Short-Term Trial of Etanercept in Behçet's Disease: A Double Blind, Placebo Controlled Study

MELIKE MELIKOGLU, IZZET FRESKO, CEM MAT, YILMAZ OZYAZGAN, FERIDE GOGUS, SEBAHATTIN YURDAKUL, VEDAT HAMURYUDAN, and HASAN YAZICI

ABSTRACT.

Objective. To determine the effect of the tumor necrosis factor-a 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).

Conclusion. 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. (J Rheumatol 2005;32:98-105)

Key Indexing Terms:

BEHÇET'S DISEASE
THERAPY
ETANERCEPT

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From the Behçet's Syndrome Research Center, Cerrahpasa Medical Faculty, Istanbul, Turkey.

Supported by Wyeth Pharmaceuticals, Philadelphia, PA, USA.

F. Gogus, MD, Fellow in Rheumatology; M. Melikoglu, MD; I. Fresko MD, Associate Professor of Rheumatology; S. Yurdakul, MD; V. Hamuryudan, MD; H. Yazici, MD, Professor of Rheumatology; C. Mat, MD, Professor of Dermatology; Y. Ozyazgan, MD, Professor of Ophthalmology.

Dr. Melikoglu and Dr. Fresko contributed equally to this work.

Address reprint requests to Dr. H. Yazici, Safa Sok 17/7, Kadiköy, Istanbul, Turkey 81310. E-mail: hyazici@attglobal.net

Submitted February 3, 2004; revision accepted August 30, 2004.

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