Lee JK et al. – This study evaluated the safety and efficacy of repeated intra–articular injection of high molecular weight hyaluronic acid (LBSA0103) at a 26–week interval, in 185 patients with osteoarthritis of the knee. In conclusion, repeated intra–articular injection of LBSA0103 was safe at a 26–week interval and it was shown to be effective for reduction of osteoarthritis knee pain and in maintenance of pain reduction for a period of 39 weeks following administration of a second injection.

Methods

• Open–label, single–arm multicenter prospective trial, in which 174 patients received the first injection and 153 patients received both the injections of LBSA0103.

Results

• A total of 9 adverse reactions were reported in 4.02% patients following the first injection, whereas only 1 adverse drug reaction was reported in 0.65% patients following the second injection.
• Significant improvements in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score and weight–bearing pain were reported at both 13 and 39 weeks compared to baseline, which were consistent after the second injection.
Improvements following the second injection were consistent with those following the first injection (between weeks 26 and 39).