A 52-WEEK, OPEN-LABEL STUDY OF A SECOND COURSE OF HYLAN G-F 20 FOR THE TREATMENT OF OSTEOARTHRITIC KNEE PAIN

Abstract

Hylan G-F 20 is approved to treat pain of osteoarthritis (OA) of the knee for up to 6 months. A second course of therapy may extend pain relief for longer periods. PURPOSE To evaluate the efficacy and safety of a second course of hylan G-F 20 for the treatment of OA knee pain for up to 52 weeks. METHODS Generally healthy men or women (n=70; age ≥ 40years) with knee OA received a second course of 3 intra-articular injections of hylan G-F 20 (2 mL) at 1-week intervals starting at baseline. Patients received a first course of therapy at least 3 months earlier. RESULTS Mean time between first and second courses was 19.6 months. All efficacy parameters (see table) were significantly lower than baseline with hylan G-F 20 at all timepoints measured (weeks 1, 2, 4, 8, 12, 26, and 52; p < 0.001). The table shows results for weeks 26 and 52. At baseline, the majority of patients had moderate to severe pain with no patients reporting mild or no pain, while most patients reported mild or no pain at weeks 26 and 52. The incidence of arthralgia (0.9%), arthrosis (4.6%), and arthritis (0.5%) in the target knee per injection was low. The types of related local adverse events seen with the second course of therapy were similar to those reported in the current prescribing materials.Table: Changes from Baseline at Weeks 26 and 52 for the Intent-to-Treat PopulationCONCLUSION A second course of hylan G-F 20 is generally well tolerated and may provide pain relief for up to 52 weeks after an initial successful course of therapy.