Flexion Therapeutics Announces Publication of Phase 2 Diabetes Data in September Issue of Rheumatology
- Phase 2 data evaluating ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) in patients with Type 2 diabetes demonstrated lower blood glucose levels following ZILRETTA injection compared to TAcs injection
- Approximately 30% of patients with Type 2 diabetes also have osteoarthritis of the knee
An estimated 29 million Americans are living with Type 2 diabetes and approximately 30% of them also have osteoarthritis of the knee.1,2 Intra-articular corticosteroids are commonly used to manage osteoarthritis pain and inflammation and may affect blood glucose levels. Changes in blood glucose levels can pose critical clinical challenges for people with Type 2 diabetes. Recurrent and unaddressed hyperglycemia can lead to ketoacidosis (diabetic coma), kidney damage, heart disease and other serious complications.
“These data show that ZILRETTA did not significantly disrupt glycemic control, an important factor when considering a treatment option to help manage osteoarthritic knee pain for people with diabetes,” said
The primary endpoint compared the change in average glucose values from the period of 72 hours before to the period 72 hours after injection with ZILRETTA versus TAcs. Key findings and conclusions showed:
- Change in average daily glucose levels were significantly lower in the 72 hours following injection of ZILRETTA compared to TAcs with a difference of 19.2mg/dL (p=0.0452);
- Blood glucose increase after injection was statistically significant in those treated with TAcs (p=0.0354), but not in those treated with ZILRETTA (p=0.6665);
- Average daily and hourly blood glucose levels 1-3 days following ZILRETTA injection were well within the
American Diabetes Association-recommended target range; and
- ZILRETTA administration appeared to be associated with minimal disruption of glycemic control in people with osteoarthritis knee pain and Type 2 diabetes.
“Managing osteoarthritis knee pain with immediate-release corticosteroids in the diabetic patient population can be challenging as blood glucose levels often increase substantially following injection,” said
Incidences of adverse events (AEs) in the study were low and similar between the ZILRETTA and TAcs treatment arms. All AEs were Grade 1 (ZILRETTA: 0/18, 0%; TAcs: 2/15, 13.3%) or Grade 2 (ZILRETTA: 2/18, 11.1%; TAcs: 0/15, 0%). No patients treated with ZILRETTA experienced an index-knee or injection-related AE.
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; 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
- Russell SJ, Sala R, Conaghan PG, et al. Triamcinolone acetonide extended-release in patients with osteoarthritis and Type 2 diabetes: a randomized, phase 2 study. Rheumatology. 2018; https://doi.org/10.1093/rheumatology/key265
American Diabetes Association. Accessed July 31, 2018. Available at: http://www.diabetes.org/diabetes-basics/statistics/
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Manager, Corporate Communications
Source: Flexion Therapeutics, Inc.