Evaluating the tolerability and efficacy of etanercept compared to triamcinolone acetonide for the intralesional treatment of keloids.

BACKGROUND: Tumor necrosis factor-alpha (TNF-alpha) is a proinflammatory and profibrotic cytokine that inhibits degradation of collagen and glycosaminoglycans. Etanercept, a recombinant TNF-alpha receptor fusion protein, may decrease excessive fibrous tissue in keloids. OBJECTIVE: To evaluate the tolerability and efficacy of etanercept as compared to triamcinolone acetonide (TAC) for the treatment of keloids. METHODS: Twenty subjects were randomly assigned to receive monthly intralesional injections of either 25 mg of etanercept or 20 mg of TAC for 2 months. Keloids were evaluated at baseline, week 4, and week 8 by subjects and investigators in a blinded fashion using physical, clinical, and cosmetic parameters. Photographs were taken and adverse events were noted during each evaluation. RESULTS: Etanercept improved 5/12 parameters including significant pruritus reduction, while TAC improved 11/12 parameters at week 8, although no statistical difference was observed as compared to baseline. There was no significant difference between the 2 treatment groups. Both treatments were safe and well tolerated. CONCLUSION: Etanercept was safe, well tolerated, improved several keloid parameters, and reduced pruritus to a greater degree than TAC therapy. However, further studies are required before it can be recommended for the treatment of keloids.