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Objective To assess the effectiveness, safety and cost of Etanercept biosimilar in patients with rheumatoid arthritis (RA), spondyloarthritis (SpA) and psoriatic arthritis (PsA) compared to the standard drug in real clinical practice. Patients and methods Retrospective observational study. Case series of 138 patients with RA, SpA or PsA treated with at least one dose of Benepali® (n = 79) or Enbrel® (n = 59). Drug retention time was the primary efficacy endpoint compared to the biosimilar and the original. The proportion of patients achieving low disease activity or remission after 52 weeks was used as the secondary outcome. Safety was assessed by means of the adverse effects incidence rate. A cost minimization analysis was performed. Results No differences were observed regarding treatment retention time between drugs (median [95% confidence interval, 95% CI] at 12.0 months [10.2-12.0] for the biosimilar and 12.0 months [12.0-12.0] for the original). Similar improvements, in terms of inflammatory activity and physical function, were obtained after 52 weeks except for patients with SpA and PsA who, in general, experienced improvements of BASDAI and ASDAS with the original compared with the biosimilar. No significant differences were observed in the total number of adverse effects (.43 events/patient-years versus the biosimilar and .53 versus the original). Using the biosimilar in place of the original drug resulted in a net savings of 118,383.55 € (1,747.20 €/patient-years) for the hospital. Conclusion The biosimilar Benepali is as effective and safe as the original and much more cost-effective.

espanolEl registro de lupus de la Sociedad Espanola de Reumatologia (RELESSER) es un registro multicentrico de pacientes con lupus eritematoso sistemico seguidos en servicios de reumatologia espanoles, que contiene cuantiosa informacion sobre 4.024 pacientes. Hasta la fecha han sido publicados 14 analisis sobre la fase transversal del registro. Se describen los resultados mas relevantes, a criterio de los autores, concernientes a las caracteristicas clinicas acumuladas, nivel de actividad, tratamientos, refractariedad, dano y mortalidad. Se revisan asimismo los resultados de analisis especificos sobre el lupus incompleto, la nefritis lupica, las manifestaciones respiratorias, los eventos cardiovasculares, las infecciones graves, las neoplasias, la fibromialgia, el lupus en varones, el lupus en latinoamericanos y el lupus de inicio juvenil, comparando los diferentes subgrupos con el total de la cohorte. RELESSER se ha constituido como uno de los registros clinicos de lupus eritematoso sistemico mas importantes del mundo, resultando altamente productivo en terminos de generacion de conocimiento de la enfermedad en pacientes espanoles, util tambien para toda la comunidad cientifica. EnglishThe lupus register of the Spanish Society of Rheumatology (RELESSER) is a multicentre register of patients with systemic lupus erythematosus (SLE) under follow-up by Spanish Rheumatology Services. It contains data on a total of 4024 patients with SLE. So far, 14 studies have been published from the transversal phase of RELESSER. Here we report the more relevant contributions of those studies, according to the authors’ perspective, concerning cumulative clinical characteristics, level of activity, treatments, refractory disease, damage and mortality. We also review the main results of the analysis regarding incomplete SLE, lupus nephritis, respiratory manifestations, cardiovascular disease, serious infection, malignancies, fibromyalgia, SLE in males, SLE in Hispanics and juvenile-onset SLE, comparing the main characteristics of each subgroup to the global cohort. RELESSER has become one of the most important clinical SLE registers around the world, with a high yield in terms of knowledge generation about the disease in Spain, also useful for the entire scientific community.

Resumen Objetivos Estudiar las diferencias en pacientes con artritis reumatoide (AR) y enfermedad pulmonar intersticial (EPID) y pacientes con AR sin EPID, e identificar factores asociados con la EPID en pacientes con AR. Pacientes y metodos Estudio observacional de casos y controles. Pacientes: se seleccionaron pacientes de una cohorte con AR y EPID de diferentes centros de Andalucia. Controles: pacientes con AR sin EPID pareados por edad, genero y tiempo de evolucion. Protocolo: los pacientes con AR se revisan cada 3-6 meses en consulta. Todos los pacientes son revisados de acuerdo con un protocolo predeterminado con recogida de datos sistematica. Desenlaces: descripcion del tipo radiologico de EPID, diferencias en los marcadores de gravedad en casos y controles y en la actividad de la enfermedad. Otras variables: descripcion del tipo de EPID por TACAR: neumonia intersticial usual (NIU), neumonia intersticial no especifica (NINE) y de la funcion pulmonar por PFR; marcadores de actividad y gravedad de artritis: DAS28, HAQ, FR, ACPA, erosiones. Tratamiento con FAME. Analisis: descriptivo, χ2 o t de Student, seguida de regresion logistica binaria (Vd:EPID en pacientes con AR). Resultados Se incluyeron 82 pacientes: 41 con AR y EPID y 41 controles AR sin EPID. Los pacientes con EPID presentaron un mayor porcentaje de pacientes con FR y ACPA positivos y una mayor frecuencia de serositis y osteoporosis. No hubo diferencias significativas en DAS28 en casos y controles(p = 0,145), pero los pacientes de AR con EPID presentaron peor HAQ (p = 0,006). Todos los pacientes estaban en tratamiento con FAME. El analisis multivariante mostro que los pacientes con AR exfumadores y con artritis erosiva triplicaron el riesgo de presentar EPID (R2 = 0,36). Conclusiones Los resultados de nuestro estudio apoyan la mayor frecuencia de NIU y NINE en pacientes con AR, asi como la alteracion de DLCO como el parametro mas importante. Los pacientes con AR y EPID se asociaron con una enfermedad mas grave (erosiones y ACPA) y con el tabaco.

Objectives To describe the therapeutic management of rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) in patients initiating treatment with biological agents. Materials and methods Observational, retrospective, longitudinal study in 33 Spanish hospitals. Patients with RA, PsA and AS starting treatment with biological agents between September 2009 and August 2010 and a follow-up longer than 3 years were included. Clinical-demographic characteristics, drugs, biological therapy survival, and reasons for discontinuation or switching were analysed. Results Four hundred and sixty-three patients were included (183 RA, 119 PsA and 161 AS), with a mean follow-up of 3.8 years. At the end of follow-up, a high proportion continued with the first biological prescribed (41.0% of RA, 59.7% of PsA and 51.6% of AS), 31.1%, 47.9% and 42.9% of RA, PsA and AS patients requiring dosage adjustments, respectively. There was temporary discontinuation in 8.2%, 8.4% and 15.5% of patients, and a switch of biologic agent was required in 37.7%, 26.1% and 24.2%. Definitive discontinuation occurred in 13.1%, 5.9% and 8.7% of RA, PsA and AS patients, respectively. Mean time to discontinuation or switching was 30.1 months for RA and 35.7 months for PsA and AS. Conclusions Our results suggest that, in practice, half of patients with RA and two thirds with PsA or AS maintained the first biological, but with frequent dose adjustments.

Resumen Objetivo Generar recomendaciones sobre el bloqueo de la interleucina 6 (IL-6) en pacientes con artritis reumatoide (AR), basadas en la mejor evidencia y experiencia. Metodos Se selecciono a 10 expertos reumatologos en el manejo de los inhibidores de la IL-6. Los 2 coordinadores generaron 23 preguntas sobre el bloqueo de la IL-6 en la AR (perfiles de indicacion, eficacia, seguridad, etc.) para ser contestadas mediante una revision sistematica de la literatura. Con base en las preguntas se definieron los criterios de inclusion y exclusion, y las estrategias de busqueda (para interrogar Medline, Embase y la Cochrane Library). Dos revisores seleccionaron los articulos resultantes de la busqueda. Se generaron tablas de evidencia. Paralelamente, se evaluaron abstracts de congresos de EULAR y ACR. Con toda esta evidencia los coordinadores propusieron 8 recomendaciones preliminares que se evaluaron, discutieron y votaron en una reunion de grupo nominal con el resto de los expertos. Para cada recomendacion se establecio el nivel de evidencia y grado de recomendacion, y el grado de acuerdo mediante un Delphi. Se definio acuerdo si al menos el 80% de los participantes contestaban si a la recomendacion (si o no). Resultados Las 8 recomendaciones preliminares se aceptaron tras el Delphi. Abarcan aspectos como su uso en monoterapia, en combinacion, en pacientes refractarios o intolerantes, la evaluacion de su respuesta, la optimizacion o la gestion del riesgo. Conclusiones Este documento pretende resolver algunos interrogantes clinicos habituales y facilitar la toma de decisiones con el bloqueo de la IL-6 en el manejo de la AR.

To evaluate the effectiveness and safety of tocilizumab (TCZ) monotherapy in biologic-naïve patients with rheumatoid arthritis (RA) versus patients with previous biologic exposure in a real-world setting.Non-controlled clinical-trial, 32-week prospective multicenter study including RA patients with moderate-severe disease activity starting TCZ in monotherapy who had a prior inadequate response or were intolerant to methotrexate (MTX). Effectiveness according to EULAR response evaluated at 24-week and safety at 32-weekwere assessed.Of the 93 were enrolled of whom 84 (90%) were eligible for the effectiveness analysis. Biologic-naïve patients (n=46, 54.8%) were younger (51.5 versus 57.9) with shorter disease duration (6.4 versus 13.3) but presented similar comorbidities in comparison with non-naïve patients. DAS28 remission was achieved in a higher percentage in the group of patients with prior biological treatment. 89 adverse events (AE) were recorded in 50 patients, most of them non-serious AE (non-SAE) (86.3%).In a real world setting, TCZ exhibit similar effectiveness and safety in monotherapy in patients with RA regardless previous exposure to other biologic therapies. This study provides additional and valuable real-world findings on the use of TCZ in patients with RA.

espanolObjetivo Revisar la eficacia y seguridad del rituximab en neuropatia vasculitica (NV). Metodos Se realizo una busqueda en la literatura de Medline y Embase hasta 2017. Los terminos incluidos guardaron relacion con «vasculitis», «neuropatia vasculitica» y «rituximab». Dicha busqueda fue realizada por 2 revisores. El resultado principal fue la eficacia del rituximab. Resultados Tras seleccionar inicialmente 702 articulos, 5 de ellos permanecieron con un nivel de evidencia de entre 1+ y 3, y un grado de recomendacion variable. En el unico ensayo clinico incluido, el rituximab fue superior a la terapia convencional para vasculitis crioglobulinemica, mostrando NV un incremento en la tasa de retencion farmacologica (64,3 vs. 3,5%; p Conclusiones Rituximab parece ser un tratamiento eficaz y seguro para NV, en el contexto de vasculitis crioglobulinemica. Se carece de evidencia sobre la eficacia especifica de NV en el contexto de otras vasculitis. EnglishObjective To review the efficacy and safety of rituximab in vasculitic neuropathy (VN). Methods A literature search was performed on Medline and Embase up until 2017. It included terms related to “vasculitis”,“vasculitic neuropathy” and “Rituximab”. Research was carried out by two reviewers. The main outcome was rituximab efficacy. Results Of an initial selection of 702 articles, 5 remained with a level of evidence between 1+ and 3 and variable recommendation degree. In the only clinical trial included, rituximab was superior to conventional therapy for cryoglobulinemic vasculitis with VN showing an increase in drug retention rate (64.3% vs. 3.5%; P Conclusions Rituximab seems an effective and safe treatment for VN in the context of cryoglobulinemic vasculitis. Evidence for specific efficacy in VN in the context of other types of vasculitis is lacking.

Resumen Objetivo Evaluar la efectividad y la seguridad de tocilizumab (TCZ) en pacientes con artritis reumatoide (AR) en practica clinica; la optimizacion de dosis y el cambio de formulacion intravenosa (iv) a subcutanea (sc). Material y metodos Estudio observacional retrospectivo. Se incluyo a 53 pacientes con AR tratados con TCZ. El desenlace principal fue efectividad de TCZ en la semana 24. Variables de desenlace secundarias incluyeron: efectividad en la semana 52, tiempo de retencion del tratamiento, funcion fisica y seguridad. Tambien se midio efectividad de la optimizacion de dosis y del cambio de formulacion iv a sc a los 3 y 6 meses. La efectividad se midio con el indice de actividad segun el Disease activity score-28. Se uso la prueba T pareada o prueba de rangos con signos de Wilcoxon para evaluar efectividad y el tiempo de supervivencia mediante curvas de Kaplan-Meier. Resultados La proporcion de pacientes que alcanzaron la remision o baja actividad de la enfermedad en las semanas 24 y 52 fue del 75,5 y el 87,3%, respectivamente. La media de tiempo de retencion (intervalo de confianza del 95% [IC del 95%]) fue de 81,7 meses (76,6-86,7). Veintiuno de 53 pacientes (39,6%) optimizaron la dosis de TCZ y 35 pacientes cambiaron a TCZ sc desde iv, sin cambios en resultados de efectividad. La tasa de efectos adversos fue 13,6 eventos/100 pacientes-ano. Conclusiones Tocilizumab parece efectivo y seguro en AR en practica clinica. La reduccion de dosis parece efectiva en la mayoria de los pacientes en remision, incluso cuando cambian de iv a sc. Objective To evaluate the effectiveness and safety of tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) in clinical practice, establishing the optimized regimen and switching from intravenous (IV) to subcutaneous (SC) therapy. Material and methods Retrospective observational study. We included 53 RA patients treated with TCZ. The main outcome was TCZ effectiveness at week 24. Secondary outcome variables included effectiveness at week 52, therapeutic maintenance, physical function and safety. The effectiveness of optimization and the switch from IV to SC was evaluated at 3 and 6 months. The efficacy was measured with the Disease Activity Score. Paired t-tests or Wilcoxon were used to evaluate effectiveness and survival time using Kaplan-Meier. Results The proportion of patients who achieved remission or low disease activity at weeks 24 and 52 was 75.5% and 87.3%, respectively. The mean retention time (95% confidence interval [95% CI] was 81.7 months [76.6-86.7]). Twenty-one of 53 patients (39.6%) optimized the TCZ dose and 35 patients switched from IV TCZ to SC, with no changes in effectiveness. The adverse event rate was 13.6 events/100 patient-years. Conclusions Tocilizumab appears to be effective and safe in RA in clinical practice. The optimized regimen appears to be effective in most patients in remission, even when they change from IV to SC.

Resumen OBJETIVO: Describir si las enfermedades inflamatorias reumaticas (EIR) se asocian con mayor riesgo de hospitalizacion y/o mortalidad por COVID-19 e identificar los factores asociados a la hospitalizacion y mortalidad en EIR y COVID-19 en diferentes Hospitales de Andalucia METODOS: Diseno: Estudio multicentrico observacional de casos y controles Pacientes: Casos: EIR y COVID-19 de diferentes centros de Andalucia Controles: pacientes sin EIR pareados por sexo, edad y PCR-COVID Protocolo: se solicito al servicio de microbiologia un listado de pacientes con PCR para COVID-19 desde 14 de marzo al 14 de abril de 2020 Se identificaron los pacientes que tuvieran EIR y luego consecutivamente un control pareado para cada caso Variables: La variable de desenlace principal fue ingreso hospitalario y mortalidad por COVID-19 Analisis estadistico: bivariante seguida de modelos de regresion logistica binaria (Vd : mortalidad/ingreso hospitalario) RESULTADOS: Se incluyeron 156 pacientes con COVID-19, 78 con EIR y 78 sin EIR Los pacientes con EIR no presentaron caracteristicas de la enfermedad COVID-19 diferentes a la poblacion general, tampoco mayor ingreso hospitalario ni mortalidad El factor asociado con mortalidad en los pacientes con EIR fue edad (OR [IC 95%], 1,1 [1,0-1,2];p=0,025), mientras que los factores asociados a ingreso hospitalario fueron edad (OR [IC 95%], 1,1 [1,1-1,2];p=0,007) e hipertension arterial (OR [IC 95%], 3,9 [1,5-6,7];p=0,003) CONCLUSION: La mortalidad y el ingreso hospitalario por COVID-19 no parecen aumentados en las EIR La edad se asocio con mortalidad en EIR y, ademas, la hipertension arterial se asocio con ingreso hospitalario ABSTRACT OBJECTIVE: To describe whether rheumatic inflammatory diseases (RID) are associated with a higher risk of hospitalization and / or mortality from COVID-19 and identify the factors associated with hospitalization and mortality in RID and COVID-19 in different Hospitals in Andalusia METHODS: Design: Multicentre observational case-control study Patients: RID and COVID-19 from different centres in Andalusia Controls: patients without RIS matched by sex, age and CRP-COVID Protocol: a list of patients with PCR for COVID-19 was requested from the microbiology service from March 14 to April 14, 2020 The patients who had RID were identified and then consecutively a paired control for each case Variables: The main outcome variable was hospital admission and mortality from COVID-19 Statistical analysis: bivariate followed by binary logistic regression models (DV: mortality / hospital admission) RESULTS: One hundred and fifty-six patients were included, 78 with RID and COVID-19 and 78 without RID with COVID-19 The patients did not present characteristics of COVID-19 disease different from the general population, nor did they present higher hospital admission or mortality The factor associated with mortality in patients with RID was advanced age (OR [95% CI], 1 1 [1 0-1 2];p = 025), while the factors associated with hospitalization were advanced age (OR [95% CI], 1 1 [1 0-1 1];p = 007) and hypertension (OR [95% CI], 3 9 [1 5-6 7] ;p = 003) CONCLUSION: Mortality and hospital admission due to COVID-19 do not seem to increase in RID Advanced age was associated with mortality in RID and, in addition, HTN was associated with hospital admission

To establish a set of recommendations for the management of patients diagnosed with rheumatoid arthritis (RA) who cannot be treated with methotrexate (MTX) due to contraindications, drug toxicity or lack of adherence, and to establish therapeutic strategies more effective and safer in these RA patients. A qualitative analysis of the scientific evidence available to June 2015. The 2-round Delphi technique of consensus was used to collect and establish expert opinion based on the participants' clinical experience when only low quality evidence was available. A total of eighteen recommendations were developed for the management of this patient profile. Fourteen of these recommendations were related to drug safety aspects. Recommendations on contraindication and toxicity of MTX have been updated. The experts recommend the use of biological monotherapy, a preferred treatment option, in patients whose profiles reveal a contraindication, intolerance or circumstances that prevent us against the use of MTX. There is some high-quality scientific evidence that supports contraindication and establishes certain conditions of MTX use in RA patients with specific clinical profiles.

To study the differences between rheumatoid arthritis (RA)-interstitial lung disease (ILD) patients and RA patients without ILD in severity markers and disease activity and to identify factors associated with the presence of ILD in RA patients.Patients: RA-ILD patients selected from a multicentre cohort in Andalusia, Spain.RA-patients without ILD paired by sex, age and disease duration.RA patients are reviewed every 3-6months in rheumatology consultation. All patients are reviewed according to a predetermined protocol with systematic data collection.description of ILD type, differences in severity markers and disease activity in both groups. Other variables: ILD type by imaging technique (HRCT): nonspecific interstitial pneumonia (NSIP)/usual interstitial pneumonia (UIP). Lung function by PTF. Activity and severity markers of arthritis by DAS28-ESR, HAQ, RF, ACPA and erosions. Treatment with DMARD.descriptive and paired T-test or Chi-square test followed by binary logistic regression (DV: ILD in patients with RA).Eighty-two patients were included, 41 RA-ILD and 41 RA controls. RF and ACPA positivity, serositis and osteoporosis were more frequent in RA-ILD patients. No significant differences in DAS28 were observed (P=.145) between RA-ILD and RA control patients. RA-ILD patients presented worse HAQ scores (P=.006). All patients were treated with disease modifying antirheumatic drugs (DMARDs). The risk of developing ILD in RA patients is tripled by a history of smoking or the presence of erosive arthritis (RThe results of our study support the higher frequency of UIP and NSIP in RA patients. DLCO is the most sensitive parameter to detect ILD in RA patients. Our study showed that ILD in RA patients was associated with RA severity (presence of erosions and ACPA) and with a history of smoking.

Resumen Introduccion En los ultimos anos, el peso especifico de las consultas externas ha aumentado considerablemente. En la actualidad, la mayor parte de la atencion reumatologica se lleva a cabo en esta area del hospital. Sin embargo, apenas existe documentacion respecto a estandares de calidad asistencial. Objetivo Desarrollar, mediante consenso, estandares de calidad asistencial especificos para las consultas externas de reumatologia. Metodo El proyecto se llevo a cabo mediante metodologia Delphi a 2 rondas. Se conto con la participacion de un comite cientifico (13 reumatologos), 5 grupos nominales (45 reumatologos y 12 enfermeras especializadas) y un grupo de discusion formado por 9 pacientes. Se generaron de forma sucesiva diversos borradores hasta obtener un documento final que incluyo los estandares que recibieron una puntuacion igual o superior a 7 en al menos el 70% de los participantes. Resultados El documento consta de 148 estandares distribuidos en 9 areas tematicas: a) estructura (22); b) actividad clinica y relacion con los pacientes (34); c) planificacion (7); d) niveles de prioridad (5); e) relacion con atencion primaria, con el servicio de urgencias y con otros servicios del hospital (20); f) proceso (26); g) enfermeria (13); h) docencia e investigacion (13), e i) computo de actividad (8). Conclusion Se han consensuado unos estandares de calidad asistencial que pueden ser utiles para organizar la actividad en las consultas externas de los servicios de reumatologia y servir como marco de referencia a la hora de elevar propuestas de mejora a la gerencia del hospital o a otros estamentos de la administracion.

Resumen Objetivo Evaluar la efectividad, seguridad y coste de rituximab en pacientes con artritis reumatoide (AR) dependiendo de la dosis utilizada. Material y metodos Estudio observacional retrospectivo. Se incluyo a 52 pacientes con AR tratados al menos con una dosis de rituximab durante 135,3 pacientes-ano. Se obtuvieron 3 grupos de tratamiento: G1, primer curso y siguientes de 2 infusiones de 1 g separadas 15 dias; G2, primer curso de 2 infusiones de 1 g seguido por cursos de 2 infusiones de 500 mg, y G3, primer curso y siguientes de 2 infusiones de 500 mg separadas por 15 dias. Los retratamientos fueron a demanda segun la clinica. Se analizaron por grupos: el tiempo retencion (Log-Rank), las tasas de retratamientos y de eventos adversos (razon de tasas de incidencia) y los costes del tratamiento por paciente-mes de rituximab. Resultados El grupo 2 mostro una mejor relacion coste-efectividad que el grupo 1 ya que se asocio a una mayor retencion de rituximab (media [IC del 95%] 65,7 [60,8-70,7] meses vs. 33,5 [22,7-44,3]; p Conclusiones El uso de rituximab a dosis completa al inicio seguido de dosis reducida en los sucesivos cursos administrados a demanda parece la opcion mas coste-efectiva.

OBJECTIVE To review the efficacy and safety of rituximab in vasculitic neuropathy (VN) METHODS: A literature search was performed on Medline and Embase up until 2017. It included terms related to "vasculitis","vasculitic neuropathy" and "Rituximab". Research was carried out by two reviewers. The main outcome was rituximab efficacy. RESULTS Of an initial selection of 702 articles, 5 remained with a level of evidence between 1+ and 3 and variable recommendation degree. In the only clinical trial included, rituximab was superior to conventional therapy for cryoglobulinemic vasculitis with VN showing an increase in drug retention rate (64.3% vs. 3.5%; P

OBJECTIVE: To draft recommendations on interleukin 6 (IL-6) blockade in rheumatoid arthritis (RA), based on best evidence and experience.; METHODS: A group of 10 experts on IL-6 blockade in RA was selected. The 2 coordinators formulated 23 questions about IL-6 blockade (indications, efficacy, safety, etc.). A systematic review was conducted to answer the questions. Using this information, inclusion and exclusion criteria were established, as were the search strategies (Medline, EMBASE and the Cochrane Library were searched). Two different reviewers selected the articles. Evidence tables were created. At the same time, European League Against Rheumatism and American College of Rheumatology abstracts were evaluated. Based on this evidence, the coordinators proposed preliminary recommendations that the experts discussed and voted on in a nominal group meeting. The level of evidence and grade of recommendation were established using the Oxford Centre for Evidence Based Medicine and the level of agreement with the Delphi technique (2 rounds). Agreement was established if at least 80% of the experts voted yes (yes/no).; RESULTS: The 8 preliminary recommendations were accepted after the Delphi process. They covered aspects such as the use of these therapies in monotherapy, in combination, in patients with refractory disease or intolerant patients, response evaluation, optimization and risk management.; CONCLUSIONS: The manuscript aims to solve frequently asked questions and aid in decision making strategies when treating RA patients with IL-6 blockade. Copyright © 2018 Elsevier Espana, S.L.U. and Sociedad Espanola de Reumatologia y Colegio Mexicano de Reumatologia. All rights reserved.

Objetivo Establecer recomendaciones para el manejo de pacientes con artritis reumatoide (AR) centrado en el papel de los farmacos antirreumaticos modificadores de enfermedad (FAME) sinteticos y biologicos disponibles, que sirvan de referencia para todos los profesionales implicados en la atencion de estos pacientes. Metodos Las recomendaciones se consensuaron a traves de un panel de 14 expertos previamente seleccionados por la Sociedad Espanola de Reumatologia (SER). Se recogio la evidencia disponible mediante la actualizacion de las 3 revisiones sistematicas (RS) que se utilizaron para las recomendaciones EULAR 2013, a las que se anadio una nueva RS para dar respuesta a una pregunta adicional. Todas fueron realizadas por miembros del grupo de revisores de la SER. La clasificacion del nivel de la evidencia y del grado de la recomendacion se realizo utilizando el sistema del Centre for Evidence-Based Medicine de Oxford. Se utilizo la metodologia Delphi para evaluar el grado de acuerdo entre los panelistas para cada recomendacion. Resultados Se emiten un total de 13 recomendaciones sobre el manejo terapeutico de pacientes con AR del adulto. El objetivo terapeutico debe ser tratar al paciente en fases precoces de la enfermedad, con el objetivo de la remision clinica, teniendo un papel central el metotrexato como FAME sintetico de referencia. Se actualizan las indicaciones de los FAME biologicos disponibles, se enfatiza la importancia de los factores pronosticos y se incide en el concepto de optimizacion de biologicos. Conclusiones Se presenta la quinta actualizacion de las recomendaciones SER para el manejo de la AR con FAME sinteticos y biologicos.

Objectives: To describe the prevalence of comorbidities in patients with RA in Spain and discuss their management and implications using data from the Spanish cohort of the multinational study on COMOrbidities in Rheumatoid Arthritis (COMORA). Methods: This is a national sub-analysis of the COMORA study. We studied the demographics and disease characteristics of 200 adults patients diagnosed with RA (1987 ACR), and routine practices for screening and preventing the following selected comorbidities: cardiovascular, infections, cancer, gastrointestinal, pulmonary, osteoporosis and depression. Results: Patients had a mean age of 58 years and a mean RA duration of 10 years. Mean DAS28 score was 3.3 and approximately 25% of patients were in remission (DAS28 20% (51%), hypercholesterolemia (46%) or hypertension (41%) and smoking (25%) were the most common CV risk factors. For prostate, colon and skin cancers, only 9%, 10% and 18% of patients, respectively, were optimally monitored. Infections were also inadequately managed, with 7% and 17% of patients vaccinated against influenza and pneumococcal, respectively, as was osteoporosis, with 47% of patients supplemented with vitamin D and 56% with a bone densitometry performed. Conclusions: In Spain, the prevalence of comorbidities and CV risk factors in RA patients with established and advanced disease is relatively high, and their management in clinical daily practice remains suboptimal. Objetivos: Describir la prevalencia de comorbilidades en pacientes con AR en España y discutir sobre su manejo en la clínica diaria utilizando los datos de la cohorte española del estudio internacional COMORA. Métodos: Subanálisis nacional del estudio COMORA en el que se analizaron las características demográficas y clínicas de 200 pacientes con AR (1987 ACR) y las prácticas rutinarias para el cribado y la prevención de eventos cardiovasculares (CV), gastrointestinales y pulmonares, infecciones, cáncer, osteoporosis y depresión. Resultados: Los pacientes tenían una edad media de 58 años, una duración media de la enfermedad de 10 años, un DAS28 de 3,3 y el 25% estaba en remisión (DAS28 20% (51%), tener hipercolesterolemia (46%), hipertensión (41%) y fumar (25%) fueron los factores de riesgo CV más comunes. En relación con el cáncer de próstata, colon y piel, solo el 9, 10 y el 18% de los pacientes, respectivamente, estaban óptimamente controlados. Las infecciones tampoco se manejaban de forma óptima, con solo el 7 y el 17% de los pacientes vacunados contra la influenza y neumococo, respectivamente, al igual que la osteoporosis, con el 47% suplementados con la vitamina D y el 56% con una densitometría realizada. Conclusiones: En España, la prevalencia de comorbilidades y factores de riesgo CV en pacientes con AR establecida y avanzada es relativamente alta, y su manejo en la clínica diaria continúa siendo subóptimo. Sin financiación No data JCR 2019 0.256 SJR (2019) Q4, 49/64 Rheumatology No data IDR 2019 UEM

Resumen Objetivos Analizar la experiencia espanola en un estudio internacional para evaluar tocilizumab en pacientes con artritis reumatoide (AR) con respuesta insuficiente al tratamiento con farmacos antirreumaticos modificadores de la enfermedad convencionales (FAME) o anti-TNF en condiciones cercanas a la practica clinica habitual. Material y metodos Subanalisis de 170 pacientes con AR que participaron en Espana en un ensayo clinico, internacional abierto de fase iii b, que presentaban una respuesta inadecuada al tratamiento con FAME o anti-TNF. Los pacientes recibieron 8 mg/kg de tocilizumab cada 4 semanas en combinacion con FAME o en monoterapia durante un periodo de 20 semanas. Se evaluaron la seguridad y la eficacia de tocilizumab distinguiendo entre pacientes con fallo a FAME o anti-TNF y, dentro de estos, entre los que habian hecho o no periodo de lavado del anti-TNF. Resultados Los acontecimientos adversos mas frecuentes fueron infecciones (25%) y elevacion de colesterol total (38%) y transaminasas (15%). Cinco pacientes abandonaron el estudio por un acontecimiento adverso. El 71/50/30% de los pacientes cumplia criterios de respuesta ACR 20/50/70 a los 6 meses del inicio del tratamiento con tocilizumab. Los pacientes naive para anti-TNF presentaron una mayor respuesta ACR20: el 76% frente a un 64% en el grupo anti-TNF con lavado previo y el 66% en el grupo anti-TNF sin lavado previo. Conclusiones Se confirma el perfil de seguridad de tocilizumab en pacientes con AR y fallo a FAME o anti-TNF. Tocilizumab es mas eficaz en pacientes que no responden de forma satisfactoria al tratamiento con FAME convencionales que con anti-TNF.

a b s t r a c t Objective: To determine the incidence and prevalence of cancer in a cohort of patients with systemic lupus erythematosus (SLE) and identify associated risk factors. Patients and methods: The study comprised a dynamic cohort of SLE patients (November 1989 to Decem- ber 2006) at a tertiary referral centre. An adjusted external control from the hospital tumour registry was used. Results: The study included 175 SLE patients (90% women), with a mean time at risk of 1370.5 patient- years. Fourteen women (8%) died, mainly from cardiovascular events. No patient died due to malignancy. We found 35 tumours in 28 patients, 25 of them after the diagnosis of SLE, of which 5 were malignant. The rate of benign tumours was 14.6/1000 patient-years (95% CI, 8.9-22.5) and of malignant tumours 3.6/1000 patient-years (95% CI, 1.5-8.8), with a crude incidence odds ratio for malignant tumours of 3.5 (95% CI, 1.5-7.9). However, this significance was lost after standardizing the rates. Concerning associated risk factors, differences were found in the mean erythrocyte sedimentation rate (HR 1.4 (1.1-1.7)), and the presence of thrombosis (HR 6.9 (1.49-41.2)), especially arterial thrombosis. Conclusions: We found a crude incidence rate of cancer that was almost four times greater in our SLE patients as compared with the expected rate in the hospital area of western Malaga.

Objetivo Elaborar unas recomendaciones que sirvan de referencia a los reumatologos y otros profesionales implicados en el tratamiento del lupus eritematoso sistemico (LES) que vayan a utilizar o consideren la utilizacion de terapias biologicas en su manejo. Metodos Las recomendaciones se emitieron siguiendo la metodologia de grupos nominales y basadas en revisiones sistematicas. El nivel de evidencia y el grado de recomendacion se clasificaron segun el modelo del Center for Evidence Based Medicine de Oxford y el grado de acuerdo se extrajo por tecnica Delphi. Resultados Se realizan recomendaciones sobre el uso de belimumab, actualmente unica terapia biologica con aprobacion para el tratamiento del LES, y otras terapias biologicas sin indicacion aprobada en LES. El objetivo del tratamiento es la respuesta clinica completa, entendida como la ausencia de actividad clinica percibida o constatable. Se matiza el uso de terapias biologicas en LES y cual debe ser la evaluacion previa y la vigilancia del paciente que recibe estos farmacos. Conclusiones Se presentan las recomendaciones SER sobre el uso de terapias biologicas en el LES.

Aim To determine whether rheumatoid arthritis (RA) patients who have been prescribed biological agents exhibit a different comorbidity burden than RA patients who take disease-modifying antirheumatic drugs (DMARDs) alone, and to understand the association between comorbidity and other variables, as well as the association between comorbidity and multimorbidity. Methods This observational case–control study included 114 RA patients treated with biological agents and a control group comprising 163 sex- and age-matched RA patients treated with DMARDs only. Current and previous data regarding the patients’ disease activity, comorbidities, and treatments were collected. The data were analysed using bivariate and multivariate regression models. Results The patients who were prescribed biological agents exhibited poorer disease control, received more DMARDs and steroids, and underwent more total joint arthroplasties compared with the patients in the control group. However, the risk factors for cardiovascular disease and the comorbidity frequency were similar between cases and controls. The most prevalent comorbidities were hypertension, obesity, and respiratory, thyroid, and upper gastrointestinal disorders. The incidence of cardiovascular disease was low, and only 29% of the patients exhibited multimorbidities. A bivariate association of age, late diagnosis, joint replacements and a high score on the health assessment questionnaire score (HAQ) with comorbidity was observed. There were also correlations between the Charlson index and age, joint reconstructive surgery, disease activity (DAS28), and HAQ score. However, when binary logarithmic regression models were applied, only patient age remained significantly associated with comorbidity and multimorbidity [hazard ratio, 1.08; 95% confidence interval, 1.05–1.12; p Conclusion RA patients taking biological drugs have a comorbidity burden equivalent to those treated with DMARDs alone. Age is the main predictive factor of comorbidity in these patients.

To establish a set of recommendations for the management of patients diagnosed with rheumatoid arthritis (RA) who cannot be treated with methotrexate (MTX) due to contraindications, drug toxicity or lack of adherence, and to establish therapeutic strategies more effective and safer in these RA patients. A qualitative analysis of the scientific evidence available to June 2015. The 2-round Delphi technique of consensus was used to collect and establish expert opinion based on the participants' clinical experience when only low quality evidence was available. A total of eighteen recommendations were developed for the management of this patient profile. Fourteen of these recommendations were related to drug safety aspects. Recommendations on contraindication and toxicity of MTX have been updated. The experts recommend the use of biological monotherapy, a preferred treatment option, in patients whose profiles reveal a contraindication, intolerance or circumstances that prevent us against the use of MTX. There is some high-quality scientific evidence that supports contraindication and establishes certain conditions of MTX use in RA patients with specific clinical profiles.

Objetivo Conocer el numero anual y la tendencia de las protesis implantadas en nuestro hospital a los pacientes con artritis reumatoide (AR) durante la ultima decada. Material y metodos Estudio observacional retrospectivo. Los pacientes fueron localizados mediante busqueda exhaustiva en la base de datos del servicio de documentacion clinica entre 1998 y 2007. Los datos se extrajeron de las historias clinicas siguiendo un cuestionario predisenado. El analisis estadistico longitudinal de las protesis colocadas se efectuo mediante la Q de Cochrane y las curvas de Kaplan-Meier. Resultado Sesenta y un pacientes con AR fueron intervenidos con 78 protesis como consecuencia directa de su enfermedad en nuestro hospital entre 1998 y 2007. La mayoria eran mujeres (80%) con factor reumatoide positivo (84%). La media de edad fue de 58 anos y el tiempo de evolucion medio de la AR fue de 13 anos. Todos excepto uno habian recibido previamente farmacos antirreumaticos (88% metotrexato), pero solo el 11% habia accedido a una terapia biologica. No se observaron cambios en el numero de artroplastias a lo largo de toda la decada, aunque si hubo una tendencia a la reduccion en el numero de pacientes que precisaron por primera vez una protesis de rodilla (Q Cochrane; p=0,05). Conclusion No hemos observado cambios significativos en la colocacion de protesis articulares en su conjunto en la ultima decada en nuestro hospital, aunque podria estar produciendose un descenso del numero de pacientes que acceden por primera vez a una protesis de rodilla.

Systemic lupus erythematosus is an autoimmune disease that may involve the function of organs and reduce the survival of patients. Advances in the diagnosis and treatment have improved the short-term prognosis.However, most therapeutic improvements come from progress in other areas of medicine and only in recent years is this trend changing. Unfortunately, the development of new drugs for lupus is facing specific difficulties and the development of rituximab in lupus has been stopped despite good results in the observational studies. This review examines some of the aspects that influence these difficulties from the perspective of the LESIMAB database.