Objectives: To observe the effects of etanercept treatment on the cutaneous manifestations of hidradenitis suppurative (HS) and to evaluate physician and patient global assessment scores of cutaneous manifestations.
Design: Single-center, randomized, prospective, double-blind, placebo-controlled study.
Setting: Academic dermatology practice.
Patients: Twenty patients with active moderate to severe HS who fulfilled all inclusion criteria.
Intervention: Etanercept, 50 mg, or placebo was administered subcutaneously (SC) twice weekly for 12 weeks. After 12 weeks, all patients received open-label etanercept, 50 mg, SC twice weekly for 12 more weeks.
Main outcome measures: Primary end point: physician global assessment of HS as clear or mild at week 12. Secondary end points: patient global assessment and Dermatology Life Quality Index (DLQI).
Results: There was no statistically significant difference among physician global assessment, patient global assessment, and DLQI at 12 or 24 weeks between treatment and placebo groups (P > .05 for all comparisons).
Conclusions: Etanercept, 50 mg, SC administered twice weekly did not have significant efficacy in the improvement of HS. In light of our negative results, as well as those of previous studies, we suggest that future studies focus on other agents for the treatment of HS. Trial Registration clinicaltrials.gov Identifier: NCT00949546.