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Abstract Number: 1371

Systemic Exposure of Triamcinolone Acetonide Following Bilateral Injection of Extended-Release Triamcinolone Acetonide and Standard Triamcinolone in Patients with Bilateral Knee Osteoarthritis

Alan J. Kivitz1, Louis Kwong2, Tammi Shlotzhauer3, Joelle Lufkin4, Teresa Curto5 and Scott Kelley4, 1Altoona Center for Clinical Research, Duncansville, PA, 2Department of Orthopaedic Surgery, Harbor-UCLA Medical Center, Torrance, CA, 3Rochester Clinical Research, Inc., Rochester, NY, 4Flexion Therapeutics, Inc., Burlington, MA, 5Cytel Inc., Waltham, MA

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: corticosteroids, Knee, Osteoarthritis, pharmacokinetics and safety

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Session Information

Date: Monday, October 22, 2018

Session Title: Osteoarthritis – Clinical Poster II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Current ACR guidelines recommend the use of IACS for short-term acute pain relief in patients (pts) with knee OA.1 Bilateral knee OA can occur concurrently or subsequently develop in 80-90% of pts with unilateral disease.2,3 These pts may benefit from simultaneous IACS treatment of both knees. Triamcinolone acetonide extended-release (TA-ER; formerly FX006) is an extended-release, microsphere-based formulation of triamcinolone acetonide (TA) recently approved by the FDA for knee OA pain.4 In a phase 2 study, a single TA-ER injection demonstrated reduced systemic TA exposure relative to standard TA crystalline suspension (TAcs).5 Here, we assessed safety and systemic TA exposure following IA injection of TA-ER or TAcs into both knees in pts with bilateral knee OA.

 

Methods: In this phase 2, randomized, open-label study (NCT03378076), pts (≥40 years, BMI ≤40 kg/m2) meeting ACR clinical/radiographic criteria for bilateral knee OA received 2 IA injections (one in each knee) of TA-ER 32 mg (total 64 mg) or TAcs 40 mg (total 80 mg) and followed for 6 weeks. Safety was evaluated based on adverse events (AEs), physical exams, knee assessments, vital signs, and laboratory evaluations. Blood samples for plasma pharmacokinetics (PK) were collected at baseline (within 1 hour prior to injection), at Hours 1-6, 8, 10, and 12 postinjection, and on Days 2, 8, 15, 29, and 43. Plasma TA concentrations were assayed with a validated LC-MS/MS method.

 

Results: Twenty-four pts (TA-ER, n=12; TAcs, n=12) were randomized and included in safety and PK analyses. Baseline characteristics were well balanced. Eight of 12 and 5 of 12 pts had ≥1 treatment-emergent AE in the TA-ER and TAcs treatment group, respectively. AE profiles were similar, and both treatments were well tolerated. TA-ER plasma concentrations peaked at median 4.5 hours with a mean Cmax (±SD) of 2577.8 (1225.22) pg/mL, whereas TAcs peaked at median 6.5 hours with a mean Cmax (±SD) of 24289.4 (27123.34) pg/mL (Figure 1 and Table 1).

 

Conclusion: In pts with bilateral knee OA, IA injection of TA-ER into both knees was generally safe and well tolerated. Peak plasma TA concentrations were substantially lower in patients treated with TA-ER, demonstrating reduced systemic exposure relative to TAcs consistent with the PK profile of a single TA-ER injection.

 

References:

1.     Hochberg M et al. Arthritis Care Res (Hoboken). 2012;64(4):465-74

2.     Metcalfe A et al. BMC Musculoskelet Disord. 2012;13:153

3.     Jones R et al. J Rheumatol. 2013;40(3):309-15

4.     Conaghan P et al. J Bone Joint Surg Am. 2018;100(8):666-77

5.     Kraus V et al. Osteoarthritis Cartilage. 2018;26(1):34-42

 

 

 


Disclosure: A. J. Kivitz, Flexion Therapeutics, 8; L. Kwong, Flexion Therapeutics, 2, 8,Bone Support, 2,Janssen, 2,Pfizer, Inc., 2,Regeneron, 2,Stryker, 2,ConvaTec, 8,Journal of Surgical Orthopaedic Advances, 6,Zimmer, 1, 2, 5, 8; T. Shlotzhauer, None; J. Lufkin, FlexionTherapeutics, 1, 3; T. Curto, None; S. Kelley, Flexion Therapeutics, 1, 3.

To cite this abstract in AMA style:

Kivitz AJ, Kwong L, Shlotzhauer T, Lufkin J, Curto T, Kelley S. Systemic Exposure of Triamcinolone Acetonide Following Bilateral Injection of Extended-Release Triamcinolone Acetonide and Standard Triamcinolone in Patients with Bilateral Knee Osteoarthritis [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/systemic-exposure-of-triamcinolone-acetonide-following-bilateral-injection-of-extended-release-triamcinolone-acetonide-and-standard-triamcinolone-in-patients-with-bilateral-knee-osteoarthritis/. Accessed January 31, 2023.
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