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

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.

Received August 29, 2004. Accepted for publication December 8, 2004.

Acknowledgments: We thank Paulina Munalem and the staff of the LWM laboratory for superb technical support, Dr. Paktiya Teja-Isavadharm (U.S. Army Medical Component, Armed Forces Research Institute of the Medical Sciences, Bangkok, Thailand) for measuring neopterin levels, and Guillerma Lim and Pris Reed for administrative assistance.

Financial support: This study was supported by Celgene Corporation.

Disclaimer: The opinions and assertions contained in this article are the private views of the authors and are not to be construed as official or as reflecting the views of the U.S. Department of the Army or the Department of Defense.

Disclosure: Jeffrey P. Palmer, Janet Wittes, and Karin A. Kook were retained on contract by Celgene Corporation.

Authors’ addresses: Laarni G. Villahermosa, Tranquilino T. Fajardo, Jr., Rodolfo M. Abalos, Maria V. Balagon, Esterlina V. Tan, Roland V. Cellona, and Gerald P. Walsh, Leonard Wood Memorial Center for Leprosy Research (American Leprosy Foundation) Cebu City, The Philippines. Jeffrey P. Palmer and Janet Wittes, Statistics Collaborative, Inc., 1710 Rhode Island Avenue NW, Washington, DC 20036. Steven D. Thomas, Celgene Corporation 7 Powder Horn Drive, Warren, NJ 07059. Karin A. Kook, Salamandra, Inc., Bethesda, MD 20815. Douglas P. Walsh, Dermatology Service, Eisenhower Army Medical Center, Fort Gordon, GA 30905.

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{at}se.amedd.army.mil.