Study: This Corticosteroid Reduces OA Pain

April 5, 2016
Whitney L. Jackson

For osteoarthritis patients in pain, this corticosteriod provides sustained and "highly effective" pain relief, study presented at OARSI 2016 shows.

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. [[{"type":"media","view_mode":"media_crop","fid":"47323","attributes":{"alt":"","class":"media-image media-image-right","id":"media_crop_6152096700682","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"5557","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"font-size: 13.008px; line-height: 1.538em; float: right;","title":" ","typeof":"foaf:Image"}}]]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.

 

 

References:

“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.

 

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OARSI | Osteoarthritis