Bolsa Família and Family Health Programs mean (standard deviation) coverage and the variables for selected municipalities, Brazil 2004–2011.

<p>BFP = <i>Bolsa Familia</i> Programme. FHP = Family Health Programme.</p><p>Bolsa Família and Family Health Programs mean (standard deviation) coverage and the variables for selected municipalities, Brazil 2004–2011.</p

Leprosy reactions: The predictive value of <i>Mycobacterium leprae</i>-specific serology evaluated in a Brazilian cohort of leprosy patients (U-MDT/CT-BR)

<div><p>Background</p><p>Leprosy reactions, reversal reactions/RR and erythema nodosum leprosum/ENL, can cause irreversible nerve damage, handicaps and deformities. The study of <i>Mycobacterium leprae</i>-specific serologic responses at diagnosis in the cohort of patients enrolled at the <i>Clinical Trial for Uniform Multidrug Therapy Regimen for Leprosy Patients in Brazil/U-MDT/CT-BR</i> is suitable to evaluate its prognostic value for the development of reactions.</p><p>Methodology</p><p>IgM and IgG antibody responses to PGL-I, LID-1, ND-O-LID were evaluated by ELISA in 452 reaction-free leprosy patients at diagnosis, enrolled and monitored for the development of leprosy reactions during a total person-time of 780,930 person-days, i.e. 2139.5 person-years, with a maximum of 6.66 years follow-up time.</p><p>Principal findings</p><p>Among these patients, 36% (160/452) developed reactions during follow-up: 26% (119/452) RR and 10% (41/452) had ENL. At baseline higher anti-PGL-I, anti-LID-1 and anti-ND-O-LID seropositivity rates were seen in patients who developed ENL and RR compared to reaction-free patients (p<0.0001). Seroreactivity in reactional and reaction-free patients was stratified by bacilloscopic index/BI categories. Among BI negative patients, higher anti-PGL-I levels were seen in RR compared to reaction-free patients (p = 0.014). In patients with 0</p><p>Conclusions</p><p>Overall, detection of anti-PGL-I, anti-LID-1 and anti-ND-O-LID antibodies at diagnosis, showed low sensitivity and specificity for RR prediction, indicating low applicability of serological tests for RR prognosis. On the other hand, anti-LID-1 serology at diagnosis has shown prognostic value for ENL development in BI positive patients.</p><p>Trial Registration</p><p>ClinicalTrials.gov <a href="https://clinicaltrials.gov/ct2/show/NCT00669643" target="_blank">NCT00669643</a></p></div

Group 3- Patients with BI≥3 (n = 161): Baseline antibody responses to different <i>M</i>. <i>leprae</i> antigens.

<p>Seropositivity to PGL-I (A), LID-1 (B) and ND-O-LID (C) antigens in patients that developed RR (n = 60), ENL (n = 41) and reaction-free (n = 60) patients. The box shows the interval between the first and the third quartiles, the middle line represents the median. The <i>p</i> value refers to differences in OD median. The traced horizontal line is the cut-off: PGL-I OD>0.25; LID-1: OD>0.3; ND-O-LID: OD>0.923. The numbers above each box represent the positivity rate and the points above each box are outliers results. OD = optical density; RR: reversal reaction; ENL: erythema nodosum leprosum.</p

Kaplan Meyer survival curve of reaction free multibacillary leprosy patients comparing U-MDT <i>versus</i> R-MDT groups.

<p>Kaplan Meyer survival curve of reaction free multibacillary leprosy patients comparing U-MDT <i>versus</i> R-MDT groups.</p

MB Patients’ selection flow diagram.

<p>MB Patients’ selection flow diagram.</p

Analysis of bacilloscopic index decrease among multibacillary patients and parameters of the multilevel linear model with mixed effects.

<p>Analysis of bacilloscopic index decrease among multibacillary patients and parameters of the multilevel linear model with mixed effects.</p

Socio-demographic and clinical characteristics of MB patients from the U-MDT arm that relapsed during active follow up period.

<p>Socio-demographic and clinical characteristics of MB patients from the U-MDT arm that relapsed during active follow up period.</p

Adjusted average bacilloscopic index/aBI by time (days) for each multibacillary leprosy patient.

<p>*linear adjusted declining trend usually produces negative values as in this graph, although this is not biological plausible.</p

Main baseline characteristics of multibacillary leprosy patients stratified according to U-MDT and R-MDT Groups.

<p>Main baseline characteristics of multibacillary leprosy patients stratified according to U-MDT and R-MDT Groups.</p

Daily bacilloscopic index decrease in multibacillary leprosy patients allocated into the U-MDT and the R-MDT groups after 180^th days of starting treatment.

<p>Daily bacilloscopic index decrease in multibacillary leprosy patients allocated into the U-MDT and the R-MDT groups after 180^th days of starting treatment.</p