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Thalidomide in the Treatment of the Mucocutaneous Lesions of the Behcet Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial

Vedat Hamuryudan, MD; Cem Mat, MD; Sebahattin Saip, MD; Yilmaz Ozyazgan, MD; Aksel Siva, MD; Sebahattin Yurdakul, MD; Kai Zwingenberger, MD; and Hasan Yazici, MD
[+] Article, Author, and Disclosure Information

From Behcet's Syndrome Research Center, Cerrahpasa Medical Faculty, University of Istanbul, Turkey; and Grunenthal GmbH, Aachen, Germany. Grant Support: By Grunenthal GmbH, Aachen, Germany. Acknowledgments: The authors thank Grunenthal's Department of Biometrics (especially Ms. S. Dickhut) for statistical analyses and Professor M. Senocak from the Biostatistics Department of Cerrahpasa Medical Faculty. Requests for Reprints: Vedat Hamuryudan, MD, Veysipasa Sokak 100 Yil Sitesi I Blok D 16, Uskudar, 81190 Istanbul, Turkey. Current Author Addresses: Drs. Hamuryudan, Yurdakul, and Yazici: Division of Rheumatology, Department of Internal Medicine, Cerrahpasa Medical Faculty, University of Istanbul, 34303 Aksaray, Istanbul, Turkey.

Copyright ©2004 by the American College of Physicians

Ann Intern Med. 1998;128(6):443-450. doi:10.7326/0003-4819-128-6-199803150-00004
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Background: Recurrent oral and genital ulcers are the most frequent problem in the management of the Behcet syndrome. Uncontrolled experience suggests that thalidomide may help prevent recurrences of these ulcers.

Objective: To determine the efficacy of two thalidomide dosages in the treatment of mucocutaneous lesions of the Behcet syndrome.

Design: Randomized, double-blind, placebo-controlled trial.

Setting: Specialist outpatient clinic for the Behcet syndrome in Turkey.

Patients: 96 male patients with the Behcet syndrome who primarily had mucocutaneous lesions without major organ involvement.

Intervention: Thalidomide, 100 mg/d or 300 mg/d, or placebo for 24 weeks.

Measurements: Sustained absence of any oral and genital ulceration during treatment (complete response) and changes in the number of mucocutaneous lesions. An additional evaluation was done 4 weeks after treatment ended.

Results: A complete response occurred in 2 of the 32 patients (6% [95% CI, 0.8% to 20.8%]) receiving thalidomide, 100 mg/d; in 5 of the 31 patients (16% [CI, 5.5% to 33.7%]) receiving thalidomide, 300 mg/d; and in none of the 32 patients (0% [CI, 0% to 10.9%]) receiving placebo (P = 0.031). The suppressive effect of thalidomide with either dosage was evident at 4 weeks for oral ulcers (P < 0.001) and at 8 weeks for genital ulcers (P < 0.001) and follicular lesions (P = 0.008). This effect persisted during treatment but diminished rapidly after treatment was discontinued. Both thalidomide dosages led to significant increases in the number of erythema nodosum lesions during the first 8 weeks of treatment (P = 0.03). Polyneuropathy developed in 4 patients (1 in the 100-mg/d group and 3 in the 300-mg/d group); in 3 of these patients, the condition was diagnosed after the trial had ended.

Conclusions: Thalidomide is effective for treating the oral and genital ulcers and follicular lesions of the Behcet syndrome. A dosage of 100 mg/d is as effective as a dosage of 300 mg/day.


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Figure 1.
Mucocutaneous manifestations of the Behcet syndrome.Top left.Top right.Bottom left.Bottom right.

Oral ulcers are usually the first sign of the Behcet syndrome and can occur anywhere within the oral cavity. Erythema nodosum: painful nodular lesions that tend to leave a pigmented area. Genital ulcers usually develop on the scrotum or the labia and heal with scarring. Positive result on a pathergy test: pustule formation 48 hours after a sterile needle prick.

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Figure 2.
Time-dependent distribution of patients with sustained absence of oral or genital ulcers.

Combined data obtained at the visits and from reports by patients on the occurrence of ulcers between the visits.

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Figure 3.
Unadjusted mean differences in the numbers of mucocutaneous lesions at admission (week 0), during treatment (weeks 4 to 24), and 4 weeks after treatment (week 28).

Combined data obtained at the visits and from reports by patients on the occurrence of lesions between the visits. Bars represent SEs. Diamonds = placebo group; squares = 100-mg/d thalidomide group; triangles = 300-mg/d thalidomide group.

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