Safety and Efficacy Findings from a Non-interventional Study of a New Hyaluronic Acid/Sorbitol Formulation (GO-ON^® Matrix) for Intra-articular Injection to Relieve Pain and Disability in Osteoarthritis Patients

Abstract

This non-interventional study was intended to examine the efficacy and tolerability of intra-articular injections with the GO-ON^® matrix, a new viscosupplement product made of non-animal sodium hyaluronate combined with the oxygen free radical scavenger sorbitol, when used in routine clinical practice. A total of 1 147 patients (43.5% male, 53,5% female, 3% missing) aged on average 63.3 years with osteoarthritis were enrolled in 398 centers and treated with the product. The most commonly treated joint was the knee (92.9%) with a Kellgren-Lawrence classification of Grade I (6.7%), Grade II (31.4%), Grade III (48.0%), and Grade IV (13.9%).

Most patients (58–66%, imputing for missing data) received 1 injection, 29–40% received 3 injections. Using a Likert scale to asses pain, the mean change in pain due to osteoarthritis was a reduction of 56.5% from baseline (2.61±0.80) to 6 months (1.07±0.86). At baseline, 56.2% of patients reported severe/very severe pain versus 5.9% after 6 months. Accordingly, 6.8% of patients reported no pain/mild pain at baseline vs. 67.1% after 6 months. At baseline, 28.9% reported no pain/mild pain vs. to 66.4% after 6 months. At baseline, 29.1% of patients reported severe/very severe functional impairment vs. 3.9% 6 months after the first injection. The 3 and 6 month results were comparable.

Adverse reactions were rare and confined to musculoskeletal and connective tissue disorders. No infections were reported in any treated joints. The results confirm that the GO-ON matrix^® treatment is effective and well tolerated in the treatment of symptoms due to osteoarthritis.

Key words

viscosupplementation - ROS scavenger - rapid onset

• References

• 1 Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clinics in geriatric medicine 2010; 26: 355-369 [Epub 2010/08/12]
• 2 Michael JW, Schluter-Brust KU, Eysel P. The epidemiology, etiology, diagnosis, and treatment of osteoarthritis of the knee. Deutsches Arzteblatt international 2010; 107: 152-162 [Epub 2010/03/23]
• 3 Sandmark H, Hogstedt C, Lewold S et al. Osteoarthrosis of the knee in men and women in association with overweight, smoking, and hormone therapy. Ann Rheum Dis 1999; 58: 151-155
• 4 Coggon D, Reading I, Croft P et al. Knee osteoarthritis and obesity. International Journal of Obesity 2001; 25: 622-627
• 5 Loeser RF. Aging and osteoarthritis. Current opinion in rheumatology 2011; 23: 492-496 [Epub 2011/06/29]
• 6 Sowers MR, Karvonen-Gutierrez CA. The evolving role of obesity in knee osteoarthritis. Current opinion in rheumatology 2010; 22: 533-537 [Epub 2010/05/21]
• 7 Balazs EA, Watson D, Duff IF et al. Hyaluronic acid in synovial fluid. I. Molecular parameters of hyaluronic acid in normal and arthritic human fluids. Arthritis & Rheumatism 1967; 10: 357-376
• 8 Balazs EA, Denlinger JL. Sodium hyaluronate and joint function. J Equine Vet Sci 1985; 5: 217-228
• 9 Balazs EA, Denlinger JL. Viscosupplementation: a new concept in the treatment of osteoarthritis. The Journal of rheumatology Supplement 1993; 39: 3-9 [Epub 1993/08/01]
• 10 Myint P, Deeble DJ, Beaumont PC et al. The reactivity of various free radicals with hyaluronic acid: steady-state and pulse radiolysis studies. Biochimica et biophysica acta 1987; 925: 194-202 [Epub 1987/08/13]
• 11 Bellamy N, Campbell J, Robinson V et al. Viscosupplementation for the treatment of osteoarthritis of the knee. Cochrane database of systematic reviews 2006; CD005321. [Epub 2006/04/21]
• 12 Migliore A, Granata M. Intra-articular use of hyaluronic acid in the treatment of osteoarthritis. Clinical interventions in aging 2008; 3: 365-369 [Epub 2008/08/09]
• 13 Conrozier T, Mason C, Vignon E et al. Early efficacy of a novel viscosupplement conbining hyaluronic acid and sorbitol, ANTI-OX-VS (Synolis) in patients with knee osteoarthritis ECCEO11. Valencia 2011
• 14 Balazs EA, Darzynkiewicz Z. The effect of hyaluronic acid on fibroblasts, mononuclear phagocytes and lymphocytes. In: Kulonen Pikkarainen J. (ed.). The Biology of the Fibroblast. London, New York: Academic Press; 1973: 237-252
• 15 Forrester JV, Wilkinson PC. Inhibition of leucocyte locomotion by hayluronic acid. J Cell Set 1981; 48: 315-331
• 16 Heisel J, Kipshoven C. Hyaluronsäure mit Sorbitol – Wirksamkeit und Verträglichkeit einer intraartikulären Behandlung der Gonarthrose. Deutscher Ärzteverlag|OUP 2012; 1: 261-266
• 17 Kellgren JH, Lawrence JS. Radiological assessment of osteoarthrosis. Annals of the Rheumatic Diseases 1957; 16: 494-502
• 18 Bannuru RR, Natov NS, Dasi UR et al. Therapeutic trajectory following intra-articular hyaluronic acid injection in knee osteoarthritis – meta-analysis. Osteoarthritis and cartilage/OARS, Osteoarthritis Research Society 2011; 19: 611-619 [Epub 2011/03/30]