SPRINGBOARD: Extended-release Intra-articular Corticosteroid Injection in Knee OA Save
A phase 2 trial of EP-104IAR (long-acting, fluticasone propionate) has shown 14 weeks of clinically meaningful pain relief in knee osteoarthritis (OA). This intra-articular formulation is optimised by novel diffusion-based extended-release technology.
The SPRINGBOARD trial (ClinicalTrials.gov, NCT04120402) assessed the efficacy, safety, and pharmacokinetics of EP-104IAR in people with knee OA. It was conducted at 12 research sites in Denmark, Poland, and Czech Republic and enrolled and randomized 319 adults (>40 years) with primary knee OA (Kellgren–Lawrence grade 2–3) and active by having a WOMAC pain score of at least 4, but no more than 9 out of 10. Patients received either one intra-articular dose of 25 mg EP-104IAR or vehicle control. The primary outcome was the difference between groups in change in WOMAC pain score from baseline to week 12.
Of the 319 treated, 1 patient (EP-104IAR group) was excluded for an adverse event before treatment. Patients were mostly femail [58%] and Whie [99%].
At week 12 WOMAC pain score change from baseline was:
- EP-104IAR group: –2.89 (95% CI –3·22 to –2·56)
- Placebo: –2·23 (–2·56 to –1·89)
- Between-group difference of –0·66 (–1·11 to –0·21; p=0·0044);
- Significance persisted to week 14.
There were more adverse events with EP-104IAR ((65% vs 57%), with minimal effects on serum glucose and cortisol. There were no deaths.
The fluticasone propionate terminal half-life was approximately 18–20 weeks. Clinically meaningful pain relief in knee OA in this tria (14 weeks) was more than published data for currently marketed IA corticosteroids.
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We have been using the ER triamcinolone (Zilretta) since it came out and have found it more helpful and well-tolerated in those who:
- have brittle diabetes
- those in whom regular triamcinolone wears off quickly
I wonder how fluticasone propionate will compare.
Thanks for the information, Jack! We need more and better options for our OA patients.
Surprising how little research is done on intraarticular steroids, esp. with a large number of such injections being done daily!
It would be interesting to see head to head trial triamcinolone vs fluticasone effects on cartillage breakdown and tendon weakening
as undesired side effect
Surprising how little research is done on intraarticular steroids, esp. with a large number of such injections being done daily!
Disclosures
The author has no conflicts of interest to disclose related to this subject
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