Dear Dr. Barve,
Thank you very much for your comments regarding our paper “Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach”.11 Cruz RCS, Bührer-Sékula S, Penna GO, Moraes MEA, Gonçalves HS, Stefani MMA, et al. Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach. An Bras Dermatol. 2018;93:377-84.
Let us clarify some points:
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Indeed, both pigmentation and xerosis are caused by clofazimine. We definitely did not imply that these were due to rifampicin and/or dapsone.
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It is clear that paucibacillary (PB) patients treated with R-MDT do not use clofazimine. However, as mentioned in reference 2, the inclusion of clofazimine in the treatment of PB patients did not lead to an increase in non-compliance when we used U-MDT.22 Ferreira IP, Bührer-Sékula S, De Oliveira MR, Gonçalves H de S, Pontes MA, Penna ML, et al. Patient profile and treatment satisfaction of Brazilian leprosy patients in a clinical trial of uniform six-month multidrug therapy (U-MDT/CT-BR). Lepr Rev. 2014;85:267-74.
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Definitely, we cannot compare data from leprosy control programs with a randomized and controlled clinical trial.33 Penna GO, Bührer-Sékula S, Kerr LRS, Stefani MMA, Rodrigues LC, de Araújo MG, et al. Uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): results of an open label, randomized and controlled clinical trial, among multibacillary patients. PLoS Negl Trop Dis. 2017;11:e0005725. It would be a fundamental and serious mistake. However, it is very important to stress that only 24 patients had to interrupt treatment due to adverse effects (AE).11 Cruz RCS, Bührer-Sékula S, Penna GO, Moraes MEA, Gonçalves HS, Stefani MMA, et al. Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach. An Bras Dermatol. 2018;93:377-84.
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Despite your question about the moment of AE onset, for us it is clear and elementary that the shorter the treatment is, the less AE we are likely to find.
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*
Study conducted at the Centro de Dermatologia Dona Libânia and Fundação de Dermatologia Tropical e Venereologia “Alfredo da Matta,” Manaus (AM), Brazil.
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Financial support: Department of Science and Technology (DECIT), Ministry of Health CNPq, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Brasília, DF, Brazil.
REFERENCES
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1Cruz RCS, Bührer-Sékula S, Penna GO, Moraes MEA, Gonçalves HS, Stefani MMA, et al. Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach. An Bras Dermatol. 2018;93:377-84.
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2Ferreira IP, Bührer-Sékula S, De Oliveira MR, Gonçalves H de S, Pontes MA, Penna ML, et al. Patient profile and treatment satisfaction of Brazilian leprosy patients in a clinical trial of uniform six-month multidrug therapy (U-MDT/CT-BR). Lepr Rev. 2014;85:267-74.
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3Penna GO, Bührer-Sékula S, Kerr LRS, Stefani MMA, Rodrigues LC, de Araújo MG, et al. Uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): results of an open label, randomized and controlled clinical trial, among multibacillary patients. PLoS Negl Trop Dis. 2017;11:e0005725.
Publication Dates
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Publication in this collection
17 Oct 2019 -
Date of issue
Jul-Aug 2019
History
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Received
03 Dec 2018 -
Accepted
03 Apr 2019