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A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, CONTROLLED DOSE COMPARISON OF THALIDOMIDE FOR TREATMENT OF ERYTHEMA NODOSUM LEPROSUM

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  • 1 Leonard Wood Memorial Center for Leprosy Research (American Leprosy Foundation) Cebu City, The Philippines; Statistics Collaborative, Inc., Washington, District of Columbia; Celgene Corporation, Warren, New Jersey; Salamandra, Inc., Bethesda, Maryland; Dermatology Service, Eisenhower Army Medical Center, Fort Gordon, Georgia

In a randomized, double-blind, double-dummy controlled study, 22 men with erythema nodosum leprosum (ENL) received six capsules containing either 100 mg (group A, n = 12) or 300 mg (group B, n = 10) of thalidomide daily for one week. A six-week, four capsules per day taper followed, in which group A received 50 mg/day of thalidomide in weeks 2 and 3, then dummy capsules in weeks 4 through 7, while group B had gradual decrements every two weeks. Both regimens caused comparable improvement in 19 patients at day 7 (group A [12 of 12] versus group B [7 of 10]; P = 0.08), but slower tapering in group B showed less re-emergence of ENL through week 7 (P = 0.02, versus group A). Most patients developed new lesions soon after stopping treatment. Slower tapering from a higher initial thalidomide dose may improve clinical ENL responses, but high recurrence rates after discontinuation indicates further assessment is needed to identify better tapering regimens.

Author Notes

Reprint requests: Douglas S. Walsh, Dermatology Service, Eisenhower Army Medical Center, Fort Gordon, GA 30905, Telephone: 706-787-1472, Fax: 706-787-1354, E-mail: douglas.walsh@se.amedd.army.mil.
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