A double-blind, randomized, saline-controlled study of the efficacy and safety of Euflexxa® for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX trial)
Altman RD et al. – Study demonstrates that Euflexxa (1% sodium hyaluronate; IA-BioHA) therapy resulted in significant osteoarthritis (OA) knee pain relief at 26 weeks compared with intra-articular saline (IA-SA). Subjects treated with IA-BioHA also experienced significant improvements in joint function, treatment satisfaction, and HRQoL.Methods- FLEXX trial: assessing the safety and efficacy of IA-BioHA therapy for knee OA at 26 wks
- Subjects with chronic knee OA were randomized to 3 weekly IA injections IA-SA or IA-BioHA (20 mg/2 ml)
- Primary efficacy outcome: subject recorded difference in least-squares means between IA-BioHA and IA-SA following a 50-foot walk test, measured via 100-mm VAS
- Secondary outcome measures:
- Osteoarthritis Research Society International responder index
- Western Ontario McMaster University Osteoarthritis Index VA 3.1 subscales
- Patient global assessment
- Rescue medication, and
- Health-related quality of life (HRQoL) by the SF-36
- Safety assessed by monitoring and reporting vital signs, physical examination of the target knee following injection, adverse events, and concomitant medications
Results- 588 subjects randomized to either IA-BioHA (n=293) or IA-SA (n=295), with an 88% 26 wk completion rate
- No differences were noted between the treatment groups at baseline
- In the IA-BioHA group, mean VAS scores decreased by 25.7 mm, vs 18.5 mm in the IA-SA group
- This corresponded to a median reduction of 53% from baseline for IA-BioHA and a 38% reduction for IA-SA
- The difference in least-squares means was -6.6 mm
- Secondary outcome measures were consistent
- Both IA-SA and IA-BioHA injections were well tolerated, with a low incidence of AEs
- Injection-site reactions were reported by 1 (<1%) subject in the IA-SA group and 2 (1%) in the IA-BioHA group
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