The efficacy and safety of glycosaminoglycan-peptide complex in patients with knee osteoarthritis and comorbidity: a multicenter prospective study

Objective: to evaluate the efficacy and safety of glycosaminoglycan-peptide complex (GPC, Rumalon) used in patients with knee osteoarthritis (OA) and comorbidities (hypertension and/or type 2 diabetes mellitus (T2DM).

Patients and methods: A 10-month multicenter (13 centers from 10 subjects of the Russian Federation) prospective study included 179 patients with Stages II–III primary tibiofemoral knee OA and comorbidity, a walking pain intensity of ≥40 mm on a visual analogue scale (VAS), and a need for nonsteroidal anti-inflammatory drugs (for at least 30 days in the previous 3 months). The efficiency of treatment was evaluated from the changes in VAS scores for knee pain intensity during walking, the overall WOMAC score and scores of its individual indicators, laboratory parameters, and ultrasound data. All the patients received 2 cycles of GPC treatment with 25 injections, by following the manufacturer's instructions.

Results and discussion. Even at 2 months after starting the treatment, there was a statistically significant reduction in pain during walking from 60 (50–69) to 40 (27–53.5) mm on the VAS (p< 0.05), which persisted during the follow-up period. A similar pattern was found when assessing the WOMAC index and its components. The drug demonstrated an anti-inflammatory effect: a decrease in the number of patients with synovitis from 55.7 to 39.2% (p=0.02), the level of high-sensitivity C-reactive protein (hsCRP) from 3.2 (1.3–6.2) to 2.6 (1.2–5.7) mg/l (p< 0.05). GPC was ascertained to have a safety profile.

Conclusion. The data of this study confirm the good therapeutic effect and safety of GPC Rumalon in knee OA patients with hypertension and/or T2DM. The drug is shown to have a rapid analgesic and anti-inflammatory effect, as well as a positive influence on all clinical manifestations of OA.

1. Strauss WL Jr, Cave AJE. Pathology and the posture of Neanderthal man. Q Rev Biol. 1957 Dec;32(4):348-63. doi: 10.1086/401979.

2. Heberden W. Commentaries on the History and Cure of Diseases. London: T. Payne; 1802.

3. Sandifort E. Museum Anatomicum Academiae Lugduno-Batavae. Vol. 2. Leiden: University of Leiden; 1793. Table LXIV.

4. Haygarth J. A clinical history of the nodosity of the joints. London: Gadell and Davies; 1805.

5. Brodie BC. Pathological and Surgical Observations on the Diseases of the Joints. 2nd ed. London: Longman, Hurst, Rees, Orne and Brown; 1822.

6. Garrod AE. A Treatise of Rheumatism and Rheumatoid Arthritis. London: Griffin; 1890.

7. Willy C, Schneider P, Engelhardt M, et al. Richard von Volkmann: surgeon and Renaissance man. Clin Orthop Relat Res. 2008 Feb;466(2):500-6. doi: 10.1007/s11999-007-0007-4. Epub 2008 Jan 10.

8. Forsbrook WH. A Dissertation on Osteoarthritis. London: H.K. Lewis; 1893.

9. Alekseeva LI, Taskina EA, Kashevarova NG. Osteoarthritis: epidemiology, classification, risk factors, and progression, clinical presentation, diagnosis, and treatment. Sovremennaya revmatologiya = Modern Rheumatology Journal. 2019;13(2):9-21. (In Russ.). doi: 10.14412/1996-7012-2019-2-9-21

10. Lila AM, Alekseeva LI, Taskina EA. Modern approaches to the treatment of osteoarthritis based on the updated international recommendations. Meditsinskoe obozrenie. 2019; 3(11-2):48-52. (In Russ.).

11. Veronese N, Cereda E, Maggi S, et al. Osteoarthritis and mortality: A prospective cohort study and systematic review with meta-analysis. Semin Arthritis Rheum. 2016 Oct;46(2):160-7. doi: 10.1016/j.semarthrit.2016.04.002.

12. Kovari E, Kaposi A, Bekes G, et al. Comorbidity clusters in generalized osteoarthritis among female patients: A crosssectional study. Semin Arthritis Rheum. 2019 Sep 9. pii: S0049-0172(19)30233-1. doi: 10.1016/j.semarthrit.2019.09.001.

13. Adler E, Wolf E, Taustein I. A double blind trial with cartilage and bone marrow extract in degenerative gonarthrosis. Acta Rheumatol Scand. 1970;16(1):6-11.

14. Katona G. A clinical trial of glycosaminoglycan-peptide complex (Rumalon) in patients with osteoarthritis of the knee. Curr Med Res Opin. 1987;10(9):625-33. doi: 10.1185/03007998709112416.

15. Gramajo RJ, Cutroneo EJ, Fernandez DE, et al. A single-blind, placebo-controlled study of glycosaminoglycan-peptide complex (Rumalon) in patients with osteoarthritis of the hip or knee. Curr Med Res Opin. 1989; 11(6): 366-73. doi: 10.1185/03007998909110137.

16. Alekseeva LI, Karyakin AN, Smirnov AV, Benevolenskaya LI. Use of Rumalon in gonarthrosis. Terapevticheskii arkhiv. 1997;(5):64-6. (In Russ.).

17. Naumov AV, Tkacheva ON, Kotovskaya YuV, Khovasova NO. Efficacy and safety of the glycosaminoglycanopeptide complex in the treatment of exacerbations of chronic pain in knee osteoarthritis in comorbid patients (results of DARTS observation program). Lechashchii vrach. 2018;(7):2-7. (In Russ.).

18. Karateev AE, Alekseeva LI, Lila AM, et al. Evaluation of the efficacy and safety of a glycosaminoglycan-peptide complex in the treatment of knee osteoarthritis in patients with previous inefficiency of slow-release oral anti-inflammatory drugs (the multicenter open-label study PRIMULA: use of Rumalon® with initially small success in the treatment of osteoarthritis). Nauchno-prakticheskaya revmatologiya. 2018;56(1):22-7. (In Russ.).

19. Alekseeva LI, Karateev AE, Pogozheva EYu, et al. Evaluation of the efficacy and safety of injectable glycosaminoglycan-peptide complex (GPC) in patients with osteoarthritis: a multicenter observational study GLADIOLUS (GPC in the treatment of osteoarthritis: a follow-up study of pain relief and local symptom reduction). Sovremennaya revmatologiya = Modern Rheumatology Journal. 2020;14(2): 76–83. (In Russ.) doi: 10.14412/1996-7012-2020-2-76-83.

20. Schacht E, Roetz R. Answer: Nephrotic syndrome after injections of bovine cartilage and marrow extract. Lancet. 1989 Apr 29; 1(8644):963. doi: 10.1016/s0140-6736(89)92547-6.