An open-label phase II study of the safety and efficacy of etanercept for the therapy of hidradenitis suppurativa.
OBJECTIVE
To evaluate the safety and efficacy of etanercept for the management of hidradenitis suppurativa.


METHODS
In a prospective open-label phase II study, etanercept was administered subcutaneously in a dose of 50 mg once weekly for 12 weeks in 10 patients. They were followed up to 24 weeks and their disease activity and Sartorius score were assessed, with also a self-evaluation by visual analogue scale (VAS). Disease activity was an assessment of the extent of the disease by the attending physicians who were unaware of the protocol.


RESULTS
A >50% score improvement was found in six patients at week 12 and in seven patients at week 24. The VAS was decreased compared with baseline in seven patients at week 12 and in six patients at week 24. All changes were statistically significant. All patients reported a decrease of local pain at the site of lesions after week 4. Drainage of pus from the affected areas recurred in eight patients within 4-8 weeks after the end of administration of etanercept. The treatment was well-tolerated.


CONCLUSIONS
Etanercept is a safe and effective therapy for hidradenitis suppurativa and decreases the extent of the disease and improves the quality of life. A double-blind, placebo-controlled trial is required to elucidate fully the role of etanercept for hidradenitis suppurativa.
Giamarellos-Bourboulis
E J
EJ
4th Department of Internal Medicine, University of Athens, Medical School, University General Hospital ATTIKON, 1 Rimini Str, 124 64 Athens, Greece. giamarel@ath.forthnet.gr
Pelekanou
E
E
Antonopoulou
A
A
Petropoulou
H
H
Baziaka
F
F
Karagianni
V
V
Stavrianeas
N
N
Giamarellou
H
H
D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004812:Epidemiologic Methods; D000068800:Etanercept; D005260:Female; D017497:Hidradenitis Suppurativa / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage* / Q000009:adverse effects; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D011788:Quality of Life / Q000523:psychology; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage*; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000069285:Infliximab; D000068800:Etanercept