The extended-release corticosteroid FX006 (Zilretta) has been shown to have a maximal analgesic effect in patients with knee osteoarthritis (OA) over the standard TCA 40 mg suspension after an intra-articular injection. However, the dose response rate for FX006 between 20mg and 40mg has, to-date, been unknown.
In an April 2 presentation entitled, “Sustained and Profound Analgesic Benefits in People With Osteoporosis of the Knee Using FX006, an Intra-Articular Extended-Release Formulation of Triamcinolone Acetonide: Results From a Double-Blind, Randomized, Parallel-Group, Dose-Ranging Study,” Philip Conaghan, from the University of Leeds in the United Kingdom discussed FX006 effectiveness over other options.
A total of 306 patients, with documented knee OA with Kellgren-Lawrence grade 2 or 3 and pain intensities from 5-to-9 on a scale of 1-to-10, were treated with either a single IA injection of 20mg or 40mg FX006 or a saline placebo. Baseline age, race, body mass index, and knee characteristics were similar across groups. Researchers monitored participants over 24 weeks for efficacy and safety. The primary endpoint was a change from baseline measures at week 12.
According to the results, Mixed Model Repeat Measures FX006 20mg demonstrated significant improvement in daily pain levels from weeks 1 through 9. FX006 also offered improvement from weeks 1 to 13. In the LOCF/BOCF analysis, FX006 20mg from weeks 1 through 8, and FX006 showed improvement from weeks 1 to 13. In a secondary analysis, FX006 performed better than the placebo for each week.
For all patients with OA, FX006 demonstrated higher efficacy than a placebo. FX006 20mg and 40mg reach maximum performance at week 5, and a phase 3 trial is underway to compare FX006 40mg with standard TCA suspension 40mg and placebo.
“Sustained and Profound Analgesic Benefits in People With Osteoporosis of the Knee Using FX006, an Intra-Articular Extended-Release Formulation of Triamcinolone Acetonide: Results From a Double-Blind, Randomized, Parlallel-Group, Dose-Ranging Study,” Philip Conaghan, OARSI 2016 World Congress, April 2.