Short-term trial of etanercept in Behçet's disease: a double blind, placebo controlled study.
OBJECTIVE
To determine the effect of the tumor necrosis factor-alpha blocker etanercept on the pathergy and monosodium urate (MSU) status and on the mucocutaneous and articular manifestations of patients with Behçet's disease (BD).


METHODS
Forty male patients with BD, all with positive pathergy and MSU tests and mucocutaneous disease and/or arthritis, were randomized (20 patients to each study arm) to receive either etanercept 25 mg twice a week or placebo for 4 weeks. The pathergy and MSU responses and the frequencies of mucocutaneous and articular manifestations were compared between the 2 groups.


RESULTS
There were no decreases in the pathergy and MSU responses in the etanercept group compared to the placebo group at any time. The mean numbers of oral ulcers, nodular lesions, and papulopustular lesions were less in the etanercept group compared to the placebo group at all weekly evaluations, except for the second week for papulopustular lesions. The probability of being free of oral ulcers and nodular lesions was also significantly higher in the former group (log-rank chi-square = 9.83, p = 0.0017; log-rank chi-square = 14.17, p = 0.0002, respectively).


CONCLUSIONS
Etanercept did not affect the pathergy reaction and the cutaneous response to MSU crystals. However, the drug was effective in suppressing most of the mucocutaneous manifestations of BD.
Melikoglu
Melike
M
The Behçet's Syndrome Research Center, Cerrahpasa Medical Faculty, Istanbul, Turkey.
Fresko
Izzet
I
Mat
Cem
C
Ozyazgan
Yilmaz
Y
Gogus
Feride
F
Yurdakul
Sebahattin
S
Hamuryudan
Vedat
V
Yazici
Hasan
H
D000293:Adolescent; D000328:Adult; D001528:Behcet Syndrome / Q000150:complications / Q000188:drug therapy* / Q000276:immunology; D004311:Double-Blind Method; D000068800:Etanercept; D005832:Genital Diseases, Male / Q000188:drug therapy / Q000209:etiology / Q000473:pathology; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007249:Inflammation / Q000175:diagnosis; D008297:Male; D008875:Middle Aged; D009092:Mucous Membrane / Q000473:pathology; D019226:Oral Ulcer / Q000188:drug therapy / Q000209:etiology / Q000473:pathology; D010919:Placebos; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use*; D012871:Skin Diseases / Q000209:etiology / Q000473:pathology; D012882:Skin Tests; D016896:Treatment Outcome; D014527:Uric Acid
D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D010919:Placebos; D018124:Receptors, Tumor Necrosis Factor; D011993:Recombinant Fusion Proteins; D014527:Uric Acid; D000068800:Etanercept