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

Abstract

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.

• Authors: Robert A Lee, Erica Dommasch, James Treat, Joslyn Sciacca-Kirby, Samuel Chachkin, Jennifer Williams, Daniel B Shin, James J Leyden, Carmela Vittorio, Joel M Gelfand
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 60 Issue 4 Pg. 565-73 (Apr 2009) ISSN: 1097-6787 [Electronic] United States
• PMID: 19185954 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Immunoglobulin G
• Receptors, Tumor Necrosis Factor
• Tumor Necrosis Factor-alpha
• Etanercept

Topics

• Adult
• Etanercept
• Female
• Hidradenitis Suppurativa (drug therapy)
• Humans
• Immunoglobulin G (therapeutic use)
• Male
• Middle Aged
• Prospective Studies
• Receptors, Tumor Necrosis Factor (therapeutic use)
• Tumor Necrosis Factor-alpha (antagonists & inhibitors)