Abstract
BackgroundCorticosteroid injection for knee osteoarthritis is limited by its modest duration of treatment effect. The liposome formulation of dexamethasone sodium phosphate (TLC599) was developed for the sustained relief of osteoarthritis pain. This clinical study was conducted to evaluate the efficacy and safety of TLC599 at two dose levels in patients with knee osteoarthritis.MethodsA randomized, double-blinded, placebo-controlled study was conducted in 75 patients with osteoarthritis of the knee from 13 study centers. Patients were randomized and administered a single intra-articular injection of TLC599 or placebo and assessed for efficacy and safety for 24 weeks. Patient-reported outcomes included the Western Ontario and McMaster Universities Arthritis (WOMAC) Index for pain and function and visual analog scale for pain.ResultsTLC599 at 12 mg demonstrated significantly greater reduction in WOMAC pain through 12 weeks (least squares (LS) mean difference = − 0.37, p = 0.0027) and through 24 weeks (LS mean difference = − 0.35, p = 0.0037) when compared to placebo. TLC599 12 mg also exhibited significantly greater improvement in function when compared to placebo at 24 weeks (LS mean difference = − 0.26, p = 0.0457). TLC599 18 mg did not significantly improve pain or function in comparison with placebo. The use of acetaminophen during the study was less in both TLC599 groups in comparison with placebo. No major or unexpected safety issues were reported.ConclusionsIn participants with symptomatic knee osteoarthritis, TLC599 is a well-tolerated treatment that reduces pain and improves function for up to 24 weeks, a longer duration than that reported for existing IA treatments.Trial registrationClinicalTrials.gov, NCT03005873. Registered on 29 December 2016
Highlights
Corticosteroid injection for knee osteoarthritis is limited by its modest duration of treatment effect
Repeat injections are normally limited to 4 injections annually [10, 11], and it was shown that repeated quarterly IA corticosteroids in knee OA for 2 years were associated with more cartilage loss than saline injection [12]
The 76 participants in the intent-to-treat population included 26 participants assigned to placebo, 26 to TLC599 12 mg, and 24 to TLC599 18 mg (Fig. 1)
Summary
Corticosteroid injection for knee osteoarthritis is limited by its modest duration of treatment effect. The liposome formulation of dexamethasone sodium phosphate (TLC599) was developed for the sustained relief of osteoarthritis pain This clinical study was conducted to evaluate the efficacy and safety of TLC599 at two dose levels in patients with knee osteoarthritis. Non-surgical treatments are usually effective for patients in the early stages of OA (KL grades 1 to 3), while surgical treatment with joint replacement is frequently a choice for patients with endstage knee OA. Pharmacological treatments, such as acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 inhibitors, corticosteroid injections, and tramadol are used by OA patients for symptom relief [6, 7]. A non-opioid treatment that could effectively reduce pain and provide sustained pain relief could fulfill a large unmet need
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