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:

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.