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A Second Cycle of Injectable Hyaluronic Acid for Knee Osteoarthritis Pain Is Safe, Effective: Presented at EULAR
By Bruce Sylvester
COPENHAGEN -- June 14, 2009 -- A second cycle of hyaluronic acid (hylan) G-F 20 injection therapy is safe for treating patients with symptomatic knee osteoarthritis, researchers reported at the 10th Annual Congress of the European League Against Rheumatism (EULAR).
"Previously, we did not have data to determine whether or not a second hylan G-F 20 was as safe and as effective as the first injection. In this study we found that it is both," said Axel Schulz, MD, Genzyme Germany, Neu Isenberg, Germany, on June 12.
The investigators conducted this prospective, multicentre, observational study to evaluate the safety and efficacy of a second cycle of hylan G-F 20 injection treatments (1 injection of 2 mL per week for 3 consecutive weeks) in 171 patients with osteoarthritic knee pain.
The patients self-assessed their pain on a 5-point scale before, and 3 weeks after, the first injection. The investigators evaluated patient and physician global assessments. They also evaluated adverse events at the same timepoints.
For comparison, the researchers also observed a set of 412 patients receiving a first treatment cycle of hylan G-F 20.
Interim analysis showed local treatment-related adverse events in the injected knee in 2.3% of patients (1.23% of injections), and they were mostly mild or moderate. The investigators reported no serious, treatment-related adverse events.
For patients receiving a second treatment cycle 3 weeks after the first injection, pain decreased significantly (P < .001) compared with pretreatment baseline scores, and 90.6% of patients described their knee osteoarthritis pain as "better" (56.7%) or "much better" (33.9%).
For 91.3% of patients, physician assessments showed outcomes as "good" (59.1%) or "excellent" (32.2%).
The investigators found no statistically significant differences in the incidence of adverse events or in efficacy measures between the repeat-treatment group and the comparison group.
Funding for this study was provided by Genzyme Germany.
[Presentation title: Tolerability and Short Term Effectiveness of Repeated Treatment Cycles of Hylan G-F 20 in 171 Patients With Knee Osteoarthritis Pain. Abstract FRI0373]
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