A prospective clinical trial of open-label etanercept for the treatment of hidradenitis suppurativa.

Author(s): Lee RA, Dommasch E, Treat J, Sciacca-Kirby J, Chachkin S, Williams J, Shin DB, Leyden JJ, Vittorio C, Gelfand JM

Affiliation(s): Department of Dermatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104, USA.

Publication date & source: 2009-04, J Am Acad Dermatol., 60(4):565-73. Epub 2009 Jan 31.

Publication type: Clinical Trial, Phase II; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't

BACKGROUND: Medical therapies for hidradenitis suppurativa (HS) are often ineffective. Tumor necrosis factor-alpha inhibitors may be a potential treatment for patients with moderate to severe HS. OBJECTIVES: We sought to evaluate the safety and efficacy of etanercept for patients with severe HS. METHODS: We conducted a phase II clinical trial of etanercept (50 mg/wk subcutaneously) in patients with moderate to severe HS. Efficacy was measured using a Physician Global Assessment and several secondary physician- and patient-reported outcome measures. Responders were classified as those achieving at least a 50% reduction on the Physician Global Assessment score at week 12 compared with baseline. RESULTS: Only 3 of the 15 patients who entered the study were classified as responders (response rate of 20%; 95% confidence interval: 4.3-48.1) based on the intention-to-treat analysis. Dermatology Life Quality Index scores improved slightly from a median of 19 to 15 (P = .02). Comparison of baseline with week-12 Physician Global Assessment scores, and secondary outcome measures of lesion counts and patient pain scores, failed to show statistically significant improvement. Etanercept was generally well tolerated; however, two patients discontinued the study as a result of skin infections at the site of hidradenitis lesions requiring oral antibiotics. LIMITATIONS: Lack of a control group and a small number of participants are limitations. CONCLUSIONS: Our study demonstrated minimal evidence of clinically significant efficacy of etanercept (50 mg/wk subcutaneously) in the treatment of hidradenitis. Future studies using higher doses of etanercept are indicated; however, patients need to be carefully monitored for infection and other adverse events. Randomized, controlled trials will be necessary to demonstrate the risk-to-benefit ratio of tumor necrosis factor-alpha inhibitors in the treatment of hidradenitis.