Post-hoc analysis of phase III trial of Zilretta shows significant pain relief post osteoarthritis knee surgery.- Flexion Therapeutics
Flexion Therapeutics announced results from a sensitivity analysis evaluating the treatment effects of a single administration of Zilretta (triamcinolone acetonide extended-release injectable suspension) in patients with moderate-to-severe osteoarthritis (OA) pain on both the Average Daily Pain (ADP) and WOMAC-A1 (pain) scales. The post-hoc analysis of data from the pivotal Phase III trial indicated that in patients who reported moderate-to-severe pain at baseline on the two reporting instruments, Zilretta provided statistically significant and clinically meaningful pain relief compared with immediate-release triamcinolone acetonide in crystalline suspension (TAcs) and placebo.
The findings suggest that pre-treatment concordance across two pain assays may serve as an important patient eligibility criterion in future clinical trials. Zilretta significantly (P<0.05) improved adp scores compared with tacs (weeks 5-19) and placebo (weeks 1-20), and the proportion of patients reporting no knee pain (adp score="0)" at week 12 was higher with zilretta (~28%) compared with tacs (~8%); zilretta significantly (p><0.05) improved womac-a scores at weeks 4, 8, and 12 (zilretta vs tacs) and weeks 4, 8, 12 and 16 (zilretta vs placebo); zilretta significantly (p><0.05) reduced rescue medication use from weeks 2-20 (zilretta vs tacs) and weeks 1-24 (zilretta vs placebo); and baseline characteristics and adverse event profiles were consistent with those of the overall phase iii population.>
The results of this post hoc analysis may have implications for study design and patient recruitment of future trials evaluating efficacy of intra-articular interventions for OA knee pain.The data was presented in a poster session (Poster: 285) on November 8 at the recent American Association of Hip and Knee Surgeons (AAHKS) Annual Meeting. An encore presentation of these findings will be given at the American College of Rheumatology Annual Meeting.
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