Clinical-epidemiological characteristics and temporal trend of new cases of grade 2 disability leprosy in the state of Maranhão, Brazil, 2011- 2020.

MAIN RESULTS: Out of 2,147 grade 2 disability leprosy cases, the majority were male, of mixed race/skin color, multibacillary and borderline. The São Luís regional health unit showed a falling trend. IMPLICATIONS FOR SERVICES: The results can guide strategies for the leprosy control program in the state, aiming at new approaches towards early diagnosis, treatment and prevention of disabilities. PERSPECTIVES: Further studies are needed, such as spatial distribution of cases and detection rates of leprosy in children under 15 years of age, in order to gain a better understanding of the epidemiological profile of leprosy in Maranhão. OBJECTIVE: to describe the clinical and epidemiological characteristics of new cases of grade 2 disability leprosy and to analyze its trend in the state of Maranhão, from 2011 to 2020. METHODS: this was a descriptive cross-sectional and ecological time-series study, using data from the Notifiable Health Conditions Information System. A descriptive analysis of the event was carried out according to the sociodemographic and clinical-laboratory characteristics of the cases. The temporal trend of event incidence was analyzed using Prais-Winsten regression. RESULTS: of the 2,147 cases, 71.5% were male, 48.9% had up to 8 years of schooling, 66.5% were of mixed race/color, 95.5% had the multibacillary form, 58.8% were borderline, 32.3% had negative bacilloscopy at diagnosis. There was a stationary trend in the state and a falling trend in the São Luís Health Region (annual percentage change = -64.4%; 95% confidence interval: -73.7;-51.9). CONCLUSION: incidence trend was stable in the state of Maranhão and falling in São Luís.

Factors associated with multibacillary leprosy in a region of northeastern Brazil.

INTRODUCTION: The analysis of factors associated with multibacillary leprosy is important for the development of strategies to mitigate the disease, which persists as a public health problem in Brazil and the world. The objective of this study was to verify the associations between sociodemographic and clinical-epidemiological variables and multibacillary leprosy in the state of northeastern Brazil. METHODOLOGY: This is a cross-sectional, analytical, and retrospective study, with a quantitative approach, carried out in 16 municipalities in the southwest of Maranhão State, northeastern Brazil. All cases of leprosy reported between January 2008 and December 2017 were considered. Sociodemographic and clinical-epidemiological variables were analyzed using descriptive statistics. The identification of the risk factors associated with multibacillary leprosy was conducted using Poisson regression models. The prevalence ratios and respective 95% confidence intervals were estimated using regression coefficients at a 5% significance level. RESULTS: A total of 3,903 leprosy cases were analyzed. Individuals older than 15 years, males, with less than 8 years of education, with level I, II, or "not evaluated" disability, and with type 1 or 2 or both reactional states were more likely to have multibacillary leprosy. Therefore, these characteristics may be considered risk factors. No protective factors were identified. CONCLUSIONS: The investigation revealed important associations between risk factors and multibacillary leprosy. The findings can be considered during the creation of strategies to control and combat the disease.

Características clínico-epidemiológicas e tendência temporal de casos novos de hanseníase com grau 2 de incapacidade física, no estado do Maranhão, 2011-2020 / Clinical-epidemiological characteristics and temporal trend of new cases of grade 2 disability leprosy in the state of Maranhão, Brazil, 2011- 2020 / Características clínico-epidemiológicas y tendencia temporal de los nuevos casos de lepra grado 2 de discapacidad en el estado de Maranhão, Brasil, 2011-2020

Objetivo: descrever as características clínico-epidemiológicas dos casos novos de hanseníase com grau 2 de incapacidade física e analisar sua tendência no estado do Maranhão, Brasil, 2011-2020. Métodos: estudo transversal descritivo e ecológico de série temporal, com dados do Sistema de Informação de Agravos de Notificação; realizou-se análise descritiva do evento segundo características sociodemográficas e clínico-laboratoriais dos casos; a tendência temporal da incidência do evento foi analisada pela regressão de Prais-Winsten. Resultados: dos 2.147 casos notificados, 71,5% foram do sexo masculino, 48,9% possuíam até 8 anos de estudo, 66,5% eram de raça/cor da pele parda, 95,5% da forma multibacilar, 58,8% da forma dimorfa e 32,3% com baciloscopia negativa no diagnóstico; observou-se estacionaridade na tendência no estado, e tendência decrescente na regional de saúde de São Luís (variação anual = -64,4%; intervalo de confiança de 95% -73,7;-51,9). Conclusão: a tendência da incidência foi estável no estado do Maranhão e decrescente em São Luís.

Objective: to describe the clinical and epidemiological characteristics of new cases of grade 2 disability leprosy and to analyze its trend in the state of Maranhão, from 2011 to 2020. Methods: this was a descriptive cross-sectional and ecological time-series study, using data from the Notifiable Health Conditions Information System. A descriptive analysis of the event was carried out according to the sociodemographic and clinical-laboratory characteristics of the cases. The temporal trend of event incidence was analyzed using Prais-Winsten regression. Results: of the 2,147 cases, 71.5% were male, 48.9% had up to 8 years of schooling, 66.5% were of mixed race/color, 95.5% had the multibacillary form, 58.8% were borderline, 32.3% had negative bacilloscopy at diagnosis. There was a stationary trend in the state and a falling trend in the São Luís Health Region (annual percentage change = -64.4%; 95% confidence interval: -73.7;-51.9). Conclusion: incidence trend was stable in the state of Maranhão and falling in São Luís.

Objetivo: describir las características clínicas y epidemiológicas de los nuevos casos de lepra con discapacidad física grado 2 y analizar su tendencia en el estado de Maranhão, de 2011 a 2020. Métodos: estudio transversal descriptivo y ecológico de serie temporal con datos del Sistema de Información de Agravamiento de Notificaciones. Se realizó un análisis descriptivo de características sociodemográficas y clínico-laboratoriales. La tendencia temporal de la incidencia de eventos se analizó mediante la regresión de Prais-Winsten. Resultados: de los 2.147 casos, 71,5% era masculino, 48,9% tenía hasta 8 años de escolaridad, 66,5% era de raza/piel parda, 95,5% de forma multibacilar, 58,8% dimorfa, 32,3% con baciloscopia negativa al diagnóstico. Hubo tendencia estacionaria en el estado y tendencia decreciente en la Región de Salud São Luís (variación anual = -64,4%; intervalo de confianza 95%: -73,7;-51,9). Conclusión: la tendencia de la incidencia se mantuvo estable en el estado de Maranhão y decreciente en São Luís.

Factors Associated with Multibacillary Leprosy in a Priority Region for Disease Control in Northeastern Brazil: A Retrospective Observational Study.

BACKGROUND: Leprosy is an infectious disease that can lead to physical disabilities and stigmatization. It remains an important public health problem, especially in Brazil. OBJECTIVE: To analyse sociodemographic and clinical factors associated with multibacillary leprosy in a hyperendemic region of the disease in northeastern Brazil. METHOD: This is a retrospective observational study with secondary data acquired from 2012 to 2015, from a group of leprosy cases reported in a reference outpatient clinic for the treatment and followup of leprosy in the city of Imperatriz, Maranhao, in northeastern Brazil. RESULTS: From 905 new cases of leprosy studied, 656 (72.5%) were classified as multibacillary leprosy and 249 (27.5%) as paucibacillary leprosy. We observed that men were more likely to present 5 to 15 skin lesions (OR: 1.32; 95% CI: 1.18-1.49; p <0.0001) and >15 skin lesions (OR: 1.26; 95% CI: 1.09 -1.45; p = 0.005) and a lower chance of having <5 skin lesions (OR: 0.67; 95% CI: 0.59-0.76; p <0.0001). Women were more likely to have no affected nerves compared to men (OR: 1.46; 95% CI: 1.20-1.77; p <0.0001). The age range of 16 to 60 years showed a greater chance of having <5 skin lesions (OR: 1.01; 95% CI: 1.007-1.20; p = 0.03) and a lower chance of having 5 to 15 skin lesions (OR: 1.12, 95% CI: 1.03-1.23; p= 0.008) and a lower chance of being a grade I disability ( CI= 0.73-0.94; p=0.83) and II (OR: 0.82; 95% CI: 0.77-0.98; p=000.1). CONCLUSION: Cases of multibacillary leprosy were associated with male gender, low educational level, and clinical variables such as number of skin lesions and grade I or II disability.

Desempenho de antígenos nativo, recombinante e sintético, em testes imunoenzimáticos, para diagnóstico e prognóstico de pacientes com diferentes formas clínicas de hanseníase / Performance of native, recombinant and synthetic antigens by enzyme immunoassays for the diagnosis and prognosis of leprosy patients classified in the wide spectrum of the disease

Apesar da Organização Mundial de Saúde (OMS) ter adotado medidas de controle, a hanseníase permanece como um problema social e de saúde pública em muitos países. O diagnóstico clínico e a baciloscopia permanecem como as principais ferramentas utilizadas para a classificação dos pacientes e definição da terapêutica a ser instituída. A identificação de novos antígenos de M. leprae, o desenvolvimento de novos métodos laboratoriais e melhorar o desempenho de testes sorológicos já existentes são prioridades para tentar atingir as metas da OMS programadas para o período de 2011-2015. Neste estudo avaliamos o desempenho diagnóstico dos antígenos glicolipídeo sintético ND-O-BSA para pesquisa de anticorpos totais e recombinante LID-1, para pesquisa anticorpos IgG por ELISA; e o perfil de reatividade de anticorpos IgG contra proteínas nativas de M. leprae por Western Blotting, em amostras de soros de pacientes de área endêmica com diferentes formas clínicas da doença. Nossos resultados mostraram que os testes ELISA ND-O-BSA e LID-1 auxiliaram na detecção de 70% dos pacientes multibacilares com baciloscopia negativa. O valor preditivo negativo foi de 94% para ambos os testes. A análise do Western Blotting mostrou que pacientes multibacilares possuem anticorpos IgG para a fração de 38kDa e região de 3,5kDa, esta reatividade não foi observada no grupo controle. Nosso estudo sugere a utilização do ELISA, com antígenos recombinante e sintético, na rotina diagnóstica; e que a fração de 38kDa e região de 3,5kDa, de antígeno nativo de M. leprae, são bons marcadores no diagnóstico de hanseníase e no prognóstico de pacientes com as formas borderline e indeterminada da doença

Although several control measures have been adopted by the World Health Organization, (WHO) leprosy continues to be a social and public health problem in many countries. Clinical diagnosis and acid-fast bacilli skin smear are the main tools used to classify patients and define therapy. According to the WHO program for 2011-2015, the identification of new Mycobacterium leprae antigens, the development of new laboratory methods and improved serological tests are the priorities. In the present study, we evaluated the diagnostic performance of the synthetic glycolipid antigen, ND-O-BSA, to detect total antibodies and the recombinant antigen LID-1 to detect IgG antibodies by ELISA and the IgG reactivity profile against native M. leprae proteins by Western blot in serum samples from leprosy patients classified in the wide spectrum of the disease. Our results showed that ND-O-BSA and LID-1 ELISA are able to detect the disease in 70% of multibacillary patients with negative skin smears. The negative predictive values were 94% for both tests. The Western blot analysis revealed that most multibacillary patients had IgG antibodies against the 38 kDa and 3.5 kDa regions; this reactivity was not observed in the control group. Our study suggests the use of ELISA, with recombinant or synthetic antigens, in routine diagnosis and that the 38 kDa fraction and the 3.5 kDa region, from native M leprae antigen, are good markers for the diagnosis of leprosy and its prognosis as shown for the borderline and indeterminate forms of the disease.