A single intra-articular injection of 2.0% non-chemically modified sodium hyaluronate vs 0.8% hylan G-F 20 in the treatment of symptomatic knee osteoarthritis: A 6-month, multicenter, randomized, controlled non-inferiority trial

English version

Autoři: Emmanuel Maheu ^aff001; Bernard Avouac ^aff002; Renée Liliane Dreiser ^aff003; Thomas Bardin ^aff004
Působiště autorů: Department of Rheumatology, AP-HP, Hôpital Saint-Antoine, Paris, France, Private office, Paris, France ^aff001; Department of Rheumatology, CHU Henri Mondor, Créteil, France (currently: rheumatologist, consultant, Paris, France) ^aff002; Department of Rheumatology, AP-HP, Hôpital Bichat-Claude Bernard, Paris, France ^aff003; Department of Rheumatology, AP-HP, Hôpital Lariboisière, Université Paris Diderot, Paris, France ^aff004
Vyšlo v časopise: PLoS ONE 14(12)
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pone.0226007

Souhrn

Objectives

The aim of the study was to demonstrate the non-inferiority of a single intra-articular injection of 2.0% non-chemically modified sodium hyaluronate (SH) vs 0.8% hylan G-F 20 (control) in symptomatic knee osteoarthritis.

Design

This was a double-blind, randomized, controlled trial conducted in patients with painful tibiofemoral osteoarthritis (American College of Rheumatology criteria) with insufficient response or intolerance to first-line analgesics and regular non-steroidal anti-inflammatory drugs. Subjects received a single intra-articular injection of either SH or hylan G-F 20. The primary outcome was the 6-month change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index pain subscale (WOMAC A), with a pre-specified lower margin for non-inferiority of 8 mm.

Results

Of the 292 patients randomized (SH: 144), 288 received an injection (SH: 142), 266 completed the study (SH: 134). In the Per Protocol dataset (SH: 113, control: 112), the WOMAC A change at 6 months was -34.3 mm (95% confidence interval (CI): -37.8, -30.8) and -36.2 mm (95% CI: -40.3, -32.1) for the SH and hylan G-F 20 patients, respectively (P = 0.5). The intergroup difference was -1.9 mm (95% CI: -7.3, 3.5). Results were similar in the Full Analysis Set (SH: 139, control: 141) with a difference between the groups of -2.9 mm (95% CI: -7.9, 2.2).

A total of 31.3% of the injected patients reported a treatment-emergent adverse event, including injection site reactions (pain, inflammation or effusion) which occurred in 8.5% of the SH patients vs 13.0% of the hylan G-F 20 patients. No serious reactions were reported.

Conclusions

This clinical trial demonstrated the non-inferiority of a single intra-articular injection of SH vs hylan G-F 20 on the WOMAC A change from baseline at 6 months.

Klíčová slova:

Adverse events – Analgesics – Skeletal joints – Knee joints – Stiffness – Osteoarthritis – NSAIDs – Knees

Zdroje

1. Felson DT. An update on the pathogenesis and epidemiology of osteoarthritis. Radiol Clin North Am. 2004;42(1):1–9, v. doi: 10.1016/S0033-8389(03)00161-1 15049520

2. Litwic A, Edwards MH, Dennison EM, Cooper C. Epidemiology and burden of osteoarthritis. Br Med Bull. 2013;105:185–99. doi: 10.1093/bmb/lds038 23337796.

3. Johnson VL, Hunter DJ. The epidemiology of osteoarthritis. Best Pract Res Clin Rheumatol. 2014;28(1):5–15. doi: 10.1016/j.berh.2014.01.004 24792942.

4. Bijlsma JW, Berenbaum F, Lafeber FP. Osteoarthritis: an update with relevance for clinical practice. Lancet. 2011;377(9783):2115–26. doi: 10.1016/S0140-6736(11)60243-2 21684382.

5. Nuesch E, Dieppe P, Reichenbach S, Williams S, Iff S, Juni P. All cause and disease specific mortality in patients with knee or hip osteoarthritis: population based cohort study. BMJ. 2011;342:d1165. doi: 10.1136/bmj.d1165 21385807.

6. Wittenauer R, Smith L, Aden K. Update on 2004 Background Paper 6.12 Osteoarthritis written by Tanna S. In: Kaplan W, Laing R, editors. Priority Medicines for Europe and the World "A Public Health Approach to Innovation". Geneva, Switzerland: World Health Organization (WHO); 2013.

7. Murphy LB, Moss S, Do BT, Helmick CG, Schwartz TA, Barbour KE, et al. Annual incidence of knee symptoms and four knee osteoarthritis outcomes in the johnston county osteoarthritis project. Arthritis Care Res (Hoboken). 2016;68(1):55–65. doi: 10.1002/acr.22641 26097226.

8. Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, 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(12):1145–55. doi: 10.1136/ard.2003.011742 14644851.

9. Hochberg MC, Altman RD, Toupin April K, Benkhalti M, Guyatt G, McGowan J, et al. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012;64(4):465–74. doi: 10.1002/acr.21596 22563589.

10. McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014;22(3):363–88. doi: 10.1016/j.joca.2014.01.003 24462672

11. Bruyere O, Cooper C, Pelletier JP, Branco J, Brandi ML, Guillemin F, 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):253–63. doi: 10.1016/j.semarthrit.2014.05.014 24953861

12. Henrotin Y, Raman R, Richette P, Bard H, Jerosch J, Conrozier T, et al. Consensus statement on viscosupplementation with hyaluronic acid for the management of osteoarthritis. Semin Arthritis Rheum. 2015;45(2):140–9. doi: 10.1016/j.semarthrit.2015.04.011 26094903.

13. Maheu E, Rannou F, Reginster JY. Efficacy and safety of hyaluronic acid in the management of osteoarthritis: Evidence from real-life setting trials and surveys. Semin Arthritis Rheum. 2016;45(4 Suppl):S28–33. doi: 10.1016/j.semarthrit.2015.11.008 26806183.

14. Bannuru RR, Natov NS, Obadan IE, Price LL, Schmid CH, McAlindon TE. Therapeutic trajectory of hyaluronic acid versus corticosteroids in the treatment of knee osteoarthritis: A systematic review and meta-analysis. Arthritis Rheum. 2009;61(12):1704–11. doi: 10.1002/art.24925 19950318.

15. Bannuru RR, Natov NS, Dasi UR, Schmid CH, McAlindon TE. Therapeutic trajectory following intra-articular hyaluronic acid injection in knee osteoarthritis—meta-analysis. Osteoarthritis Cartilage. 2011;19(6):611–9. doi: 10.1016/j.joca.2010.09.014 21443958.

16. Rutjes AW, Jüni P, da Costa BR, Trelle S, Nüesch E, Reichenbach S. Viscosupplementation for osteoarthritis of the knee: A systematic review and meta-analysis. Ann Intern Med. 2012;157(3):180–91. doi: 10.7326/0003-4819-157-3-201208070-00473 22868835.

17. Colen S, van den Bekerom MP, Mulier M, Haverkamp D. Hyaluronic acid in the treatment of knee osteoarthritis: a systematic review and meta-analysis with emphasis on the efficacy of different products. Biodrugs. 2012;26(4):257–68. doi: 10.2165/11632580-000000000-00000 22734561.

18. Miller LE, Block JE. US-approved intra-articular hyaluronic acid injections are safe and effective in patients with knee osteoarthritis: systematic review and meta-analysis of randomized, saline-controlled trials. Clin Med Insights Arthritis Musculoskelet Disord. 2013;6:57–63. doi: 10.4137/CMAMD.S12743 24027421.

19. 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):593–9. doi: 10.1016/j.semarthrit.2013.10.002 24216297.

20. Bannuru RR, Schmid CH, Kent DM, Vaysbrot EE, Wong JB, McAlindon TE. Comparative effectiveness of pharmacologic interventions for knee osteoarthritis: A systematic review and network meta-analysis. Ann Intern Med. 2015;162(1):46–54. doi: 10.7326/M14-1231 25560713.

21. Campbell KA, Erickson BJ, Saltzman BM, Mascarenhas R, Bach BR Jr., Cole BJ, 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.e14. doi: 10.1016/j.arthro.2015.03.030 25998016.

22. Richette P, Chevalier X, Ea HK, Eymard F, Henrotin Y, Ornetti P, et al. Hyaluronan for knee osteoarthritis: An updated meta-analysis of trials with low risk of bias. RMD Open. 2015;1(1):e000071. doi: 10.1136/rmdopen-2015-000071 26509069.

23. Strand V, McIntyre LF, Beach WR, Miller LE, Block JE. Safety and efficacy of US-approved viscosupplements for knee osteoarthritis: a systematic review and meta-analysis of randomized, saline-controlled trials. J Pain Res. 2015;8:217–28. doi: 10.2147/JPR.S83076 26005358.

24. Jevsevar D, Donnelly P, Brown GA, Cummins DS. Viscosupplementation for osteoarthritis of the knee: A systematic review of the evidence. J Bone Joint Surg Am. 2015;97(24):2047–60. doi: 10.2106/JBJS.N.00743 26677239.

25. Johansen M, Bahrt H, Altman RD, Bartels EM, Juhl CB, Bliddal H, et al. Exploring reasons for the observed inconsistent trial reports on intra-articular injections with hyaluronic acid in the treatment of osteoarthritis: Meta-regression analyses of randomized trials. Semin Arthritis Rheum. 2016;46(1):34–48. doi: 10.1016/j.semarthrit.2016.02.010 27139169.

26. Trojian TH, Concoff AL, Joy SM, Hatzenbuehler JR, Saulsberry WJ, Coleman CI. AMSSM scientific statement concerning viscosupplementation injections for knee osteoarthritis: importance for individual patient outcomes. Clin J Sport Med. 2016;26(1):1–11. doi: 10.1097/JSM.0000000000000274 26562453.

27. He WW, Kuang MJ, Zhao J, Sun L, Lu B, Wang Y, et al. Efficacy and safety of intraarticular hyaluronic acid and corticosteroid for knee osteoarthritis: A meta-analysis. Int J Surg. 2017;39:95–103. doi: 10.1016/j.ijsu.2017.01.087 28137554.

28. Maheu E, Bannuru RR, Herrero-Beaumont G, Allali F, Bard H, Migliore A. Why we should definitely include intra-articular hyaluronic acid as a therapeutic option in the management of knee osteoarthritis: Results of an extensive critical literature review. Semin Arthritis Rheum. 2019;48(4):563–72. doi: 10.1016/j.semarthrit.2018.06.002 30072113.

29. Balazs EA, Denlinger JL. Viscosupplementation: a new concept in the treatment of osteoarthritis. J Rheumatol. 1993;39(Suppl 39):3–9. 8410881.

30. Aviad AD, Houpt JB. The molecular weight of therapeutic hyaluronan (sodium hyaluronate): how significant is it? J Rheumatol. 1994;21(2):297–301. 8182640.

31. Altman RD, Manjoo A, Fierlinger A, Niazi F, Nicholls M. The mechanism of action for hyaluronic acid treatment in the osteoarthritic knee: a systematic review. BMC Musculoskelet Disord. 2015;16:321. doi: 10.1186/s12891-015-0775-z 26503103.

32. Chevalier X, Jerosch J, Goupille P, van Dijk N, Luyten FP, Scott DL, et al. Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial. Ann Rheum Dis. 2010;69(1):113–9. doi: 10.1136/ard.2008.094623 19304567.

33. Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Arthritis Rheum. 1986;29(8):1039–49. doi: 10.1002/art.1780290816 3741515.

34. Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957;16(4):494–502. doi: 10.1136/ard.16.4.494 13498604.

35. Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15(12):1833–40. 3068365.

36. Lequesne M, Mery C, Samson M, Gérard P. Indexes of severity for osteoarthritis of the hip and knee. Validation—Value in comparison with other assessment tests. Scand J Rheumatol. 1987;65(Suppl):85–9. doi: 10.3109/03009748709102182 3479839.

37. Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, et al. OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage. 2004;12(5):389–99. doi: 10.1016/j.joca.2004.02.001 15094138.

38. Ehrich EW, Davies GM, Watson DJ, Bolognese JA, Seidenberg BC, Bellamy N. Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire and global assessments in patients with osteoarthritis. J Rheumatol. 2000;27(11):2635–41. 11093446.

39. Pavelka K, Uebelhart D. Efficacy evaluation of highly purified intra-articular hyaluronic acid (Sinovial) vs hylan G-F 20 (Synvisc) in the treatment of symptomatic knee osteoarthritis. A double-blind, controlled, randomized, parallel-group non-inferiority study. Osteoarthritis Cartilage. 2011;19(11):1294–300. doi: 10.1016/j.joca.2011.07.016 21875678.

40. Berenbaum F, Grifka J, Cazzaniga S, D'Amato M, Giacovelli G, Chevalier X, et al. A randomised, double-blind, controlled trial comparing two intra-articular hyaluronic acid preparations differing by their molecular weight in symptomatic knee osteoarthritis. Ann Rheum Dis. 2012;71(9):1454–60. doi: 10.1136/annrheumdis-2011-200972 22294639.

41. Olsen IC, Kvien TK, Uhlig T. Consequences of handling missing data for treatment response in osteoarthritis: a simulation study. Osteoarthritis Cartilage. 2012;20(8):822–8. doi: 10.1016/j.joca.2012.03.005 22441031

42. Raman R, Dutta A, Day N, Sharma HK, Shaw CJ, Johnson GV. 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(4):318–24. doi: 10.1016/j.knee.2008.02.012 18430574.

43. Xing D, Wang B, Liu Q, Ke Y, Xu Y, Li Z, et al. Intra-articular hyaluronic acid in treating knee osteoarthritis: a PRISMA-compliant systematic review of overlapping meta-analysis. Sci Rep. 2016;6(32790). doi: 10.1038/srep32790 27616273.

44. Maheu E, Zaim M, Appelboom T, Jeka S, Trc T, Berenbaum F, et al. Comparative efficacy and safety of two different molecular weight (MW) hyaluronans F60027 and Hylan G-F 20 in symptomatic osteoarthritis of the knee (KOA). Results of a non inferiority, prospective, randomized, controlled trial. Clin Exp Rheumatol. 2011;29(3):527–35. 21722501.

45. Dreiser RL, Avouac B, Bardin T. Efficacy of sodium hyaluronate versus hylan G-F 20 in the treatment of tibiofemoral osteoarthritis. Ann Rheum Dis. 2012;71(Suppl 3):584–5.

46. Bannuru RR, McAlindon TE, Sullivan MC, Wong JB, Kent DM, Schmid CH. Effectiveness and implications of alternative placebo treatments: A systematic review and network meta-analysis of osteoarthritis trials. Ann Intern Med. 2015;163(5):365–72. doi: 10.7326/M15-0623 26215539.

47. Desmarais MH. Value of intra-articular injections in osteo-arthritis. Ann Rheum Dis. 1952;11(4):277–81. doi: 10.1136/ard.11.4.277 13017478

48. Zhang W, Robertson J, Jones AC, Dieppe PA, Doherty M. The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trials. Ann Rheum Dis. 2008;67(12):1716–23. doi: 10.1136/ard.2008.092015 18541604.

49. Zhang W, Zou K, Doherty M. Placebos for knee osteoarthritis: Reaffirmation of "Needle is better than pill". Ann Intern Med. 2015;163(5):392–3. doi: 10.7326/M15-1580 26215902.

50. Wallace IJ, Worthington S, Felson DT, Jurmain RD, Wren KT, Maijanen H, et al. Knee osteoarthritis has doubled in prevalence since the mid-20th century. Proc Natl Acad Sci U S A. 2017;114(35):9332–6. doi: 10.1073/pnas.1703856114 28808025.

51. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89(4):780–5. doi: 10.2106/JBJS.F.00222 17403800.

52. Otten R, van Roermund PM, Picavet HS. [Trends in the number of knee and hip arthroplasties: considerably more knee and hip prostheses due to osteoarthritis in 2030]. Ned Tijdschr Geneeskd. 2010;154:A1534. Dutch. 20619009.

53. Mar J, Romero Jurado M, Arrospide A, Enrique Fidalgo A, Soler Lopez B. [Cost-analysis of viscosupplementation treatment with hyaluronic acid in candidate knee replacement patients with osteoarhritis]. Rev Esp Cir Ortop Traumatol. 2013;57(1):6–14. Spanish. doi: 10.1016/j.recot.2012.08.006 23594977.

54. Altman R, Lim S, Steen RG, Dasa V. Hyaluronic acid injections are associated with delay of total knee replacement surgery in patients with knee osteoarthritis: Evidence from a large U.S. health claims database. PLoS One. 2015;10(12):e0145776. doi: 10.1371/journal.pone.0145776 26694145

55. Altman R, Fredericson M, Bhattacharyya SK, Bisson B, Abbott T, Yadalam S, et al. Association between hyaluronic acid injections and time-to-total knee replacement surgery. J Knee Surg. 2015;29(7):564–70. doi: 10.1055/s-0035-1568992 26641076.

56. Delbarre A, Amor B, Bardoulat I, Tetafort A, Pelletier-Fleury N. Do intra-articular hyaluronic acid injections delay total knee replacement in patients with osteoarthritis—A Cox model analysis. PLoS One. 2017;12(11):e0187227. doi: 10.1371/journal.pone.0187227 29155833.

57. Shewale AR, Barnes CL, Fischbach LA, Ounpraseuth ST, Painter JT, Martin BC. Comparative effectiveness of intra-articular hyaluronic acid and corticosteroid injections on the time to surgical knee procedures. J Arthroplasty. 2017;32(12):3591–7 e1-24. doi: 10.1016/j.arth.2017.07.007 28781020.