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Efficacy and Safety of Single-Application Hyaluronic Acid in Osteoarthritis Therapy

6. 11. 2020

Causal therapy for osteoarthritis does not yet exist. Patients suffering from progressive joint disease are thus dependent on symptomatic medications that alleviate symptoms and partially slow the progression of osteoarthritis. An essential role in therapy is played by viscosupplementation in the form of intra-articular application of hyaluronic acid (HA). Currently, 3rd generation preparations intended for single application are preferred due to their efficiency and safety.

Characteristics and Properties of 3rd Generation HA Products

The aim of viscosupplementation is to improve the rheological properties of the synovial joint through the intra-articular application of HA. This is a method of symptomatic therapy with a long-standing tradition, proven effectiveness, and safety. As with other areas of medicine, the development of hyaluronic acid has undergone significant changes. Currently, 3rd generation HA products are available.

These are characterized not only by a special production process using bacterial fermentation, which increases the safety of the product, but also by the special modification of high-molecular HA through cross-linking, which prolongs the activity of the applied hyaluronic acid in the joint, thereby enhancing the clinical effect. Among these preparations is Hyruan One, whose efficacy is supported by numerous studies.

There are fewer than 10 single-application products on the current market. Hyruan One exhibits a viscoelasticity profile that is most similar to physiological synovial fluid. As mentioned, the product is manufactured via bacterial fermentation. Another method of obtaining hyaluronic acid is production from rooster combs, which, however, requires extraordinary purification and carries a risk of adverse effects.

Effectiveness and Safety of Hyruan One - Findings from Clinical Studies

Wooley et al. published a study comparing the safety of individual types of products. The significantly lowest risk of adverse effects was observed with single-application high-molecular HA, with the safety of administration approaching that of physiological saline (p = 0.2).

Petrella et al. compared the effectiveness of the product from bacterial fermentation with the product of animal origin. After the 10th treatment series, a statistically significant reduction in load pain evaluated by VAS was seen with the product made via bacterial fermentation (-8.8 vs. -7.2; p < 0.01).

Ha et al. published a multicenter phase III clinical study in 2017 comparing the effectiveness of cross-linked single-application HA with linear HA for three consecutive applications. Both modalities were comparable in terms of analgesic effect and improvement in functional parameters of the affected joint. The study demonstrated the non-inferiority of Hyruan One in terms of clinical effect compared to multiple applications of hyaluronic acid.

Lee et al. evaluated repeated administration of Hyruan One in a clinical study involving 174 patients with knee osteoarthritis. The product was administered to patients twice at 26-week intervals, with a 43% reduction in pain evaluated by VAS following the first application (p < 0.0001) compared to the baseline and an additional 13% reduction (p = 0.0002) after the second application.

Conclusion

Viscosupplementation plays an irreplaceable role in the symptomatic therapy of osteoarthritis. The highest standard currently is the high-molecular cross-linked hyaluronic acid produced through bacterial fermentation. Among these products is Hyruan One, distributed by Zentiva, whose efficacy and safety has been demonstrated by numerous clinical studies.

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Sources:
1. Wooley P. H., Song Z., Harrison A. Hyaluronic acid viscosupplements from avian and non-mammalian sources exhibit biocompatibility profiles with unique, source-specific, antigenic profiles. J Biomed Mater Res B Appl Biomater 2012; 100 (3): 808–816, doi: 10.1002/jbm.b.32514.
2. Petrella R., Cogliano A., Decaria J. Comparison of avian and nonavian hyaluronic acid in osteoarthritis of the knee. Orthop Res Rev 2010; 2: 5–9, doi: 10.2147/ORR.S8419.
3. Ha C. W., Park Y. B., Choi C. H. et al. Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study. BMC Musculoskelet Disord 2017; 18 (1): 223, doi: 10.1186/s12891-017-1591-4.
4. Lee J. K., Choi C., Oh K. et al. Safety and efficacy of bi-annual intra-articular LBSA0103 injections in patients with knee osteoarthritis. Rheumatol Int 2017; 37: 1807–1815, doi: 10.1007/s00296-017-3803-5.



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Surgery Orthopaedics Rheumatology
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