SYNOLIS VA® CLINICAL PERFORMANCE ON PAIN AND SAFETY AT 6 MONTHS
Single injection of Synolis VA (80mg hyaluronic acid and 160 mg sorbitol) met the non-inferiority primary endpoint versus 0.8% hylan G F 20, which was the reduction in pain at 6 months post injection.
The results of a French multicenter, randomized, double-blind, controlled, non-inferiority study involving 202 patients with Kelgren-Lawrence grade II/III knee osteoarthritis, comparing a single injection of 80mg hyaluronic acid and 160 mg sorbitol (Synolis VA) with a single injection of 0.8% hylan G F 20 (Synvisc One) have been presented at EULAR 2020. This was the first study directly comparing a non-cross-linked HA (Synolis VA) with a cross-linked one (Synvisc One).
The results demonstrate that Synolis VA was non-inferior to hylan G F 20 in reducing pain measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale six months after the injection, thus meeting the primary endpoint of the study. It also showed a fast pain relief, with 44% responders at the secondary endpoint of Day 14.
The analysis of secondary outcomes including changes in joint stiffness, physical function, patient’s assessment of treatment efficacy, and rate of responders did not show any statistically significant difference between Synolis VA and hylan G F 20.
Both treatments were well tolerated. Treatment-emergent adverse events were mainly local and resolved spontaneously in most of the cases. The rate of study discontinuation due to adverse events was very low (3.5%).