INJECTABLE HYALURONIC ACID DRUGS FOR THE TREATMENT OF KNEE OSTEOARTHRITIS IN THE CONTEXT OF EVIDENCE-BASED MEDICINE
https://doi.org/10.14412/1995-4484-2018-239-248
Abstract
To evaluate the efficacy and safety of intraarticular hyaluronic acid (HA) in osteoarthritis (OA), the authors have analyzed the scientific publications included in foreign databases (Medline/PubMed) on the relevant laboratory, experimental, and clinical studies conducted over the past 20 years. A few in vitro laboratory studies of individual HA drugs confirm their positive effect on articular cartilage. Analysis of the literature on their in vivo use has shown that a variety of intraarticular HA drugs permitted for use in Russia have not been studied in clinical trials, which raises doubts about their efficacy. At the same time, the published works suggest that a significant clinical effect is achieved with HA therapy mainly in early OA and that this therapy for end-stage knee OA yields poor results. The data regarding the clinical efficacy of different HA drugs are very contradictory. Thus, there is a need for additional comparative postmarketing research of HA drugs permitted for use in the Russian Federation, by stratifying patients according to the characteristics of the clinical phenotype of the disease, available risk factors for OA progression, and the magnitude of morphological changes in joint tissues, as verified by magnetic resonance imaging and/or arthroscopy.
About the Authors
A. I. Petukhov
R.R.Vreden Russian Order of the Red Banner of Labor Research Institute of Traumatology and Orthopedics, Ministry of Health of Russia
Russian Federation
Russian Federation
Aleksey Petukhov.
Saint Petersburg
N. N. Kornilov
R.R.Vreden Russian Order of the Red Banner of Labor Research Institute of Traumatology and Orthopedics, Ministry of Health of Russia
Russian Federation
Saint Petersburg
Russian Federation
Saint Petersburg
T. A. Kulyaba
R.R.Vreden Russian Order of the Red Banner of Labor Research Institute of Traumatology and Orthopedics, Ministry of Health of Russia
Russian Federation
Saint Petersburg
Russian Federation
Saint Petersburg
References
1. Zhu J, Lei P, Hu Y. Intraarticular hyaluronate injection for knee osteoarthritis – reconsider the rationale. Ann Transl Med. 2015;3(15):214. doi: 10.3978/j.issn.2305-5839.2015.07.21
2. Altman RD, Schemitsch E, Bedi A. Assessment of clinical practice guideline methodology for the treatment of knee osteoarthritis with intra-articular hyaluronic acid. Semin Arthritis Rheum. 2015;45(2):132-9. doi: 10.1016/j.semarthrit.2015.04.013
3. Chichasova NV. Hyaluronic acid preparations in the treatment of osteoarthritis. Synvisk® (Hylan G-F 20): Efficacy and safety. Sovremennaya Revmatologiya = Modern Rheumatology Journal. 2013;7(4):85-91 (In Russ.). doi: 10.14412/1996-7012-2013-2444
4. Kovalenko VN, Bortkevich OP. Osteoartroz. Prakticheskoe rukovodstvo [Osteoarthritis. A Practical Guide]. 2nd ed. Kiev: Morion; 2005. 592 p.
5. Korzh NA, Golovakha ML, Orlyanskii V. Povrezhdeniya khryashcha kolennogo sustava: Monografiya [Knee cartilage damage: Monograph]. Zaporozh'e, Ukraina: Prosvita; 2013.128 p.
6. Bobacz K, Sunk IG, Hofstaetter JG, et al. Toll-like receptors and chondrocytes: The lipopolysaccharide-induced decrease in cartilage matrix synthesis is dependent on the presence of toll-like receptor 4 and antagonized by bone morphogenetic protein
7. Arthritis Rheum. 2007;56:1880-93. doi: 10.1002/art.22637 7. Du Souich P. Absorption, distribution and mechanism of action of SYSADOAS. Pharm Ther. 2014;142(3):362-74. doi: 10.1016/j.pharmthera.2014.01.002
8. Hiraoka N, Takahashi KA, Arai Y, et al. Intra-articular injection of hyaluronan restores the aberrant expression of matrix metalloproteinase-13 in osteoarthritic subchondral bone. J Orthop Res. 2011;29:354-60. doi: 10.1002/jor.21240
9. Heinegard D, Saxne T. The role of the cartilagematrix in osteoarthritis. Nat Rev Rheumatol. 2011;7:50-6. doi: 10.1038/nrrheum.2010.198
10. Campo GM, Avenoso A, Campo S, et al. Molecular size hyaluronan differently odulates toll-like receptor-4 in LPS-induced inflammation in mouse chondrocytes. Biochimie. 2010;92:204-15. doi: 10.1016/j.biochi.2009.10.006
11. Campo GM, Avenoso A, Campo S, et al. Small hyaluronan oligosaccharides induce nflammation by engaging both tolllike-4 and CD44 receptors in human chondrocytes. Biochem Pharmacol. 2010;80:480-90. doi: 10.1016/j.bcp.2010.04.024
12. Yasuda T. Activation of p38 mitogen-activated protein kinase is inhibited by hyaluronan via intercellular adhesionmolecule-1 in articular chondrocytes stimulated with type II collagen peptide. J Pharmacol Sci. 2012;118:25-32. doi: 10.1254/jphs.11044FP
13. Yatabe T, Mochizuki S, Takizawa M, et al. Hyaluronan inhibits expression of ADAMTS4 (aggrecanase-1) in human osteoarthritic chondrocytes. Ann Rheum Dis. 2009;68:1051-8. doi: 10.1136/ard.2007.086884
14. Del Fresno C, Otero K, Gomez-Garcia L, et al. Tumor cells deactivate human monocytes by up-regulating IL-1 receptor associated kinase-M expression via CD44 and TLR4. J Immunol. 2005;174:3032-40. doi: 10.4049/jimmunol.174.5.3032
15. Hashizume M, Mihara M. High molecular weight hyaluronic acid inhibits IL-6-induced MMP production from human chondrocytes by up-regulating the ERK inhibitor, MKP-1. Biochem Biophys Res Commun. 2010;403:184-9. doi: 10.1016/j.bbrc.2010.10.135
16. Wancket LM, Frazier WJ, Liu Y. Mitogen-activated protein kinase phosphatase (MKP)-1 in immunology, physiology, and disease. Life Sci. 2012;90:237-48. doi: 10.1016/j.lfs.2011.11.017
17. Bollyky P, Lord JD, Masewicz SA, et al. Cutting edge: high molecular weight hyaluronan promotes the suppressive effects of CD4+CD25+ regulatory T cells. J Immunol. 2007;179(2):744-7. doi: 10.4049/jimmunol.179.2.744
18. Reitinger S, Lepperdinger G. Hyaluronan, a ready choice to fuel regeneration: a mini-review. Gerontology. 2013;59:71-6. doi: 10.1159/000342200
19. Knudson W, Loeser RF. CD44 and integrin matrix receptors participate in cartilage homeostasis. Cel Mol Life Sci. 2002;59:36-44. doi: 10.1007/s00018-002-8403-0
20. Peyron JG, Balazs EA. Preliminary clinical assessment of Nahyaluronate injection into human arthritic joints. Pathol Biol (Paris). 1974;22(8):731-6.
21. Belen'kii AG. Preparaty gialuronovoi kisloty v lechenii osteoartroza. Uchebnoe posobie [Preparations of hyaluronic acid in the treatment of osteoarthritis. Tutorial]. Moscow; 2005. 28 p. (In Russ.).
22. Sackett D, Rosenberg W, Grey J, et al. Evidence based medicine: what it is and what it isn’t. BMJ. 1996;312:71-2. doi: 10.1136/bmj.312.7023.71
23. Lisignoli G, Grassi F, Zini N, et al. Anti-FAS-induced apoptosis in chondrocytes reduced by hyaluronan. Evidence for CD44 and CD54 (intercellular adhesion molecule 1) involvement. Arthritis Rheum. 2001;44(8):1800-7. doi: 10.1002/15290131(200108)44:8<1800::AID-ART317>3.0.CO;2-1
24. Brun P, Panfilo S, Daga Gordini D, et al. The effect of hyaluronan on CD44-mediated survival of normal and hydroxyl radical-damaged chondrocytes. Osteoarthritis Cartilage. 2003;11(3):208-16. doi: 10.1016/S1063-4584(02)00352-7
25. Mathieu P, Conrozier T, Vignon E, et al. Rheologic behavior of osteoarthritic synovial fluid after addition of hyaluronic acid: a pilot study. Clin Orthop Relat Res. 2009;467(11):3002-9. doi: 10.1007/s11999-009-0867-x
26. Schiavinato A, Whiteside RA. Effective lubrication of articular cartilage by an amphiphilic hyaluronic acid derivative. Clin Biomech (Bristol, Avon). 2012;27(5):515-9. doi: 10.1016/j.clinbiomech.2011.11.012
27. Waller KA, Zhang LX, Fleming BC, et al. Preventing friction induced chondrocyte apoptosis: comparison of human synovial fluid and hylan G-F20. J Rheumatol. 2012;39(7):1473-80. doi: 10.3899/jrheum.111427
28. Smith MM, Russell AK, Schiavinato A, et al. A hexadecylamide derivative of hyaluronan (HYMOVIS®) has superior beneficial effects on human osteoarthritic chondrocytes and synoviocytes than unmodified hyaluronan. J Inflamm (Lond). 2013;27(10):26. doi: 10.1186/1476-9255-10-26
29. Greenberg DD, Stoker A, Kane S, et al. Biochemical effects of two different hyaluronic acid products in a co-culture model of osteoarthritis. Osteoarthritis Cartilage. 2006;14(8):814-22. doi: 10.1016/j.joca.2006.02.006
30. Ottaviani RA, Wooley P, Song Z, et al. Inflammatory and immunological responses to hyaluronan preparations. Study of a murine biocompatibility model. J Bone Joint Surg Am. 2007;89(1):148-57. doi: 10.2106/JBJS.E.01135
31. Cake M, Read R, Edwards S, et al. Changes in gait after bilateral meniscectomy in sheep: effect of two hyaluronan preparations. J Orthop Sci. 2008;13(6):514-23. doi: 10.1007/s00776-008-1279-6
32. Smith MM, Cake MA, Ghosh P, et al. Significant synovial pathology in a meniscectomy model of osteoarthritis: modification by intra-articular hyaluronan therapy. Rheumatology (Oxford). 2008;47(8):1172-8. doi: 10.1093/rheumatology/ken219
33. Gomis A, Miralles A, Schmidt RF, et al. Intra-articular injections of hyaluronan solutions of different elastoviscosity reduce nociceptive nerve activity in a model of osteoarthritic knee joint of the guinea pig. Osteoarthritis Cartilage. 2009;17(6):798-804. doi: 10.1016/j.joca.2008.11.013
34. Boettger MK, Kümmel D, Harrison A, et al. Evaluation of longterm antinociceptive properties of stabilized hyaluronic acid preparation (NASHA) in an animal model of repetitive joint pain. Arthritis Res Ther. 2011;13(4):110. doi: 10.1186/ar3394
35. Li P, Raitcheva D, Hawes M, et al. Hylan G-F 20 maintains cartilage integrity and decreases osteophyte formation in osteoarthritis through both anabolic and anti-catabolic mechanisms. Osteoarthritis Cartilage. 2012;20(11):1336-46. doi: 10.1016/j.joca.2012.07.004
36. Elmorsy S, Funakoshi T, Sasazawa F, et al. Chondroprotective effects of high-molecular-weight cross-linked hyaluronic acid in a rabbit knee osteoarthritis model. Osteoarthritis Cartilage. 2014;22(1):121-7. doi: 10.1016/j.joca.2013.10.005
37. Liu СС, Su LJ, Tsai WY, et al. Hylan G-F 20 attenuates posttraumatic osteoarthritis progression: Association with upregulated expression of the circardian gene NPAS2. Life Sci. 2015 Nov 15;141:20-4. doi: 10.1016/j.lfs.2015.09.007. Epub 2015 Sep 24.
38. Roszdravnadzor. Electronic resource: www.roszdravnadsor.ru.
39. Vitanzo PC, Sennett BJ. Hyaluronans: is clinical effectiveness dependent on molecular weight. Am J Orthop (Belle Mead NJ). 2006;35(9):421-8.
40. Undqvist U, Tolmachev V, Kalremo K, et al. Elimination of stablised hyaluronan from the knee joint in healthy men. Clin Pharmacokinet. 2002;41(8):603-13. doi: 10.2165/00003088200241080-00004
41. Migliore A, Bizzi E, De Lucia O, et al. Differences Regarding Branded HA in Italy, Part 2: Data from Clinical Studies on Knee, Hip, Shoulder, Ankle, Temporomandibular Joint, Vertebral Facets, and Carpometacarpal Joint. Clin Med Insights: Arthr Musculoskelet Disord. 2016;9:117-31. doi: 10.4137/CMAMD.S39143
42. Chevalier X, Jerosch J, Goupille P, et al. Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicenter, double-blind, placebo controlled trial. Ann Rheum Dis. 2010;69(1):113-9. doi: 10.1136/ard.2008.094623
43. Karatosun V, Unver B, Gocen Z, et al. Comparison of two hyaluronan drugs in patients with advanced osteoarthritis of the knee. A prospective, randomized, double-blind study with long term follow-up. Clin Exp Rheumatol. 2005;23:213-8.
44. Ozturk C, Atamaz F, Hepguler S, et al. The safety and efficacy of intraarticular hyaluronan with/without corticosteroid in knee osteoarthritis: 1-year, single-blind, randomized study. Rheumatol Int. 2006;26:314-9. doi: 10.1007/s00296-005-0584-z
45. Petrella RJ, Petrella M. A prospective, randomized, double-blind, placebo controlled study to evaluate the efficacy of intraarticular hyaluronic acid for osteoarthritis of the knee. J Rheumatol. 2006;33:951-6.
46. Kotevoglu N, Iyibozkurt PC, Hi O, et al. A prospective randomised controlled clinical trial comparing the efficacy of different molecular weight hyaluronan solutions in the treatment of knee osteoarthritis. Rheumatol Int. 2006;26:325-30. doi: 10.1007/s00296-005-0611-0
47. Atamaz F, Kirazli Y, Akkoc Y. A comparison of two different intraarticular hyaluronan drugs and physical therapy in the management of knee osteoarthritis. Rheumatol Int. 2006;26:873-8. doi: 10.1007/s00296-005-0096-x
48. Jüni P, Reichenbach S, Trelle S, et al. Swiss Viscosupplementation Trial Group. Efficacy and safety of intraarticular hylan or hyaluronic acids for osteoarthritis of the knee: a randomized controlled trial. Arthritis Rheum. 2007;56:3610-9. doi: 10.1002/art.23026
49. Raman R, Dutta A, Day N, et al. Efficacy of hylan G-F 20 and sodium hyaluronate in the treatment of osteoarthritis of the knee – a prospective randomized clinical trial. Knee. 2008;15;318-24. doi: 10.1016/j.knee.2008.02.012. Epub 2008 Apr.
50. Diracoglu D, Vural M, Baskent A. The effect of viscosupplementation on neuromuscular control of the knee in patients with osteoarthritis. J Back Musculoskelet Rehabil. 2009;22:1-9. doi: 10.3233/BMR-2009-0207
51. Rossini M, Viapiana O, Ramonda R, et al. Intra-articular clodronate for the treatment of knee osteoarthritis: dose ranging study vs hyaluronic acid. Rheumatology (Oxford). 2009;48:773-8. doi: 10.1093/rheumatology/kep084
52. Pavelka K, Uebelhart D. Efficacy evaluation of highly purified intra-articular hyaluronic acid (Sinovial(®)) vs hylan G-F20 (Synvisc(®)) in the treatment of symptomatic knee osteoarthritis. A double-blind, controlled, randomized, parallel-group non-inferiority study. Osteoarthritis Cartilage. 2011;19:1294-300. doi: 10.1016/j.joca.2011.07.016
53. Wang Y, Hall S, Hanna F, et al. Effects of hylan G-F 20 supplementation on cartilage preservation detected by magnetic resonance imaging in osteoarthritis of the knee: a two-year single-blind clinical trial. BMC Musculoskelet Disord. 2011;12:195. doi: 10.1186/1471-2474-12-195
54. Filardo G, Kon E, Di Martino A, et al. Platelet-rich plasma vs hyaluronic acid to treat knee degenerative pathology: study design and preliminary results of a randomized controlled trial. BMC Musculoskelet Disord. 2012;13:229. doi: 10.1186/1471-2474-13229
55. Berenbaum F, Grifka J, Cazzaniga S, et al. A randomised, doubleblind, controlled trial comparing two intra-articular hyaluronic acid preparations differing by their molecular weight in symptomatic knee osteoarthritis. Ann Rheum Dis. 2012;71:1454-60. doi: 10.1136/annrheumdis-2011-200972
56. Saw KY, Anz A, Siew-Yoke Jee C, et al. Articular cartilage regeneration with autologous peripheral blood stem cells versus hyaluronic acid: a randomized controlled trial. Arthroscopy. 2013;29:684-94. doi: 10.1016/j.arthro.2012.12.008
57. Waddell DD, Joseph B. Delayed total knee replacement with HylanG-F 20. J Knee Surg. 2016;29(2):159-68.
58. Altman RD, Farrokhyar F, Fierlinger A, et al. Analysis for Prognostic Factors from a Database for the Intra-Articular Hyaluronic Acid (Euflexxa) Treatment for Osteoarthritis of the Knee. Cartilage. 2016;7(3):229-37. doi: 10.1177/1947603515620890
59. Mir AP, Metin O, Aysin P. Accuracy and outcome of sonographically guided intra-articular sodium hyaluronate injection in patients with osteoarthritis of the hip. J Ultrasound Med. 2005;24:1391-5. doi: 10.7863/jum.2005.24.10.1391
60. Tikiz C, Unlu Z, Sener A, Efe M. Comparison of the efficacy of lower and higher molecular weight viscosupplementation in the treatment of hip osteoarthritis. Clin Rheumathol. 2005;24:244-50. doi: 10.1007/s10067-004-1013-5
61. Lussier A, Cividino AA, McFarlane CA, et al. Viscosupplementation with Hylan for the treatment of osteoarthritis findings from clinical practice in Canada. J Rheumatol. 1996;23(1):579-85.
62. Shemesh S, Heller S, Salai M, et al. Septic arthritis of the knee following intraarticular injections in elderly patients: report of six patients. Isr Med Assoc J. 2011;13(12):757-60.
63. Lee YK, Kim KC, Ha YC, et al. Utilization of Hyaluronate and Incidence of Septic Knee Arthritis in Adults: Results from the Korean National Claim Registry. Clin Orthop Surg. 2015 Sep;7(3):318-22. doi: 10.4055/cios.2015.7.3.318. Epub 2015 Aug 13.
64. Galois L, Etienne S, Henrionnet C, et al. Ambivalent properties of hyaluronate and hylan during post-traumatic OA in the rat knee. Biomed Mater Eng. 2012;22(4):235-42. doi: 10.3233/BME-20120713
65. Chen СР. Changes of synovial fluid protein concentrations in supra-patellar bursitis patients after the injection of different molecular weights of hyaluronic acid. Exper Gerontol. 2014 Apr;52:30-5. doi: 10.1016/j.exger.2014.01.016
66. 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 Oct;30(5):387-96. doi: 10.1017/s40259-016-0186-1
67. Wang F, He X. Intra-articular hyaluronic acid and corticosteroids in the treatment of knee osteoarthritis: A meta-analysis. Exper Ther Med. 2014;5:493-500. doi: 10.3892/etm.2014.2131
68. Kostyuk A, Al'madieva A, Akanova A. Clinical and cost-effectiveness of the use of g-f 20 gilan in the management of patients with pain and mobility restriction in osteoarthritis. Revmatologiya. 2016;9(171):56-70 (In Russ.).
69. Campbell KA, Erickson BJ, Saltzman BM, et al. Is Local Viscosupplementation Injection Clinically Superior to Other Therapies in the Treatment of Osteoarthritis of the Knee: A Systematic Review of Overlapping Meta-analyses. Arthroscopy. 2015;31(10):2036-45. doi: 10.1016/j.arthro.2015.03.030
70. Kuropatkin GV. Evaluation of the use of gf-20 gilant in patients with knee osteoarthritis (preliminary results). Travmatologiya i Ortopediya Rossii. 2016;22(3):79-87 (In Russ.). doi: 10.21823/2311-2905-2016-22-3-79-87.
71. Denisov LN, Tsvetkova ES, Golubev GSh, et al. The European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) algorithm for the management of knee osteoarthritis is applicable in Russian clinical practice: A joint opinion of leading Russian specialists and ESCEO experts. NauchnoPrakticheskaya Revmatologiya = Rheumatology Science and Practice. 2016;54(6):641-53 (In Russ.). doi: 10.14412/19954484-2016-641-653
Review
For citations:
Petukhov A.I., Kornilov N.N., Kulyaba T.A. INJECTABLE HYALURONIC ACID DRUGS FOR THE TREATMENT OF KNEE OSTEOARTHRITIS IN THE CONTEXT OF EVIDENCE-BASED MEDICINE. Rheumatology Science and Practice. 2018;56(2):239-248. (In Russ.) https://doi.org/10.14412/1995-4484-2018-239-248
Views:
1431
Email this article 