AB0811 MULTICENTER PROSPECTIVE STUDY TO ASSESS EFFICACY AND SAFETY OF INTRA-ARTICULAR INJECTIONS OF A SOLUTION COMBINING HYALURONIC ACID AND CHONDROITIN SULPHATE IN PATIENTS WITH KNEE OSTEOARTHRITIS

Abstract

Background Objectives To assess efficacy and safety of a single intra-articular injection of a solution combining hyaluronic acid (HA) 60 mg and chondroitin sulphate (CS) 90 mg in 3 mL on patients with knee osteoarthritis (OA) in a multicenter prospective study. Methods 79 outpatients (predominantly females - 81,0%) from 5 RF constituent territories with primary tibiofemoral Kellgren-Lawrence score grade II or III knee OA, ≤40 mm pain intensity during walking on visual analogue scale (VAS), requiring NSAIDs intake (for at least 30 days during 3 months prior to enrollment) were included into the study after signing the informed consent form. Mean age was 60,3 ± 8,7 years, mean BMI – 29,2 ± 4,7 kg/m2, disease duration – 6 (3 - 10) years. Grade II OA was documented in 68,4% of patients, Grade III - in 31,6%. The study lasted for 6 months. Efficacy and safety evaluations were made based on VAS pain assessment, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - (WOMAC pain (0-500), WOMAC function (0-1700), WOMAC stiffness (0-200)), VAS patients’ health status, EQ-5D-based assessment of patients’ quality of life, global physician’s and patient’s efficacy assessment, and daily NSAIDs requirements. Results Obtained results demonstrate statistically significant VAS pain reduction during walking already in 1 week after intra-articular injection of the combination (respectively, 62 (55-72) and 41 (32-51) mm, p Conclusion These results suggest that intra-articular injections of hyaluronic acid plus chondroitin sulfate in patients with knee OA are efficient and safe. A single injection of the drug resulted in statistically significant reduction of pain and stiffness, reduction in NSAIDs intake, as well as improvement in patients’ quality of life and function: Disclosure of Interests: Elena Taskina Speakers bureau: Bayer, Sandoz, Boeringer-ingelheim, Ludmila Alekseeva Speakers bureau: Bayer, Boeringer-ingelheim, Gedeon-Richter, Servier, Natalia Kashevarova: None declared, Evgenia Sharapova: None declared, Ekaterina Strebkova: None declared, Sergey Anikin: None declared, Lena Zonova Speakers bureau: Sandoz, Pfizer, Abbvie, Novartis, Bayer, Tatiana Raskina: None declared, Elvira Otteva Speakers bureau: Pfizer, Abbvie, Novartis, Aleksandr Lila Speakers bureau: Sandoz, Pfizer, Abbvie, Novartis, Bayer