TOPLINE:
The extended-release fluticasone propionate injection (EP-104IAR) significantly reduces knee osteoarthritis (OA) pain over 12 weeks, compared with a vehicle control, with no serious treatment-related adverse events.
METHODOLOGY:
- EP-104IAR utilizes a novel diffusion-based extended-release technology to optimize the action of fluticasone propionate.
- The researchers conducted a phase 2 trial at 12 research sites in Denmark, Poland, and the Czech Republic to assess the clinical efficacy, pharmacokinetics, and safety of EP-104IAR in 318 participants (58% women; 99% White) with a diagnosis of primary knee OA.
- Eligible patients, with a score of at least 4 out of 10 on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain rating scale, were randomly assigned to receive either 25 mg EP-104IAR (n = 163; mean age, 64 years) or a vehicle control (n = 155; mean age, 63.2 years).
- The primary outcome was the between-group difference in the change in the WOMAC pain score from baseline to week 12.
TAKEAWAY:
- The reduction in WOMAC pain scores from baseline to week 12 was significantly higher with EP-104IAR than with a vehicle control (between-group difference, −0.66; P = .0044), with the difference maintained through week 14.
- The treatment resulted in a significant improvement in WOMAC function scores (P = .014) and the area under the curve for changes in the WOMAC pain score (P < .0001) over 12 weeks.
- Treatment-emergent adverse events were noted in 9% of participants in the EP-104IAR group and 7% of participants in the vehicle control group. No serious treatment-related adverse events or discontinuations related to EP-104IAR were reported.
- Fluticasone propionate levels were maintained at around 66% to 33% of peak values between weeks 2 and 24 at near-constant levels. The effects on glucose and cortisol levels were minimal and transient.
IN PRACTICE:
“The results of this trial show that EP-104IAR has the potential for clinically meaningful benefit in reducing knee osteoarthritis pain, addressing a substantial unmet medical need,” the authors wrote. “Additionally, the stable delivery of fluticasone propionate over an extended period with fewer systemic and local side effects than other corticosteroid treatments for knee osteoarthritis support the possibility of bilateral and repeat dosing.”
SOURCE:
The study was led by Amanda Malone, PhD, Eupraxia Pharmaceuticals, Victoria, British Columbia, Canada. It was published online in The Lancet Rheumatology.
LIMITATIONS:
The study’s generalizability may be limited because of the predominantly White participant population. The success of masking was not evaluated, and the treatment was administered by an unmasked injector. Efficacy outcomes were patient-reported, with no objective measurement of knee function.
DISCLOSURES:
This study was supported by Eupraxia Pharmaceuticals. Some authors disclosed their employment with Eupraxia Pharmaceuticals or with companies contracted by Eupraxia Pharmaceuticals for clinical research and trial and data management. One author reported serving as a consultant or participating in a speakers’ bureau. Another reported being on the board of directors for Eupraxia Pharmaceuticals and receiving royalties from a medical technology company.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.