Efficacy and safety of a diffusion-based extended-release fluticasone propionate intra-articular injection (EP-104IAR) in knee osteoarthritis (SPRINGBOARD): a 24-week, multicentre, randomised, double-blind, vehicle-controlled, phase 2 trial
Primary result · Least squares mean change in WOMAC pain score from baselineResult — go to the resultBetween-group difference −0.66 95% CI −1.11 to −0.21Authors' conclusion
These phase 2 results suggest that EP-104IAR has the potential to offer clinically meaningful pain relief in knee osteoarthritis for an extended period of up to 14 weeks, longer than published data for currently marketed corticosteroids.
Study context
- Population
- Adults aged ≥40 years with primary knee OA (Kellgren-Lawrence grade 2–3) and WOMAC pain scores of 4–9 out of 10; 12 sites in Denmark, Poland and Czech Republic318 treated and analysed
- Participants
- 319 adults
- Comparison
- One intra-articular dose of 25 mg EP-104IAR vs vehicle control
- EP-104IARn = 164
- Vehicle controln = 155reference
- Primary endpoint
- Difference between groups in change in WOMAC pain score from baseline to week 12
- Follow-up
- Week 12
Methodological detailsphase 2, double-blind, vehicle-controlled, multicentre, Participants and assessors masked to treatment allocation, Followed up for 24 weeks
- Phase 2
- Double-blind
- Vehicle-controlled
- Multicentre
- Participants and assessors masked to treatment allocation
- Followed up for 24 weeks
Primary result
As reported in the abstract
Between-group difference
−0.66
95% CI −1.11 to −0.21
P = 0.0044
Change by group
EP-104IAR
−2.89
least squares mean · 95% CI −3.22–-2.56
Vehicle control
−2.23
least squares mean · 95% CI −2.56–-1.89
Further findings
WOMAC pain, duration of significant between-group difference · week 14
- Significant between-group difference persisted to week 14
Treatment-emergent deaths and treatment-related serious adverse events
- None
- 0
Safety
One or more treatment-emergent adverse event
Serum glucose and cortisol
- Effects minimal and transient
Original publication
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