Talidomida no tratamento do eritema nodoso hansênico: revisão sistemática dos ensaios clínicos e perspectivas de novas investigações

Abstract

BACKGROUND - Leprosy remains a public health problem. Episodes of erythema nodosum leprosum (ENL) are acute events that occur before, during and after polychemotherapy. In the last decade, the use of thalidomide as an immunomodulating agent was expand-ed to other diseases. OBJECTIVES - To perform a systematic review of published clinical trials on efficacy and side effects of thalidomide in ENL. To describe the methodology and screening results of recruiting for a clinical trial performed in Brazil, which aimed to assess the dose-response of thalido-mide followed by tapering regimen in severe and moderate cases of ENL. METHODS - Published clinical trials on the use of thalidomide in ENL were analyzed. A randomized, double-blind clinical trial was designed to evaluate the doses of 100mg versus 300mg/day thalidomide during the acute stage of ENL, followed by thalidomide tapering regimen versus placebo. For this clinical trial, the methodology and data for enrollment of patients were described, with an emphasis on severity of ENL episodes. RESULTS - Six clinical trials published in the 1960´s and 1970´s indicated the benefits of thalidomide in ENL, although methodological dif-ferences made comparison difficult. In the enrollment stage of the Brazilian trial, 65% of patients were potentially eligible out of 143 ENL patients screened. The association with neuritis in 56.4% of moderate and severe cases of ENL required the co-intervention with steroids. CONCLUSION - The patients' enrollment pattern demonstrated high frequency of neuritis in ENL episodes. The treatment regimen with thalido-mide in monotherapy for ENL was considered infrequent in the clinical practice in Brazil. The current challenge is to accumulate evidence about efficacy and side effects of thalidomide in combination with steroids.