EFFICACY AND SAFETY OF HYLAN G-F 20 (SINGLE DOSE) VS. PLACEBO IN PATIENTS WITH KNEE OSTEOARTHRITIS PAIN

Abstract

Introduction: Viscosupplementation is an effective treatment for patients suffering from knee osteoarthritis (OA). Most available products use 3 or 5 injection regimens. The objective of this study was to compare the safety and efficacy of a single 6 mL intra-articular administration of hylan G-F 20 with placebo.

Methods: In this prospective, multicenter, randomized, double-blind study, patients diagnosed with knee OA were randomized to one 6-mL injection of hylan G-F 20 or saline. The primary efficacy analysis (WOMAC A) was performed on the intent-to-treat population and was based on a repeated-measures model over the 26 weeks of the study. The incidence of adverse events (AEs) was collected over the study duration

Results: 253 patients were randomized to hylan G-F 20 (n=124) or placebo (n=129). Mean age was 63 years (42–84), BMI 29.4 (19.5–52.4 kg/m2), 71% were female, and all had primary knee OA of Kellgren Lawrence grade 2 (45%) or 3 (55%). Patients in the hylan G-F 20 group experienced a mean change from baseline in their WOMAC A Likert pain score (0–4 scale) over 26 weeks (primary efficacy criteria) of −0.84, which was statistically significantly different from the change reported in the placebo group (−0.69, p=0.047). Statistically significant differences favoring hylan G-F 20 were also reported for most of the secondary efficacy criteria: WOMAC A1 (estimate Odds Ratio over 26 weeks placebo/hylan G-F 20, 0.64, p=0.013), patient global assessment (0.69, p=0.029), and clinical observer global assessment (0.71, p=0.041); WOMAC B and C changes were not statistically significant between groups. There was no statistically significant difference in the use of rescue medication between the 2 groups. There were no serious AEs related to treatment. In the target knee, injection-related AEs occurred in 4.9% and 3.1% of patients for hylan G-F 20 and placebo, respectively, and treatment-related AEs occurred in 3.3% and 0.8% of patients, respectively. All target knee AEs were local pain, with or without joint swelling or effusion, and were of mild or moderate intensity.

Conclusion: This double-blind placebo-controlled study showed one injection of hylan G-F 20, possibly repeated 6 months later, was safe and provided symptomatic relief lasting up to 6 months in patients with knee OA.