Assessment of the Health-Related Quality of Life Impact of EUFLEXXAïÂÂ(1% Sodium Hyaluronate) Using Short Form 36 (SF-36) Data Collected inaRandomized Clinical Trial Evaluating Treatment of Osteoarthritis KneePain

Background: Outcome measurements of clinical trials such as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) have provided disease specific data on lower extremity osteoarthritis (OA). The impact of the disease, condition, or treatment on the dimensions of functioning and well-being has been supplemented by the use of general health-related quality of life (HRQoL) instruments. Objective: To examine patients’ general HRQoL measures using the Short Form 36 (SF-36) from the 26-wk double-blind, randomized, saline (IA-SA)-controlled FLEXX Trial and the 26-wk open-label Extension Study, which evaluated efficacy and safety of intra-articular (IA) injections of a bioengineered hyaluronic acid (HA [BioHA]) for treatment of OA knee pain. Methods: HRQoL of participants treated with IA-BioHA in the FLEXX Trial was compared to patients’ baseline HRQoL and to United States population and OA norms using the SF-36v2.This study evaluated the durability of improvement in physical health related domains of the SF-36 observed at week 26 of the FLEXX Trial by assessing the physical functioning scores at week 52 for patients who received a second course of 3 weekly injections of IABioHA during the FLEXX Trial Extension Study. Results: Baseline SF-36 scores indicated significant physical limitations in patients enrolled in the FLEXX Trial relative to United States population and OA population norms. Changes between the SF-36 scores for IABioHA– treated patients at week 26 continued to improve following a repeat injection series through week 52, with a significantly lower bodily pain domain (P=0.014). Conclusions: Patients treated with IA-BioHA in the FLEXX Trial experienced significantly greater improvement in physical functioning and disability at 26 weeks as measured by the SF-36. A repeat injection series of IA-BioHA resulted in further improvement towards United States population norms in their physical ability with a significant reduction in bodily pain from the end of the FLEXX trial to the end of the Extension Study (week 52).