EVALUATION OF SAFETY AND EFFECTIVENESS OF HYLAN GF-20 IN PATIENTS WITH KNEE OSTEOARTHRITIS IN REAL LIFE PRACTICE: PRELIMINARY RESULTS

Abstract

Combined conservative treatment of osteoarthritis includes intra-articular injections of hyaluronic acid. The paper presents the interim results of a prospective observational multicenter non-comparative study conducted in accordance with routine clinical practice to assess the safety and effectiveness of Hylan GF-20 in patients with knee osteoarthritis. The primary objective of the study is to assess walking and rest pain severity by WOMAC VA3.1 scale after 26 weeks and 52 weeks compared to the baseline. To date, 42 patients completed the study (71.43% women, 28.57% men), patients mean age is 59.79 years. After intraarticular injection of Hylan GF-20 patients were examined after 3, 6 and 12 months. After 3 months a positive clinical response was observed: pain severity decreased by 51.31% (p0,001) on WOMAC A, joint stiffness decreased by 51.02% (p0,001) on WOMAC B, daily life difficulties decreased by 42.03% (p0,001) on WOMAC C. The same tendency was observed in the following periods. By week 52 pain severity reduced by 53.25% (p0,001) on WOMAC A, joint stiffness by 41.63% (p0,001) on WOMAC B, daily life difficulties -by 47.55% (p0.001) on WOMAC C. Level of clinical response didn't correlate with the osteoarthritis stage. Therapy resulted in improvement of life quality of patients with knee osteoarthritis by 36% (p0,001) according to the questionnaire EQ-5D. The general patients status according to physicians improved by 33.96% (p0,001) on VAS, and by 45.91% (p0,001) according to patients response on VAS. By week 52 of follow-up 11,90% of patients demonstrated a decrease in required concomitant therapy of osteoarthritis. Given the chronic nature of the osteoarthritis it's the most important that the therapeutic effect of Hylan GF-20 maintains until week 52. The above results confirm the efficiency of intraar-ticular injection of hyaluronic acid in patients with knee osteoarthritis especially in early disease stage.