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.

Figure 1. Flowchart of participant enrollment

1. (Week #) denotes the last patient visit before withdrawal from study.

Figure 2. Outcome Measures^1,2

1. All outcome variables shown are continuous. The Patient’s Global Assessment was given at each visit, except at Day 0. 2. For all outcome variables under the intention to treat (ITT) analysis, median values were calculated with the last outcome carried forward for patients who withdrew from the study. 3. Under both the intention to treat (ITT) and as-treated analyses, blinded physician outcome measures were missing for 3 patients at week 2 and for 2 patients at week 14. In these instances, median values were calculated without those particular patients. 4. Under both the intention to treat (ITT) and as-treated analyses, the patient’s global assessment was missing for 1 patient at week 14. The median value was calculated without this patient.