A Controlled Trial of Azathioprine in Behçet's Syndrome

Cytotoxic agents have long been used in Behçet's syndrome, especially for eye involvement, but their effectiveness has been uncertain. We conducted a two-year randomized, placebo-controlled, double-blind trial of azathioprine (2.5 mg per kilogram of body weight per day) in Turkish men with Behç...

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Bibliographic Details
Published in:	The New England journal of medicine Vol. 322; no. 5; pp. 281 - 285
Main Authors:	Yazici, Berrin, Yazici, Hasan, Pazarli, Halit, Barnes, Colin G, Tüzün, Yalçin, Özyazgan, Yilmaz, Silman, Alan, Serdaroğlu, Server, Oğuz, Velieddin, Yurdakul, Sebahattin, Lovatt, George E, Somani, Shenaz, Müftüoğlu, Asuman
Format:	Journal Article
Language:	English
Published:	Boston, MA Massachusetts Medical Society 01-02-1990
Subjects:	Adult Arthritis Azathioprine Azathioprine - adverse effects Azathioprine - therapeutic use Behcet Syndrome - drug therapy Biological and medical sciences Blood tests Body weight Clinical trials Corticosteroids Cytotoxic agents Cytotoxicity Dermatology Double-Blind Method Drug therapy Eye Eye diseases Eye Diseases - drug therapy Eye Diseases - prevention & control Humans Male Medical sciences Patient Compliance Patients Randomized Controlled Trials as Topic Retinitis - drug therapy Retinitis - prevention & control Rheumatology Suppuration Ulcers Uveitis Uveitis - drug therapy Uveitis - prevention & control Vein & artery diseases Visual Acuity Human Behcet syndrome Pharmacologic test Eye disease Skin disease Exploration Complex syndrome
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Summary:	Cytotoxic agents have long been used in Behçet's syndrome, especially for eye involvement, but their effectiveness has been uncertain. We conducted a two-year randomized, placebo-controlled, double-blind trial of azathioprine (2.5 mg per kilogram of body weight per day) in Turkish men with Behçet's syndrome without eye disease (group 1; n = 25) or with eye disease (group 2; n = 48). Corticosteroid treatment remained available to all the patients. All six patients withdrawn from the study because of severe eye disease were receiving placebo (P<0.001). Azathioprine was superior to placebo in the prevention of new eye disease in group 1 (1 vs. 8 patients; P<0.01) and in group 2 among the 14 patients who at entry had disease in only one eye (P<0.001 ). There were fewer episodes of hypopyon uveitis (1 vs. 15; P<0.001) among the group 2 patients who took azathioprine. The patients taking azathioprine also had less frequent oral ulcers, genital ulcers, and arthritis. There were no serious side effects attributable to azathioprine. We conclude that azathioprine is effective in controlling the progression of Behçet's syndrome, especially its most serious manifestation, eye disease. (N Engl J Med 1990; 322:281–5.) BEHçET'S syndrome is a multisystem disorder characterized by recurrent oral and genital ulcers, arthritis, thrombophlebitis, and uveitis. Its cause is presumed to be viral or immunologic, 1 , 2 and its basic underlying pathologic process is that of a vasculitis. Eye disease — an indolent anterior and posterior uveitis and retinitis that can lead to blindness — occurs in approximately half the patients with the disorder. 1 , 3 Azathioprine, among other immunosuppressive agents, has been reported to be effective in Behçet's syndrome, 4 , 5 although controlled studies are lacking. We conducted a two-year randomized, double-blind trial comparing azathioprine (2.5 mg per kilogram of body weight per day) . . .
ISSN:	0028-4793 1533-4406
DOI:	10.1056/NEJM199002013220501