Flexion Therapeutics Presents New Data Evaluating Repeat Administration of ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) in Patients with Advanced Knee OA
- An analysis of clinical trial data indicates ZILRETTA reduced pain with similar improvements observed after each of two injections in patients with knee OA classified as Kellgren-Lawrence (KL) Grades 2-4
- >80% of KL Grade 4 patients entering the trial with moderate to severe knee pain subsequently reported either no pain or only mild pain at the earliest timepoint measured (Week 4) following the initial and repeat ZILRETTA injections
- Results presented during a podium session at the
American Orthopaedic SocietySports Medicine conference
An exploratory analysis evaluating the efficacy of initial and repeat administration of ZILRETTA in patients with symptomatic knee OA ranging in radiographic severity from Kellgren-Lawrence (KL) Grades 2 to 4 indicated that ZILRETTA consistently reduced OA knee pain for 12 weeks after each injection, regardless of KL Grade.
“These findings add to the growing body of data for ZILRETTA and highlight the important role it can play in helping patients manage recurrent OA knee pain,” said
The analysis looked at 179 patients with OA knee pain who received two injections of ZILRETTA, 56 (31.3%) of whom had KL Grade 2, 68 (38.0%) had KL Grade 3, and 55 (30.7%) had KL Grade 4. The key findings from the analysis include:
- Median times to second injection were 16.1 weeks for KL Grade 2, 16.9 weeks for KL Grade 3, and 17.1 weeks for KL Grade 4;
- >80% of patients were considered moderate responders (≥30% reduction in pain) and ≥65% of patients were considered substantial responders (≥50% reduction in pain) at Week 12 following each injection;
- ZILRETTA appeared to reliably reduce knee OA pain with similar improvements observed after each injection across all KL Grade subgroups;
- Mean baseline WOMAC-A1 (pain) score was 2.15 across all KL groups;
- At Week 12, mean WOMAC-A scores were 1.24 and 1.20 (KL Grade 2), 1.37 each (KL Grade 3), and 1.34 and 1.36 (KL Grade 4) for the initial and second injection, respectively;
- Prior to injection, >77% of KL Grade 4 patients reported moderate to severe pain, and following initial and repeat ZILRETTA injections 92.5% and 82.4% of these patients, respectively, reported no to mild pain at the earliest timepoint measured (Week 4);
- 63.0% and 60.0% of KL Grade 4 patients reported no to mild pain at Week 12 following initial and repeat ZILRETTA injections, respectively; and
- The incidence of treatment emergent adverse events (AEs) were similar across all KL Grades and the most commonly reported AEs were consistent with those reported in previous clinical studies of ZILRETTA. Importantly, there were no indications of chondrolysis, osteonecrosis, subchondral insufficiency fractures, or clinically significant subchondral bone changes in any subgroup.
An encore presentation of these data will be held on
Indication and Select Important Safety Information for ZILRETTA
Indication: ZILRETTA 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 adults living in the U.S. 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; ZILRETTA's market potential and potential benefits; 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 associated with developing and obtaining regulatory approval for product candidates; the fact that results of past clinical trials may not be predictive of subsequent trials; risks associated with commercializing new pharmaceutical products in
1. WOMAC (Western Ontario and McMaster Universities Arthritis Index) is a validated, widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness and physical functioning of the joints.
Vice President, Corporate Communications & Investor Relations
Senior Manager, Corporate Communications & Investor Relations
Source: Flexion Therapeutics, Inc.