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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
- 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.
Abstract
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.
- Copyright ©2004 by the American College of Physicians
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