References

  1. Tang T, Muneta T, Ju YJ, et al. Serum keratin sulfate transiently increases in the early stage of osteoarthritis during strenuous running of rats; protective effect of intraarticular hyaluronan injection. Arthritis Res Ther. 2008;10(1):R13. doi:10.1186/ar2363
  2. Takahashi K, Hashimoto S, Kubo T, Hirasawa Y, Lotz M, Amiel D. Effect of hyaluronan on chondrocyte apoptosis and nitric oxide production in experimentally induced osteoarthritis. J Rheumatol. 2000;27(7):1713-20.
  3. Fukuda K, Dan H, Takayama M, Kumano F, Saitoh M, Tanaka S. Hyaluronic acid increases proteoglycan synthesis in bovine articular cartilage in the presence of interleukin-1. J Pharm Exp Ther. 1996;277(3):1672-5.
  4. Asari A, Miyauchi S, Matsuzaka S, Ito T, Kominami E, Uchiyama Y. Molecular weight-dependent effects of hyaluronate on the arthritic synovium. Arch Histol Cytol. 1998;61(2):125-35. doi:10.1679/aohc.61.125
  5. Mitsui Y, Gotoh M, Nakama K, Yamada T, Higuchi F, Nagata K. Hyaluronic acid inhibits mRNA expression of proinflammatory cytokines and cyclooxygenase-2/prostaglandin E2 production via CD44 in interleukin-1-stimulated subacromial synovial fibroblasts from patients with rotator cuff disease. J Orthop Res. 2008;26(7):1032-7. doi:10.1002/jor.20558
  6. Wang CT, Lin YT, Chiang BL, Lin YH, Hou SM. High molecular weight hyaluronic acid down-regulates the gene expression of osteoarthritis-associated cytokines and enzymes in fibroblast-like synoviocytes from patients with early osteoarthritis. Osteoarthritis Cartilage. 2006;14(12):1237-47. doi:10.1016/j.joca.2006.05.009
  7. Julovi SM, Yasuda T, Shimizu M, Hiramitsu T, Nakamura T. Inhibition of interleukin-1ß-stimulated production of matrix metalloproteinases by hyaluronan via CD44 in human articular cartilage. Arthritis Rheum. 2004;50(2):516-25. doi:10.1002/art.20004
  8. Waddell DD, Kolomytkin OV, Dunn S, Marino AA. Hyaluronan suppresses IL-1ß-induced metalloproteinase activity from synovial tissue. Clin Orthop Relat Res. 2007;465:241-8. doi:10.1097/BLO.0b013e31815873f9
  9. 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(11):1294-300. doi:10.1016/j.joca.2011.07.016
  10. Ågerup B, Berg P, Åkermark C. Non-animal stabilized hyaluronic acid: a new formulation for the treatment of osteoarthritis. BioDrugs. 2005;19(1):23-30. doi:10.2165/00063030-200519010-00003
  11. Leighton R, Åkermark C, Therrien R, et al. NASHA hyaluronic acid vs. methylprednisolone for knee osteoarthritis: a prospective, multi-center, randomized, non-inferiority trial. Osteoarthritis Cartilage. 2014;22(1):17-25. doi:10.1016/j.joca.2013.10.009
  12. 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
  13. DUROLANE [package insert]. Durham, NC: Bioventus LLC; 2019.
  14. GELSYN-3 [package insert]. Durham, NC: Bioventus LLC; 2017.
  15. Balazs EA, Denlinger JL. Viscosupplementation:a new concept in the treatment of osteoarthritis. J Rheumatol Suppl. 1993;39:3-9.
  16. SUPARTZ FX [package insert]. Durham, NC: Bioventus LLC; 2015
  17. Centers for Medicare & Medicaid Services. 2021 ASP Drug Pricing Files. Last updated December 10, 2021. cms.gov/medicare/medicare-part-b-drug-average-sales-price/2021-asp-drug-pricing-files
  18. Sutter Health. Help for arthritic knees. Accessed August 13, 2021. www.sutterhealth.org/services/orthopedic/non-surgical-treatment-knee-osteoarthritis
  19. 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
  20. Krocker D, Matziolis G, Tuischer J, et al. Reduction of arthrosis associated knee pain through a single intra-articular injection of synthetic hyaluronic acid. Z Rheumatol. 2006;65(4):327-31. doi:10.1007/s00393-006-0063-2
  21. WebMD. What are NSAIDs for arthritis? Accessed August 14, 2021. Last updated December 4, 2020. www.webmd.com/arthritis/anti-inflammatory-drugs
  22. Sun SF, Hsu CW, Hwang CW, et al. Hyaluronate improves pain, physical function and balance in the geriatric osteoarthritic knee: a 6-month follow-up study using clinical tests. Osteoarthritis Cartilage. 2006;14(7):696-701. doi.org/10.1016/j.joca.2006.01.010 *NOTE: SUPARTZ FX is referred to as Artzal in this publication.
  23. Arthritis Foundation. Arthritis by the numbers. Accessed August 14, 2021. Posted March 2019. www.arthritis.org/getmedia/e1256607-fa87-4593-aa8a-8db4f291072a/2019-abtn-final-march-2019.pdf
  24. Zhang H, Zhang K, Zhang X, et al. Comparison of two hyaluronic acid formulations for safety and efficacy (CHASE) study in knee osteoarthritis: a multicenter, randomized, double-blind, 26-week non-inferiority trial comparing Durolane to Artz. Arthritis Res Ther. 2015;17(1):51. doi:10.1186/s13075-015-0557-x
  25. McGrath AF, McGrath AM, Jessop ZM, et al. A comparison of intra-articular hyaluronic acid competitors in the treatment of mild to moderate knee osteoarthritis. J Arthritis. 2013:2(1);1000108. doi:10.4172/2167-7921.1000108
  26. Arthritis Foundation. Osteoarthritis. Accessed September 3, 2021. www.arthritis.org/diseases/osteoarthritis
  27. Orthoinfo. Arthritis of the Knee. American Academy of Orthopaedic Surgeons. Arthritis of the knee. Last updated February 2021. https://orthoinfo.aaos.org/en/diseases–conditions/arthritis-of-the-knee/
  28. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Osteoarthritis. Last updated October 2019. niams.nih.gov/health-topics/osteoarthritis
  29. Cleveland Clinic. Osteoarthritis. Last updated November 26, 2019. https://my.clevelandclinic.org/health/diseases/5599-osteoarthritis
  30. Messier SP, Resnik AE, Beavers DP, et al. Intentional weight loss in overweight and obese patients with knee osteoarthritis:is more better? Arthritis Care Res (Hoboken). 2018;70(11):1569-75. doi:10.1002/acr.23608
  31. McAlindon TE, LaValley MP, Harvey WF, et al. Effect of intra-articular triamcinolone vs saline on knee cartilage volume and pain in patients with knee osteoarthritis:a randomized clinical trial. JAMA. 2017;317(19):1967-75. doi:10.1001/jama.2017.5283
  32. Edsman K, Hjelm R, Lärkner H, et al. Intra-articular duration of Durolane™ after single injection into the rabbit knee. Cartilage. 2011;2(4):384-8. doi:10.1177/1947603511400184
  33. Larsen NE, Dursema HD, Pollak CT, Skrabut EM. Clearance kinetics of a hylan-based viscosupplement after intra-articular and intravenous administration in animal models. J Biomed Mater Res B Appl Biomater. 2012;100(2):457-62. doi:10.1002/jbm.b.31971
  34. Sakamoto T. Biological fate of sodium hyaluronate (SPH). (1) Studies on distribution, metabolism and excretion of 14C-SPH in rabbits after intraarticular administration.
  35. Lindqvist U, Tolmachev V, Kairemo K, Åström G, Jonsson E, Lundqvist H. Elimination of stabilised hyaluronan from the knee joint in healthy men. Clin Pharmacokinet. 2002;41(8):603-13. doi:10.2165/00003088-200241080-00004
  36. IBSA Institut Biochimique SA. Technologies. Accessed September 2021. www.ibsagroup.com/ibsa-group/technologies.html
  37. Bioventus LLC. Based on Seikagaku Corporation Annual Report 2017. Regulatory file 12000.29. Data on file, RPT-000309.
  38. Strand V, Conaghan PG, Lohmander LS, et al. An integrated analysis of five double-blind, randomized controlled trials evaluating the safety and efficacy of a hyaluronan product for intra-articular injection in osteoarthritis of the knee. Osteoarthritis Cartilage. 2006;14(9):859-66. doi:1016/j.joca.2006.02.012
  39. Day R, Brooks P, Conaghan PG, Petersen M, Multicenter Trial Group. A double blind, randomized, multicenter, parallel group study of the effectiveness and tolerance of intraarticular hyaluronan in osteoarthritis of the knee. J Rheumatol. 2004;31(4):775-82.
  40. HTL Biotechnology. Biopolymer solutions: hyaluronic acid. Accessed November 2021. https://htlbiotech.com/biopolymer-solutions/hyaluronic-acid/
  41. Bioventus LLC. SUPARTZ FX file of prospective clinical studies. Regulatory file 29000.142. Data on file, RPT-000310.
  42. Ohshima Y, Yokota S, Kasama K, Ono H. Comparative studies on levels of proteins, bacterial endotoxins and nucleic acids in hyaluronan preparations used to treat ostheoarthritis of the knee. Could residual proteins and bacterial endotoxins relate to complications? Jpn Pharmacol Ther. 2004;32(10):655-62.
  43. Bioventus LLC. Q-Med Molecular Weight of DUROLANE, MA-10789. Data on file, RPT-001314. June 2021.
  44. Bioventus LLC. DUROLANE Most Preferred Medical Benefit Lives. Data on file, RPT-001486.
  45. Bioventus LLC. Sinovial sales data. Data on file, RPT-000529.
  46. Nicholls M, Manjoo A, Shaw P, Niazi F, Rosen J. Rheological properties of commercially available hyaluronic acid products in the United States for the treatment of osteoarthritis knee pain. Clin Med Insights Arthritis Musculoskelet Disord. 2018;11:1179544117751622. doi:10.1177/1179544117751622
  47. Bioventus LLC. Data on file, RPT-001428.
  48. Edsman K, Melin H, Nasstrom J. A study of the ability of Durolane™ to withstand degradation by free radicals while maintaining its viscoelastic properties. Poster presented at: 55th Annual Meeting of the Orthopaedic Research Society; February 22-25, 2009; Las Vegas, NV. Poster 1149
  49. Bioventus LLC. DUROLANE Medicare Lives. Data on file, RPT-001806.
  50. Jurado RM, Fidalgo AE, Villar VR, Medina JM, López BS. Factors related with the time to surgery in waiting-list patients for knee prostheses. Reumatol Clin. 2013;9(3):148-155. doi:10.1016/j.reuma.2012.09.003