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EFFICACY OUTCOMES IN PATIENTS WITH KNEE OSTEOARTHRITIS: PER-PROTOCOL ANALYSES FROM SPRINGBOARD, A PHASE 2, RANDOMIZED, 24-WEEK STUDY OF EP-104IAR (LONG-ACTING INTRA-ARTICULAR INJECTION OF FLUTICASONE PROPIONATE)

James A. Helliwell,Amanda Malone, Mark M. Kowalski,Helene Rovsing, Sidsel Lynggard Boll,Asger R. Bihlet,Claire Prener Miller, Alejandro Castillo Mondragon, Yanqi Li, Christine Dobek,Vik Peck, Mike Wilmink,Philip Conaghan,Lee S. Simon

Osteoarthritis and Cartilage(2024)

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摘要
Purpose (the aim of the study): Global prevalence of knee osteoarthritis (KOA) was estimated at 365 million in 2019. Recommended treatment includes topical and oral NSAIDs, and intra-articular (IA) corticosteroids. However, available IA corticosteroids have limited duration of effect and risk of side effects. EP-104IAR is a long-acting fluticasone propionate (FP) IA injection being developed for OA symptoms. EP-104IAR employs a novel controlled-release technology to optimize the pharmacokinetics of FP, maximizing IA residence time while limiting systemic exposure, providing a greater duration of efficacy with fewer systemic and local side effects.
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