Diffusion-based extended-release fluticasone propionate helps alleviate knee OA pain

EP-104IAR, a diffusion-based long-acting formulation of fluticasone propionate for intra-articular injection, appears to produce meaningful reductions in knee osteoarthritis (OA) pain that last up to 14 weeks, according to data from a phase II SPRINGBOARD study.

SPRINGBOARD included 319 adults aged 40 years or older with primary knee osteoarthritis (Kellgren–Lawrence grade 2–3) who had Western Ontario and McMaster Universities Osteoarthritis Arthritis Index (WOMAC) pain scores of at least 4 and no more than 9 out of 10.

The patients were randomly assigned to receive a single intra-articular dose of 25 mg EP-104IAR (n=164) or vehicle control (n=155). All of them were followed up for 24 weeks. The primary endpoint was the difference between groups in change in WOMAC pain score from baseline to week 12. Safety, including laboratory analyses, and pharmacokinetics from quantification of fluticasone propionate in peripheral blood were also evaluated.

Of the patients, one in the EP-104IAR group was excluded from all analyses because treatment was not administered due to an adverse event (AE). This left 318 participants (42 percent male, 99 percent White) in the primary and safety analyses (EP-104IAR n=163, vehicle control n=155).

At week 12, least squares mean change in WOMAC pain score was significantly greater in the EP-104IAR group than in the vehicle control group (–2.89 vs –2.23; p=0.0044). This significant between-group difference persisted through week 14.

The proportion of patients with one or more treatment-emergent AE was 65 percent in the EP-104IAR group and 57 percent in the vehicle control group. Minimal, transient effects on serum glucose and cortisol concentrations were observed. None of the patients died or had treatment-related serious AEs. Plasma concentrations of fluticasone propionate increased slowly and then remained elevated for a prolonged period, with a terminal half-life of around 18 to 20 weeks.