Flexion Therapeutics Announces Publication of Analysis of Patients with Unilateral Knee OA from Pivotal Trial of ZILRETTA® (triamcinolone acetonide extended-release injectable suspension)
- Post-hoc analysis published in Advances in Therapy indicated patients with unilateral knee osteoarthritis experienced significant and durable reductions in pain with ZILRETTA vs. immediate-release triamcinolone acetonide
- Patients in ZILRETTA arm experienced profound magnitude of analgesic effect with pain scores reduced by >60%, as measured by Average Daily Pain
- Analysis indicated improvements on OA-specific measures of pain, stiffness, function (WOMAC A, B, C), and quality of life scores lasting up to six months
- Paper examines the debilitating consequences of knee OA among military personnel and highlights ZILRETTA as an important non-opioid option to help manage OA pain
The objective of the analysis was to characterize the primary endpoint of the trial, change in ADP, within a subgroup of randomized patients with unilateral OA knee pain. The analysis showed that patients in this subgroup who were treated with ZILRETTA experienced a profound magnitude of analgesic effect, with ADP scores that were reduced by >60% at Week 3-17. These results suggest that bilateral knee pain may have been a confounding factor in the pivotal trial, which assessed the impact of ZILRETTA treatment in only one knee.
The authors, led by
“Military service members and others working in physically demanding professions often must modify their activity or change roles as a result of persistent OA knee pain, thus highlighting a large unmet medical need for active professionals,” said Dr. Langworthy. “I believe the results of this subgroup analysis lend even further support for ZILRETTA as an effective non-opioid alternative for people suffering from painful knee OA.”
Key topline results from the post-hoc analysis of the Phase 3 study:
- A single intra-articular injection of ZILRETTA provided significant improvement in pain at Week 12 compared with placebo (P<0.0001) and TAcs (P<0.01) to patients with unilateral knee OA, as measured by ADP-intensity scores;
- ZILRETTA provided participants with unilateral knee OA improvements in WOMAC-A (pain), WOMAC-B (stiffness), WOMAC-C (physical function), and quality of life scores (KOOS-QoL) at Weeks 4, 8, and 12 (measured through standardized, verified instruments; P<0.05 for all instruments) compared with TAcs and up to six months compared with placebo (P<0.05); 3,4
- Patients treated with ZILRETTA used less rescue medication for pain compared with both the placebo and TAcs groups; and
- Adverse events (AEs) were similar in frequency across treatment groups, with most AEs reported as mild or moderate and unrelated to the study agent.
“We are pleased to have this post-hoc analysis published in a peer-reviewed journal, as it further reinforces ZILRETTA as an important and effective treatment option offering pain relief to those suffering from OA of the knee,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “This analysis provides us with important insight into the significant benefit ZILRETTA may confer when used to treat isolated knee pain, where the impact is more easily discerned.”
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 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; ZILRETTA's market potential and potential benefits; and expected increases in the rate of individuals with OA of the knee, 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 commercializing new pharmaceutical products in
1. Cameron KL, Driban JB, Svoboda SJ. Osteoarthritis and the tactical athlete: A systematic review. J Athl Train. 2016; 51(11).
2. Cameron KL, Hsiao MS, Owens BD, Burks R, Svoboda SJ. Incidence of physician-diagnosed osteoarthritis among active duty
3. 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.
4. The KOOS (Knee Injury and Osteoarthritis Outcome Score) QoL (Quality of Life) subscale Assesses patients' perceptions about their treated knee and associated problems related to quality of life.
Vice President, Corporate Communications & Investor Relations
Senior Manager, Corporate Communications & Investor Relations
Source: Flexion Therapeutics, Inc.