Lepromatous Reaction Type II: Clinical and Laboratory Aspects.

In Type II lepromatous reaction, there is exacerbation of humoral immunity, classified as Gell & Coombs Type III hypersensitivity reaction. It is more common in lepromatous borderline (LB) and lepromatous lepromatous (LL) patients. Our objective was to study the clinical and laboratorial expressions of lepromatous Type II reactions, establishing concordances between them, and for this the medical records of leprosy patients observed at the Clementino Fraga Filho University Hospital of the Federal University of Rio de Janeiro (HUCFF/UFRJ) were reviewed. There were a total of 358 leprosy cases over a period of 12 years. Demographic, clinical, and laboratory data of 133 patients with Type II reaction were collected. Among the 133 patients, 19 were classified as borderline borderline (BB), 15 (11.3%) as LB, and 97 (72.9%) as LL. Mitsuda intradermal reaction was negative in all the 49 patients who underwent this test. Histopathologic study confirmed the diagnosis. Lepromatous patients (LP) presented positive bacilloscopy more frequently (73.91% of 68 patients) than borderline patients (BP) (26.9% of 24 patients). Among BP, 44% presented erythema nodosum leprosum (ENL), which was seen in 71% of LP. Erythema multiforme (EM) occurred in 32% of BP and 13% of LP. Lucio phenomenon (LPh) was observed in 8 of 34 BP (23.6%), and 15 of 97 LP (15.4%). The understanding of the laboratorial and clinical presentations of reactional episodes are relevant to the development of preventive and therapeutic strategies, in order to avoid potential complications and comorbidities that cause disability, paralysis, deformities, and stigma of leprosy.

A prospective study to validate various clinical criteria used in classification of leprosy: a study from a tertiary care center in India.

BACKGROUND: Various clinical criteria are used to categorize leprosy patients into paucibacillary (PB) and multibacillary (MB), thus aiding in appropriate treatment. However, comprehensive studies validating these criteria are minimal. AIMS: To assess sensitivity and specificity of different clinical criteria individually and in combination for classifying leprosy into PB/MB spectrum. METHOD: A prospective study was conducted wherein 50 newly diagnosed, untreated leprosy cases were recruited and classified into PB and MB using the following clinical criteria: number of skin lesions (NSL), number of body areas affected (NBAA), and size of largest skin lesion (SLSL). Patients with pure neuritic leprosy, diffuse macular type of lepromatous leprosy, and with reactions were excluded. Sensitivity and specificity of these clinical criteria in classification was calculated taking histopathological findings as gold standard. RESULTS: Among 50 patients, 37 were males and 13 were females with a mean age of 32.08 ± 16.55 years. The sensitivity and specificity of NSL, NBAA, and SLSL was 94.74 and 87.1%, 94.74 and 61.29%, and 73.68 and 16.13%, respectively. Combining all three criteria, the sensitivity increased to 100%, but specificity decreased drastically to 12.9%. The ROC curve for NSL, NBAA, and SLSL showed a cutoff of ≥6 skin lesions, ≥3 body areas affected, and ≤2 cm lesion to classify as MB. CONCLUSION: The current WHO system of leprosy classification based on NSL seems to be best among available clinical criteria. Uniform and sensible application of this criteria itself assures appropriate categorizing and leprosy treatment with reasonable sensitivity and specificity.

Analysis of clinical data and T helper 1/T helper 2 responses in patients with different clinical forms of leprosy.

INTRODUCTION:: Currently, there are no laboratory tests or sensitive and specific molecular markers for the early diagnosis of leprosy. The aim of this study was to analyze the clinical characteristics of patients with leprosy and investigate their immunological profile, comparing this with the type of lesion and the presence or absence of a Bacillus Calmette-Guérin (BCG) vaccination scar. METHODS:: Statistical analyzes were performed by employing comparative tests (Pearson´s chi-square) to evaluate the variables in different clinical forms, considering significance at the 5% level. RESULTS:: The study identified a predominance of lepromatous leprosy (26.9%) in patients aged between 34-53 years. Caucasians predominantly had borderline tuberculoid (BT) clinical forms (42%); a predominance of males with borderline lepromatous (19%) and lepromatous leprosy (26.9%) forms was observed; and the presence of BCG vaccination scars (27.5%) and lower limb nerves were more affected (38%) predominantly in the BT clinical form. Significant differences were identified, which included hypochromic lesions predominantly in the BT clinical form (24%); diffuse-type lesions predominantly in the tuberculoid (TT) clinical form (28%); ill-defined lesion border dominance in lepromatous leprosy (LL) clinical forms (30%); an irregular lesion limit predominantly in LL clinical forms (32%); and a predominant Th1 immune response in the BT clinical form (41.7%). CONCLUSIONS:: The evaluation of the immunological profile in leprosy patients may contribute to the more detailed diagnosis and possibly better characterization of the prognosis for these individuals.

Analysis of clinical data and T helper 1/T helper 2 responses in patients with different clinical forms of leprosy

Abstract INTRODUCTION: Currently, there are no laboratory tests or sensitive and specific molecular markers for the early diagnosis of leprosy. The aim of this study was to analyze the clinical characteristics of patients with leprosy and investigate their immunological profile, comparing this with the type of lesion and the presence or absence of a Bacillus Calmette-Guérin (BCG) vaccination scar. METHODS: Statistical analyzes were performed by employing comparative tests (Pearson´s chi-square) to evaluate the variables in different clinical forms, considering significance at the 5% level. RESULTS: The study identified a predominance of lepromatous leprosy (26.9%) in patients aged between 34-53 years. Caucasians predominantly had borderline tuberculoid (BT) clinical forms (42%); a predominance of males with borderline lepromatous (19%) and lepromatous leprosy (26.9%) forms was observed; and the presence of BCG vaccination scars (27.5%) and lower limb nerves were more affected (38%) predominantly in the BT clinical form. Significant differences were identified, which included hypochromic lesions predominantly in the BT clinical form (24%); diffuse-type lesions predominantly in the tuberculoid (TT) clinical form (28%); ill-defined lesion border dominance in lepromatous leprosy (LL) clinical forms (30%); an irregular lesion limit predominantly in LL clinical forms (32%); and a predominant Th1 immune response in the BT clinical form (41.7%). CONCLUSIONS: The evaluation of the immunological profile in leprosy patients may contribute to the more detailed diagnosis and possibly better characterization of the prognosis for these individuals.

Description of leprosy classification at baseline among patients enrolled at the uniform multidrug therapy clinical trial for leprosy patients in Brazil.

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.

Concordance between expected and observed bacilloscopy results of clinical forms of leprosy: a 6-year retrospective study in Recife, State of Pernambuco, Brazil.

INTRODUCTION: Operational classification of leprosy based on the number of skin lesions was conceived to screen patients presenting severe forms of the disease to enable their reception of a more intense multidrug regimen without having to undergo lymph smear testing. We evaluated the concordance between operational classification and bacilloscopy to define multibacillary and paucibacillary leprosy. METHODS: We selected 1,213 records of individuals with leprosy, who were untreated (new cases) and admitted to a dermatology clinic in Recife, Brazil, from 2000 to 2005, and who underwent bacteriological examination at diagnosis for ratification of the operational classification. RESULTS: Compared to bacilloscopy, operational classification demonstrated 88.6% sensitivity, 76.9% specificity, a positive predictive value of 61.8%, and a negative predictive value of 94.1%, with 80% accuracy and a moderate kappa index. Among the bacilloscopy-negative cases, 23% had more than 5 skin lesions. Additionally, 11% of the bacilloscopy-positive cases had up to 5 lesions, which would have led to multibacillary cases being treated as paucibacillary leprosy if the operational classification had not been confirmed by bacilloscopy. CONCLUSIONS: Operational classification has limitations that are more obvious in borderline cases, suggesting that in these cases, lymph smear testing is advisable to enable the selection of true multibacillary cases for more intense treatment, thereby contributing to minimization of resistant strain selection and possible relapse.

Concordance between expected and observed bacilloscopy results of clinical forms of leprosy: a 6-year retrospective study in Recife, State of Pernambuco, Brazil / Concordância entre os resultados observados e esperados da forma clinica da hanseníase de acordo com a baciloscopia: um estudo retrospectivo de seis anos em Recife, Estado de Pernambuco, Brasil

INTRODUCTION: Operational classification of leprosy based on the number of skin lesions was conceived to screen patients presenting severe forms of the disease to enable their reception of a more intense multidrug regimen without having to undergo lymph smear testing. We evaluated the concordance between operational classification and bacilloscopy to define multibacillary and paucibacillary leprosy. METHODS: We selected 1,213 records of individuals with leprosy, who were untreated (new cases) and admitted to a dermatology clinic in Recife, Brazil, from 2000 to 2005, and who underwent bacteriological examination at diagnosis for ratification of the operational classification. RESULTS: Compared to bacilloscopy, operational classification demonstrated 88.6% sensitivity, 76.9% specificity, a positive predictive value of 61.8%, and a negative predictive value of 94.1%, with 80% accuracy and a moderate kappa index. Among the bacilloscopy-negative cases, 23% had more than 5 skin lesions. Additionally, 11% of the bacilloscopy-positive cases had up to 5 lesions, which would have led to multibacillary cases being treated as paucibacillary leprosy if the operational classification had not been confirmed by bacilloscopy. CONCLUSIONS: Operational classification has limitations that are more obvious in borderline cases, suggesting that in these cases, lymph smear testing is advisable to enable the selection of true multibacillary cases for more intense treatment, thereby contributing to minimization of resistant strain selection and possible relapse.

INTRODUÇÃO: A classificação operacional da hanseníase baseada no número de lesões de pele foi concebida para selecionar pacientes que apresentam formas graves da doença para receber regime terapêutico mais intenso com múltiplas drogas sem o exame de baciloscopia da linfa. Nós avaliamos a concordância entre a classificação operacional e a baciloscopia para a definição de hanseníase multibacilar e paucibacilar. MÉTODOS: Nós selecionamos 1.213 registros de indivíduos com hanseníase não tratada (casos novos), atendidos em um Ambulatório de Dermatologia, em Recife, Brasil, no período de 2000 a 2005, que foram submetidos a exame bacteriológico ao diagnóstico para a ratificação da classificação operacional. RESULTADOS: Comparando com a baciloscopia, a classificação operacional baseada no número de lesões cutâneas mostrou sensibilidade de 88,6%, especificidade 76,9%, valor preditivo positivo de 61,8% e valor preditivo negativo de 94,1%, com uma precisão de 80% e um moderado índice kappa. Entre os casos com baciloscopia negativa, 23% tinham mais de cinco lesões de pele, recebendo um tratamento mais intensivo. Além disso, 11% dos casos baciloscopia positiva tinham até cinco lesões, o que induziriam casos multibacilares de serem tratados com hanseníase paucibacilar se a classificação operacional não tivesse sido confirmada pela baciloscopia. CONCLUSÕES: Concluímos que a classificação operacional tem limitações mais visíveis nos casos borderline, sugerindo que, nestes casos, o esfregaço seria aconselhável por permitir que os verdadeiros casos multibacilares fossem selecionados para um tratamento mais intenso, contribuindo para minimizar a seleção de cepas resistentes e uma possível recidiva.

Revalidation of various clinical criteria for the classification of leprosy--a clinic-pathological study.

UNLABELLED: WHO guidelines classify leprosy patients clinically into PB and MB group based on the number of skin lesions (NSL) with > or = 6 skin lesions as a criterion for MB leprosy. Other clinical criteria for classification are based on the number of body areas affected (NBAA) and on size of the largest skin lesions (SLSL). They are also fairly simple and easily practicable in the field. OBJECTIVES: The objective of this study is to explore whether sensitivity and specificity of the WHO classification can be improved by addition of clinical criteria based on NBAA and SLSL to WHO classification. STUDY DESIGN: Among 100 newly diagnosed untreated leprosy patients classified into PB and MB group according to WHO classification, the NSL and NBAA were recorded and the size (longest diameter) of largest skin lesion was measured in centimeters. The Receiver Operator Characteristic (ROC) curves were plotted for each parameter to find the best cut off point (with highest sensitivity and specificity). RESULTS: The sensitivity and specificity of the WHO classification tested, using slit-skin smear (SSS) and skin biopsy results as the gold standard, was found to be 63% and 85% respectively. The ROC curve for NSL found the best cut off of three and more lesions for MB group (sensitivity 90% & specificity 80%). Similarly, ROC curves for NBAA and SLSL found the best cut off points for classification into MB group to be two or more (sensitivity 90% & specificity 75%) and 5 cm or more (sensitivity 87% and specificity 65%) respectively. On combining all these criteria together sensitivity was increased to 98.5% with no significant change in specificity, which was 77.5%. CONCLUSION: The study concluded that the sensitivity of the present clinical classification can be further improved by addition of two other clinical criteria.

El ML Flow test como técnica de diagnóstico inmediato para programas de control de la lepra: posible impacto sobre la clasificación de los pacientes / No disponible

Objetivo: Evaluar la utilidad de la técnica ML Flow como un instrumento adicional, de tipo serológico, para la clasificación en Brasil, Nepal y Nigeria, 2.632 pacientes de lepra mediante tres métodos: (1) como pacientes multibacilares (MB) o paucibacilares (PB) de acuerdo al número de lesiones (clasificación OMS), (2) mediante la baloscopia y (3) con serología utilizando el ML Flow Test que detecta anticuerpos IgM específicos frente al Mycobacterium leprae PGL-1. Resultados: La proporción de pacientes MB era del 39,5, 35,6 y 19,4% en Brasil, Nepaly Nigeria, respectivamente. La seropositividad mayor fue observada en los pacientes de Nigeria (62,9%), seguido por Brasil (50,8%) y Nepal (35,6%). Los resultados del ML Flor Test y baciloscopia resultaron negativos en el 69,1 y 82,7% de los pacientes PB, mientras que fueron positivos en el 58,6% de los pacientes MB de Brasil y 28,3% de Nepal. En los pacientes MB, tanto los frotis como el ML Flow Test resultaron negativos en el 15,6% de los pacientes de Brasil y 38,3% en Nepal. La evaluación de todos los pacientes PB con el ML Flow para prevenir un posible sub-tratamiento podría incrementar el grupo MB un 18, 11 y 46,2% para Brasil, Nepal y Nigeria, respectivamente. Con el ML Flow Test como único criterio para la clasificación, el incremento resultante sería del 11.3 y 43,5% de pacientes que requerirían tratamiento para la lepra MB en Brasil y Nigeria, respectivamente y una disminución del 3.7% en Nepal. Conclusiones: El test ML Flow puede ser útil para mejorar la clasificación, reducir el riesgo de sub-tratamiento con el consiguiente fracaso terapéutico y minimizar la necesidad de frotis cutáneos (AU)

Objective: To evaluate the use of the ML Flow test as an additional, serological, tool for the classification of new leprosy patients. Design: In Brazil, Nepal and Nigeria, 2.632 leprosy patients were classified by three metods: (1) as multibacillary (MB) or paucibacillary (PB) according to the number of lesions (WHO classification), (2) by slit skin smear examination, and (3) by serology using the ML Flow test detecting IgM antibodies to Mycobacterium leprae-specific phenolic glycolipid-I. Results: The proportion of MB leprosy patients was 39.5, 35,6 and 19,4% in Brazil, Nepal and Nigeria, respectively. The highest seropositivity in patients was observed in Nigeria (62,9%), followed by Brazil (50,8%) and Nepal (35,6%). ML Flow test results and smears were negative in 69.1 and 82,7% of PB patients, while smears were positive in 58.6% of MB patients in Brazil and 28.3% in Nepal. In MB patients, both smears and ML Flow test were negative in 15.6% in Brazil and 38.3% in Nepal. Testing all PB patients with the ML Flow test to prevent under-treatment would increase the MB group by 18, 11 and 46,2% for brazil, Nepal and Nigeria, respectively. Using the ML Flow test as the sole criterion for classification would result in an increase of 11.3 and 43,5% of patients requiring treatment for MB leprosy in Brazil and Nigeria, respectively, and a decrease of 3.7% for Nepal. Conclusions: The ML Flow test could be used to strengthen classification, reduce the risk of under-treatment and minimize the need for slit skin smears (AU)