title: 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.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinical Trial Registry of India (CTRI/2010/091/000052) www.ctri.nic.in/Clinicaltrials/login.php.
authors.affiliation: Advance Rheumatology Clinic, Andhra Pradesh, India.
authors.forename: Sarvajeet
authors.initials: S
authors.lastname: Pal
authors.affiliation: Kamineni Hospitals, Andhra Pradesh, India.
authors.forename: Sreedhar
authors.initials: S
authors.lastname: Thuppal
authors.affiliation: Apollo Hospitals, Andhra Pradesh, India.
authors.forename: K J
authors.initials: KJ
authors.lastname: Reddy
authors.affiliation: Department of Orthopaedics, GSVM Medical College and Associated Hospital, Uttar Pradesh, India.
authors.forename: Sachin
authors.initials: S
authors.lastname: Avasthi
authors.affiliation: Brij Medical Centre, Uttar Pradesh, India.
authors.forename: Anish
authors.initials: A
authors.lastname: Aggarwal
authors.affiliation: Genzyme India Pvt. Ltd., Haryana, India.
authors.forename: Himanshu
authors.initials: H
authors.lastname: Bansal
authors.affiliation: Sanofi-Synthelabo (India) Ltd., Mumbai, India.
authors.forename: Senthilnathan
authors.initials: S
authors.lastname: Mohanasundaram
authors.affiliation: Genzyme Biosurgery (Formerly), Saint Germain en Laye Cedex, France.
authors.forename: Francois
authors.initials: F
authors.lastname: Bailleul
keywords: Hyaluronan; Western Ontario and McMaster Universities Osteoarthritis Index.; hylan G-F 20; osteoarthritis