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



Robert Heger1, *, Günther Paulsen2, Ulrich Fickert3, Michael Kresmann4
1 Praxis für Orthopädie, Eltinger Straße 56 71229 Leonberg, Germany
2 Chirurgische Gemeinschaftspraxis, Katharinenstr 34, 75031 Eppingen, Germany
3 Chirurgische Praxis, Am Kutzschenstein 2, 01591 Riesa, Germany
4 Gemeinschaftspraxis für Orthopädie, Bahnhofsallee 20, 40721 Hilden, Germany


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© Heger et al.; Licensee Bentham Open

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution-Non-Commercial 4.0 International Public License (CC BY-NC 4.0) (https://creativecommons.org/licenses/by-nc/4.0/legalcode), which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

* Address correspondence to this author at the Praxis für Orthopädie, Eltinger Straße 56 71229 Leonberg, Germany; Tel: +49 7152 25083; Fax:+49 715 221 699; E-mail: robert-heger@t-online.de


Abstract

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.

Keywords: Hyaluronan, Hyaluronic acid, Hylan, Knee, Osteoarthritis, Pain.