DF-conjugated hyaluronate eases pain in knee OA
Repeated doses of diclofenac etalhyaluronate (DF-HA) yield improvements in knee osteoarthritis (OA) pain without major safety signals, with the effect occurring as early as week 1, according to the results of a phase II trial.
In the trial, 176 patients (average age, 64.25 years; 73.3 percent female; mean body mass index, 25 kg/m2) were randomized to receive treatment with 30-mg DF-HA (n=87) or placebo (n=89), administered intra-articularly at weeks 0, 4, and 8 and were followed for 24 weeks.
Both groups achieved pain relief over 12 weeks, although DF-HA produced significantly greater changes in the WOMAC pain subscore (mean difference [MD], –7.0 mm, 95 percent confidence interval [CI], 12.7–1.2; p=0.018), 50-foot walk test pain score (MD, –5.0 mm, 95 percent CI, 10.3–0.3; p=0.065), and daily pain score (MD, –0.61, 95 percent CI, 1.06–0.16; p=0.008).
Pain relief in the DF-HA group was observed at week 1 and sustained through week 12 and week 24.
Treatment with DF-HA also led to substantial improvements in the secondary outcomes of WOMAC physical function subscore (MD, –6.7, 95 percent CI, 12.0–1.4; p=0.014), patient global assessment (MD, –7.6, 95 percent CI, 12.7–2.5; p=0.004), and physician global assessment (MD, 5.1, 95 percent CI, 9.4–0.7; p=0.023).
There was no significant difference in the incidence of treatment-emergent adverse events (TEAEs) between the two treatment groups (57.5 percent vs 58.4 percent). None of the patients died, and serious TEAEs occurred in one patient injected with DF-HA and two patients injected with placebo, none of which were treatment-related.