A Review of the Clinical Effectiveness and Safety of Hybrid Cooperative Complexes in Intra-articular Viscosupplementation.

Hyaluronic acid Hybrid cooperative complexes Intra-articular Osteoarthritis Sodium chondroitin Viscosupplementation

Journal

Rheumatology and therapy
ISSN: 2198-6576
Titre abrégé: Rheumatol Ther
Pays: England
ID NLM: 101674543

Informations de publication

Date de publication:
Aug 2022
Historique:
received: 09 02 2022
accepted: 07 04 2022
pubmed: 3 5 2022
medline: 3 5 2022
entrez: 2 5 2022
Statut: ppublish

Résumé

Viscosupplementation by intra-articular (i.a.) injection of the non-sulfated glycosaminoglycan (GAG) hyaluronic acid (HA) is a conservative therapy widely accepted in clinical practice for the management of osteoarthritis (OA) and joint diseases. The aim of viscosupplementation is to restore the rheological properties of the synovial fluid to relieve joint inflammation and pain and improve joint function through a chondroprotective effect. However, there is a range of hyaluronic acid products for OA that differ in preparation, molecular weight, rheological characteristics and concentration, and different i.a. formulations are more suited to particular patient populations and clinical situations, in part because of anatomical differences between joints. This paper focuses on innovative hybrid cooperative complexes of high and low molecular weight hyaluronic acid (HA-HL) and hyaluronic acid plus sodium chondroitin (HA-SC) that have been developed. Both products are formulated with pharmaceutical-grade, highly purified hyaluronic acid obtained with a multi-step biofermentation process, with properties that make them suitable across a range of degenerative joint diseases. They represent progress in building on the symptomatic and functional benefits of viscosupplementation in joint disease, with the additional beneficial effect of treating the patient with a high concentration of GAGs by a low number of injections. Here, we review the clinical evidence for the efficacy of a hybrid cooperative compound of HA-HL in various degenerative joint diseases, which suggests a synergistic effect of the different molecular weight hyaluronans that together more closely mimic the physiological composition of synovial fluid. Similarly, the evidence shows that HA-SC is safe, effective, and well tolerated in hip OA, with rapid and clinically significant improvements in pain symptoms and functionality. Such innovations in viscosupplementation expand the usefulness of the modality in the management of OA and other joint diseases, complemented by a lack of systemic or local side effects that allow the concurrent use of other drugs if needed.

Identifiants

pubmed: 35501596
doi: 10.1007/s40744-022-00450-z
pii: 10.1007/s40744-022-00450-z
pmc: PMC9314521
doi:

Types de publication

Journal Article Review

Langues

eng

Pagination

957-974

Informations de copyright

© 2022. The Author(s).

Références

GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159):1789–858.
doi: 10.1016/S0140-6736(18)32279-7
GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2019;396(10258):1204–22.
Hunter DJ, Schofield D, Callander E. The individual and socioeconomic impact of osteoarthritis. Nat Rev Rheumatol. 2014;10(7):437–41.
pubmed: 24662640 doi: 10.1038/nrrheum.2014.44
Gupta S, Hawker GA, Laporte A, Croxford R, Coyte PC. The economic burden of disabling hip and knee osteoarthritis (OA) from the perspective of individuals living with this condition. Rheumatology (Oxford). 2005;44(12):1531–7.
doi: 10.1093/rheumatology/kei049
Salaffi F, Carotti M, Stancati A, Grassi W. Health-related quality of life in older adults with symptomatic hip and knee osteoarthritis: a comparison with matched healthy controls. Aging Clin Exp Res. 2005;17(4):255–63.
pubmed: 16285189 doi: 10.1007/BF03324607
Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019;393(10182):1745–59.
pubmed: 31034380 doi: 10.1016/S0140-6736(19)30417-9
Abramoff B, Caldera FE. Osteoarthritis: pathology, diagnosis, and treatment options. Med Clin North Am. 2020;104(2):293–311.
pubmed: 32035570 doi: 10.1016/j.mcna.2019.10.007
Bannuru RR, Osani MC, Vaysbrot EE, et al. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthr Cartil. 2019;27(11):1578–89.
doi: 10.1016/j.joca.2019.06.011
Mobasheri A, Saarakkala S, Finnila M, et al. Recent advances in understanding the phenotypes of osteoarthritis. RF1000Res. 2019;8:11.
doi: 10.12688/f1000research.15869.1
Migliore A, Paoletta M, Moretti A, Liguori S, Iolascon G. The perspectives of intra-articular therapy in the management of osteoarthritis. Expert Opin Drug Deliv. 2020;17(9):1213–26.
pubmed: 32543240 doi: 10.1080/17425247.2020.1783234
Bruyere O, Honvo G, Veronese N, et al. An updated algorithm recommendation for the management of knee osteoarthritis from the European society for clinical and economic aspects of osteoporosis, osteoarthritis and musculoskeletal diseases (ESCEO). Semin Arthritis Rheum. 2019;49(3):337–50.
pubmed: 31126594 doi: 10.1016/j.semarthrit.2019.04.008
Iannitti T, Lodi D, Palmieri B. Intra-articular injections for the treatment of osteoarthritis: focus on the clinical use of hyaluronic acid. Drugs R D. 2011;11(1):13–27.
pubmed: 21142290 doi: 10.2165/11539760-000000000-00000
Beaudart C, Lengele L, Leclercq V, et al. Symptomatic efficacy of pharmacological treatments for knee osteoarthritis: a systematic review and a network meta-analysis with a 6-month time horizon. Drugs. 2020;80(18):1947–59.
pubmed: 33074440 pmcid: 7716887 doi: 10.1007/s40265-020-01423-8
Abate M, Pulcini D, Di Iorio A, Schiavone C. Viscosupplementation with intra-articular hyaluronic acid for treatment of osteoarthritis in the elderly. Curr Pharm Des. 2010;16(6):631–40.
pubmed: 20388073 doi: 10.2174/138161210790883859
Migliore A, Procopio S. Effectiveness and utility of hyaluronic acid in osteoarthritis. Clin Cases Miner Bone Metab. 2015;12(1):31–3.
pubmed: 26136793 pmcid: 4469223
Gigante A, Callegari L. The role of intra-articular hyaluronan (Sinovial) in the treatment of osteoarthritis. Rheumatol Int. 2011;31(4):427–44.
pubmed: 21113807 doi: 10.1007/s00296-010-1660-6
Maheu E, Bannuru RR, Herrero-Beaumont G, et al. 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.
pubmed: 30072113 doi: 10.1016/j.semarthrit.2018.06.002
Henrotin Y, Raman R, Richette P, et al. Consensus statement on viscosupplementation with hyaluronic acid for the management of osteoarthritis. Semin Arthritis Rheum. 2015;45(2):140–9.
pubmed: 26094903 doi: 10.1016/j.semarthrit.2015.04.011
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.
pubmed: 26694145 pmcid: 4687851 doi: 10.1371/journal.pone.0145776
Cooper C, Rannou F, Richette P, et al. Use of intraarticular hyaluronic acid in the management of knee osteoarthritis in clinical practice. Arthritis Care Res (Hoboken). 2017;69(9):1287–96.
doi: 10.1002/acr.23204
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.
pubmed: 26806183 doi: 10.1016/j.semarthrit.2015.11.008
Frizziero A, Vittadini F, Oliva F, et al. Hyaluronic acid injections in musculoskeletal disorders guidelines. Muscles Ligaments and Tendons Journal. 2018;8(3):364–98.
doi: 10.32098/mltj.03.2018.04
Conrozier T, Raman R, Chevalier X, et al. Viscosupplementation for the treatment of osteoarthritis. The contribution of EUROVISCO group. Ther Adv Musculoskelet Dis. 2021. https://doi.org/10.1177/1759720x211018605 .
doi: 10.1177/1759720x211018605 pubmed: 34104232 pmcid: 8165874
Henrotin Y, Chevalier X, Raman R, et al. EUROVISCO Guidelines for the design and conduct of clinical trials assessing the disease-modifying effect of knee viscosupplementation. Cartilage. 2020;11(1):60–70.
pubmed: 29972025 doi: 10.1177/1947603518783521
Committee for Medicinal Products for Human Use (CHMP). Guideline on clinical investigation of medicinal products used in the treatment of osteoarthritis (CPMP/EWP/784/97 Rev 1). London, UK: European Medicines Agency; 2010.
McAlindon TE, Driban JB, Henrotin Y, et al. OARSI clinical trials recommendations: design, conduct, and reporting of clinical trials for knee osteoarthritis. Osteoarthr Cartil. 2015;23(5):747–60.
doi: 10.1016/j.joca.2015.03.005
Reginster JY, Reiter-Niesert S, Bruyere O, et al. Recommendations for an update of the 2010 European regulatory guideline on clinical investigation of medicinal products used in the treatment of osteoarthritis and reflections about related clinically relevant outcomes: expert consensus statement. Osteoarthr Cartil. 2015;23(12):2086–93.
doi: 10.1016/j.joca.2015.07.001
Abate M, Andia I, Salini V. The conservative management of osteoarthritis—hyaluronic acid, platelet-rich plasma or the combination? In: Chian Q, editor. Osteoarthritis: progress in basic research and treatment. London: IntechOpen; 2015. p. 225–48.
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.
pubmed: 26503103 pmcid: 4621876 doi: 10.1186/s12891-015-0775-z
Abate M, Salini V. Efficacy and safety study on a new compound associating low and high molecular weight hyaluronic acid in the treatment of hip osteoarthritis. Int J Immunopathol Pharmacol. 2017;30(1):89–93.
pubmed: 28134596 pmcid: 5806785 doi: 10.1177/0394632016689275
Conrozier T, Monfort J, Chevalier X, et al. EUROVISCO recommendations for optimizing the clinical results of viscosupplementation in osteoarthritis. Cartilage. 2020;11(1):47–59.
pubmed: 29926748 doi: 10.1177/1947603518783455
Bannuru RR, Natov NS, Dasi UR, Schmid CH, McAlindon TE. Therapeutic trajectory following intra-articular hyaluronic acid injection in knee osteoarthritis–meta-analysis. Osteoarthr Cartil. 2011;19(6):611–9.
doi: 10.1016/j.joca.2010.09.014
Altman R, Fredericson M, Bhattacharyya SK, et al. Association between hyaluronic acid injections and time-to-total knee replacement surgery. J Knee Surg. 2016;29(7):564–70.
pubmed: 26641076 doi: 10.1055/s-0035-1568992
Dougados M. Sodium hyaluronate therapy in osteoarthritis: arguments for a potential beneficial structural effect. Semin Arthritis Rheum. 2000;30(2 Suppl 1):19–25.
pubmed: 11071578 doi: 10.1053/sarh.2000.0246
Migliore A, Gigliucci G, Alekseeva L, et al. Systematic literature review and expert opinion for the use of viscosupplementation with hyaluronic acid in different localizations of osteoarthritis. Orthop Res Rev. 2021;13:255–73.
pubmed: 34880685 pmcid: 8648269
Conrozier T, Monet M, Lohse A, Raman R. Getting better or getting well? The patient acceptable symptom state (PASS) better predicts patient’s satisfaction than the decrease of pain, in knee osteoarthritis subjects treated with viscosupplementation. Cartilage. 2018;9(4):370–7.
pubmed: 28800711 doi: 10.1177/1947603517723072
Stellavato A, Corsuto L, D’Agostino A, et al. Hyaluronan hybrid cooperative complexes as a novel frontier for cellular bioprocesses re-activation. PLoS ONE. 2016;11(10):e0163510.
pubmed: 27723763 pmcid: 5056743 doi: 10.1371/journal.pone.0163510
D’Agostino A, Stellavato A, Busico T, et al. In vitro analysis of the effects on wound healing of high- and low-molecular weight chains of hyaluronan and their hybrid H-HA/L-HA complexes. BMC Cell Biol. 2015;16:19.
pubmed: 26163378 pmcid: 4499215 doi: 10.1186/s12860-015-0064-6
De Rosa M, D’Agostino A, La Gatta A, Schiraldi C, Inventors; World intellectual property organization, issuing organization; assignee, Altergon S.A., Lugano. hybrid cooperative complexes of hyaluronic acid. Worldwide patent WO 2012/032151. 15 Mar 2012.
De Rosa M, D’Agostino A, La Gatta A, Schiraldi C, Inventors; U. S. Patent Office, issuing organization; Assignee, Altergon S.A., Lugano. Patent US 10,266,611 Hybrid Cooperative Complexes of Hyaluronic Acid. 23 Apr 2019.
Russo F, D’Este M, Vadala G, et al. Platelet rich plasma and hyaluronic acid blend for the treatment of osteoarthritis: rheological and biological evaluation. PLoS ONE. 2016;11(6):e0157048.
pubmed: 27310019 pmcid: 4911091 doi: 10.1371/journal.pone.0157048
Tenti S, Pascarelli NA, Giannotti S, et al. Can hybrid hyaluronic acid represent a valid approach to treat rizoarthrosis? A retrospective comparative study. BMC Musculoskelet Disord. 2017;18(1):444.
pubmed: 29132341 pmcid: 5684762 doi: 10.1186/s12891-017-1809-5
Gallorini M, Berardi AC, Berardocco M, et al. Hyaluronic acid increases tendon derived cell viability and proliferation in vitro: comparative study of two different hyaluronic acid preparations by molecular weight. Muscles Ligaments Tendons J. 2017;7(2):208–14.
pubmed: 29264330 pmcid: 5725168 doi: 10.32098/mltj.02.2017.02
Szczęsny G, Tomaszewski W, Domżalski M. Evolution of the hyaluronic acid in viscosupplementation—from linear particles to hybrid complexes [Polish]. Ortop Traumatol Rehabil. 2021;23(3):229–38.
pubmed: 34190048 doi: 10.5604/01.3001.0014.9625
Prydz K, Dalen KT. Synthesis and sorting of proteoglycans. J Cell Sci. 2000;113(Pt 2):193–205.
pubmed: 10633071 doi: 10.1242/jcs.113.2.193
Schiraldi C, Cimini D, De Rosa M. Production of chondroitin sulfate and chondroitin. Appl Microbiol Biotechnol. 2010;87(4):1209–20.
pubmed: 20521042 doi: 10.1007/s00253-010-2677-1
De Rosa M, Schiraldi C, Cimini D (2010) Biotechnological production of chondroitin. European Patent Specification, WO 2010/136435.
Cimini D, Restaino OF, Schiraldi C. Microbial production and metabolic engineering of chondroitin and chondroitin sulfate. Emerg Top Life Sci. 2018;2(3):349–61.
pubmed: 33525790 doi: 10.1042/ETLS20180006
Stellavato A, Tirino V, de Novellis F, et al. Biotechnological chondroitin a novel glycosamminoglycan with remarkable biological function on human primary chondrocytes. J Cell Biochem. 2016;117(9):2158–69.
pubmed: 27018169 pmcid: 5084766 doi: 10.1002/jcb.25556
Vassallo V, Stellavato A, Cimini D, et al. Unsulfated biotechnological chondroitin by itself as well as in combination with high molecular weight hyaluronan improves the inflammation profile in osteoarthritis in vitro model. J Cell Biochem. 2021;122:1021–36. https://doi.org/10.1002/jcb.29907 .
doi: 10.1002/jcb.29907 pmcid: 8453819
Manciameli A, Peruzzi M. Treating moderate gonarthrosis with intra-articular injections of sodium salt hyaluronic acid [Italian]. Giornale Ital Ortop Traumatol. 2018;44:146–9.
Migliore A, Blicharski T, Plebanski R, et al. Knee osteoarthritis pain management with an innovative high and low molecular weight hyaluronic acid formulation (HA-HL): a randomized clinical trial. Rheumatol Ther. 2021;8(4):1617–36.
pubmed: 34462887 pmcid: 8572249 doi: 10.1007/s40744-021-00363-3
Papalia R, Russo F, Torre G, et al. Hybrid hyaluronic acid versus high molecular weight hyaluronic acid for the treatment of osteoarthritis in obese patients. J Biol Regul Homeost Agents. 2017;31(4 Suppl 2):103–9.
pubmed: 29202568
Papalia R, Zampogna B, Russo F, et al. The combined use of platelet rich plasma and hyaluronic acid: prospective results for the treatment of knee osteoarthritis. J Biol Regul Homeost Agents. 2019;33(2 Suppl. 1):21–8.
pubmed: 31168999
Scaturro D, Vitagliani F, Terrana P, et al. Intra-articular hybrid hyaluronic acid injection treatment in overweight patients with knee osteoarthritis: A single-center, open-label, prospective study. Appl Sci. 2021;11(18):8711.
doi: 10.3390/app11188711
La Paglia E, Barbero S, Belletti M, et al. Femoro-acetabular impingement syndrome in young patients: Efficacy of US-guided treatment with platelet rich plasma in association with hybrid form hyaluronic acid in comparison with the hyaluronic acid control group. G Ital Ortop Traumatol. 2017;43:215–26.
Mandelbaum B, Waddell D. Etiology and pathophysiology of osteoarthritis. Orthopedics. 2005;28(2 Suppl):s207–14.
pubmed: 15747608
Papalia R, Zampogna B, Russo F, et al. Comparing hybrid hyaluronic acid with PRP in end career athletes with degenerative cartilage lesions of the knee. J Biol Regul Homeost Agents. 2016;30(4 Suppl 1):17–23.
pubmed: 28002896
Conforti M. Combination of laser needling and hyaluronic acid infiltration treatments for rotator cuff calcific tendinopathies. Gazz Med Ital. 2020;179(12):665–74.
Bartoloni E, Luccioli F, La Paglia GMC, et al. Effect of Sinovial high-low(R) injections in trapeziometacarpal osteoarthritis. Clin Exp Rheumatol. 2019;37(1):166.
pubmed: 30620294
Papalia R, Salini V, Voglino N, et al. Single-dose intra-articular administration of a hybrid cooperative complex of sodium hyaluronate and sodium chondroitin in the treatment of symptomatic hip osteoarthritis: a single-arm, open-label, pilot study. Rheumatol Ther. 2021;8(1):151–65.
pubmed: 33245554 doi: 10.1007/s40744-020-00255-y
Mobasheri A, Batt M. An update on the pathophysiology of osteoarthritis. Ann Phys Rehabil Med. 2016;59(5–6):333–9.
pubmed: 27546496 doi: 10.1016/j.rehab.2016.07.004
Hamburger MI, Lakhanpal S, Mooar PA, Oster D. Intra-articular hyaluronans: a review of product-specific safety profiles. Semin Arthritis Rheum. 2003;32(5):296–309.
pubmed: 12701040 doi: 10.1053/sarh.2002.50008
Chen AL, Desai P, Adler EM, Di Cesare PE. Granulomatous inflammation after Hylan G-F 20 viscosupplementation of the knee : a report of six cases. J Bone Joint Surg Am. 2002;84(7):1142–7.
pubmed: 12107313 doi: 10.2106/00004623-200207000-00008
Reichenbach S, Blank S, Rutjes AW, et al. Hylan versus hyaluronic acid for osteoarthritis of the knee: a systematic review and meta-analysis. Arthritis Rheum. 2007;57(8):1410–8.
pubmed: 18050181 doi: 10.1002/art.23103
Rivera F. Single intra-articular injection of high molecular weight hyaluronic acid for hip osteoarthritis. J Orthop Traumatol. 2016;17(1):21–6.
pubmed: 26449357 doi: 10.1007/s10195-015-0381-8
Migliore A, Massafra U, Bizzi E, Giovannangeli F, Tormenta S. Intra-articular ultrasound-guided injection of Sinovial® Forte 1.6% in patients affected by symptomatic hip osteoarthritis: effectiveness and safety in a large cohort of patients. Eur J Inflamm. 2012;10(1):71–9.
doi: 10.1177/1721727X1201000108
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.
pubmed: 18541604 doi: 10.1136/ard.2008.092015
Previtali D, Merli G, Di Laura FG, et al. The long-lasting effects of “placebo injections” in knee osteoarthritis: a meta-analysis. Cartilage. 2020. https://doi.org/10.1177/1947603520906597 .
doi: 10.1177/1947603520906597 pubmed: 32551947 pmcid: 8808870
Migliore A, Granata M, Tormenta S, et al. Hip viscosupplementation under ultra-sound guidance reduces NSAID consumption in symptomatic hip osteoarthritis patients in a long follow-up. Data from an Italian registry. Eur Rev Med Pharmacol Sci. 2011;15(1):25–34.
pubmed: 21381497

Auteurs

Marcin Domżalski (M)

Department of Orthopaedics and Trauma, Veteran's Memorial Hospital, Medical University of Lodz, Lodz, Poland.

Alberto Migliore (A)

Unit of Rheumatology, S. Pietro Fatebenefratelli Hospital, Via Cassia 600, 00189, Rome, Italy. migliore.alberto60@gmail.com.

Classifications MeSH