AB0799 ART- QUALIVIE: ASSESSMENT OF THE QUALITY OF LIFE OF PATIENTS WITH KNEE OSTEOARTHRITIS SIX MONTHS AFTER TREATMENT WITH THREE INTRA-ARTICULAR INJECTIONS OF ARTHRUM H 2%
Authors: Milka Maravic, Christian Pascaretti, Paolo Insalaco, Antoine Lesort, Patrice Vincent, Hakima Miotti, Isabelle Bardoulat, Cathy Maillard
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> Knee osteoarthritis (KOA) is a chronic condition affecting mainly the elderly and considered as the leading cause of disability after cardiovascular disease. KOA is characterized by functional discomfort and deformities, leading to a deterioration in the quality of life (QoL) of patients. <h3>Objectives</h3> The main objective was to demonstrate that 3 intra-articular injections of aRTHRUM H 2% improves the physical QoL of patients over a 6-month period. <h3>Methods</h3> A French observational, prospective, multi-centre study was conducted between 02/2016 and 07/2017 in patients over 40 suffering from Kellgren and Lawrence (KL) grade I, II or III primary KOA and treated with 3 intra-articular injections of aRTHRUM H 2%. The variables included a questionnaire completed by a physician and the validated 12 items Short form Health Survey (SF-12), completed by patients at baseline (right before the injections), and then at 90 and 180 days. The primary endpoint was the change in physical summary score from baseline to 180 days (paired Student t-tests). Logistic regression analyses were used to identify the mains drivers of significant increase of physical summary score, adjusted for sociodemographic and health covariates. <h3>Results</h3> Of the 134 patients treated with aRTHRUM H 2% included in the study, 115 were evaluable for the primary outcome (non-exploitable data for 19 patients). The baseline characteristics of the analysable population were as follows: mean age of 66.4 years (±10.7); majority female (66.4%); mean BMI of 28.7 (±5.3) kg/m<sup>2</sup> (43.3% overweight and 35.1% obese); KL grade KOA grade: I 13.6%, II 40.2%, III 46.2%; localization: uni-compartmental 53.0% (78.6% medial, 15.7% lateral, 5.7% patellofemoral), bi-compartmental 40.2% and tri-compartmental 6.8%. Regarding management history, respectively 6.7% and 44.8% of patients had previously received physical therapy or rehabilitation, and a visco-supplementation (2.2 treatments on average). Comorbidities observed in 73.9% of patients were metabolic-related in 54.5%, cardiovascular-related in 46.3%, gastrointestinal-related in 20.9%, and neurological-related in 8%. A clinically and statistically significant improvement in the QoL of patients was observed with an increase from 40.0 at baseline to 44.8 at 6 months (p&lt;0.001). A significant improvement was achieved during the 3 months following visco-supplementation (D0: 40.0 vs. D90: 44.8) and maintained from three to 6 months from baseline (D90: 44.8 vs. D180: 44.9). The factors significantly associated with an improvement in QoL were: grade III KOA (OR=5.254, p=0.032), grade II KOA (OR=3.507, p=0.100), lateral femorotibial osteoarthritis (OR=3.175, p=0.029) and a single history of visco-supplementation (OR=2.936, p=0.044). <h3>Conclusion</h3> ART-QUALIVIE is a French study providing real-world data on the evolution of QoL of visco-supplemented KOA patients. It has demonstrated the positive impact of aRTHRUM H 2% on the QoL of patients over the 3 months following injections maintained until 6 months after treatment. <h3>References</h3> [1] Maheu E, Zaim M, appelboom T, et al. Comparative efficacy and safety of two different molecular weight (MW) hyaluronans F60027 and Hylan G-F 20 in the symptomatic osteoarthritis of the knee (KOA). Results of a non-inferiority, prospective, randomised, controlled trial. Clin Exp Rheumatol2011; 29:527-535. [2] Gandek B, Ware JE, aaronson NK, et al. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: Results from the IQOLA Project. International Quality of Life assessment, J Clin Epidemiol1998;51(11):1171-1178. <h3>Disclosure of interests</h3> Milka Maravic Consultant for: Previous 2014 : MSD, Roche, Schering-Plough, Pfizer, Lilly, Employee of: aSTRAZENECA (2014-2017), Christian Pascaretti Consultant for: LCA Pharma, Paolo insalaco Consultant for: LCA Pharma, antoine Lesort Consultant for: LCA Pharma, Patrice Vincent Shareholder of: LCA Pharma, Employee of: LCA Pharma, Hakima Miotti: None declared, Isabelle Bardoulat: None declared, Cathy Maillard Employee of: Prior 2008 : BMS, Roche Janssen