Novel intra articular Corticosteroid Injection Eases Knee OA Pain with Single Dose: Study

Intra articular corticosteroids relieve osteoarthritis pain, but rapid systemic absorption limits efficacy. FX006, a novel, microsphere-based, extended-release triamcinolone acetonide (TA) formulation, prolongs TA joint residence and reduces systemic exposure compared with standard TA crystalline suspension (TAcs). Philip G.Conaghan et al conduted a study to assess the symptomatic benefits and safety of FX006 compared with saline-solution placebo and TAcs.

In this phase-3, multicenter, double-blinded, 24-week study, adults aged 40 years or older with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) and average daily pain ADP intensity scores between 5 and 9 on a 0–10 numeric rating scale were randomized (1:1:1) to receive a single intra-articular injection of FX006 (32 mg), saline-solution placebo, or TAcs (40 mg). The primary endpoint was the change from baseline to week 12 in weekly mean average daily pain intensity scores for FX006 compared with placebo. Secondary and exploratory endpoints included additional pain measures, WOMAC scores, KOOS-QOL scores, and safety assessments.

The key findings of the study were:

• The primary endpoint was achieved.

• Among 484 treated patients (161 FX006, 162 placebo, and 161 TAcs), FX006 produced a significant improvement in average daily pain intensity at week 12 compared with placebo (least-squares mean change from baseline: −3.12 versus −2.14; p < 0.0001), representing approximately a 50% improvement.

• FX006 was superior to placebo for all secondary and exploratory endpoints (p < 0.05).

• Improvements in osteoarthritis pain were not significantly different between FX006 and TAcs on the predefined average daily pain-based secondary measures.

• Exploratory analyses of WOMAC pain, stiffness, physical function, and KOOS-QOL favored FX006 (p ≤ 0.05).

• Adverse events were generally mild and occurred at similar frequencies across treatment groups.

“In summary, this randomized, double-blinded trial demonstrated sustained and clinically meaningful reductions in pain in knee osteoarthritis following a single intra-articular injection of a novel microsphere-based corticosteroid formulation that prolongs triamcinolone acetonide (TA) residency in synovial tissues compared with saline-solution placebo (primary outcome). No osteoarthritis flare or important adverse event (AE) signals were observed. The observed magnitude and persistence of pain-intensity reduction suggest that FX006 may have a place in knee osteoarthritis treatment paradigms” the authors commented.

Level of Evidence: Therapeutic Level I.

For further details on the article refer to:

Effects of a Single Intra-Articular Injection of a Microsphere Formulation of Triamcinolone Acetonide on Knee Osteoarthritis Pain A Double-Blinded, Randomized, Placebo-Controlled, Multinational Study

Philip G.Conaghan et al

J Bone Joint Surg Am.2018;100:666-77

http://dx.doi.org/10.2106/JBJS.17.00154