Abstract
BackgroundLeprosy reactions, reversal reactions/RR and erythema nodosum leprosum/ENL, can cause irreversible nerve damage, handicaps and deformities. The study of Mycobacterium leprae-specific serologic responses at diagnosis in the cohort of patients enrolled at the Clinical Trial for Uniform Multidrug Therapy Regimen for Leprosy Patients in Brazil/U-MDT/CT-BR is suitable to evaluate its prognostic value for the development of reactions.MethodologyIgM 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.Principal findingsAmong 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<BI<3, (36 RR, 36 reaction-free), higher antibody levels to PGL-I (p = 0.014) and to LID-1 (p = 0.035) were seen in RR while difference in anti-ND-O-LID positivity was borderline (p = 0.052). Patients with BI≥3 that developed ENL had higher levels of anti-LID-1 antibodies (p = 0.028) compared to reaction-free patients. Anti-PGL-I serology had a limited predictive value for RR according to receiver operating curve/ROC analyses (area-under-the-curve/AUC = 0.7). Anti LID-1 serology at baseline showed the best performance to predict ENL (AUC 0.85).ConclusionsOverall, 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.Trial RegistrationClinicalTrials.gov NCT00669643
Highlights
Leprosy is a complex dermato-neurologic disease caused by Mycobacterium leprae that presents a wide spectrum of clinical manifestations characterized by distinct bacteriologic, immunologic and histopathologic features [1]
Detection of anti-phenolic glycolipid I (PGL-I), anti-LID-1 and anti-ND-O-LID antibodies at diagnosis, showed low sensitivity and specificity for reversal reaction (RR) prediction, indicating low applicability of serological tests for RR prognosis
In order to investigate laboratory markers for the occurrence of leprosy reactions, we investigated the prognostic value of serologic responses to M. leprae antigens (PGL-I, LID-1, ND-O-LID) in 452 leprosy patients enrolled at the Clinical Trial for Uniform Multidrug Therapy Regimen for Leprosy Patients in Brazil/U-multidrug therapy (MDT)/CTBR
Summary
Leprosy is a complex dermato-neurologic disease caused by Mycobacterium leprae that presents a wide spectrum of clinical manifestations characterized by distinct bacteriologic, immunologic and histopathologic features [1]. Tuberculoid leprosy (TT) is characterized by few skin lesions, low or absent bacilloscopic index (BI), strong M. leprae-specific Th1-type cellmediated immunity (CMI) and low or absent specific antibodies. On the other extreme of the spectrum, lepromatous leprosy (LL) is characterized by multiple disseminated skin lesions, high BI, Th2-type immunity with vigorous antibody production and low or absent M. leprae-specific CMI. Clinical monitoring is still under way in Brazil regarding mainly the development of reactions and relapses (Clinical Trial for Uniform Multidrug Therapy Regimen for Leprosy Patients in Brazil, U-MDT/CT-BR) [4,5,6,7,8]. The study of Mycobacterium leprae-specific serologic responses at diagnosis in the cohort of patients enrolled at the Clinical Trial for Uniform Multidrug Therapy Regimen for Leprosy Patients in Brazil/U-MDT/CTBR is suitable to evaluate its prognostic value for the development of reactions
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