Long-Term (1-Year) Safety and Efficacy of a Single 6-mL Injection of Hylan G-F 20 in Indian Patients with Symptomatic Knee Osteoarthritis



Sarvajeet Pal 1, Sreedhar Thuppal 2, K.J Reddy3, Sachin Avasthi4, Anish Aggarwal 5, Himanshu Bansal 6, Senthilnathan Mohanasundaram*, 7, Francois Bailleul 8
1 Advance Rheumatology Clinic, Andhra Pradesh, India
2 Kamineni Hospitals, Andhra Pradesh, India
3 Apollo Hospitals, Andhra Pradesh, India
4 Department of Orthopaedics, GSVM Medical College and Associated Hospital, Uttar Pradesh, India
5 Brij Medical Centre, Uttar Pradesh, India
6 Genzyme India Pvt. Ltd., Haryana, India
7 Sanofi-Synthelabo (India) Ltd., Mumbai, India
8 Genzyme Biosurgery (Formerly), Saint Germain en Laye Cedex, France


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© Pal 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 License (http://creativecommons.org/licenses/by-nc/3.0/) 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 Sanofi-Synthelabo (India) Limited, 54/A, Sir Mathuradas Vasanji Road, Andheri (E), Mumbai – 400093, India; Tel: +91 (0) 22 2827 8059; Fax: +91 (0) 22 2827 8052; E-mail: senthilnathan.mohanasundaram@sanofi.com


Abstract

Introduction:

The prevalence of symptomatic knee osteoarthritis (OA) among Asians ≥65 years is estimated to double by 2040. This study was designed to evaluate the safety and efficacy of a single, 6-mL intra-articular injection of hylan G-F 20 in Indian patients with knee OA at 26 weeks through to 52 weeks.

Methods:

This study was an open-label, multicentre, phase 4 clinical trial. Enrolled patients (N=394) were ≥30 years old with Kellgren-Lawrence grade 1–3 OA; all patients received hylan G-F 20. WOMAC, SF-12, PTGA, and COGA scores, and OA medication use were evaluated at weeks 1, 4, 12, 26, 39, and 52 (initial treatment phase). At 26, 39, or 52 weeks, eligible patients could participate in a repeat treatment phase. McNemar-Bowkers, paired t-tests and ANOVA analyses were performed (alpha=0.05).

Results:

At 26 weeks, statistically significant changes from baseline were observed in all efficacy parameters, including the primary efficacy endpoint of WOMAC A1 (p<0.0001). Improvements continued for 52 weeks. No significant changes occurred in concomitant medication use. Eleven patients (2.8%) were re-injected at week 26 or 52. After repeat injection, statistically significant decreases were observed in WOMAC A1, WOMAC C and PTGA scores (p≤0.028). Twenty-three (5.8%) patients reported 26 local target knee AEs.

Conclusion:

Among Indian patients within this study, a 6-mL hylan G-F 20 injection was well tolerated and effective in treating symptomatic knee OA with significant long-term (1 year) improvement of outcomes. When needed, repeat treatment was safe and efficacious for 4 weeks.

Trial Registration:

Clinical Trial Registry of India (CTRI/2010/091/000052) www.ctri.nic.in/Clinicaltrials/login.php.

Keywords: Hyaluronan, hylan G-F 20, osteoarthritis, Western Ontario and McMaster Universities Osteoarthritis Index..