Psoriasis Severity, Health-Related Quality of Life, Work Productivity, and Activity Impairments Among Patients With Moderate to Severe Psoriasis Receiving Systemic Treatment: Real-World Data From Clinical Practice in Spain.

BACKGROUND AND OBJECTIVE: The treatment of psoriasis should not only focus on skin affectations but also weigh the parameters for health-related quality of life (HRQoL), thereby tackling the concept of cumulative life course impairment (CLCI) and treating the patient from a holistic perspective. The CRYSTAL study aimed to characterize psoriasis with real-word data from Spanish clinical practice in patients with moderate to severe disease who received continuous systemic treatment for at least 24 weeks by using the absolute Psoriasis Area and Severity Index (PASI) score and its correlation to HRQoL. MATERIAL AND METHODS: This was a non-interventional, cross-sectional study conducted in 30 centers in Spain, with 301 patients between the ages of 18 and 75 years. The study collected data regarding current treatment and absolute PASI and their relationship to HRQoL using the Dermatology Life Quality Index (DLQI), to activity impairment using the Work Productivity and Activity Impairment (WPAI) questionnaire, and to treatment satisfaction. RESULTS: The mean (SD) age was 50.5 (12.5) years, with a duration of disease of 14 (14.1) years. The mean (SD) absolute PASI reported was 2.3 (3.5), with 28.7% of patients presenting with PASI from >1 to ≤3 and 22.6% with PASI>3. Higher PASI scores were associated with higher DLQI (p<0.001) and WPAI scores and lower levels of treatment satisfaction (p<0.001). CONCLUSIONS: These data indicate that achieving lower absolute PASI values may correlate not only with better HRQoL but also with better work productivity and treatment satisfaction.

Psoriasis Severity, Health-Related Quality of Life, Work Productivity, and Activity Impairments Among Patients With Moderate to Severe Psoriasis Receiving Systemic Treatment: Real-World Data From Clinical Practice in Spain. / [Artículo traducido] Gravedad de la psoriasis, calidad de vida relacionada con la salud, productividad laboral y deterioro de la actividad en pacientes con psoriasis moderada a grave que reciben tratamiento sistémico: datos de la vida real de la práctica clínica en España.

BACKGROUND AND OBJECTIVE: The treatment of psoriasis should not only focus on skin affectations but also weigh the parameters for health-related quality of life (HRQoL), thereby tackling the concept of cumulative life course impairment (CLCI) and treating the patient from a holistic perspective. The CRYSTAL study aimed to characterize psoriasis with real-word data from Spanish clinical practice in patients with moderate to severe disease who received continuous systemic treatment for at least 24 weeks by using the absolute Psoriasis Area and Severity Index (PASI) score and its correlation to HRQoL. MATERIAL AND METHODS: This was a non-interventional, cross-sectional study conducted in 30 centers in Spain, with 301 patients between the ages of 18 and 75 years. The study collected data regarding current treatment and absolute PASI and their relationship to HRQoL using the Dermatology Life Quality Index (DLQI), to activity impairment using the Work Productivity and Activity Impairment (WPAI) questionnaire, and to treatment satisfaction. RESULTS: The mean (SD) age was 50.5 (12.5) years, with a duration of disease of 14 (14.1) years. The mean (SD) absolute PASI reported was 2.3 (3.5), with 28.7% of patients presenting with PASI from >1 to ≤3 and 22.6% with PASI>3. Higher PASI scores were associated with higher DLQI (p<0.001) and WPAI scores and lower levels of treatment satisfaction (p<0.001). CONCLUSIONS: These data indicate that achieving lower absolute PASI values may correlate not only with better HRQoL but also with better work productivity and treatment satisfaction.

Consenso multidisciplinar sobre prevención y tratamiento de la tuberculosis en pacientes candidatos a tratamiento biológico. Adaptación al paciente dermatológico / Prevention and treatment of tuberculosis infection in candidates for biologic therapy: A multidisciplinary consensus statement adapted to the dermatology patient

El riesgo de infección por Mycobacterium tuberculosis se halla aumentado en los pacientes con enfermedades inflamatorias crónicas y en tratamiento inmunosupresor, en particular con terapia antifactor de necrosis tumoral α. La detección de la infección tuberculosa latente y el tratamiento preventivo dirigido a reducir el riesgo de progresión a tuberculosis activa es obligatoria en este grupo de pacientes. Este documento de consenso multidisciplinar actualiza la opinión de expertos y establece recomendaciones para el diagnóstico y tratamiento de la infección tuberculosa latente en estos pacientes, según los conocimientos actuales en terapias biológicas

Patients with chronic inflammatory diseases being treated with immunosuppressive drugs, and with tumor necrosis factor inhibitors in particular, have an increased risk of infection by Mycobacterium tuberculosis. Screening for latent tuberculosis infection and preventive therapy to reduce the risk of progression to active tuberculosis are mandatory in this group of patients. This updated multidisciplinary consensus document presents the latest expert opinions on the treatment and prevention of tuberculosis in candidates for biologic therapy and establishes recommendations based on current knowledge relating to the use of biologic agents

Prevention and treatment of tuberculosis infection in candidates for biologic therapy: A multidisciplinary consensus statement adapted to the dermatology patient. / Consenso multidisciplinar sobre prevención y tratamiento de la tuberculosis en pacientes candidatos a tratamiento biológico. Adaptación al paciente dermatológico.

Patients with chronic inflammatory diseases being treated with immunosuppressive drugs, and with tumor necrosis factor inhibitors in particular, have an increased risk of infection by Mycobacterium tuberculosis. Screening for latent tuberculosis infection and preventive therapy to reduce the risk of progression to active tuberculosis are mandatory in this group of patients. This updated multidisciplinary consensus document presents the latest expert opinions on the treatment and prevention of tuberculosis in candidates for biologic therapy and establishes recommendations based on current knowledge relating to the use of biologic agents.

Psoriasis e hígado graso no alcohólico / Psoriasis and Nonalcoholic Fatty Liver Disease

El hígado graso no alcohólico es la principal causa de enfermedad hepática en nuestro medio. Los pacientes con psoriasis presentan mayor prevalencia y gravedad y peor pronóstico de esta hepatopatía. El vínculo patogénico entre ambas es el estado de inflamación crónica y la resistencia periférica a la insulina, habitual en las comorbilidades asociadas a la psoriasis. Por este motivo, en la evaluación de los pacientes con psoriasis, en particular si existen componentes del síndrome metabólico y se requiere tratamiento sistémico, se recomienda descartar esta posibilidad. La coexistencia de psoriasis e hígado graso no alcohólico, con probable sinergia entre ambos, condiciona las medidas generales que deben recomendarse en estos pacientes y también la estrategia terapéutica, por la potencial hepatotoxicidad de algunos de ellos. En este sentido, algunos de los fármacos convencionales habituales como acitretino, metotrexato o ciclosporina presentan potenciales efectos hepatotóxicos cuya repercusión en cada paciente debe evaluarse de forma individualizada. Los fármacos anti-TNF podrían tener efectos beneficiosos fundamentados en el buen control del proceso inflamatorio y de una mejoría de la resistencia periférica a la insulina. Sin embargo, se han descrito casos de hepatotoxicidad en algunos pacientes. No existe evidencia de efectos beneficiosos o perjudiciales de los fármacos anti p40 o anti IL-17 (AU)

Nonalcoholic fatty liver disease (NAFLD) is the most prevalent liver condition in the West. The prevalence and severity of NAFLD is higher and the prognosis worse in patients with psoriasis. The pathogenic link between psoriasis and NAFLD is chronic inflammation and peripheral insulin resistance, a common finding in diseases associated with psoriasis. NAFLD should therefore be ruled out during the initial evaluation of patients with psoriasis, in particular if they show signs of metabolic syndrome and require systemic treatment. Concomitant psoriasis and NAFLD and the likelihood of synergy between them place limitations on general recommendations and treatment for these patients given the potential for liver toxicity. As hepatotoxic risk is associated with some of the conventional drugs used in this setting (e.g., acitretin, methotrexate, and ciclosporin), patients prescribed these treatments should be monitored as appropriate. Anti-tumor necrosis factor agents hold the promise of potential benefits based on their effects on the inflammatory process and improving peripheral insulin resistance. However, cases of liver toxicity have also been reported in relation to these biologics. No evidence has emerged to suggest that anti-p40 or anti-interleukin 17 agents provide benefits or have adverse effects (AU)

Serie de casos de pacientes psoriásicas expuestas a terapia biológica durante el embarazo. Registro BIOBADADERM y revisión de la literatura / A case series of patients with psoriasis exposed to biologic therapy during pregnancy: the BIOBADADERM register and a review of the literature

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Manejo de los tratamientos biológicos en pacientes con psoriasis moderada-grave sometidos a intervenciones quirúrgicas en el registro español Biobadaderm / Management of biologic therapy in moderate to severe psoriasis in surgical patients: data from the Spanish Biobadaderm registry

INTRODUCCIÓN Y OBJETIVO: Disponemos de una gran experiencia en el uso de los fármacos biológicos para el tratamiento de los pacientes con psoriasis, sin embargo, existen situaciones concretas, como la cirugía, en las que pueden surgir dudas sobre su manejo. Aunque las guías de tratamiento aconsejan su suspensión programada previamente a los procedimientos de cirugía mayor, no existe evidencia de cuál es la actitud habitual en la práctica clínica y su asociación a complicaciones. Nuestro objetivo fue analizar el manejo actual de esta situación en la práctica clínica habitual. MÉTODOS: A través de un estudio retrospectivo de la base de datos Biobadaderm se analizó el manejo práctico de pacientes con psoriasis en tratamiento biológico que fueron intervenidos mediante algún procedimiento quirúrgico. RESULTADOS: De los 2.113 pacientes incluidos en Biobadaderm, 48 fueron tratados con una intervención quirúrgica, de las que fueron mayoritarias las de tipo cutáneo (31%). El tratamiento biológico se suspendió en el 42% de los casos. No se observaron asociaciones estadísticamente significativas entre la aparición de complicaciones posquirúrgicas y la interrupción del fármaco. Tampoco se detectó asociación entre la interrupción del tratamiento con otras variables como el sexo, la edad, la duración de la enfermedad y la gravedad de la psoriasis. CONCLUSIÓN: No se ha encontrado asociación entre la continuidad del tratamiento biológico y el riesgo de complicaciones posquirúrgicas, aunque el estudio presenta la limitación de tener un tamaño muestral escaso

BACKGROUND AND OBJECTIVE: We now have considerable experience in the use of biologic agents to treat psoriasis, but doubts about management arise in certain clinical settings. Surgery is one of them. Although treatment guidelines advise that biologics be suspended before major surgery, data about actual clinical practices and associated complications are lacking. We aimed to analyze current practice in the clinical management of these cases. METHODS: Retrospective study of cases in the Biobadaderm database. We analyzed the management of biologic therapy in patients with psoriasis who underwent surgical procedures. RESULTS: Forty-eight of the 2113 patients registered in Biobadaderm underwent surgery. Thelargest percentage of procedures (31%) involved skin lesions. Biologic treatment was interrupted in 42% of the cases. No postsurgical complications were significantly related to treatment interruption. Likewise we detected no associations between treatment interruption and other variables, such as sex, age, or duration or severity of psoriasis. CONCLUSION: Continuity of biologic treatment and the risk of postsurgical complications were not associated in this study, although conclusions are limited by the small sample size

Consensus document on the evaluation and treatment of moderate-to-severe psoriasis: Psoriasis Group of the Spanish Academy of Dermatology and Venereology.

Psoriasis is a highly prevalent disease with a major impact on quality of life; therefore, appropriate patient management is mandatory. Given that many issues in psoriasis are controversial and not clearly defined by evidence-based medicine, management of psoriasis is very variable. Expert consensus can generate practical guidelines for optimization of patient care. Much has changed since 2009, when the Consensus Document on the Evaluation and Treatment of Moderate to Severe Psoriasis was published by the Spanish Psoriasis Group (GEP) of the Spanish Academy of Dermatology and Venereology (AEDV). The objective of the present consensus document is to provide the dermatologist with updated recommendations for the evaluation and treatment of patients with moderate-to-severe plaque psoriasis. All active members of the GEP of the AEDV were invited to participate in the survey. The final group comprised 46 members from various areas of Spain and with substantial experience in managing psoriasis. A 3-round Delphi process was used to reach consensus. Consistent agreement and consistent disagreement (consensus) required the achievement of at least two of the following three criteria: Criterion 1, which was based on the position occupied by the mean on a scale of 1-9 and an SD <2; Criterion 2, which was based on the median and interquartile range (IQR) on a scale of 1-9; Criterion 3, which considered the percentage of the voting experts on a scale of 1-9. The items studied were definition of severity, therapeutic objectives, indications for systemic treatment and biologic therapy, induction and maintenance periods, therapeutic failure, loss of response, relapse and rebound, continuous and intermittent therapy, screening of patients before treatment, adherence to therapy, follow-up of treatment outcome, combination of drugs, transitioning and associated comorbidities. Consistent agreement or disagreement (consensus) was achieved for 198 items (agreement, 3 criteria 146 items, 2 criteria 43 items; disagreement, 3 criteria 9 items, 2 criteria 0 items) based on the criteria described above. Completion of the Delphi consensus process enabled a broad and experienced group of Spanish psoriasis experts to provide useful and practical guidelines for the management and treatment of patients with moderate-to-severe psoriasis, particularly in areas where evidence is lacking.

Does the treatment ladder for systemic therapy in moderate to severe psoriasis only go up? The percentage of patients with severe psoriasis on biologics increases over time / Escalera terapéutica en la psoriasis moderada y grave ¿ Sólo hacia arriba?: El porcentaje de pacientes con psoriasis grave tratados con biológicos se incrementa con el tiempo

BACKGROUND: With the advent of biologic drugs in the management of moderate to severe psoriasis, there may have been a shift in therapeutic approach from rotational strategies to a unidirectional progression from topical treatments to the highest rung of the therapeutic ladder. We studied the frequency of switching from classic to biologic therapy and vice versa in a cohort of patients with psoriasis over a period of up to 5 years. METHODS: Patients are included in the BIOBADADERM prospective registry when they are first prescribed any specific conventional or biologic systemic treatment. The data for each patient refer to the follow-up period from the time they entered the cohort until October 2013. To describe the pattern of switches from classic to biologic therapy and vice versa, we used the data in the registry on the first day of every 365-day period following the date each patient was included in the cohort. RESULTS: In total, 47.3% of the patients (926/1956) were prescribed a classic systemic drug and 52.7% (1030/1956) a biologic agent on entry into the study. Of the 741 patients who accumulated 5 years of follow-up, 21.9% (155) were receiving nonbiologic drugs and 78.1% (553) were on biologic therapy on the first day of their 5th year of follow-up. CONCLUSIONS: The proportion of patients receiving biologic therapy increased with longer follow-up

INTRODUCCIÓN: Con el advenimiento de fármacos biológicos en el manejo de la psoriasis moderada a grave, es probable que haya habido un cambio en la actitud terapéutica desde estrategias de rotación a una progresión unidireccional desde tratamientos tópicos al escalón más alta de la escalera terapéutica. Evaluamos la frecuencia del cambio desde el tratamiento clásico al biológico y vice-versa en una cohorte de pacientes con psoriasis durante un periodo de hasta 5 años. MÉTODOS: Los pacientes fueron incluidos en el registro prospectivo de Biobadaderm cuando se les fueron prescritos por primera vez cualquier tratamiento convencional o biológico sistémico. Los datos para cada paciente se refieren al período de seguimiento desde la hora de su inclusión en la cohorte hasta octubre de 2013. Para describir el patrón de cambio desde el tratamiento clásico al biológico y vice-versa, utilizamos los datos en el registro en el primer día de cada periodo de 365 días después de la fecha de inclusión de cada paciente en la cohorte. RESULTADOS: En total, 47,3% de los pacientes (926/1956) fueren prescritos un medicamento sistémico clásico y 52,7% (1030/1956) un biológico al entrar en el estudio. De los 741 pacientes que acabaron 5 años de seguimiento, 21,9% (155) recibieron medicamentos no biológicos y 78,1% (553) recibieron tratamiento biológico en el primera día del quinto año de seguimiento. CONCLUSIONES: La proporción de pacientes recibiendo tratamiento biológico aumento con el seguimiento más prolongado

Riesgo de reactivación de hepatitis B pasada en pacientes con psoriasis tratados con biológicos. Análisis retrospectivo de 20 casos. Registro de BIOBADADERM / Risk of Reactivation of Hepatitis B Virus Infection in Psoriasis Patients Treated With Biologics: A Retrospective Analysis of 20 Cases From the BIOBADADERM Database

INTRODUCCIÓN Y OBJETIVOS: Se ha reportado un riesgo de reactivación de hepatitis B pasada de hasta el 5% en pacientes tratados con fármacos dirigidos contra el factor de necrosis tumoral para enfermedades distintas a la psoriasis. Nuestro objetivo es investigar el riesgo de reactivación del virus de la hepatitis B en pacientes con hepatitis B pasada y psoriasis tratada con biológicos. MATERIAL Y MÉTODOS: Estudio multicéntrico en el que se incluyeron 20 pacientes con serología sugestiva de hepatitis B pasada (antiHBc+, antígeno HBs-) y diagnóstico de psoriasis tratada con al menos un biológico. Se recogieron variables clínicas, serológicas y de función hepática antes, durante y al final del seguimiento. Se obtuvo una carga viral al final del seguimiento en todos los pacientes. RESULTADOS: Ningún paciente mostró criterios de reactivación de hepatitis B al final del estudio, con una mediana de seguimiento de 40 meses. Sumando los datos de otras series publicadas de pacientes con psoriasis y hepatitis B pasada tratados con biológicos, el riesgo máximo sería de 2,7 reactivaciones por 100 pacientes tratados con un seguimiento medio de unos 30 meses. CONCLUSIONES: En nuestro estudio el tratamiento con biológicos no provocó ninguna reactivación de hepatitis B. Sin embargo, debido a las graves complicaciones asociadas a la misma, se aconseja descartar portadores ocultos en pacientes con hepatitis B pasada antes de iniciar tratamiento biológico (solicitando una carga viral al inicio del mismo), así como un seguimiento conjunto con un hepatólogo

INTRODUCTION AND OBJECTIVES: A 5% risk of reactivation of hepatitis B virus (HBV) infection has been reported in patients with diseases other than psoriasis treated with tumor necrosis factor inhibitors. The aim of this study was to investigate the risk of HBV reactivation in patients with a past history of HBV infection who were receiving biologic therapy for psoriasis. MATERIAL AND METHODS: This was a multicenter study of 20 patients with psoriasis who were treated with at least 1 biologic agent. All the patients had serologic evidence of past HBV infection (positive total hepatitis B core antibody and negative hepatitis B surface antibody). We analyzed the clinical, serological, and liver function variables recorded before, during, and at the end of follow-up. The viral load at the end of follow-up was also analyzed for all patients. RESULTS: None of the patients fulfilled the criteria for HBV reactivation at the end of a median follow-up period of 40 months. Combining our data with data from other studies of psoriasis patients with a past history of HBV infection who were treated with a biologic, we calculated a maximum estimated risk of HBV reactivation for a mean follow-up period of 30 months of 2.7 reactivations per 100 patients. CONCLUSIONS: Biologic therapy did not cause HBV reactivation in our series of patients. Nonetheless, because of the potentially serious complications associated with HBV reactivation, it is important to measure viral load in patients with a history of HBV infection prior to initiation of biologic therapy to rule out occult carriage. These patients should also be monitored regularly in conjunction with a hepatologist

Resolución de granuloma anular diseminado con fototerapia UVB de banda estrecha / Successful Treatment of Disseminated Granuloma Annulare With Narrowband UV-B Phototherapy

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Percepción del médico y paciente de la gravedad de la psoriasis, su impacto en la calidad de vida y satisfacción con la atención y el tratamiento recibido. Estudio observacional en España / Physician and Patient Perception of Disease Severity, Quality of Life, and Treatment Satisfaction in Psoriasis: An Observational Study in Spain

Introducción: El objetivo de este estudio fue evaluar el impacto de la psoriasis en la calidad de vida del paciente, las diferencias entre médicos y pacientes en las percepciones sobre la calidad de vida, los tratamientos y las necesidades de los pacientes y la relación médico-paciente. Material y métodos: Estudio observacional, multicéntrico, de corte transversal, en el cual un grupo de dermatólogos representativos de toda la geografía española, con ejercicio tanto en el ámbito hospitalario como ambulatorio, y de pacientes con diagnóstico de psoriasis, cumplimentaron una encuesta especialmente diseñada para el estudio. La encuesta incluía preguntas sobre datos demográficos del paciente, características de la enfermedad, impacto de esta sobre la calidad de vida, manejo terapéutico de la psoriasis y relación paciente-dermatólogo. Resultados: Un total de 151 dermatólogos de toda España incluyeron una media de 5 pacientes cada uno. Se incluyeron en el análisis un total de 771 encuestas cumplimentadas por los dermatólogos y 732 encuestas cumplimentadas por los pacientes. Dos terceras partes de los pacientes presentaban una enfermedad moderada a grave con una importante repercusión en la calidad de vida, en especial sobre el estado emocional. No obstante, la calidad de vida sóloe ra evaluada de forma sistemática y rutinaria por el 19,9% de los dermatólogos. El 47% de los pacientes estaba muy satisfecho o bastante satisfecho con el tratamiento que recibía. No se encontraron diferencias relevantes entre las percepciones del paciente y del médico sobre los aspectos evaluados. Conclusiones: Nuestros resultados señalan el importante impacto que tiene la psoriasis sobre la calidad de vida del paciente y la necesidad de evaluar este parámetro de forma sistemática. Los pacientes refieren un buen grado de satisfacción con la atención recibida por los dermatólogos y los tratamientos administrados. Existe bastante concordancia entre los pacientes y los dermatólogos en la valoración de los parámetros evaluados (AU)

Objectives: The aims of this study were to determine the impact of psoriasis on patient quality of life, to analyze differences in perception between patients and physicians regarding quality of life, treatment satisfaction, and patient needs, and to assess the physician—patient relationship. Material and methods: A multicenter, observational, cross-sectional study was undertaken in which a representative group of dermatologists—–working in hospitals and outpatient clinics throughout Spain—–and their patients with a diagnosis of psoriasis completed specifically designed questionnaires. The questionnaires covered patient demographics, disease characteristics, impact of the disease on quality of life, treatment of psoriasis, and the relationship between patient and dermatologist. Results: A total of 151 dermatologists from throughout Spain included a mean of 5 patients each. The analysis included 771 questionnaires completed by dermatologists and 732 completed by patients. Two-thirds of patients had moderate-to-severe psoriasis with a major impact on quality of life, particularly in relation to emotional wellbeing. Nevertheless, quality of life was only assessed routinely and systematically by 19.9% of dermatologists. Overall, 47% of patients reported being quite satisfied or very satisfied with the treatment they received. No significant differences were observed between patients and dermatologists on the aspects analyzed. Conclusions: Our results highlight the substantial impact of psoriasis on patient quality of life and the consequent need for systematic quality-of-life assessment in affected patients. Patients reported a high level of satisfaction with the care provided by dermatologists and the treatment received. There was good agreement between patients and dermatologists in their assessment of the variables analyzed (AU)

Documento de consenso de fototerapia en psoriasis del Grupo Español de Psoriasis: ultravioleta B de banda estrecha (UVBBE), láser y fuentes monocromáticas de excímeros y terapia fotodinámica / Narrowband UV-B, Monochromatic Excimer Laser, and Photodynamic Therapy in Psoriasis: A Consensus Statement of the Spanish Psoriasis Group

Los nuevos conocimientos y estrategias terapéuticas y de manejo de la psoriasis moderada y grave justifican la reevaluación del papel de los tratamientos clásicos en el manejo de estas formas de la enfermedad. En el presente documento se lleva a cabo la evaluación de la terapia ultravioleta B de banda estrecha (UVBBE) considerada en la actualidad, por su relación entre riesgo y beneficio, como la de primera elección en la fototerapia de la psoriasis. Por otra parte, se ha revisado y evaluado la terapia con sistemas y láseres de excímeros y la terapia fotodinámica en la psoriasis. El uso de estas terapias localizadas, aún limitado a pocos centros a escala nacional, constituye una alternativa terapéutica fundamentalmente en formas limitadas y recalcitrantes de psoriasis. En el siguiente documento se evalúan el perfil de eficacia, la seguridad, los esquemas terapéuticos, el tratamiento combinado y diversas consideraciones clínicas en función del perfil del paciente o de las características de la enfermedad (AU)

Novel treatment strategies and new information concerning the management of moderate to severe psoriasis justify a reassessment of the role of the classic therapies in this setting. This consensus statement evaluates narrowband UV-B therapy, which is currently considered the phototherapy option of choice in psoriasis because of its risk-to-benefit ratio. The role of excimer laser and photodynamic therapies are also discussed. These targeted therapies are still only available in a small number of centers in Spain and are used principally in the treatment of localized and recalcitrant forms of psoriasis. We discuss the efficacy and safety of phototherapy as well as treatment regimens, combination therapy, and clinical considerations relating to the characteristics of the patient or the disease (AU)

[BIOBADADERM, the Spanish Registry of Adverse Events Associated with Biologic Drugs in Dermatology: first report]. / BIOBADADERM: registro español de acontecimientos adversos de terapias biológicas en Dermatología. Primer informe.

BACKGROUND AND OBJECTIVES: The Working Group on Psoriasis of the Spanish Academy of Dermatology and Venereology has initiated BIOBADADERM, a registry of patients with psoriasis receiving treatment with biologic drugs, in order to assess the long-term risk of adverse events (AEs). MATERIAL AND METHODS: A multicenter study was undertaken in 2 cohorts of patients with psoriasis: patients receiving biologic therapy and patients receiving nonbiologic systemic therapy other than phototherapy. Similar numbers of patients were included in each group. Information was recorded on demographic and clinical variables, treatment, and relevant AEs. The risk of specific AEs was determined by comparison of the frequencies for those events in the 2 cohorts. RESULTS: Data on the 2 cohorts were evaluated for the period from October, 2008 to November, 2009 alongside retrospective data on patients treated with biologics since 2005. Thirteen Spanish hospitals participated in the study. A total of 632 patients were included in the analysis: 417 treated with biologic drugs and 215 controls. Suspension of biologic therapy due to AEs was rare (72 cycles, 10%). A total of 232 AEs were reported in patients receiving biologic therapy. The majority were not serious. The most frequent AEs were infections (mostly upper respiratory tract infections and nasopharyngitis), followed by conditions affecting the skin or subcutaneous tissue. Forty-three AEs were reported in control subjects. The most frequent events were metabolic and nutritional abnormalities and abnormal transaminase levels. Comparison of the incidence of any AE in patients treated with biologics compared with control subjects revealed a relative risk of 2.2 (P<.001) The relative risks of infections or infestations and disorders of the skin or subcutaneous tissue in patients receiving biologic drugs were 23 (P<.01) and 4.9 (P<.05), respectively. CONCLUSIONS: Patients treated with biologic drugs had a greater number of AEs, particularly infections and skin conditions. Definitive conclusions, however, are difficult to draw due to the small number of patients included in the registry, particularly in the control cohort, and the short follow-up period. Differences in the percentages of events reported by the different hospitals reveal the difficulties associated with the concept of AEs in clinical practice and highlight the need to harmonize criteria in the future. Since the problems identified in this analysis should be overcome in future years, we expect BIOBADADERM to become an important source of information on the safety profile of biologic drugs in dermatology.

[Narrowband UV-B, monochromatic excimer laser, and photodynamic therapy in psoriasis: a consensus statement of the Spanish Psoriasis Group]. / Documento de consenso de fototerapia en psoriasis del Grupo Español de Psoriasis: ultravioleta B de banda estrecha (UVBBE), láser y fuentes monocromáticas de excímeros y terapia fotodinámica.

Novel treatment strategies and new information concerning the management of moderate to severe psoriasis justify a reassessment of the role of the classic therapies in this setting. This consensus statement evaluates narrowband UV-B therapy, which is currently considered the phototherapy option of choice in psoriasis because of its risk-to-benefit ratio. The role of excimer laser and photodynamic therapies are also discussed. These targeted therapies are still only available in a small number of centers in Spain and are used principally in the treatment of localized and recalcitrant forms of psoriasis. We discuss the efficacy and safety of phototherapy as well as treatment regimens, combination therapy, and clinical considerations relating to the characteristics of the patient or the disease.

Introducción. Estructura química de etanercept, farmacocinética y mecanismo de acción / Introduction. Chemical structure of etanercept, pharmacokinetics and mechanism of action

Se presenta el contenido de esta monografía sobre el conocimiento actual de etanercept en relación con la psoriasis y la artritis psoriásica. Etanercept se empleó por primera vez en estudios clínicos humanos en 1992. Se hace referencia a las actuales indicaciones aprobadas por la Agencia Europea de Evaluación de Medicamentos; se describe su estructura química, se analizan los datos farmacocinéticos y su mecanismo de acción (AU)

The contents of this monography on the current knowledge of etanercept in relationship with psoriasis and psoriatic arthritis is presented. Etanercept was first used in clinical studies in humans in 1992. Reference is made to the current indications approved by the European Medicines Agency. Its chemical structure is described, and the pharmacokinetics data and its mechanism of action are analyzed (AU)