Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee

• Published in: Drugs (New York, N.Y.) N.Y.), 2019-03, Vol.79 (4), p.455-462
• Main Authors: Paik, Julia, Duggan, Sean T., Keam, Susan J.
• Format: Article
• Language: English
• Subjects: Acids; Adis Drug Evaluation; Arthritis; Biocompatibility; Cartilage; Cartilage diseases; Clinical trials; Clinical Trials, Phase III as Topic; Corticoids; Corticosteroids; Delayed-Action Preparations - adverse effects; Delayed-Action Preparations - therapeutic use; Diabetes; Drug Approval; Drug Delivery Systems; Feasibility studies; Glycolic acid; Humans; Injection; Injections, Intra-Articular; Internal Medicine; Joints (anatomy); Knee; Medicine; Medicine & Public Health; Microspheres; Osteoarthritis; Osteoarthritis, Knee - drug therapy; Pain; Pain - drug therapy; Pharmacology/Toxicology; Pharmacotherapy; Polylactic Acid-Polyglycolic Acid Copolymer - chemistry; Polylactide-co-glycolide; Randomized Controlled Trials as Topic; Rheumatology; Stiffness; Synovial Membrane - drug effects; Synovium; Triamcinolone acetonide; Triamcinolone Acetonide - adverse effects; Triamcinolone Acetonide - therapeutic use; United States; United States Food and Drug Administration
• ISSN: 0012-6667; 1179-1950
• DOI: 10.1007/s40265-019-01083-3

Triamcinolone acetonide extended-release (ER) 32 mg (Zilretta ® ) is approved in the USA for the management of osteoarthritis (OA) pain of the knee and is administered as a single, 5 mL intra-articular (IA) injection. Although the therapeutic effects from IA corticosteroids are typically short-lived, triamcinolone acetonide ER is formulated in poly (lactic-co-glycolic acid) (PLGA) microspheres that slowly release triamcinolone acetonide in the synovium, enabling their prolonged presence in the joint. This reduces systemic exposure and lessens corticosteroid-related systemic adverse reactions, such as blood glucose elevations. In a 24-week, randomized, phase III clinical trial, triamcinolone acetonide ER 32 mg significantly improved mean average daily pain intensity in patients with knee OA relative to placebo, and pain, stiffness and physical function (according to WOMAC criteria) relative to placebo and triamcinolone acetonide crystalline suspension (CS). Triamcinolone acetonide ER was generally well tolerated, with a tolerability profile similar to that of triamcinolone acetonide CS and placebo. Findings from a single-arm phase IIIb study indicated that a repeat administration of triamcinolone acetonide ER may be similarly efficacious to an initial injection without having deleterious effects on cartilage or other aspects of joint structure. Thus, triamcinolone acetonide ER expands the treatment options available for the management of OA pain of the knee.