Flexion Therapeutics Presents ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) Efficacy Data at the AAHKS and ACR Annual Meetings
- Post-hoc sensitivity analysis assessed efficacy in patients who reported moderate-to-severe osteoarthritis (OA) pain prior to treatment on both ADP and WOMAC-A scales
- In this analysis of concordant pain reporters, ZILRETTA provided durable pain relief that was statistically significant and clinically meaningful compared with immediate-release triamcinolone acetonide
The findings suggest that pre-treatment concordance across two pain assays may serve as an important patient eligibility criterion in future clinical trials. The data was presented in a poster session (Poster: 285) on
“The results indicate that concordant pain reporters may be better able to discern treatment effect. Our analysis revealed that a number of study participants had elevated baseline ADP scores compared to WOMAC-A pain scores prior to treatment,” said
Study participants received either a single injection of ZILRETTA, TAcs or placebo. Patient-reported ADP‐intensity, WOMAC-A scores, and rescue medication usage were assessed throughout the study, and 60.3% (292/484) of patients with knee OA (Kellgren-Lawrence Grade 2-3) reported moderate-to-severe OA pain at baseline using both instruments (ADP ≥5 to ≤9 and WOMAC-A ≥2).
In concordant pain reporters:
- 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 3 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.
Indication and Select Important Safety Information for ZILRETTA® (triamcinolone acetonide extended-release injectable suspension)
Indication: ZILRETTA (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. It is not intended for repeat administration.
Contraindication: ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product.
Warnings and Precautions:
- Intra-articular Use Only: ZILRETTA has not been evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. ZILRETTA should not be considered safe for epidural or intrathecal administration.
- Serious Neurologic Adverse Reactions with
Epidural and Intrathecal Administration: Serious neurologic events have been reported following epidural or intrathecal corticosteroid administration. Corticosteroids are not approved for this use.
- Hypersensitivity reactions: Serious reactions have been reported with triamcinolone acetonide injection. Institute appropriate care if an anaphylactic reaction occurs.
- Joint infection and damage: A marked increase in joint pain, joint swelling, restricted motion, fever and malaise may suggest septic arthritis. If this occurs, conduct appropriate evaluation and if confirmed, institute appropriate antimicrobial treatment.
Adverse Reactions: The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough, and contusions.
Please see ZilrettaLabel.com for full Prescribing Information.
About Osteoarthritis (OA) of the Knee
OA, also known as degenerative joint disease, affects more than 30 million Americans and accounts for more than
This release contains forward-looking statements that are based on the current expectations and beliefs of Flexion. Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; potential implications of data analysis for future clinical trial designs; expected increases in the rate of individuals with OA of the knee; and the potential therapeutic and other benefits of ZILRETTA, are forward looking statements. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation; risks inherent in clinical development and the regulatory approval process, including the risk that future clinical results will not be consistent with prior results; risks related to the market and market conditions; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (
1. WOMAC (
Source: Flexion Therapeutics, Inc.