Open-label Study of Initial and Repeat Treatment Cycles of Hylan G-F 20 in Patients with Symptomatic Knee Osteoarthritis.

OBJECTIVE

To evaluate the efficacy and safety of initial and repeat treatment with hylan G-F 20 in patients with symptomatic osteoarthritis (OA) of the knee.

METHODS

A prospective, multicenter, open-label study in adult patients with symptomatic knee OA (Kellgren-Lawrence grades I-III) undergoing repeat (SC group) or initial (IC group) treatment courses (3 x 2 mL of hylan G-F 20 at weekly intervals) was conducted with a maximum follow-up of 26 weeks. Reduction of pain using the Verbal Pain Questionnaire (VPQ) and Patient Global Assessment (PTGA) scores, concomitant pain medications use, and adverse events (AEs) were evaluated.

RESULTS

A total of 842 patients were included (SC group, n=314; IC group, n=528), of whom 616 formed the intent-to-treat (ITT) population (SC group, n=235; IC group, n=381). Of the 462 patients with follow-up at week 26, 311 (67.3%) were defined as responders. In the ITT population, VPQ scores decreased significantly at 26 weeks (p<0.001) compared with baseline. VPQ and PTGA scores decreased significantly (p<0.001) from baseline at all time points, without any significant changes in concomitant medication use. Twenty-four treatment-related AEs (TEAEs) were reported in 2.9% of patients, with most being mild or moderate in intensity and resolving without sequelae.

CONCLUSION

Initial and repeat courses of hylan G-F 20 were effective with a favorable safety profile for knee OA. The large patient population and the study's pragmatic design suggest that these results could be replicated in routine clinical practice.