Description of Leprosy Classification at Baseline Among Patients Enrolled at the Uniform Multidrug Therapy Clinical Trial for Leprosy Patients in Brazil

Rodrigo Scaliante Moura Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil; Centre for Tropical Medicine, University of Brasília, Brasília DF, Brazil; Dona Libânia Dermatology Centre, Fortaleza, Ceará, Brazil; Alfredo da Matta Tropical Dermatology and Venereology Foundation, Manaus, Amazonas, Brazil; Epidemiology and Biostatistics Department, Fluminense Federal University, Rio de Janeiro, Brazil

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Gerson Oliveira Penna Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil; Centre for Tropical Medicine, University of Brasília, Brasília DF, Brazil; Dona Libânia Dermatology Centre, Fortaleza, Ceará, Brazil; Alfredo da Matta Tropical Dermatology and Venereology Foundation, Manaus, Amazonas, Brazil; Epidemiology and Biostatistics Department, Fluminense Federal University, Rio de Janeiro, Brazil

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Ludimila Paula Vaz Cardoso Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil; Centre for Tropical Medicine, University of Brasília, Brasília DF, Brazil; Dona Libânia Dermatology Centre, Fortaleza, Ceará, Brazil; Alfredo da Matta Tropical Dermatology and Venereology Foundation, Manaus, Amazonas, Brazil; Epidemiology and Biostatistics Department, Fluminense Federal University, Rio de Janeiro, Brazil

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Maria Araci de Andrade Pontes Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil; Centre for Tropical Medicine, University of Brasília, Brasília DF, Brazil; Dona Libânia Dermatology Centre, Fortaleza, Ceará, Brazil; Alfredo da Matta Tropical Dermatology and Venereology Foundation, Manaus, Amazonas, Brazil; Epidemiology and Biostatistics Department, Fluminense Federal University, Rio de Janeiro, Brazil

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Rossilene Cruz Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil; Centre for Tropical Medicine, University of Brasília, Brasília DF, Brazil; Dona Libânia Dermatology Centre, Fortaleza, Ceará, Brazil; Alfredo da Matta Tropical Dermatology and Venereology Foundation, Manaus, Amazonas, Brazil; Epidemiology and Biostatistics Department, Fluminense Federal University, Rio de Janeiro, Brazil

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Heitor de Sá Gonçalves Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil; Centre for Tropical Medicine, University of Brasília, Brasília DF, Brazil; Dona Libânia Dermatology Centre, Fortaleza, Ceará, Brazil; Alfredo da Matta Tropical Dermatology and Venereology Foundation, Manaus, Amazonas, Brazil; Epidemiology and Biostatistics Department, Fluminense Federal University, Rio de Janeiro, Brazil

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Maria Lúcia Fernandes Penna Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil; Centre for Tropical Medicine, University of Brasília, Brasília DF, Brazil; Dona Libânia Dermatology Centre, Fortaleza, Ceará, Brazil; Alfredo da Matta Tropical Dermatology and Venereology Foundation, Manaus, Amazonas, Brazil; Epidemiology and Biostatistics Department, Fluminense Federal University, Rio de Janeiro, Brazil

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Mariane Martins de Araújo Stefani Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil; Centre for Tropical Medicine, University of Brasília, Brasília DF, Brazil; Dona Libânia Dermatology Centre, Fortaleza, Ceará, Brazil; Alfredo da Matta Tropical Dermatology and Venereology Foundation, Manaus, Amazonas, Brazil; Epidemiology and Biostatistics Department, Fluminense Federal University, Rio de Janeiro, Brazil

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Samira Bührer-Sékula Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil; Centre for Tropical Medicine, University of Brasília, Brasília DF, Brazil; Dona Libânia Dermatology Centre, Fortaleza, Ceará, Brazil; Alfredo da Matta Tropical Dermatology and Venereology Foundation, Manaus, Amazonas, Brazil; Epidemiology and Biostatistics Department, Fluminense Federal University, Rio de Janeiro, Brazil

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The uniform multidrug therapy clinical trial, Brazil (U-MDT/CT-BR), database was used to describe and report the performance of available tools to classify 830 leprosy patients as paucibacillary (PB) and multibacillary (MB) at baseline. In a modified Ridley and Jopling (R&J) classification, considering clinical features, histopathological results of skin biopsies and the slit-skin smear bacterial load results were used as the gold standard method for classification. Anti-phenolic glycolipid-I (PGL-I) serology by ML Flow test, the slit skin smear bacterial load, and the number of skin lesions were evaluated. Considering the R&J classification system as gold standard, ML Flow tests correctly allocated 70% patients in the PB group and 87% in the MB group. The classification based on counting the number of skin lesions correctly allocated 46% PB patients and 99% MB leprosy cases. Slit skin smears properly classified 91% and 97% of PB and MB patients, respectively. Based on U-MDT/CT-BR results, classification of leprosy patients for treatment purposes is unnecessary because it does not impact clinical and laboratories outcomes. In this context, the identification of new biomarkers to detect patients at a higher risk to develop leprosy reactions or relapse remains an important research challenge.

Author Notes

* Address correspondence to Samira Bührer-Sékula, IPTSP—Sala 335, Rua 235, s/n, Setor Leste Universitário, Goiania, Goias, Brazil 74605-050. E-mail: samira@buhrer.net

Financial support: Rodrigo Scaliante Moura was a recipient of a scholarship from the National Council for Scientific and Technological Development/CNPq, Brazil (grant #152678/2011-5) and Ludimila Paula Vaz Cardoso was supported by a fellowship from the Coordination for the Improvement of Higher Education Personnel/CAPES, Brazil (grant #02479/09-5). Mariane Martins De Araújo Stefani is a recipient of a fellowship from CNPq (grant # 304869/2008-2). U-MDT/CT-BR was funded by the Department of Science and Technology (DECIT) of Brazilian Ministry of Health and CNPq (grant # 40.3293/2005-7).

Authors' addresses: Rodrigo Scaliante Moura, Ludimila Paula Vaz Cardoso, Mariane Martins de Araújo Stefani, and Samira Bührer-Sékula, Departamento de Imunologia, Instituto de Patologia Tropical e Saúde Pública, Sala 335, Rua 235 s/n, Setor Leste Universitário Goiânia, Goias, Brazil, E-mails: rodrigoscaliant@gmail.com, ludimilacardoso@gmail.com, mmastefani@gmail.com, samira@buhrer.net, and samira.buhrer@gmail.com. Gerson Oliveira Penna, Núcleo de Medicina Tropical, Campus Universitário Darci Ribeiro, Universidade de Brasília, Brasília–DF, E-mail: gpenna@gpenna.net. Maria Araci de Andrade Pontes and Heitor de Sá Gonçalves, Centro de Referência Nacional Dona Libânia–CDERM, Rua Pedro I, Centro, Fortaleza, Brazil–CE, E-mails: maracipontes@gmail.com and heitorsg@terra.com.br. Rossilene Cruz, Centro de Referência Nacional Alfredo da Matta–FUAM, Avenida Codajás, Cachoeirinha, Manaus–AM. Maria Lúcia Fernandes Penna, Centro de Ciências Médicas, Instituto de Saúde da Comunidade, Universidade Federal Fluminense, Rua Marques do Paraná, Centro, Niteroi, Brazil–RJ, E-mail: mlfpenna@gmail.com.

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