DALLAS — A phase 3 study of sustained-release triamcinolone acetonide showed improvements in pain, stiffness and function for patients with knee osteoarthritis, according to a speaker here.
“If we look at our results, FX006 [sustained-release triamcinolone acetonide, Flexion Therapeutics] did provide statistically significant reductions in average daily pain intensity scores. We met our primary endpoint at week 12,” Andrew I. Spitzer, MD, said at the American Association of Hip and Knee Surgeons Annual Meeting. “If we look at secondary outcomes, you can see that FX006 also provides statistically significant reductions in comparison to placebo and standard triamcinolone acetonide.”
Andrew I. Spitzer
The phase 3 study included 484 patients with a Kellgren Lawrence grade 2/3 knee osteoarthritis and a baseline average daily pain (ADP) score between five and nine on an 11-point rating scale. Spitzer and his colleagues randomly assigned patients to receive daily doses of 40 mg of sustained-release triamcinolone acetonide, placebo or standard triamcinolone acetonide.
Patients’ mean weekly ADP, WOMAC A (pain), B (stiffness), C (function) and KOOS quality-of-life were evaluated at 4-week intervals for 24 weeks. Safety assessments included adverse events monitoring and clinical, laboratory and radiographic evaluations, Spitzer noted.
Compared with the placebo and standard triamcinolone acetonide groups, the sustained-release group had better statistically significant improvements in mean ADP at week 12 and WOMAC A, B and C at 4 weeks, 8 weeks and 12 weeks.
Furthermore, sustained-release triamcinolone acetonide achieved the American Academy of Orthopaedic Surgeons (AAOS) definition for clinically significant improvement.
No patients had serious drug-related adverse events.
“To our knowledge, this is the first time a nonoperative osteoarthritis therapy has surpassed the AAOS defined threshold for clinical relevance. We are continuing to look at other measures of clinical relevance, with pulled datasets that are being accumulated currently,” Spitzer said. – by Nhu Te
Spitzer A, et al. Paper #8. Presented at: American Association of Hip and Knee Surgeons Annual Meeting; Nov. 10-13, 2016; Dallas.
Disclosure: Spitzer reports he has financial interests in DePuy Synthes, Flexion Therapeutics and Sanofi-Aventis.