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THU0488 A 6 Month Trial Evaluating Efficacy of One Intra Articular Injection of 2% Sodium Hyaluronate Versus Hylan G F 20 in the Treatment of Painful Tibiofemoral Osteoarthritis
  1. R.L. Dreiser1,
  2. B. Avouac2,
  3. T. Bardin3
  4. on behalf of the French Study Group
  1. 1APHP Hôpital Bichat–Claude Bernard, Paris
  2. 2CHU Henri Mondor, Créteil
  3. 3APHP Hôpital Lariboisière, Paris, France

Abstract

Background Chemically crosslinked hylan G-F 20 (hylan) is perceived to have longer efficacy than natural non-chemically modified sodium hyaluronate (SH) in the treatment of osteoarthritis (OA).

Objectives To demonstrate that efficacy of one intra-articular (i.a.) injection of 2% SH is non-inferior to hylan in patients with symptomatic tibiofemoral OA.

Methods This was a randomised, double-blind, controlled, parallel-group, multicentre, non-inferiority trial evaluating patients with tibiofemoral OA (KL grade Ib to III) and a WOMAC A pain ≥40 mm. After an NSAID washout period, eligible patients were randomised to receive one i.a. injection of either 40 mg/2.0 ml SH (Ostenil Plus) or 48 mg/6.0 ml hylan (Synvisc-One). Efficacy parameters were collected by a blinded assessor on Days 0 (D0), 30, 90 and 180. The primary endpoint was the change from D0 in WOMAC A at Day 180. The lower margin of non-inferiority was pre-specified at -8 mm.

Results On the 292 randomised patients (SH =144, hylan =148), 142 were injected with SH, 146 with hylan, and 4 did not receive the injection due to consent withdrawal (2 patients) or presence of effusion (2 patients). A total of 266 patients (91.1%) completed the study. Both groups were homogeneous at D0 for demographic and disease characteristics (SH: 143 patients, age =67.1±9.7; hylan: 147 patients, age =66.6±10.7), except for a lower male ratio in the SH group (SH: 27.3%, hylan: 39.5%; p=0.0279) which had no significant effect on the results. The efficacy analysis performed on the 280 patients of the full analysis set (SH =139, hylan =141) showed that all parameters decreased from D0 in both groups. The mean WOMAC A change from D0 at Day 180 was -33.2±20.1 mm and -36.1±21.5 mm for SH and hylan, respectively (p=0.2613). The mean observed difference between groups was -2.9±20.8 mm with a 95% confidence interval (CI) of [-7.9; 2.2] mm. Therefore, the lower margin of the 95% CI of the difference in mean WOMAC A was higher than the pre-specified bound for non-inferiority. At Day 180, improvement from D0 of the Lequesne score was 4.2±3.7 and 4.7±4.0 in the SH and hylan groups, respectively. The OMERACT-OARSI responder rate at Day 180 was 81.1% in the SH group and 86.3% in the hylan group (p=0.2543). Results were found to be similar in the per protocol set (225 patients, SH =113, hylan =112) with a mean observed difference between groups of -1.9±20.5 mm and a 95% CI of [-7.3; 3.5] mm.

From a safety point of view, 24.0% of the patients reported at least one adverse event. In the hylan group, 4 patients (2.7%) received a corticosteroid injection, 1 had knee prosthesis after about 6 months and 1 had a meniscectomy. In the SH group, 2 patients (1.4%) received a corticosteroid injection. Local reactions to the injections occurred in 8.4% of patients in the SH group versus 13.0% in the hylan group. No serious reaction related to the injection was reported.

Conclusions This clinical trial demonstrated the non-inferiority of one i.a. injection of 2 ml SH compared with 6 ml hylan for the primary efficacy outcome. Both preparations reduced pain and improved functional activity in patients with painful tibiofemoral OA over 6 months.

Disclosure of Interest None declared

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