Cost Effectiveness Analysis of Intra-Articular Triamcinolone Acetonide Extended-Release Injectable Suspension (TA-ER) Versus Triamcinolone Acetonide Crystalline Suspension For Symptomatic Knee Osteoarthritis

Background: Intra-articular corticosteroids are commonly used for pain relief in patients with knee osteoarthritis. Simultaneous intra-articular corticosteroid (CS) knee injections may be beneficial for the ~80–90% of patients who present with, or develop, bilateral knee osteoarthritis, but concurrent injections may increase systemic CS exposure and data on safety/tolerability are lacking. Triamcinolone acetonide extended release (TA-ER) has shown decreased systemic triamcinolone acetonide exposure compared with traditional triamcinolone acetonide crystalline suspension (TAcs) after a single knee injection in patients with knee osteoarthritis. This phase IIa study was designed to assess the safety and systemic triamcinolone acetonide exposure following injections of TA-ER or TAcs into each knee of patients with bilateral knee osteoarthritis. Methods: Patients (⩾40 years) meeting American College of Rheumatology criteria for knee osteoarthritis in both knees received concurrent single intra-articular injections of TA-ER 32 mg or TAcs 40 mg into each knee (total: 64 mg and 80 mg, respectively) and were followed for 6 weeks. Safety was evaluated based on treatment-emergent adverse events (TEAEs). Blood samples for pharmacokinetic analysis were collected pre-injection, and at the following postinjection time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24 h, and days 8, 15, 29, and 43. Results: Baseline characteristics were balanced between patients randomly assigned to TA-ER ( n = 12) or TAcs ( n = 12). Both treatments were well tolerated with comparable TEAE profiles. Peak plasma triamcinolone acetonide concentrations (Cmax) were lower following bilateral TA-ER injections [geometric mean, 2277.7 pg/ml (95% CI, 1602.13–3238.04)] compared with bilateral TAcs injections [7394.7 pg/ml (2201.06–24,843.43)], with median times to Cmax (Tmax) of 4.5 and 6.5 h, respectively. Conclusions: In patients with bilateral knee osteoarthritis, intra-articular injection of TA-ER into both knees was well tolerated. Consistent with pharmacokinetic profiles observed after a single knee injection, plasma triamcinolone acetonide concentrations were lower after bilateral TA-ER injections compared with the higher and more variable concentrations observed after bilateral TAcs injections. ClinicalTrials.gov identifier: NCT03378076

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Synovial and systemic pharmacokinetics (PK) of triamcinolone acetonide (TA) following intra-articular (IA) injection of an extended-release microsphere-based formulation (FX006) or standard crystalline suspension in patients with knee osteoarthritis (OA)

Osteoarthritis and Cartilage ◽

10.1016/j.joca.2017.10.003 ◽

2018 ◽

Vol 26 (1) ◽

pp. 34-42 ◽

Cited By ~ 41

Author(s):

V.B. Kraus ◽

P.G. Conaghan ◽

H.A. Aazami ◽

P. Mehra ◽

A.J. Kivitz ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Triamcinolone Acetonide ◽

Extended Release ◽

Crystalline Suspension

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Clinical and cost-effectiveness of bracing in symptomatic knee osteoarthritis management: protocol for a multicentre, primary care, randomised, parallel-group, superiority trial

BMJ Open ◽

10.1136/bmjopen-2020-048196 ◽

2021 ◽

Vol 11 (3) ◽

pp. e048196

Author(s):

Melanie A Holden ◽

Michael Callaghan ◽

David Felson ◽

Fraser Birrell ◽

Elaine Nicholls ◽

...

Keyword(s):

Cost Effectiveness ◽

Knee Osteoarthritis ◽

Controlled Trial ◽

Analysis Of Covariance ◽

Written Information ◽

Parallel Group ◽

Management Protocol ◽

Adherence Support ◽

Symptomatic Knee Osteoarthritis ◽

Symptomatic Knee

BackgroundBrace effectiveness for knee osteoarthritis (OA) remains unclear and international guidelines offer conflicting recommendations. Our trial will determine the clinical and cost-effectiveness of adding knee bracing (matched to patients’ clinical and radiographic presentation and with adherence support) to a package of advice, written information and exercise instruction delivered by physiotherapists.Methods and analysisA multicentre, pragmatic, two-parallel group, single-blind, superiority, randomised controlled trial with internal pilot and nested qualitative study. 434 eligible participants with symptomatic knee OA identified from general practice, physiotherapy referrals and self-referral will be randomised 1:1 to advice, written information and exercise instruction and knee brace versus advice, written information and exercise instruction alone. The primary analysis will be intention-to-treat comparing treatment arms on the primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score) at the primary endpoint (6 months) adjusted for prespecified covariates. Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation. Analysis of covariance and logistic regression will model continuous and dichotomous outcomes, respectively. Treatment effect estimates will be presented as mean differences or ORs with 95% CIs. Economic evaluation will estimate cost-effectiveness. Semistructured interviews to explore acceptability and experiences of trial interventions will be conducted with participants and physiotherapists delivering interventions.Ethics and disseminationNorth West Preston Research Ethics Committee, the Health Research Authority and Health and Care Research in Wales approved the study (REC Reference: 19/NW/0183; IRAS Reference: 247370). This protocol has been coproduced with stakeholders including patients and public. Findings will be disseminated to patients and a range of stakeholders.Trial registration numberISRCTN28555470.

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