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.

Objective: To evaluate the efficacy and tolerability of a second course of hylan G-F 20 for the treatment of osteoarthritic knee pain in patients who experienced a clinical benefit with an initial course of therapy.Research design and methods: In this prospective, open-label study, men or women (greater than or equal to40 years of age) with knee osteoarthritis (OA) received three weekly injections of hylan G-F 20. Consecutive patients who requested a second course of hylan G-F 20 therapy due to OA knee pain subsequent to pain relief with a first course of therapy were enrolled between October 26, 2000 and January 18, 2001.Main outcome measures: Pain while walking on a flat surface (Western Ontario and McMaster's Universities Osteoarthritis Index, WOMAC, question A1), WOMAC domain C (physical functioning), full WOMAC, and patient and investigator overall visual analog scales (VAS). Efficacy variables were measured at baseline and at weeks 1, 2, 4, 8, 12 and 26. An analgesic washout was required before all efficacy evaluations.Results: Patients receiving at least one injection of hylan G-F 20 (n = 71) were predominantly Caucasian (84.5%) and female (64.8%), with a mean age of 65.5 years and mean weight of 200.1 pounds. The mean time between the first and second courses of hylan G-F 20 was 19.6 months (median 17.6 months). With hylan G-F 20, pain while walking on a flat surface was significantly lower (p < 0.001) than baseline at all time points up to week 26 (mean +/- SEM: -1.40 +/- 0.10 at week 26). Actual scores decreased from 2.4 +/- 0.10 at baseline to 0.97 +/- 0.11 at week 26. Scores for the WOMAC domain C, full WOMAC and patient and investigator overall VAS also significantly improved (p < 0.001) at all time points. A second course of hylan G-F 20 was generally well-tolerated, based on the low incidence of local adverse events (AEs) only one patient (1.4%) experienced a severe event, the types of AEs, and the fact that no patients discontinued the study due to these AEs. The types of related AEs observed were not qualitatively different from those listed in the current product information and published literature.Conclusion: A second course of hylan G-F 20 therapy is an appropriate therapy for the treatment of OA knee pain in patients who had a previous favorable clinical response. For continued relief of osteoarthritis knee pain, this study supports repeat use of hylan G-F 20 in these patients.