jordan KM., Arden NK, Bannwarth B, et al. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003;62:1145-1155.
  13. Henrotin Y, Raman R, Richette P, et al. Consensus statement on viscosupplementation with hyaluronic acid for the management of osteoarthritis. Semin Arthritis Rheum. 2015;45(2):140-149.
  14. Altman R, Bedi A, Manjoo A, Niazi F, Shaw P, Mease P. Anti-Inflammatory Effects of Intra-Articular Hyaluronic Acid: A Systematic Review. Cartilage. 2019;10(1):43-52.
  15. Raman R, Dutta A, Day N, et al. Hylan G-F 20 and Sodium Hyaluronate in the treatment of osteoarthritis of the knee — a prospective randomized clinical trial. Knee. 2008;15(4):318-24
  16. Zhao H, Liu H, Liang X, et al. Hylan G-F 20 Versus Low Molecular Weight Hyaluronic Acids for Knee Osteoarthritis: A Meta-Analysis. BioDrugs. 2016;30(5):387-396.
  17. Altman R, Hackel J, Niazi F, Shaw P, Nicholls M. Efficacy and safety of repeated courses of hyaluronic acid injections for knee osteoarthritis: A systematic review. Semin Arthritis Rheum. 2018;48(2):168-175.
  18. Petrella RJ, Wakeford C. Pain relief and improved physical function in knee osteoarthritis patients receiving ongoing hylan G-F 20, a high-molecular-weight hyaluronan, versus other treatment options: data from a large real-world longitudinal cohort in Canada. Drug Des Devel Ther. 2015 Oct 15;9:5633-5640.
  19. Rat AC, Baumann C, Guillemin F. National, multicentre, prospective study of quality of life in patients with osteoarthritis of the knee treated with hylane G-F 20. Clin Rheumatol. 2011;30(10):1285-1293.
  20. Pal S, Thuppal S, Reddy KJ, Avasthi S, Aggarwal A, Bansal H. Mohanasundaram S, Bailleul F Long-Term (1-Year) Safety and Efficacy of a Single 6-ml Injection of Hylan G-F 20 in Indian Patients with Symptomatic Knee Osteoarthritis. Open Rheumatol J. 2014;8:54-68.
  21. Yan CH, Chan WL, Yuen WH, Yung PS, Ip KY, Fan JC, Chiu KY. Efficacy and safety of hylan G-F 20 injection in treatment of knee osteoarthritis in Chinese patients: results of a prospective, multicentre, longitudinal study. Hong Kong Med J. 2015;21(4):327-332.
  22. Boutefnouchet T, Puranik G, Holmes E, Bell KM. Hylan GF-20 Viscosupplementation in the Treatment of Symptomatic Osteoarthritis of the Knee: Clinical Effect Survivorship at 5 Years. Knee Surg Relat Res. 2017;29(2):129-136.
  23. Heger R, Paulsen G, Fickert U, Kresmann M. Open-label Study of Initial and Repeat Treatment Cycles of Hylan G-F 20 in Patients with Symptomatic Knee Osteoarthritis. Open Rheumatol J. 2016;10:88-100.

Supplementary files

Supplementary Files Action
1.
Fig. 1. Dynamics of pain at rest and walking (WOMAC VA3.1 section A). 1 — pain when walking, 2 — pain at rest

Download (45KB) Indexing metadata
2.
Fig. 2. Assessment of therapy efficacy by patient and doctor (visual analogue scale). 1 — patient, 2 — doctor

Download (43KB) Indexing metadata

Statistics

Views

Abstract - 160

PDF (Russian) - 1

Cited-By


Article Metrics

Metrics Loading ...

Refbacks

  • There are currently no refbacks.

Copyright (c) 2020 Kuropatkin G.V., Ahtyamov I.F., Stanislav M.L., Kushnir V.A., Belenkiy I.G., Kopenkin S.S., Tamazyan V.O., Vezikova N.N., Klyuchevskiy V.V.

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

This website uses cookies

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

About Cookies