Intra articular Diclofenac-hyaluronate conjugate effective in relieving hip osteoarthritis pain

When delivered every four weeks, intra-articular diclofenac etalhyaluronate (DF-HA) provided a quick response and was safe, with analgesia lasting 12 weeks in patients with osteoarthritis (OA) of the hip, says an article published in BMC Musculoskeletal Disorders.

Osteoarthritis is a joint condition that commonly affects middle-aged and older persons, lowering their quality of life (QOL) by interfering with everyday activities due to pain, swelling, and deformity. OA may affect every joint in the body, including the hip, knee, shoulder, ankle, and elbow. Diclofenac etalhyaluronate (DF-HA), which will be licensed in Japan in March 2021 for the treatment of knee and hip OA, is a new intra-articular injectable drug composed of fermentation-derived HA (600,000 to 1,200,000 Da) chemically coupled with diclofenac sodium (DF), an NSAID.

Toshikazu Kubo and colleagues designed this study to assess the efficacy and safety of intra-articular DF-HA provided every 4 weeks in joints with OA other than the knee, and in particular to see if DF-HA had comparable efficacy and safety profiles in other joints afflicted by OA as the knee.

Japanese patients aged 20 years reported with OA of the ankle, hip, shoulder, or elbow were randomly allocated 1:1 to DF-HA 30 mg or placebo in this randomized, placebo-controlled, double-blind trial in Japan (citric acid-sodium citrate buffered solution). Subjects were examined 12 weeks after the first injection and received three injections of the study medication in each joint cavity every four weeks. The primary objective was the mean change from baseline in a 12-week diary-based 11-point numerical rating scale (NRS) for pain. Treatment-emergent side effects were documented, and radiographic changes in each joint were assessed.

The key findings of this study were as follow:

1. The research treatment (DF-HA versus placebo) was given to 90, 60, 90, or 50 people with hip, ankle, shoulder, or elbow OA (46 vs 44, 30 vs 30, 45 vs 45, and 25 vs 25, respectively).

2. The mean change from baseline in the pain NRS over 12 weeks for the hip, ankle, shoulder, and elbow joints was -0.81, -0.07 (-1.03 to 0.89), 0.15 (-0.48 to 0.78), and 0.61 (-0.41 to 1.62), with statistically significant changes detected only in the hip joint.

3. At all time intervals from Weeks 1 to 12, the change from baseline in the hip joint was larger with DF-HA than with placebo and there were no clinically significant adverse effects or radiological abnormalities.

Reference:

Kubo, T., Kumai, T., Ikegami, H., Kano, K., Nishii, M., & Seo, T. (2022). Diclofenac–hyaluronate conjugate (diclofenac etalhyaluronate) intra-articular injection for hip, ankle, shoulder, and elbow osteoarthritis: a randomized controlled trial. In BMC Musculoskeletal Disorders (Vol. 23, Issue 1). Springer Science and Business Media LLC. https://doi.org/10.1186/s12891-022-05328-3