An Intra-Articular, Extended-Release Formulation of Triamcinolone Acetonide Prolongs and Amplifies Analgesic Effect in Patients with Osteoarthritis of the Knee

• DOI: 10.2106/jbjs.n.00918
• Publication Date: 2015-06-03T17:46:58Z
• Authors: Neil Bodick; Joelle Lufkin; Christina Willwerth; Anjali Kumar; James Bolognese; Chris Schoonmaker; Rahul Ballal; David Hunter; Michael Clayman
• Keywords: Male; Analgesics; Dose-Response Relationship, Drug; Anti-Inflammatory Agents; Middle Aged; Osteoarthritis, Knee; Triamcinolone Acetonide; Injections, Intra-Articular; 3. Good health; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Double-Blind Method; Musculoskeletal Pain; Delayed-Action Preparations; Humans; Female

Background: Intra-articular corticosteroids are a mainstay in the treatment of knee osteoarthritis, and clinical trials, they demonstrate large initial analgesic effect that wanes over one to four weeks with rapid efflux drug from joint. The present study was undertaken determine if FX006, an extended-release formulation triamcinolone acetonide, can provide pain relief is superior current standard care, immediate-release acetonide. Methods: In this Phase-2, double-blind, multicenter study, 228 patients moderate severe osteoarthritis were randomized single intra-articular injection FX006 (containing 10, 40, or 60 mg acetonide) 40 Data on mean daily 11-point Numeric Rating Scale collected twelve weeks; primary efficacy end point change baseline each eight, ten, weekly intensity scores analyzed longitudinal mixed-effects model. Results: 10-mg dose produced improved relative acetonide at two through weeks, although difference not significant (p ≥ 0.05). 40-mg significantly five ten < 0.05 time point). At prespecified secondary analyses, including responder analyses all Western Ontario McMaster Universities subscales, 0.05) eight time-weighted (assessed scores) = 0.04). 60-mg did additional improvement dose. Adverse events generally mild similar across treatments. Conclusions: provided clinically relevant care. Level Evidence: Therapeutic I. See Instructions for Authors complete description levels evidence.