Hope for a durable effective injection therapy in knee osteoarthritis

The long-acting fluticasone propionate intra-articular injection provisionally named EP-104IAR was associated with clinically meaningful improvements in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score up to week 20 in patients with knee osteoarthritis in the phase 2 SPRINGBOARD study. Phase 3 clinical trials are underway to further assess this promising injection therapy.

Since the durability of standard intra-articular corticosteroid injections is limited and the side effects of these injections are substantial, novel options are needed to ameliorate the clinical situation for patients with knee osteoarthritis. EP-104IAR comes with a controlled-release mechanism to improve the intra-articular residence and to reduce systemic exposure. The novel injection therapy was tested in a phase 2 study called SPRINGBOARD (NCT04120402) among 318 patients with knee osteoarthritis [1]. The included participants were randomised 1:1 to a single intra-articular injection with EP-104IAR or to a vehicle placebo. Prof. Philip Conaghan (University of Leeds, UK) and co-authors looked at clinical efficacy and safety data 12 and 20 weeks post-injection. The primary endpoint was change in WOMAC pain score.

At week 12, the per protocol analysis showed that EP-104IAR induced better outcomes than placebo in terms of least square mean changes from baseline at the WOMAC subscales of pain (-2.97 vs -2.24; P=0.003), function (-2.64 vs -1.99; P=0.005), and stiffness (-2.85 vs -2.05; P=0.001). Not surprisingly, the change in total WOMAC score was significantly better for the EP-104IAR arm than for placebo at this time (-2.79 vs -2.07; P=0.002). At week 20, this difference was still significant (P<0.05). EP-104IAR had a favourable safety profile; treatment-related knee arthralgia occurred in 5.5% of the participants on the study drug and 5.8% of those on placebo.

According to Prof. Conaghan, these results suggest that the effects of EP-104IAR last longer than the effects of standard-of-care corticosteroid injections, indicating that EP-104IAR has the potential to address an unmet need in the large population of patients with knee osteoarthritis.

1. Malone A, et al. Efficacy of a novel long-acting fluticasone propionate intra articular injection (EP-104IAR) in knee osteoarthritis: per-protocol analysis of a randomised, double-blind, phase 2 trial of EP-104IAR vs vehicle placebo (SPRINGBOARD). OP0247, EULAR 2024 Congress, 12–15 June, Vienna, Austria.

Copyright ©2024 Medicom Medical Publishers



Posted on 29 July 2024