Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial.

Autor: Petrella RJ; Aging, Rehabilitation & Geriatric Care Research Centre, Lawson Health Research Institute & Departments of Family Medicine, Kinesiology and Cardiology, Western University, London, Canada. petrella@uwo.ca., Emans PJ; Department of Orthopaedic Surgery, Maastricht University Medical Center, Maastricht, the Netherlands. pj.emans@maastrichtuniversity.nl., Alleyne J; Department of Family and Community Medicine, University of Toronto & Sport CARE, Women's College Hospital, Toronto, Canada. jkalleyne@crucible.net., Dellaert F; Care to Move, St. Niklaas, Belgium. frank.dellaert@telenet.be., Gill DP; Aging, Rehabilitation & Geriatric Care Research Centre, Lawson Health Research Institute & Department of Family Medicine and School of Health Studies, Western University, London, Canada. dawn.gill@uwo.ca.; Department of Epidemiology, University of Washington, Seattle, USA. dawn.gill@uwo.ca., Maroney M; Carbylan Therapeutics, Palo Alto, USA. mmaroney@carbylan.com.
Jazyk: angličtina
Zdroj: BMC musculoskeletal disorders [BMC Musculoskelet Disord] 2015 Mar 18; Vol. 16, pp. 57. Date of Electronic Publication: 2015 Mar 18.
DOI: 10.1186/s12891-015-0513-6
Abstrakt: Background: Studies have evaluated the concomitant use of hyaluronan (HA) with steroids, anti-inflammatory drugs and analgesic agents in an attempt to magnify the extent and duration of pain relief due to knee osteoarthritis. To date there has not been an intra-articular combination therapy available for relief of knee osteoarthritis symptoms--one that combines the fast acting onset of symptom relief provided by a corticosteroid with the long-lasting symptom relief provided by HA in a single injection. The objective of this study was to evaluate the safety and preliminary performance of two new HA formulations, Hydros (hyaluronan-based hydrogel suspended in hyaluronan solution) and Hydros-TA (HA plus 10 mg of triamcinolone acetonide [TA]) in subjects with knee osteoarthritis.
Methods: We conducted a Phase 2 prospective, multicenter, randomized, double-blind feasibility trial. Participants (n = 98; mean age 60 years) with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) were randomized to three treatment groups: Hydros, Hydros-TA, and Synvisc-One® (hylan G-F 20). Participants received one 6 ml intra-articular injection in the treatment knee and were evaluated at 2, 6, 13, and 26 weeks post-treatment. Safety was assessed from adverse events at all study visits. The primary efficacy outcome was the change from baseline on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (Pain) score for the treatment knee.
Results: Adverse events were similar across treatment groups with the most common being arthralgia, joint swelling, back pain, and joint stiffness. Arthralgia was reported 5 times with Synvisc-One, 4 with Hydros, and 1 with Hydros-TA. Each group demonstrated a reduction in the WOMAC A (Pain) score over 26 weeks: [least-square mean (standard error)] 30.5 (5.1) mm for Hydros; 34.4 (4.7) mm for Hydros-TA; 28.0 (5.4) mm for Synvisc-One and an observed improvement of 2.5 mm (p = 0.64) and 6.4 mm (p = 0.24) over Synvisc-One for Hydros and Hydros-TA, respectively.
Conclusions: A single injection of Hydros or Hydros-TA was well-tolerated and relieved pain associated with knee osteoarthritis over 26 weeks. Data indicate that Hydros-TA had a more rapid pain relief compared to Hydros alone. A Phase 3 trial is underway to confirm these preliminary results.
Trial Registration Number: NCT01134406.
Databáze: MEDLINE
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