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 (>/=40 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.