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

Background Medical therapies for hidradenitis suppurativa (HS) are often ineffective. Tumor necrosis factor-α 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 W...

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Bibliographic Details
Published in:Journal of the American Academy of Dermatology 2009-04, Vol.60 (4), p.565-573
Main Authors: Lee, Robert A., MD, PhD, Dommasch, Erica, BA, Treat, James, MD, Sciacca-Kirby, Joslyn, MD, Chachkin, Samuel, MD, Williams, Jennifer, RN, Shin, Daniel B., BA, Leyden, James J., MD, Vittorio, Carmela, MD, Gelfand, Joel M., MD, MSCE
Format: Article
Language:English
Subjects:
Adult
Biological and medical sciences
clinical trial
Dermatology
efficacy
Etanercept
Female
hidradenitis suppurativa
Hidradenitis Suppurativa - drug therapy
Humans
Immunoglobulin G - therapeutic use
Male
Medical sciences
Middle Aged
Prospective Studies
quality of life
Receptors, Tumor Necrosis Factor - therapeutic use
safety
Skin involvement in other diseases. Miscellaneous. General aspects
tumor necrosis factor inhibitor
Tumor Necrosis Factor-alpha - antagonists & inhibitors
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Summary:Background Medical therapies for hidradenitis suppurativa (HS) are often ineffective. Tumor necrosis factor-α 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-α inhibitors in the treatment of hidradenitis.
ISSN:0190-9622
1097-6787
DOI:10.1016/j.jaad.2008.11.898