NASHA hyaluronic acid vs. methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial.

Abstract

OBJECTIVE:

To compare NASHA hyaluronic acid gel as single-injection intra-articular (IA) treatment for knee osteoarthritis (OA) against methylprednisolone acetate (MPA).

DESIGN:

This was a prospective, multi-centre, randomized, active-controlled, double-blind, non-inferiority clinical trial. A unique, open-label extension phase (OLE) was undertaken to answer further important clinical questions. Subjects with painful unilateral knee OA were treated and followed for 26 weeks (blinded phase). All patients attending the clinic at 26 weeks were offered NASHA treatment, with a subsequent 26-week follow-up period (extension phase). The primary objective was to show non-inferiority of NASHA vs MPA in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain responder rate (percentage of patients with ≥40% improvement from baseline in WOMAC pain score and an absolute improvement of ≥5 points) at 12 weeks.

RESULTS:

In total, 442 participants were enrolled. The primary objective was met, with NASHA producing a non-inferior response rate vs MPA at 12 weeks (NASHA: 44.6%; MPA: 46.2%; difference [95% CI]: 1.6% [-11.2%; +7.9%]). Effect size for WOMAC pain, physical function and stiffness scores favoured NASHA over MPA from 12 to 26 weeks. In response to NASHA treatment at 26 weeks, sustained improvements were seen in WOMAC outcomes irrespective of initial treatment. No serious device-related adverse events (AEs) were reported.

CONCLUSIONS:

This study shows that single-injection NASHA was well tolerated and non-inferior to MPA at 12 weeks. The benefit of NASHA was maintained to 26 weeks while that of MPA declined. An injection of NASHA at 26 weeks conferred long-term improvements without increased sensitivity or risk of complications. STUDY IDENTIFIER: NCT01209364 (www.clinicaltrials.gov).

• Authors: R Leighton, C Akermark, R Therrien, J B Richardson, M Andersson, M G Todman, N K Arden, DUROLANE Study Group
• Journal: Osteoarthritis and cartilage (Osteoarthritis Cartilage) Vol. 22 Issue 1 Pg. 17-25 (Jan 2014) ISSN: 1522-9653 [Electronic] England
• PMID: 24185114 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2013 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Chemical References

• Glucocorticoids
• Methylprednisolone Acetate
• Hyaluronic Acid
• Methylprednisolone

Topics

• Adult
• Aged
• Aged, 80 and over
• Double-Blind Method
• Female
• Glucocorticoids (adverse effects, therapeutic use)
• Humans
• Hyaluronic Acid (administration & dosage, adverse effects, therapeutic use)
• Injections, Intra-Articular
• Male
• Methylprednisolone (adverse effects, analogs & derivatives, therapeutic use)
• Methylprednisolone Acetate
• Middle Aged
• Osteoarthritis, Knee (drug therapy)
• Pain Measurement (methods)
• Prospective Studies
• Severity of Illness Index
• Treatment Outcome