Tolerability and short-term effectiveness of hylan G-F 20 in 4253 patients with osteoarthritis of the knee in clinical practice.

OBJECTIVE

To determine the tolerability and short-term effectiveness of hylan G-F 20 (Synvisc) in patients with symptomatic osteoarthritis (OA) of the knee in standard clinical practice.

RESEARCH DESIGN AND METHODS

Over 800 orthopedic surgeons in Germany recorded adverse events (AEs) for approximately five consecutive patients each following 3 weekly intra-articular hylan G-F 20 injections. Patients assessed their pain on a 4-point scale before and 3 weeks after the first injection. Potential risk factors for local AEs and possible predictors of short-term effectiveness of hylan G-F 20 were explored with logistic regression.

RESULTS

4253 patients were treated with 12699 injections by 840 physicians at 720 sites. Local, treatment related AEs (n = 302) were reported in 180 patients (4.2% of patients; 2.4% of injections). The most frequently reported AEs were joint effusion (2.4% of patients), joint swelling (1.3%), arthralgia (1.2%), joint warmth (0.6%), and injection site erythema (0.3%). Most AEs were mild (21.4%) to moderate (40.3%) in nature. One patient experienced a serious AE of severe swelling and synovial fluid accumulation judged as possibly treatment related. Patients < 70 years old, patients with a longer time since diagnosis, and those previously treated with visco-supplementation were more likely to experience a local AE. Pain significantly (p < 0.0001) decreased 3 weeks after the first injection compared with before treatment. Potential predictors of hylan G-F 20 short-term effectiveness were being underweight, male gender, shorter time since diagnosis, and severe baseline pain.

CONCLUSIONS

In this population of 4253 patients treated with hylan G-F 20 for OA knee pain, the overall incidence of local, treatment-related AEs was low and consistent with those reported in the current US product labeling and previously published studies. Additionally, short-term effectiveness was confirmed.