02655nas a2200301   4500000000100000008004100001260001600042653003000058653001900088653001200107653001200119100001300131700001600144700001400160700001900174700001400193700001500207700001400222700002200236700001700258700001400275245011100289856007900400300000800479490000700487520184500494022001402339       2024                            d  bElsevier BV10aUniform multidrug therapy10aClinical trial10aLeprosy10aRelapse1 aPenna GO1 aPontes MADA1 aTalhari S1 aGonçalves HDS1 aTalhari C1 aPessoa ADS1 aPedroza V1 aBührer-Sékula S1 aStefani MMDA1 aPenna MLF00aLate relapses in leprosy patients in Brazil: 10-year post-trial of uniform multidrug therapy (U-MDT/CT-BR)  uhttps://www.scielo.br/j/bjid/a/QFtBLX3j9KFPFT85QDVhwJs/?format=pdf&lang=en  a1-80 v283 a<p><strong>Background: </strong>Leprosy is a neglected dermato-neurologic, infectious disease caused by Mycobacterium leprae or M. lepromatosis. Leprosy is treatable and curable by multidrug therapy/ MDT, consisting of 12 months rifampicin, dapsone and clofazimine for multibacillary/MB patients and for 6 months for paucibacillary/PB patients. The relapse rate is considered a crucial treatment outcome. A randomized Controlled Clinical Trial (U-MDT/CT-BR) conducted from 2007‒2012 compared clinical outcomes in MB patients after 12 months regular MDT/R-MDT and 6 months uniform MDT/U-MDT in two highly endemic Brazilian areas.</p>

<p><strong>Objectives: </strong>To estimate the 10 years relapse rate of MB patients treated with 6 months U-MDT.</p>

<p><strong>Methods: </strong>The statistical analyses treated the data as a case-control study, sampled from the cohort generated for the randomized trial. Analyses estimated univariate odds ratio and applied logistic regression for multivariate analysis, controlling the confounding variables.</p>

<p><strong>Results: </strong>The overall relapse rate was 4.08 %: 4.95 % (16 out of 323) in the U-MDT group and 3.10 % (9 out of 290) in the regular/R-MDT group. The difference in relapse proportion between U-MDT and R-MDT groups was 1.85 %, not statistically significant (Odds Ratio = 1.63, 95 % CI 0.71 to 3.74). However, misdiagnosis of relapses, may have introduced bias, underestimating the force of the association represented by the odds ratio.</p>

<p><strong>Conclusions: </strong>The relapse estimate of 10 years follow-up study of the first randomized, controlled study on U-MDT/CT-BR was similar to the R-MDT group, supporting strong evidence that 6 months U-MDT for MB patients is an acceptable option to be adopted by leprosy endemic countries worldwide.</p>
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