AB0875 HYBRID COOPERATIVE COMPLEXES OF SODIUM HYALURONATE + SODIUM CHONDROITIN NON-SULFATED (HA-SC) IN THE TREATMENT OF HIP OA: CLINICAL RESULTS
Authors: R. Papalia
Journal: Annals of the Rheumatic Diseases (2020)

Background: Hip Osteoarthritis (OA) is a widespread disease characterized by pain and functional impairment, which, particularly in the elderly, may compromise overall health and quality of life. In the last decades, Intra-articular (I.a.) injections of hyaluronic acid (HA) gained more space among the conservative treatment of OA because of their beneficial effects and positive outcomes without relevant complications. (1,2). An innovative and patented formulation containing hybrid cooperative complexes of sodium hyaluronate 2.4% + sodium chondroitin non-sulfated 1.6% of biotechnological origin (HA-SC) has been recently developed for the I.a. treatment of hip OA and evaluated in a pilot study (3). Objectives: 1) Primary aim: Evaluation of the safety of HA-SC in the treatment of symptomatic hip OA; 2) Secondary aim: Evaluation of the efficacy of HA-SC in terms of pain reduction (VAS) and function improvement (Lequesne) of the affected hip joint. Methods: This is a pilot, multicentric, open, prospective study. The following inclusion criteria were established: Patients (both genders) aged ≥ 40 years suffering for primary hip OA confirmed by X-Ray; Grade I-II-III according to K&amp;L grading scale; Basal VAS pain at the target hip &gt; 40 mm; Failure of at least two lines of conservative treatments. All patients underwent a single I.a. hip injection of a 3mL vial of HA-SC and followed-up for six months. Results: 48 patients have been enrolled and completed the study. The treatment was generally well-tolerated, with only ten patients out of 48 (20.8%) reporting local effects mainly consisting of injection site pain and arthralgia localized in the treated area. All these patients completed the study. The treatment with HA-SC was associated with a statistically significant decrease of VAS scale from a basal value of 67.5 (mean) to 22.8 (mean, p&lt;0.0001) at the end of the observation period at six months, with a statistically significant decrease at seven days of follow-up evaluation (29.3, mean, p&lt;0.0001). The mean Lequesne’s Index total score after the single injection of HA-SC decreased from a baseline value of 10.4 (mean) to 5.1 (mean, p&lt;0.0001) at six months. The decrease was marked and significant also at any of the other evaluated time point (p&lt;0.0001). Conclusion: A single I.a. injection of the innovative formulation containing hybrid cooperative complexes of sodium hyaluronate + sodium chondroitin non-sulfated (HA-SC) showed to be well tolerated and safe in the treatment of symptomatic hip OA. A rapid and significant decrease in hip pain (VAS) and Lequesne’s Index was also observed starting immediately after the I.a. injection and lasting until the end of the follow-up period. However, conservative treatment of hip OA is still challenging. This new formulation could represent a promising, long-lasting, and effective I.a. treatment. References: [1]Papalia R. et al. J. Biol. Regul. Homeost. Agents 2017; 31 (4 Suppl. 2): 103-109. [2]Abate M. et al. Int. J. Immunopathol.Pharmacol. 2017; 30 (1): 89-93. [3]IBSA Data on file. Acknowledgments: The author thanks all the investigators of the study: Costantino Cosimo, UO Medicina Riabilitativa, Azienda Ospedaliero-Universitaria di Parma, Italy; Fortina Mattia, Unità di Ortopedia Universitaria, AOU Senese Policlinico Santa Maria alle Scotte, Italy; Sadile Francesco, II Ortopedia - Ortopedia Infantile, Università degli studi di Napoli Federico II, Italy; Salini Vincenzo, Clinica Ortopedica e Traumatologica, Ospedale SS Annunziata di Chieti, Italy; Voglino Nicola, UO Ortopedia e Traumatologia, Ospedale Alto Tevere Città di Castello Azienda USL Umbria 1, Italy Disclosure of Interests: Rocco Papalia Speakers bureau: Speaker for IBSA