Eficacia y seguridad de ustekinumab en la práctica clínica real. Estudio multicéntrico retrospectivo. Cohorte ARAINF / Efficacy and safety of ustekinumab in real clinical practice. Retrospective multicentre study. ARAINF cohort

INTRODUCCIÓN: Ustekinumab, anticuerpo monoclonal que bloquea las interleucinas 12/23, ha demostrado en ensayos clínicos su eficacia para inducir y mantener la remisión clínica en la enfermedad de Crohn (EC). Su efectividad y su seguridad en la práctica clínica real es menos conocida y podría diferir respecto a los ensayos. OBJETIVO: Evaluar en la práctica clínica su efectividad y seguridad (pauta de inducción intravenosa esencialmente), como inducción y a largo plazo, en pacientes con EC refractarios a tratamiento biológico. MATERIAL Y MÉTODOS: Análisis retrospectivo multicéntrico (6 hospitales aragoneses), que incluye a todos los pacientes (N=69) con EC en tratamiento con ustekinumab (fuese con inducción intravenosa o subcutánea) que hubiesen alcanzado al menos 16 semanas de seguimiento. La respuesta o remisión clínica se ha evaluado en las semanas 16, 24, 32 y 48 mediante el índice de Harvey-Bradshaw. RESULTADOS: Se han incluido un total de 69 pacientes, edad media 42 años, 54% hombres. Un 89,86% (IC 95% [0,805, 0,949]) de los pacientes ha presentado mejoría clínica en la semana 16 (15,95% remisión, 73,92% respuesta). En el seguimiento posterior dicha respuesta se ha mantenido. Se han identificado mediante un modelo de regresión ordinal la edad (OR 0,95, p = 0.028) y el hábito tabáquico (OR 0,19, p = 0,027) como predictores de mala respuesta al tratamiento, mientras que la necesidad de cambio de biológico por efecto adverso (OR 96, p = 0,00017) y por pérdida de respuesta secundaria (OR 7,07, p = 0,034) han sido factores predictores de buena respuesta. No se han reportado efectos adversos graves que obligasen a interrumpir el tratamiento con ustekinumab. CONCLUSIÓN: Ustekinumab es efectivo y seguro en la práctica clínica real para lograr la inducción y el mantenimiento de la respuesta en pacientes con EC refractaria. El tabaco y la edad han mostrado ser predictores de mala respuesta, mientras que la indicación por efecto adverso a biológico previo y por pérdida de respuesta secundaria han mostrado ser predictores de buena respuesta

INTRODUCTION: Ustekinumab, a monoclonal antibody that blocks interleukins 12/23, has proven in clinical trials its efficacy in inducing and maintaining clinical remission of Crohn's disease (CD). Its effectiveness and safety in actual clinical practice is less known and may differ from trials. OBJECTIVE: To evaluate its effectiveness and safety in clinical practice (intravenous induction pattern essentially), such as induction and over the long term, in patients with CD refractory to biological treatment. MATERIAL AND METHODS: Multicentre retrospective analysis (6 hospitals in Aragón), which includes all patients (N=69) with CD undergoing treatment with ustekinumab (either with intravenous or subcutaneous induction), who had at least 16 weeks of follow-up. The clinical response or remission has been evaluated at weeks 16, 24, 32 and 48 using the Harvey-Bradshaw index. RESULTS: A total of 69 patients have been included, mean age 42 years, 54% men. A percentage of 89.86 (95% CI [0.805, 0.949]) of the patients presented clinical improvement at week 16 (15.95% remission, 73.92% response). In the subsequent follow-up, this response has been maintained. Age (OR 0.95, P=.028) and smoking habits (OR 0.19, P=.027) have been identified by an ordinal regression model as predictors of poor treatment response while the need for biological change due to adverse effect (OR 96, P=.00017) and due to loss of secondary response (OR 7.07, P=.034) have been predictors of good response. No serious adverse effects have been reported that forced them to stop taking ustekinumab. CONCLUSION: Ustekinumab is effective and safe in real clinical practice to achieve induction and maintenance of the response in patients with refractory CD. Tobacco and age have been shown to be predictors of poor response, while the indication for adverse effect to previous biological and for loss of secondary response has been shown to be predictors of good response

Informes de posicionamiento terapéutico: utilidad y transparencia / Treatment Appraisal Reports: Usefulness and Transparency

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PASI absoluto versus PASI relativo en la práctica clínica real / Absolute Versus Relative Psoriasis Area and Severity Index in Clinical Practice

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Adherencia a los tratamientos biológicos: un equilibrio entre necesidad y preocupación / Adherence to biologic treatments: a balance between need and concern

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Consortium of Microalgae for Tannery Effluent Treatment

Abstract Wastewater generated in tanneries have essential elements for microalgae growth, but it has also some toxic compounds that may hinder or restrain the growth of microalgae in this environment. This work tested microalgae consortium growth originating from a deactivated effluent treatment decanter of a complete tannery (beamhouse to finished leather) for the treatment of wastewater of a tannery processing wet-blue leather to finished leather. It was initially evaluated the growth of the microalgae consortium in the three effluents diluted in 50% distilled water: raw effluent (50RE50W), effluent after primary coagulation/flocculation (50PE50W), and effluent after primary and secondary biological treatment (50BE50W). After 16 days of cultivation, the 50PE50W presented the highest biomass concentration (1.77 g L−1). The highest removal values for effluents 50RE50W, 50PE50W and 50BE50W were 51.02%, 99.90%, 82.88%, and 91.75% for chemical oxygen demand (COD), N-NH3, TKN, and P-PO4-, respectively. It was verified low levels of nutrient removal in the raw effluent (100RE), since the consortium was not able to grow in this medium. Finally, at concentrations of 25RE75BE (25% raw effluent diluted with 75% effluent after the biological treatment) and 50RE50B (50% raw effluent diluted with 50% effluent after the biological treatment), effective removal values were reached. Biomass growth concentration up to 1.3 g L-1 and removal values for N-NH3, TKN, P-PO4, COD, total organic carbon (TOC) and biological oxygen demand (BOD5), of 99.90%, 79.36%, 87.82%, 14.26%, 35.82%, and 42.86%, respectively, were reached in 50RE50B.

Tratamiento biológico en la enfermedad pulmonar intersticial difusa asociada a las enfermedades del tejido conectivo / Biologics in the treatment of diffuse interstitial lung disease associated with connective tissue disease

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Más Platón y menos Prozac(R): llega el ASMA-ZUMAB / More Platon And Less Prozac(R): The Arrival Of ASTHMA-ZUMAB

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Electrochemical characterization of Geobacter lovleyi identifies limitations of microbial fuel cell performance in constructed wetlands

Power generation in microbial fuel cells implemented in constructed wetlands (CW-MFCs) is low despite the enrichment of anode electricigens most closely related to Geobacter lovleyi. Using the model representative G. lovleyi strain SZ, we show that acetate, but not formate or lactate, can be oxidized efficiently but growth is limited by the high sensitivity of the bacterium to oxygen. Acetate and highly reducing conditions also supported the growth of anode biofilms but only at optimal anode potentials (450 mV vs. standard hydrogen electrode). Still, electrode coverage was poor and current densities, low, consistent with the lack of key c-type cytochromes. The results suggest that the low oxygen tolerance of G. lovleyi and inability to efficiently colonize and form electroactive biofilms on the electrodes while oxidizing the range of electron donors available in constructed wetlands limits MFC performance. The implications of these findings for the optimization of CW-MFCs are discussed (AU)

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Fiebre mediterránea familiar en tratamiento con anakinra: a propósito de un caso / Familial mediterranean fever treated with anakinra: a case report

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A presença de fármacos nos esgotos domésticos e sua remoção pelos processos de lodo ativado com oxigênio puro, lagoa aerada e reator anaeróbio de fluxo ascendente / Pharmaceuticals in domestic sewage and their removal by pure oxygen activated sludge, aerated basin and upflow anaerobic sludge blanket

Processos biológicos de tratamento de esgotos são largamente utilizados mundialmente e, apesar de serem eficientes na remoção de matéria orgânica, têm capacidades limitadas na remoção de poluentes orgânios emergentes, principalmente fármacos. Este trabalho avaliou a eficiência dos processos de tratamento de esgotos por lodos ativados com oxigênio puro, lagoas aeradas e reator anaeróbio de fluxo ascendente (RAFA) na remoção de seis fármacos selecionados - paracetamol, ibuprofeno, atenolol, sinvastatina, carbamazepina e clonazepam, com altos índices de utilização pela população. Para isto, foram analisadas amostras de esgoto bruto e de esgoto tratado oriundas de três estações de tratamento de esgotos em operação no Estado de São Paulo, sendo realizadas quatro campanhas de coleta, durante dois anos, em períodos hidrológicos de seca e chuva. A técnica analítica utilizada foi a cromatografia líquida de alta eficiência acoplada à espectrometria de massas (LC-MS/MS), através de método estabelecido e validado para a execução desta pesquisa. Ibuprofeno, sinvastatina e clonazepam não foram identificados em nenhuma das amostras analisadas. Atenolol, paracetamol e carbamazepina foram detectados em todas as estações estudadas, observando-se remoção e liberação deles durante todos os processos de tratamento. A estação que adota o processo por lagoas aeradas mostrou maior eficiência na remoção de paracetamol e atenolol, sendo que um elevado tempo de detenção hidráulica empregado nela parece ter influenciado positivamente na eficácia de remoção destas subtâncias. A estação que utiliza lodos ativados com oxigênio puro apresentou remoções inferiores e maiores taxas de liberação dos fármacos paracetamol e carbamazepina. Já a estação que adota RAFA apresentou discreta superioridade na remoção de carbamazepina, e eficiências intermediárias para paracetamol e atenolol. A carbamazepina mostrou resistência à degradaçào pelos processos avaliados, porém a desinfecção do efluente final, por cloração, aparentemente elevou a remoção deste composto

Sewage biological treatment processes are the most used worldwide and, in general, they show organic matter removal high efficiency, however their pharmaceuticals removal capacity were quite limited. The aim of this study is verify the efficiency of sewage biological treatment processes per pure oxygen activated sludge, aerated basin and upflow anaerobic sludge blanket (UASB), in removal of six selected drugs acetaminophen, ibuprofen, atenolol, simvastatin, carbamazepine and clonazepam, most frequently used by population. For this purpose, it was analyzed raw sewage and treated sewage samples from three sewage treatment plants localized at Sao Paulo, Brazil, in four collection stages, during two years, at dry and wet periods. The analytical technique of choice was high performance liquid chromatography tandem mass spectrometry (LC-MS/MS), by developed and validated method for this study. Ibuprofen, simvastatin and clonazepam were not detected at any samples collected. Atenolol, acetaminophen and carbamazepine were identified at all plants investigated, with removal and production during all treatment processes here considered. Aerated basin plant was most efficient in acetaminophen and atenolol removal, and a high hydraulic detention time seem be better to remove these compounds. Pure oxygen activated sludge plant showed lower removal rates and higher production of acetaminophen and carbamazepine. Already the UASB plant revealed a little superiority in carbamazepine removal, and intermediary efficacy to acetaminophen and atenolol removal. Carbamazepine showed persistence in treatment processes evaluated, however final effluent disinfection, with chlorination, apparently raised this compound removal

Enfermedad de Still del adulto / Adult-onset Still's disease

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Actualización 2014 del Documento de Consenso de la Sociedad Española de Reumatología sobre el uso de terapias biológicas en la artritis reumatoide / 2014 update of the Consensus Statement of the Spanish Society of Rheumatology on the use of biological therapies in rheumatoid arthritis

Objetivo. Establecer recomendaciones para el manejo de pacientes con artritis reumatoide (AR) centrado en el papel de los fármacos antirreumáticos modificadores de enfermedad (FAME) sintéticos y biológicos disponibles, que sirvan de referencia para todos los profesionales implicados en la atención de estos pacientes. Métodos. Las recomendaciones se consensuaron a través de un panel de 14 expertos previamente seleccionados por la Sociedad Española de Reumatología (SER). Se recogió la evidencia disponible mediante la actualización de las 3 revisiones sistemáticas (RS) que se utilizaron para las recomendaciones EULAR 2013, a las que se añadió una nueva RS para dar respuesta a una pregunta adicional. Todas fueron realizadas por miembros del grupo de revisores de la SER. La clasificación del nivel de la evidencia y del grado de la recomendación se realizó utilizando el sistema del Centre for Evidence-Based Medicine de Oxford. Se utilizó la metodología Delphi para evaluar el grado de acuerdo entre los panelistas para cada recomendación. Resultados. Se emiten un total de 13 recomendaciones sobre el manejo terapéutico de pacientes con AR del adulto. El objetivo terapéutico debe ser tratar al paciente en fases precoces de la enfermedad, con el objetivo de la remisión clínica, teniendo un papel central el metotrexato como FAME sintético de referencia. Se actualizan las indicaciones de los FAME biológicos disponibles, se enfatiza la importancia de los factores pronósticos y se incide en el concepto de optimización de biológicos. Conclusiones. Se presenta la quinta actualización de las recomendaciones SER para el manejo de la AR con FAME sintéticos y biológicos (AU)

Objective. To establish recommendations for the management of patients with rheumatoid arthritis (RA) to serve as a reference for all health professionals involved in the care of these patients, and focusing on the role of available synthetic and biologic disease-modifying antirheumatic drugs (DMARDs). Methods. Consensual recommendations were agreed on by a panel of 14 experts selected by the Spanish Society of Rheumatology (SER). The available scientific evidence was collected by updating three systematic reviews (SR) used for the EULAR 2013 recommendations. A new SR was added to answer an additional question. The literature review of the scientific evidence was made by the SER reviewer's group. The level of evidence and the degree of recommendation was classified according to the Oxford Centre for Evidence-Based Medicine system. A Delphi panel was used to evaluate the level of agreement between panellists (strength of recommendation). Results. Thirteen recommendations for the management of adult RA were emitted. The therapeutic objective should be to treat patients in the early phases of the disease with the aim of achieving clinical remission, with methotrexate playing a central role in the therapeutic strategy of RA as the reference synthetic DMARD. Indications for biologic DMARDs were updated and the concept of the optimization of biologicals was introduced. Conclusions. We present the fifth update of the SER recommendations for the management of RA with synthetic and biologic DMARDs (AU)

Los 100 años de Tratamiento de lepra en Fontilles: 2º parte / No disponible

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Triple therapy with non-biologic DMARDs for rheumatoid arthritis or biologic therapy. Is it the same? / Triple terapia con FARME no biológico o tratamiento biológico para artritis reumatoide. ¿Son lo mismo?

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Estratégias de tratamento de lixiviado de aterro sanitário com foco na matéria orgânica biodegradável e nitrogênio amoniacal / Strategies of landfill leachate treatment focused on biodegradable organic matter and ammonia nitrogen

Sistemas de tratamento de esgotos, quando aplicados ao tratamento de lixiviado de aterro sanitário, não têm apresentado bons resultados. Por conta disso, faz-se necessário o desenvolvimento de alternativas para o tratamento de lixiviado. Objetivo avaliar o pós-tratamento de lixiviado de aterro sanitário por wetland construído de fluxo subsuperficial horizontal e reator biológico de leito móvel (RBLM). Materiais e métodos foram realizados dois experimentos com tratamento de lixiviado após remoção de amônia por dessorção. No experimento 1 utilizou-se wetlands construídos de fluxo horizontal em escala de bancada (volume total de 30,8 L), plantados com Cyperus papyrus, Heliconia psittacorum e Gynerium sagittatum, e um controle sem vegetação, preenchidos com pedrisco calcário. O sistema foi alimentado com lixiviado diluído em água em diferentes proporções (entre 10 por cento e 30 por cento ) com concentração média de DQO entre 336 e 750 mg.L-1 e nitrogênio amoniacal (N-NH4) entre 47 e 199 mg.L-1. A operação ocorreu em três etapas: (1ª) alimentação contínua e TDH médio entre 2,7 e 5,3 d; (2ª) regime de ciclos de recirculação do efluente, para avaliar o efeito do aumento de TDH para 21 dias; (3ª) alimentação contínua de duas unidades wetlands em série, visando elevar o TDH (entre 8,1 e 9,9 d) sem recirculação. O experimento 2 foi implantado em escala piloto, com uma unidade de dessorção de amônia seguida de um Reator Biológico de Leito Móvel (RBLM) e um biofiltro anóxico. O RBLM (volume efetivo de 380 L) foi preenchido em 50 por cento com anel pall. Resultados e discussão No experimento 1, obteve-se baixa remoção de DQO com médias inferiores a 40 por cento e concentração final entre 270 e 750 mg.L-1...

sewage treatment systems, when applied to the treatment of landfill leachate, have not shown good results. Thus it is necessary to develop alternatives for the treatment of leachate. Objective To assess the post-treatment of landfill leachate by horizontal subsurface flow constructed wetland and moving bed biofilm reactor (MBBR). Materials and methods Two experiments were conducted with treatment of the leachate after removal of ammonia by stripping. In experiment 1, horizontal flow constructed wetlands, at bench scale (total volume of 30.8 L), planted with Cyperus papyrus, Heliconia psittacorum and Gynerium sagittatum, and a control without vegetation, were filled with calcareous gravel. The system was fed with leachate diluted in water with different proportions (between 10 per cent and 30 per cent ) with mean COD concentration of between 336 and 750 mg.L-1 and ammonia nitrogen (NH4-N) between 47 and 199 mg L-1. The operation was divided in three stages: (1st) continuous feeding with mean HRT between 2.7 and 5.3 d; (2nd) regime of effluent recirculation to evaluate the effect of increasing the HRT to 21 days; (3rd) continuous feeding with two wetlands units in series, aimed HRT increasing (between 8.1 and 9.9 d) without recirculation. Experiment 2 was implemented on a pilot scale, with a unit of ammonia stripping followed by MBBR and an anoxic biofilter. The MBBR (380 L working volume) was filled 50 per cent with pall ring. Results and discussion In experiment 1, the COD removal was low, with averages below 40 per cent , with effluent concentration between 270 and 750 mg.L-1...

Consenso de la Sociedad Española de Reumatología sobre el uso de terapias biológicas en el lupus eritematoso sistémico / SER Consensus statement on the use of biologic therapy for systemic lupus erythematosus

Objetivo: Elaborar unas recomendaciones que sirvan de referencia a los reumatólogos y otros profesionales implicados en el tratamiento del lupus eritematoso sistémico (LES) que vayan a utilizar o consideren la utilización de terapias biológicas en su manejo. Métodos: Las recomendaciones se emitieron siguiendo la metodología de grupos nominales y basadas en revisiones sistemáticas. El nivel de evidencia y el grado de recomendación se clasificaron según el modelo del Center for Evidence Based Medicine de Oxford y el grado de acuerdo se extrajo por técnica Delphi. Resultados: Se realizan recomendaciones sobre el uso de belimumab, actualmente única terapia biológica con aprobación para el tratamiento del LES, y otras terapias biológicas sin indicación aprobada en LES. El objetivo del tratamiento es la respuesta clínica completa, entendida como la ausencia de actividad clínica percibida o constatable. Se matiza el uso de terapias biológicas en LES y cuál debe ser la evaluación previa y la vigilancia del paciente que recibe estos fármacos. Conclusiones: Se presentan las recomendaciones SER sobre el uso de terapias biológicas en el LES(AU)

Objective: To provide a reference to rheumatologists and other physicians involved in the treatment of systemic lupus erythematosus (SLE) who are using, or about to use biologic therapies. Methods: Recommendations were developed following a nominal group methodology and based on systematic reviews. The level of evidence and degree of recommendation were classified according to a model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through a Delphi technique. Results: We have produced recommendations on the use of belimumab, the only biological agent with approved indications for SLE, and other biological agents without an indication for SLE. The objective of treatment is to achieve a complete clinical response, taken as the absence of perceived or evident disease activity. Nuances regarding the use of biologic therapies in SLE were reviewed as well, such as the evaluation that should be performed prior to administration and the follow up of patients undergoing these therapies. Conclusions: We present the SER recommendations for the use of biological therapies in patients with SLE(AU)

Modelo de excelencia en el Hospital de Día de Reumatología en España: proyecto HD-Reumatolex / Model of excellence in Rheumatology Day Hospitals in Spain: the HD-Reumatolex project

Objetivos. Los tratamientos biológicos han superado en eficacia a los tratamientos tradicionales de la artritis reumatoide, aunque algunos no pueden administrarse de forma ambulatoria. La hospitalización de día supone la asistencia hospitalaria durante unas horas para aquellos tratamientos que no pueden realizarse en la consulta externa ni justifican el ingreso del paciente. Existen pocos estudios que analicen la situación de los Hospitales de Día de Reumatología (HDR) en España. El proyecto HD-Reumatolex tiene como objeto evaluar la situación de distintos HDR españoles desde una óptica estratégica, formativa, de gestión y de calidad asistencial. Material y métodos. Se diseñó un «Modelo de excelencia en HDR» que sirvió como base para realizar un análisis comparativo y anónimo (benchmarking) entre 21 Servicios de Reumatología. Se valoraron 19 criterios, clasificados en 3 categorías: Procesos estratégicos, Procesos clave y Procesos de soporte. Resultados. Los aspectos con peor puntuación media fueron los de seguimiento de guías de práctica clínica y existencia de un plan de calidad (Procesos estratégicos), formación de los profesionales del HDR (Procesos de soporte), y admisión de pacientes y procedimiento de alta (Procesos clave). Cinco HDR alcanzaron el benchmark al representar gráficamente su posición en los Procesos clave frente a los estratégicos y a los de soporte. Un HDR se posicionó como líder indiscutible en el análisis comparativo. Conclusiones. Ninguno de los HDR consiguió la puntuación máxima total, ni a nivel de categoría ni de resultados totales. Esto significa que existen oportunidades de mejora hacia la excelencia para todos los HDR participantes(AU)

Objectives: Biologics have shown greater efficacy than traditional treatments in patients with rheumatoid arthritis, although some cannot be administered on an outpatient basis. Day hospitalization requires the patient to attend the hospital for a few hours to receive those treatments that cannot be administered on an outpatient basis or that do not justify admission to hospital. Few studies have analyzed the situation of Rheumatology Day Hospitals (RDH) in Spain. The HD-Reumatolex project aims to evaluate the situation of Spanish RDHs in terms of strategy, training, management, and quality of care. Material and methods: The project was based on a “model of excellence in RDH” design, which made it possible to perform a comparative analysis (benchmarking) of 21 Rheumatology Departments. The 19 criteria evaluated were divided into 3 categories: Strategic processes, Key processes, and Support processes. Results: The lowest mean scores were recorded for follow-up of clinical practice guidelines/ recommendations and existence of a quality plan (Strategic processes), criteria for training among RDH professionals (Support processes), and admission and discharge (Key processes). Five RDH achieved the benchmark when the position obtained by the RDH in Key processes was plotted against the one obtained in Strategic processes and Support processes. One RDH emerged as a clear leader in the comparison. Conclusions: None of the RDH obtained the total maximum score at the category level or at the total results level, thus revealing room for improvement in the attainment of excellence for all the participating centers(AU)

Tocilizumab en paciente con gota tofácea severa refractaria al tratamiento / Tocilizumab in a patient with tophaceous gout resistant to treatment

La gota es una enfermedad que se caracteriza por episodios agudos de dolor como consecuencia del depósito de cristales de urato monosódico en las articulaciones y en el tejido periarticular. En algunos casos, la gota se comporta como una artropatía inflamatoria severa de difícil manejo, generándose daño estructural articular y alteración funcional secundaria. Presentamos el caso de un hombre de 44 años con artritis gotosa tofácea severa de 12 años de evolución, sin respuesta al manejo con AINE, alopurinol, colchicina y corticoides, a quien se inició tratamiento con tocilizumab, con favorable respuesta clínica y paraclínica(AU)

Gout is a disease characterized by acute episodes of pain, which occurs as the result of monosodic urate crystal deposit in the joint and periarticular tissue. In some cases, gout behaves as a severe inflammatory arthopathy that is difficult to manage, generating structural joint damage and functional impairment. We report the case of a 44 years old man with gouty arthritis for 12 years, not responding to NSAIDs, alopurinol, colchicine or corticosteroids. Tocilizumab was started with favorable clinical and laboratory results after treatment(AU)

Hepatitis C aguda en un paciente en tratamiento con etanercept / Acute Hepatitis C in a Patient Receiving Etanercept

El uso de agentes bloqueadores del factor de necrosis tumoral alfa (anti-TNFα) en pacientes con hepatitis C crónica ha sido descrito en la literatura en su conjunto como seguro y eficaz. Sin embargo, no se han descrito hasta la fecha casos de primoinfección por el virus de la hepatitis C ocurridos durante el tratamiento con un biológico. Presentamos un paciente con psoriasis moderada-severa de larga evolución que, estando en tratamiento con etanercept, sufrió una hepatitis C aguda. Sin suspender el fármaco anti-TNFα recibió tratamiento con interferón pegilado, con respuesta virológica sostenida. Etanercept no interfirió de forma negativa en la evolución de la enfermedad ni en la respuesta al tratamiento antiviral (AU)

According to the literature, the use of tumor necrosis factor (TNF) inhibitors in patients with chronic hepatitis C infection is safe and effective. There have been no reports, however, of primary infection with the hepatitis C virus during treatment with a biologic agent. We report the case of a patient with long-standing moderate to severe psoriasis who developed acute hepatitis C while being treated with etanercept. Biologic therapy was continued and the infection was successfully treated with pegylated interferon, which achieved a sustained virologic response. Etanercept did not have a negative impact on disease outcome or on response to antiviral treatment (AU)

Recomendaciones sobre el uso de belimumab en el lupus eritematoso sistémico. Guía de Práctica Clínica GEAS-SEMI / Recommendations on the use of belimumab in systemic lupus erythematosus. GEAS-SEMI Clinical Practice Guide

Los tratamientos biológicos están basados en la administración de diversos tipos de moléculas sintéticas relacionadas con la respuesta inmunitaria cuyo uso se ha extendido en los últimos años al campo de las enfermedades autoinmunes sistémicas (EAS), especialmente al lupus eritematoso sistémico (LES). Hasta el año 2011, estas enfermedades no estaban incluidas en las indicaciones terapéuticas aprobadas por las agencias reguladoras internacionales, por lo que su utilización quedaba restringida a los ensayos clínicos y al uso compasivo para los casos refractarios a tratamientos convencionales, para los que se requiere la aprobación del Ministerio de Sanidad. En 2011 se aprueba el uso de belimumab, un anticuerpo monoclonal humano que se une específicamente a la forma soluble de la proteína estimuladora de linfocitos B humanos BLyS. Debido a que la información sobre el uso de este nuevo fármaco en el paciente con LES proviene exclusivamente de los resultados obtenidos en los ensayos aleatorizados, el Grupo de Estudio de Enfermedades Autoinmunes (GEAS) de la Sociedad Española de Medicina Interna (SEMI) ha elaborado una guía terapéutica basada en la evidencia científica disponible en la actualidad sobre el uso de belimumab en los pacientes con LES en la práctica clínica(AU)

Biological therapies are based on the administration of various types of synthetic molecules related to the immune response. Their use has spread in recent years to the field of systemic autoimmune diseases, particularly to systemic lupus erythematosus (SLE). Until 2011, these diseases were not included in the therapeutic indications approved by international regulatory agencies. Therefore, the use of biological therapies was restricted to clinical trials and to compassionate use for cases refractory to standard treatments (off-label use), which require the approval of the Health Ministry. In 2011, belimumab, a human monoclonal antibody that specifically binds to the soluble form of the protein human B lymphocyte stimulator BlyS, was approved for use in patients with SLE. Because the clinical information on the use of this new drug in patients with SLE has only been obtained from the results of randomized trials, the Study Group of Autoimmune Diseases (GEAS) of the Spanish Society of Internal Medicine (SEMI) has developed therapeutic guidelines. These guidelines are based on the current scientific evidence on the use of belimumab in SLE patients in the clinical practice(AU)