SAT0333 Efficacy of sodium hyaluronate versus hylan G-F 20 in the treatment of tibiofemoral osteoarthritis
Authors: R.-L. Dreiser, B. Avouac, T. Bardin
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Background</h3> Crosslinked hylan is perceived to have longer efficacy than native hyaluronic acid in the treatment of osteoarthritis (OA). <h3>Objectives</h3> To compare the efficacy of intra-articular injections of native sodium hyaluronate 1% (SH) and crosslinked hylan G-F 20 (hylan) in patients with tibiofemoral OA. <h3>Methods</h3> This was a randomised, double-blind, controlled, non-inferiority study conducted from September 2007 through January 2010 in 64 sites in France. Selected patients were aged 40 to 80 years, with painful tibiofemoral OA (Kellgren-Lawrence radiological grade IIb to III) according to the American College of Rheumatology criteria and with WOMAC A pain on VAS of at least 40 mm. After an NSAID washout period, eligible patients were randomised to receive 1 intra-articular injection per week, for a total of 3 consecutive injections, of either SH 20 mg/2.0 ml (Ostenil®, TRB Chemedica AG, Germany) or hylan G-F 20 20 mg/2.0 ml (Synvisc®, Genzyme Biosurgery, USA). Efficacy parameters also included Lequesne index and SF-12 score, and were measured using the masked-observer technique at Days 45, 90 and 180. The main efficacy parameter was WOMAC A pain at Day 180. The PP population was used for the main analysis. The lower margin of non-inferiority for the 95% confidence interval was pre-specified at -8 mm. Data from this study were used to calculate responder rates according to the OMERACT-OARSI Set of Responder Criteria. [1] <h3>Results</h3> 256 patients (mean age 64.4 years, 171 women) were evaluated as ITT (SH=132, hylan=124). Both groups' baseline characteristics were homogeneous, except for a higher physical SF-12 in the test group (SH 34.0, hylan 32.2; p=0.028). All efficacy parameters decreased from baseline in both groups. In the PP population (226 patients, SH=119, hylan=107), the mean WOMAC A decrease at Day 80 was -28.9 mm (SD 20.8) and -27.8 mm (SD 22.9) for SH and hylan, respectively. The mean observed difference between groups was 1.04 mm (SEM 3.1), with a 95% confidence interval of [-5.0;7.1]. Therefore, the lower margin of the 95% confidence interval of the difference in mean WOMAC A was higher than the pre-specified bound for non-inferiority. Results were found to be similar in the ITT group. At baseline, 32.6% of SH patients and 22.1% of hylan patients had severe OA symptoms, as expressed with a Lequesne index of at least 14 points; at Day 180, only 5.1% of the patients in the SH group and 12.3% in the hylan group had a Lequesne index of 14 points or more. The responder rate at Day 180 was 75.7% in the SH group and 70.2% in the hylan group (p=0.38, chi-square test). Adverse reactions included burning sensation (1 occurrence), effusion (1), inflammatory reaction (3) in the SH group, and headache (3) and effusion (2) in the hylan group. <h3>Conclusions</h3> Results of this multicentre clinical study in France demonstrated the non-inferiority of SH compared with hylan for the primary efficacy outcome. Both preparations reduced pain and improved functional activity in patients with painful tibiofemoral OA over 6 months. <h3>References</h3> Pham T, van der Heijde D, Altman RD et al. OMERACT-OARSI Initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage 2004;12(5):389-99. <h3>Disclosure of Interest</h3> R.-L. Dreiser Consultant for: Member of the Scientific Board for the study, B. Avouac Consultant for: Member of the Scientific Board for the study, T. Bardin Consultant for: National Study Co-ordinator