Abstract
ObjectivesThe aim of the study was to demonstrate the non-inferiority of a single intra-articular injection of 2.0% non-chemically modified sodium hyaluronate (SH) vs 0.8% hylan G-F 20 (control) in symptomatic knee osteoarthritis.DesignThis was a double-blind, randomized, controlled trial conducted in patients with painful tibiofemoral osteoarthritis (American College of Rheumatology criteria) with insufficient response or intolerance to first-line analgesics and regular non-steroidal anti-inflammatory drugs. Subjects received a single intra-articular injection of either SH or hylan G-F 20. The primary outcome was the 6-month change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index pain subscale (WOMAC A), with a pre-specified lower margin for non-inferiority of 8 mm.ResultsOf the 292 patients randomized (SH: 144), 288 received an injection (SH: 142), 266 completed the study (SH: 134). In the Per Protocol dataset (SH: 113, control: 112), the WOMAC A change at 6 months was -34.3 mm (95% confidence interval (CI): -37.8, -30.8) and -36.2 mm (95% CI: -40.3, -32.1) for the SH and hylan G-F 20 patients, respectively (P = 0.5). The intergroup difference was -1.9 mm (95% CI: -7.3, 3.5). Results were similar in the Full Analysis Set (SH: 139, control: 141) with a difference between the groups of -2.9 mm (95% CI: -7.9, 2.2).A total of 31.3% of the injected patients reported a treatment-emergent adverse event, including injection site reactions (pain, inflammation or effusion) which occurred in 8.5% of the SH patients vs 13.0% of the hylan G-F 20 patients. No serious reactions were reported.ConclusionsThis clinical trial demonstrated the non-inferiority of a single intra-articular injection of SH vs hylan G-F 20 on the WOMAC A change from baseline at 6 months.
Highlights
Osteoarthritis (OA) is a degenerative disease mainly affecting the knee joints [1,2,3]
In the Per Protocol dataset (SH: 113, control: 112), the WOMAC A change at 6 months was -34.3 mm (95% confidence interval (CI): -37.8, -30.8) and -36.2 mm for the sodium hyaluronate (SH) and hylan G-F 20 patients, respectively (P = 0.5)
Results were similar in the Full Analysis Set (SH: 139, control: 141) with a difference between the groups of -2.9 mm
Summary
Osteoarthritis (OA) is a degenerative disease mainly affecting the knee joints [1,2,3]. Current treatment strategies for knee OA aim at relieving symptoms and are based on a combination of non-pharmacologic and pharmacologic treatments, as recommended by various scientific societies [8,9,10,11]. Intra-articular HA even seems to offer the best benefit-risk balance among pharmacologic treatments of knee OA [13,20,26,28] and is recommended by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) as second-line treatment in patients with persistent symptomatic OA [13]. The Osteoarthritis Research Society International (OARSI) recommends intra-articular HA injections only after determining whether it can have merit in the context of the individual patient characteristics, comorbidities and preferences, based on an uncertain appropriateness [10]
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