Abstract
BackgroundWe evaluated the 1-year safety and efficacy of diclofenac etalhyaluronate (DF-HA), a diclofenac-conjugated hyaluronate, in patients with osteoarthritis (OA).MethodsIn this multi-centre, open-label, noncomparative phase 3 study in Japan, patients with a diagnosis of knee, shoulder, elbow, hip, or ankle OA received an intra-articular (IA) injection of DF-HA 30 mg every 4 weeks for 1 year (13 times in total). The safety outcomes included treatment-emergent adverse events (TEAEs) and target joint structural changes by X-ray imaging tests. Efficacy outcomes included joint pain scores on an 11-point numerical rating scale. Concomitant use of analgesics was not restricted.ResultsOverall, 166 eligible patients were enrolled, comprising knee OA (n = 126) and other OA (n = 40). All TEAEs were experienced by 126/166 patients (75.9%). The incidence of treatment-related TEAEs was not associated with the treatment period. No significant worsening of joint status was observed in X-ray imaging tests at week 52 or at last assessment. The mean joint pain scores (± standard deviation) were 5.9 ± 1.2, 4.9 ± 1.9, and 3.1 ± 2.3 at baseline, and weeks 2 and 52, respectively. Improvement of pain score was observed after the first injection and was maintained until week 52 regardless of knee OA or other joint OA.ConclusionsRepeated IA injections of DF-HA every 4 weeks for 1 year were well tolerated with no clinically significant adverse events indicating they might lead to the long-term improvement of OA symptoms. DF-HA might be a useful treatment for patients with OA.Trial registration numberJapicCTI-183855 (First registered date: 6th February 2018).
Highlights
We evaluated the 1-year safety and efficacy of diclofenac etalhyaluronate (DF-HA), a diclofenacconjugated hyaluronate, in patients with osteoarthritis (OA)
Patients Between February 2018 and August 2019, 172 patients were screened for eligibility from 10 sites and 166 patients were enrolled comprising knee OA (n = 126), shoulder OA (n = 15), elbow OA (n = 8), hip OA (n = 9), and ankle OA (n = 8) (Fig. 1)
All data from 166 enrolled patients were included in the full analysis set (FAS) and safety set and 157 patients completed the study (Fig. 1)
Summary
We evaluated the 1-year safety and efficacy of diclofenac etalhyaluronate (DF-HA), a diclofenacconjugated hyaluronate, in patients with osteoarthritis (OA). The pharmacological therapy approaches for OA commonly involve the oral or topical administration of nonsteroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 inhibitors as well as intra-articular (IA) corticosteroids or hyaluronan (HA) for knee OA [2, 3]. Long-term oral administration of NSAIDs increases the risk of gastrointestinal (GI) bleeding [4]. Because of the potential risk related to the long-term use of NSAIDs, it is recommended they are used at the lowest effective dose for the shortest possible time in patients with these risks [2, 3]. There is concern about the long-term use of IA corticosteroids because of the increased risk of accelerated OA progression or adverse joint events [5,6,7]. Medications available for longterm therapy with sufficient safety and efficacy are anticipated in patients with OA [5,6,7]
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