A prospective clinical trial of open-label etanercept for the treatment of hidradenitis suppurativa - 08/08/11
Abstract |
Background |
Medical therapies for hidradenitis suppurativa (HS) are often ineffective. Tumor necrosis factor-⍺ 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-⍺ inhibitors in the treatment of hidradenitis.
Le texte complet de cet article est disponible en PDF.Key words : clinical trial, efficacy, etanercept, hidradenitis suppurativa, quality of life, safety, tumor necrosis factor inhibitor
Abbreviations used : AT, BMI, DLQI, HS, ITT, PGA, SC, TNF
Plan
Supported by an unrestricted grant from Amgen and grant K23AR051125 from the National Institute of Arthritis, Musculoskeletal, and Skin Diseases (Dr Gelfand). |
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Disclosure: Dr Gelfand has received grant support from Amgen and Centocor, and is a consultant to Amgen, Abbott, Centocor, Genentech, and Astellas. Drs Lee, Treat, Sciacca-Kirby, Chachkin, Leyden, and Vittorio, Ms Dommasch, Ms Williams, and Mr Shin have no conflicts of interest to declare. |
Vol 60 - N° 4
P. 565-573 - avril 2009 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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