RESUMEN
Objective: To assess the cost-per-responder (CpR) of biologic therapies available in Brazil to treat moderate-to-severe plaque psoriasis (PsO) from the private healthcare system's perspective. Methods: Number needed to treat (NNT) and (CpR) analyses were performed to evaluate biologic therapies' cost-effectiveness for moderate-to-severe PsO available in Brazil. The effectiveness of biologic treatments for moderate-to-severe PsO was assessed based on a previously published metanalysis, which included studies considering PsO patients and outcomes of interest (PASI 75, 90, and 100). The clinical efficacy data in terms of estimated NNT based on the network metanalysis (NMA) results were combined with drug treatment costs to determine the CpR for each treatment arm in 3-time horizons: the primary response period, 1-year, and 2-years. Results: Risankizumab was the most cost-effective option when NMA base case scenario data was used to calculate NNT in all PASI response for both the primary response period and 1- and 2-years follow-up durations. Differences in CpR between risankizumab and other biologic drugs increased with more significant PASI improvements. CpR sensitivity analysis also confirmed these findings, indicating that risankizumab has a better performance for PASI 100, and both risankizumab and guselkumab are very similar in terms of cost per additional PASI 75 and PASI 90 responder. Conclusions: Risankizumab was estimated to have a lower cost per PASI 75, 90, and 100 responders in most simulated scenarios (primary response period [12-16 weeks], 1-year and 2-years), among the evaluated biologic therapies.
Objetivo: Avaliar o custo por respondedor (CpR) das terapias biológicas disponíveis no Brasil para tratamento da psoríase em placas (PsO) moderada a grave, na perspectiva do sistema brasileiro de saúde suplementar. Métodos: Foram realizadas análises de número necessário para tratar (NNT) e CpR para avaliar o custo-efetividade das terapias biológicas para PsO moderada a grave disponíveis no Brasil. A eficácia foi avaliada por meio de dados de uma metanálise em rede (NMA), que incluiu estudos considerando pacientes com PsO moderada a grave e os desfechos de interesse (PASI 75, 90 e 100). Dados de eficácia em termos de NNT foram combinados com custos do tratamento medicamentoso para determinar o CpR para cada braço de tratamento em três horizontes temporais: período de resposta primária, 1 ano e 2 anos. Resultados: Risanquizumabe foi mais econômico quando utilizados os dados do caso-base para calcular o NNT, considerando todos os escores PASI para o período de resposta primária e em 1 e 2 anos. As diferenças no CpR entre o risanquizumabe e os outros medicamentos biológicos aumentaram com maiores ganhos de PASI. O CpR calculado pela análise de sensibilidade confirmou esses achados, indicando que risanquizumabe tem um melhor desempenho para PASI 100, e risanquizumabe e guselcumabe são muito semelhantes em termos de CpR por PASI 75 e PASI 90 adicionais. Conclusões: Risanquizumabe apresentou um custo mais baixo por respondedor PASI 75, 90 e 100 na maioria dos cenários analisados (período de resposta primária [12-16 semanas], 1 ano e 2 anos), entre as terapias biológicas avaliadas.
Asunto(s)
Psoriasis , Productos Biológicos , Costos y Análisis de Costo , Salud ComplementariaRESUMEN
Psoriasis is a chronic inflammatory disease that affects 1.3% of the Brazilian population. The most common clinical manifestations are erythematous, scaling lesions that affect both genders and can occur on any anatomical site, preferentially involving the knees, elbows, scalp and genitals. Besides the impact on the quality of life, the systemic nature of the disease makes psoriasis an independent risk factor for cardiovascular disease, especially in young patients with severe disease. By an initiative of the Brazilian Society of Dermatology, dermatologists with renowned clinical experience in the management of psoriasis were invited to form a work group that, in a partnership with the Brazilian Medical Association, dedicated themselves to create the Plaque Psoriasis Diagnostic and Treatment Guidelines. The relevant issues for the diagnosis (evaluation of severity and comorbidities) and treatment of plaque psoriasis were defined. The issues generated a search strategy in the Medline-PubMed database up to July 2018. Subsequently, the answers to the questions of the recommendations were devised, and each reference selected presented the respective level of recommendation and strength of scientific evidence. The final recommendations for making up the final text were worded by the coordinators.
Asunto(s)
Psoriasis/diagnóstico , Psoriasis/terapia , Corticoesteroides/uso terapéutico , Antralina/uso terapéutico , Anticuerpos Monoclonales/uso terapéutico , Brasil , Inhibidores de la Calcineurina/uso terapéutico , Comorbilidad , Ciclosporina/uso terapéutico , Fármacos Dermatológicos/uso terapéutico , Dermatología , Combinación de Medicamentos , Femenino , Humanos , Masculino , Metotrexato/uso terapéutico , Fototerapia/métodos , Psoriasis/epidemiología , Índice de Severidad de la Enfermedad , Sociedades Médicas , Factores de Tiempo , Vitamina D/análisisRESUMEN
The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field in order to standardize producers to assist the reasoning and decision-making of doctors. The information provided through this project must be assessed and criticized by the physician responsible for the conduct that will be adopted, depending on the conditions and the clinical status of each patient.
Asunto(s)
Anticuerpos Monoclonales/administración & dosificación , Etanercept/administración & dosificación , Factores Inmunológicos/administración & dosificación , Psoriasis/tratamiento farmacológico , Anticuerpos Monoclonales/efectos adversos , Brasil , Toma de Decisiones Clínicas , Etanercept/efectos adversos , Humanos , Factores Inmunológicos/efectos adversos , Psoriasis/patología , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del TratamientoRESUMEN
The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field in order to standardize producers to assist the reasoning and decision-making of doctors. The information provided through this project must be assessed and criticized by the physician responsible for the conduct that will be adopted, depending on the conditions and the clinical status of each patient.
Asunto(s)
Anticuerpos Monoclonales/administración & dosificación , Fármacos Dermatológicos/administración & dosificación , Inmunosupresores/administración & dosificación , Psoriasis/tratamiento farmacológico , Acitretina/administración & dosificación , Acitretina/efectos adversos , Anticuerpos Monoclonales/efectos adversos , Brasil , Toma de Decisiones Clínicas , Ciclosporina/administración & dosificación , Ciclosporina/efectos adversos , Fármacos Dermatológicos/efectos adversos , Humanos , Inmunosupresores/efectos adversos , Metotrexato/administración & dosificación , Metotrexato/efectos adversos , Psoriasis/patología , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del TratamientoRESUMEN
Abstract: Psoriasis is a chronic inflammatory disease that affects 1.3% of the Brazilian population. The most common clinical manifestations are erythematous, scaling lesions that affect both genders and can occur on any anatomical site, preferentially involving the knees, elbows, scalp and genitals. Besides the impact on the quality of life, the systemic nature of the disease makes psoriasis an independent risk factor for cardiovascular disease, especially in young patients with severe disease. By an initiative of the Brazilian Society of Dermatology, dermatologists with renowned clinical experience in the management of psoriasis were invited to form a work group that, in a partnership with the Brazilian Medical Association, dedicated themselves to create the Plaque Psoriasis Diagnostic and Treatment Guidelines. The relevant issues for the diagnosis (evaluation of severity and comorbidities) and treatment of plaque psoriasis were defined. The issues generated a search strategy in the Medline-PubMed database up to July 2018. Subsequently, the answers to the questions of the recommendations were devised, and each reference selected presented the respective level of recommendation and strength of scientific evidence. The final recommendations for making up the final text were worded by the coordinators.
Asunto(s)
Humanos , Masculino , Femenino , Psoriasis/diagnóstico , Psoriasis/terapia , Fototerapia/métodos , Psoriasis/epidemiología , Sociedades Médicas , Factores de Tiempo , Vitamina D/análisis , Índice de Severidad de la Enfermedad , Brasil , Comorbilidad , Antralina/uso terapéutico , Metotrexato/uso terapéutico , Ciclosporina/uso terapéutico , Corticoesteroides/uso terapéutico , Fármacos Dermatológicos/uso terapéutico , Dermatología , Combinación de Medicamentos , Inhibidores de la Calcineurina/uso terapéutico , Anticuerpos Monoclonales/uso terapéuticoRESUMEN
The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field in order to standardize producers to assist the reasoning and decision-making of doctors. The information provided through this project must be assessed and criticized by the physician responsible for the conduct that will be adopted, depending on the conditions and the clinical status of each patient.
Asunto(s)
Humanos , Psoriasis/tratamiento farmacológico , Fármacos Dermatológicos/administración & dosificación , Inmunosupresores/administración & dosificación , Anticuerpos Monoclonales/administración & dosificación , Psoriasis/patología , Factores de Tiempo , Índice de Severidad de la Enfermedad , Brasil , Metotrexato/administración & dosificación , Metotrexato/efectos adversos , Resultado del Tratamiento , Ciclosporina/administración & dosificación , Ciclosporina/efectos adversos , Acitretina/administración & dosificación , Acitretina/efectos adversos , Fármacos Dermatológicos/efectos adversos , Toma de Decisiones Clínicas , Inmunosupresores/efectos adversos , Anticuerpos Monoclonales/efectos adversosRESUMEN
The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field in order to standardize producers to assist the reasoning and decision-making of doctors. The information provided through this project must be assessed and criticized by the physician responsible for the conduct that will be adopted, depending on the conditions and the clinical status of each patient.
Asunto(s)
Humanos , Psoriasis/tratamiento farmacológico , Etanercept/administración & dosificación , Factores Inmunológicos/administración & dosificación , Anticuerpos Monoclonales/administración & dosificación , Psoriasis/patología , Factores de Tiempo , Índice de Severidad de la Enfermedad , Brasil , Factores de Riesgo , Resultado del Tratamiento , Etanercept/efectos adversos , Toma de Decisiones Clínicas , Factores Inmunológicos/efectos adversos , Anticuerpos Monoclonales/efectos adversosRESUMEN
BACKGROUND: Psoriasis is a chronic, immune mediated inflammatory condition that affects a significant amount of the global population. Yet geographic variability in the consequences of psoriasis warrants region-level analyses. OBJECTIVE: The current study contributes to the psoriasis outcomes literature by offering a comprehensive assessment of the humanistic and economic burden in Brazil. METHODS: The 2012 Brazil National Health and Wellness Survey (N=12,000) was used to assess health-related quality of life (Short Form-12, version 2), work productivity, and healthcare resource use associated with experiencing psoriasis vs. no psoriasis, along with varying levels of psoriasis severity. RESULTS: A total of 210 respondents reported diagnosis of psoriasis (N=157, 42, and 11 reporting mild, moderate, and severe psoriasis, respectively). Compared with controls, respondents with psoriasis reported diminished mental component summary scores and health utilities, as well as increased presenteeism, activity impairment, and physician visits over the past six months, adjusting for covariates. Among those with psoriasis, physical health decreased as psoriasis severity increased. Although work productivity and healthcare resource utilization did not differ with psoriasis severity, the high rates of productivity loss (e.g. 45.5% presenteeism in the severe psoriasis group) suggest an economic burden. STUDY LIMITATIONS: Cost analyses were not performed, and cross-sectional patient-reported data limit causal conclusions and may reflect reporting biases. CONCLUSIONS: Nevertheless, these results suggest a significant burden to patients with psoriasis across both humanistic and economic outcomes. The association between psoriasis and mental health aspects and health utilities were particularly strong and exceeded what would be considered clinically meaningful.
Asunto(s)
Recursos en Salud/estadística & datos numéricos , Psoriasis/economía , Psoriasis/fisiopatología , Calidad de Vida , Rendimiento Laboral/economía , Adulto , Análisis de Varianza , Brasil , Estudios de Casos y Controles , Enfermedad Crónica , Costo de Enfermedad , Estudios Transversales , Evaluación de la Discapacidad , Eficiencia/fisiología , Femenino , Encuestas Epidemiológicas , Humanos , Modelos Lineales , Masculino , Persona de Mediana Edad , Psoriasis/psicología , Calidad de Vida/psicología , Autoinforme , Índice de Severidad de la Enfermedad , Factores SocioeconómicosRESUMEN
Abstract: Background: Psoriasis is a chronic, immune mediated inflammatory condition that affects a significant amount of the global population. Yet geographic variability in the consequences of psoriasis warrants region-level analyses. Objective: The current study contributes to the psoriasis outcomes literature by offering a comprehensive assessment of the humanistic and economic burden in Brazil. Methods: The 2012 Brazil National Health and Wellness Survey (N=12,000) was used to assess health-related quality of life (Short Form-12, version 2), work productivity, and healthcare resource use associated with experiencing psoriasis vs. no psoriasis, along with varying levels of psoriasis severity. Results: A total of 210 respondents reported diagnosis of psoriasis (N=157, 42, and 11 reporting mild, moderate, and severe psoriasis, respectively). Compared with controls, respondents with psoriasis reported diminished mental component summary scores and health utilities, as well as increased presenteeism, activity impairment, and physician visits over the past six months, adjusting for covariates. Among those with psoriasis, physical health decreased as psoriasis severity increased. Although work productivity and healthcare resource utilization did not differ with psoriasis severity, the high rates of productivity loss (e.g. 45.5% presenteeism in the severe psoriasis group) suggest an economic burden. Study limitations: Cost analyses were not performed, and cross-sectional patient-reported data limit causal conclusions and may reflect reporting biases. Conclusions: Nevertheless, these results suggest a significant burden to patients with psoriasis across both humanistic and economic outcomes. The association between psoriasis and mental health aspects and health utilities were particularly strong and exceeded what would be considered clinically meaningful.
Asunto(s)
Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Psoriasis/economía , Psoriasis/fisiopatología , Calidad de Vida/psicología , Rendimiento Laboral/economía , Recursos en Salud/estadística & datos numéricos , Psoriasis/psicología , Factores Socioeconómicos , Índice de Severidad de la Enfermedad , Brasil , Estudios de Casos y Controles , Modelos Lineales , Enfermedad Crónica , Estudios Transversales , Análisis de Varianza , Encuestas Epidemiológicas , Costo de Enfermedad , Evaluación de la Discapacidad , Eficiencia/fisiología , AutoinformeRESUMEN
Abstract During the last decade, different studies have converged to evidence the high prevalence of comorbidities in subjects with psoriasis. Although a causal relation has not been fully elucidated, genetic relation, inflammatory pathways and/or common environmental factors appear to be underlying the development of psoriasis and the metabolic comorbidities. The concept of psoriasis as a systemic disease directed the attention of the scientific community in order to investigate the extent to which therapeutic interventions influence the onset and evolution of the most prevalent comorbidities in patients with psoriasis. This study presents scientific evidence of the influence of immunobiological treatments for psoriasis available in Brazil (infliximab, adalimumab, etanercept and ustekinumab) on the main comorbidities related to psoriasis. It highlights the importance of the inflammatory burden on the clinical outcome of patients, not only on disease activity, but also on the comorbidities. In this sense, systemic treatments, whether immunobiologicals or classic, can play a critical role to effectively control the inflammatory burden in psoriatic patients.
Asunto(s)
Humanos , Psoriasis/tratamiento farmacológico , Anticuerpos Monoclonales/uso terapéutico , Enfermedades Cardiovasculares/tratamiento farmacológico , Comorbilidad , Factores de Riesgo , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Síndrome Metabólico/tratamiento farmacológico , Diabetes Mellitus/tratamiento farmacológico , Dislipidemias/tratamiento farmacológico , Obesidad Abdominal/tratamiento farmacológico , Enfermedad del Hígado Graso no Alcohólico/tratamiento farmacológico , Hipertensión/tratamiento farmacológicoRESUMEN
During the last decade, different studies have converged to evidence the high prevalence of comorbidities in subjects with psoriasis. Although a causal relation has not been fully elucidated, genetic relation, inflammatory pathways and/or common environmental factors appear to be underlying the development of psoriasis and the metabolic comorbidities. The concept of psoriasis as a systemic disease directed the attention of the scientific community in order to investigate the extent to which therapeutic interventions influence the onset and evolution of the most prevalent comorbidities in patients with psoriasis. This study presents scientific evidence of the influence of immunobiological treatments for psoriasis available in Brazil (infliximab, adalimumab, etanercept and ustekinumab) on the main comorbidities related to psoriasis. It highlights the importance of the inflammatory burden on the clinical outcome of patients, not only on disease activity, but also on the comorbidities. In this sense, systemic treatments, whether immunobiologicals or classic, can play a critical role to effectively control the inflammatory burden in psoriatic patients.
Asunto(s)
Anticuerpos Monoclonales/uso terapéutico , Psoriasis/tratamiento farmacológico , Enfermedades Cardiovasculares/tratamiento farmacológico , Comorbilidad , Diabetes Mellitus/tratamiento farmacológico , Dislipidemias/tratamiento farmacológico , Humanos , Hipertensión/tratamiento farmacológico , Síndrome Metabólico/tratamiento farmacológico , Enfermedad del Hígado Graso no Alcohólico/tratamiento farmacológico , Obesidad Abdominal/tratamiento farmacológico , Factores de Riesgo , Factor de Necrosis Tumoral alfa/antagonistas & inhibidoresRESUMEN
Psoriasis is a chronic inflammatory, immune-mediated disease that affects 1% to 2% of the world's population. Immunobiological medications are prescribed for certain patients with severe forms of psoriasis, however, these drugs increase the risk of reactivation of viral diseases such as hepatitis B. We report the case of a patient with severe psoriasis with positive serology for the Hepatitis B virus, who received ustekinumab (a human monoclonal antibody against interleukin 12 and 23). In this patient, the use of ustekinumab did not reactivate the Hepatitis B virus. Given the high prevalence of chronic viral infections in patients who are candidates for biologic therapy, as well as the potential for reactivate chronic viral illness, randomized controlled studies are needed to assess the risks and benefits of such therapy in these populations.
Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Virus de la Hepatitis B/efectos de los fármacos , Hepatitis B/virología , Psoriasis/tratamiento farmacológico , Virus de la Hepatitis B/fisiología , Humanos , Lamivudine/uso terapéutico , Masculino , Persona de Mediana Edad , Inhibidores de la Transcriptasa Inversa/uso terapéutico , Resultado del Tratamiento , Ustekinumab , Activación Viral/efectos de los fármacosRESUMEN
Psoriasis is a chronic inflammatory, immune-mediated disease that affects 1% to 2% of the world's population. Immunobiological medications are prescribed for certain patients with severe forms of psoriasis, however, these drugs increase the risk of reactivation of viral diseases such as hepatitis B. We report the case of a patient with severe psoriasis with positive serology for the Hepatitis B virus, who received ustekinumab (a human monoclonal antibody against interleukin 12 and 23). In this patient, the use of ustekinumab did not reactivate the Hepatitis B virus. Given the high prevalence of chronic viral infections in patients who are candidates for biologic therapy, as well as the potential for reactivate chronic viral illness, randomized controlled studies are needed to assess the risks and benefits of such therapy in these populations.
Asunto(s)
Humanos , Masculino , Persona de Mediana Edad , Anticuerpos Monoclonales Humanizados/uso terapéutico , Virus de la Hepatitis B/efectos de los fármacos , Hepatitis B/virología , Psoriasis/tratamiento farmacológico , Virus de la Hepatitis B/fisiología , Lamivudine/uso terapéutico , Inhibidores de la Transcriptasa Inversa/uso terapéutico , Resultado del Tratamiento , Activación Viral/efectos de los fármacosRESUMEN
INTRODUÇÃO: Psoríase em placas é uma dermatose crônica que tem um impacto importante nas dimensões social e psicológica nos pacientes. Estudos anteriores sugeriram que intervenções educacionais e psicológicas podem ser efetivas no gerenciamento da psoríase. OBJETIVOS: Examinar as intervenções educativas e psicológicas para psoríase em período de 20 anos (1992 a 2012). MÉTODO: revisão sistemática de literatura nas bases de dados: PubMed/Medline, PsycInfo (APA), ProQuest e Pepsic. RESULTADOS: 1359 artigos foram primeiramente selecionados por busca computadorizada, dos quais 36 foram analisados por dois revisores. Sete (n=7) estudos foram posteriormente selecionados para análise detalhada, sendo um artigo (n=1) de intervenção educativa individual, dois (n=2) envolvendo intervenções psicológicas e quatro (n=4) programas de gerenciamento de sintomas. CONCLUSÃO: Embora a literatura aponte para um crescente número de estudos de intervenção para psoríase e variáveis psicológicas, são necessários estudos de maior rigor para ajudar os pacientes a lidar com a doença.(AU)
BACKGROUND: Plaque psoriasis is a chronic skin disorder that has a major impact on patient´s social and psychological abilities. Preliminary studies have suggested that educative and psychological interventions may be effective in the management of psoriasis. OBJECTIVES: To examine the educative and psychological interventions for psoriasis in the last 20 years (1992-2012). METHODS: A systematic review of literature was conducted in medical and psychological databases: PubMed / Medline, PsycInfo (APA), ProQuest and Pepsic. RESULTS: 1359 articles were first selected by computerized search, from which 36 were examined by two revisers. Seven studies (n=7) were selected to a more in depth analysis, one (n=1) was a single educative intervention, two (n=2) involved psychological interventions and four (n=4) were symptom management programmes. CONCLUSION: Although the recent literature shows an increase number of interventions targeting psoriasis and psychosocial variables, stronger studies are necessary to help patients deal with the disease.(AU)
Asunto(s)
Humanos , Psoriasis , Estrés Psicológico , Enfermedades de la PielRESUMEN
Congenital hypotrichosis and Stargardt macular dystrophy are rare autosomal recessive disorder of unknown etiology respectively characterized by hair loss, macular degeneration and severe progressive vision reduction. There are few reports in the literature with this association. Studies show that the defective gene is on the chromosome I6q22.1 and involve cadherin molecule in the pathogenesis. Early recognition of these disorders often starts with hair changes and should alert the dermatologist for an eye examination thereby avoiding more severe ocular defect.
Asunto(s)
Hipotricosis/congénito , Degeneración Macular/congénito , Adolescente , Femenino , Humanos , Hipotricosis/diagnóstico , Degeneración Macular/diagnóstico , SíndromeRESUMEN
The clinical identification of amelanotic malignant melanoma (AMM) and hypomelanotic malignant melanoma (HMM) becomes difficult due to the lack of pigmentation and to the diverse clinical presentations. Dermoscopy is very useful in these cases, increasing the level of suspicion of malignancy. We report 4 cases of amelanotic malignant melanoma and hypomelanotic malignant melanoma with characteristic dermoscopic findings. Dermoscopy under polarized light demonstrates vascular polymorphism, globules and milky-red areas, in addition to chrysalis and multiple blue-gray dots.
A identificação clínica de melanoma maligno amelanótico e hipomelanótico torna-se difícil devido à falta de pigmentação e às diversas apresentações desse tipo de tumor. A dermatoscopia é muito útil nestes casos, aumentando o grau de suspeição de malignidade. Relatamos 4 casos de melanoma maligno amelanótico e melanoma maligno hipomelanótico com achados dermatoscópicos característicos. A dermatoscopia com luz polarizada demonstra polimorfismo vascular, glóbulos e áreas vermelholeitosas, assim como crisálides e múltiplos pontos azul-acinzentados.
Asunto(s)
Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Melanoma Amelanótico/patología , Melanoma/patología , Neoplasias Cutáneas/patología , Dermoscopía , Diagnóstico DiferencialRESUMEN
Skin cancer - melanoma and non melanoma - are common neoplasm with rising incidence over the last decades. It is an important public health problem. Its pathogenesis is not completely understood and the same happens with the genetic factors involved. The genes that encode the HLA are associated with some tumors and they may be responsible for one of the mechanisms that take part in the development of the before mentioned cancers. We have reviewed the literature on the subject of HLA antigens, melanoma and non melanoma skin cancer.