One-year, efficacy and safety open label study, with a single injection of a new hyaluronan for knee OA: the SOYA trial

Carlos Gavín,1 Francisco J Blanco,2 José L Pablos,3 Miguel A Caracuel,4 José Rosas,5 Enrique Gómez-Barrena,6 Francisco Navarro,7 María Pilar Coronel,8 Mercedes Gimeno8 1Hospital Universitario Fundación Alcorcón, Madrid, Spain; 2Complejo Hospitalario Universitario aCoruña, La Coruña, Spain; 3Hospital Universitario 12 de Octubre, Madrid, Spain; 4Hospital Universitario Reina Sofía, Córdoba, Spain; 5Hospital Marina Baixa, Villajoyosa, Alicante, Spain; 6Hospital Universitario La Paz, Madrid, Spain; 7Hospital General Universitario de Elche, Alicante, Spain; 8Meiji Pharma Spain, Alcalá de Henares, Madrid, SpainCorrespondence: Mercedes GimenoClinical Development Department, Meiji Pharma Spain, Av Madrid 28802, Alcalá de Henares, Madrid, SpainTel +34 918 870 980Email m.gimeno@meiji.esPurpose: To assess the efficacy and safety of a single injection of a new formulation of hyaluronic acid (MPS-HA2%) in patients with symptomatic knee osteoarthritis after 12 months’ follow-up.Patients and Methods: Prospective, single-arm, multicentre, open-label, 12-month follow-up study. Patients with Kellgren–Lawrence (KL) 2– 3 and visual analogue scale (VAS) pain scores of ≥ 40–< 80 mm received a single injection of MPS-HA2%. The primary outcome was the reduction in VAS pain scores from baseline, and the secondary outcomes were the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index, the minimum clinically important improvement (MCII), and patient and investigator global assessments (PGA, IGA) measured on 5-point Likert scale. Adverse events were recorded throughout the study for safety purposes.Results: A total of 101 patients (mean age: 68 years; 74% female; and 78% overweight) were included. The mean reduction in pain at 12 months was 37.7%; the total WOMAC score improved by 36.5% and the pain, stiffness and physical function subscores returned improvements of 32.1%, 34.1% and 32.7%, respectively (p=0.0001 with respect to baseline). At 12 months, a statistically significant 62.2% of patients obtained an improvement equal to or greater than the MCII. The mean PGA score at baseline was 2.44 and 1.46 at 12 months (p< 0.05), and the mean IGA scores at equivalent timepoints were 2.29 and 1.48 (p< 0.05). Fourteen patients received a second injection at the 6-month follow-up visit. Eight patients reported a total of 12 treatment-related adverse events that were local, non-serious and of mild-to-moderate intensity.Conclusion: With just a single intra-articular injection, this not controlled trial suggests that MPS-HA2% is effective 12 months after the procedure in most cases. Patient tolerability and safety were both optimal (NCT03852914).Keywords: osteoarthritis, pain, hyaluronic acid, viscosupplementation