Actualización del Documento de posicionamiento de la Sociedad Española de Reumatología sobre fármacos biosimilares / Update of the Position Paper of the Spanish Society of Rheumatology on Biosimilar Drugs

En el año 2015 la Sociedad Española de Reumatología (SER) publicó su posicionamiento sobre fármacos biosimilares. En esta actualización, la SER, sigue manifestando su compromiso inequívoco con la sostenibilidad del sistema sanitario de nuestro país y se alinea con las medidas que, sin reducir la calidad asistencial, estén encaminadas a asegurar su sostenibilidad. Desde la publicación del anterior posicionamiento la Comisión Europea ha autorizado la comercialización de nuevos fármacos biosimilares, lo que abre una excelente oportunidad de avanzar en la eficiencia de la atención sanitaria. En este nuevo escenario de incremento de la oferta terapéutica de biológicos, la SER considera imprescindible preservar la libertad de prescripción de los médicos que realizan la indicación de fármacos basándose exclusivamente en las características y circunstancias individuales de cada paciente, sin olvidar los aspectos económicos que se derivan de dicha actuación.(AU)

In 2015 the Spanish Society of Rheumatology (Sociedad Española de Reumatología [SER]) published its position paper on biosimilar drugs. In this update, the SER, continues to manifest its unequivocal commitment to the sustainability of the health system of our country and is aligned with the measures that, without reducing quality of care, are aimed at ensuring its continuity. Since the publication of the previous position paper, the European Commission has authorized new biosimilar drugs, which provides an excellent opportunity to advance the efficiency of health care. In this new scenario of increased therapeutic offer of biologics, the SER considers it crucial to preserve the freedom of prescription of physicians who prescribe drugs based exclusively on the characteristics and individual circumstances of each patient, without forgetting the economic aspects there of.(AU)

Update of the Position Paper of the Spanish Society of Rheumatology on Biosimilar Drugs. / Actualización del Documento de posicionamiento de la Sociedad Española de Reumatología sobre fármacos biosimilares.

In 2015 the Spanish Society of Rheumatology (Sociedad Española de Reumatología [SER]) published its position paper on biosimilar drugs. In this update, the SER, continues to manifest its unequivocal commitment to the sustainability of the health system of our country and is aligned with the measures that, without reducing quality of care, are aimed at ensuring its continuity. Since the publication of the previous position paper, the European Commission has authorized new biosimilar drugs, which provides an excellent opportunity to advance the efficiency of health care. In this new scenario of increased therapeutic offer of biologics, the SER considers it crucial to preserve the freedom of prescription of physicians who prescribe drugs based exclusively on the characteristics and individual circumstances of each patient, without forgetting the economic aspects there of.

Nomenclátor jerarquizado en reumatología / Hierarchical nomenclature in rheumatology

INTRODUCCIÓN: Una misión de la Sociedad Española de Reumatología es aportar las herramientas necesarias para alcanzar la excelencia asistencial. En la actualidad no existe una referencia que cuantifique la complejidad de los actos médicos de esta especialidad. MATERIAL Y MÉTODO: Se elaboró una relación de los actos propios del reumatólogo y se estableció un sistema de clasificación jerárquica a partir de la construcción de un índice de complejidad, calculado mediante el tiempo de realización y el grado de dificultad de cada acto. RESULTADOS: Los resultados del método Delphi tendieron a una opinión grupal consensuada (media σ2 - σ1=0,75-1,43=-0,68, media IQR2 - IQR1=0,8-1,9=-1,1). El rango de valores del índice de complejidad osciló de 48 a 465 puntos. Entre las consultas, las que alcanzaron mayor gradación fueron la primera visita al paciente hospitalizado (366) y la visita a domicilio (369). Entre las técnicas diagnósticas, destacaron las biopsias. Las que puntuaron más alto fueron: biopsia ósea (465), de nervio sural (416) y sinovial (380). La ecografía tuvo una puntuación de 204, la capilaroscopia de 113 y la densitometría de 112. Entre las técnicas terapéuticas, la máxima dificultad (388), la alcanzó la infiltración/artrocentesis/ inyección articular infantil. La puntuación de la inyección articular con control ecográfico fue de 163. El informe clínico de minusvalía, 323 y el informe pericial, 370. CONCLUSIONES: Este trabajo ha permitido elaborar un nomenclátor de 54 actos en reumatología donde se identifican como actos más complejos la realización de biopsias (ósea, nervio sural, sinovial), la visita a paciente hospitalizado, la visita a domicilio, la infiltración infantil bajo sedación y la elaboración de un informe pericial. La ecografía osteomuscular es considerada el doble de compleja de una visita sucesiva, la capilaroscopia o la densitometría ósea

INTRODUCTION: One of the missions of the Spanish Society of Rheumatology is to provide the necessary tools for excellence in health care. Currently, there is no reference point to quantify medical actions in this specialty, and this is imperative. MATERIAL AND METHOD: A list of actions was drawn up and a hierarchical classification system was established by developing a complexity index, calculated based on the completion time and difficulty level of each action. RESULTS: The results of the Delphi method tended to the consensus opinion within a group (mean σ2 - σ1=0.75-1.43=-0.68, mean IQR2 - IQR1=0.8-1.9=-1.1). The values of the complexity index ranged between 48 and 465 points. Among consultation actions, those reaching the highest scores were the first inpatient visit (366) and visits to the patient's home (369). Among diagnostic techniques, biopsies were prominent, those with the highest score were: bone biopsy (465), sural nerve biopsy (416) and synovial biopsy (380). Ultrasound scan scored 204, capillaroscopy 113 and densitometry 112. Among therapeutic techniques, infiltration/ arthrocentesis/articular injection in children reached the highest difficulty (388). The score for ultrasound-guided articular injection was 163. The score for clinical report on disability was 323 and expert report 370. CONCLUSIONS: A nomenclature of 54 actions in Rheumatology was compiled. Biopsies (bone, sural nerve, synovial), inpatient visits, visits to the patient's home, infiltrations in children, and the preparation of the expert report were identified as the most complex actions. Musculoskeletal ultrasound is twice as complex as subsequent visits, capillaroscopy or bone densitometry

Hierarchical nomenclature in rheumatology. / Nomenclátor jerarquizado en reumatología.

INTRODUCTION: One of the missions of the Spanish Society of Rheumatology is to provide the necessary tools for excellence in health care. Currently, there is no reference point to quantify medical actions in this specialty, and this is imperative. MATERIAL AND METHOD: A list of actions was drawn up and a hierarchical classification system was established by developing a complexity index, calculated based on the completion time and difficulty level of each action. RESULTS: The results of the Delphi method tended to the consensus opinion within a group (mean σ2 - σ1=0.75-1.43=-0.68, mean IQR2 - IQR1=0.8-1.9=-1.1). The values of the complexity index ranged between 48 and 465 points. Among consultation actions, those reaching the highest scores were the first inpatient visit (366) and visits to the patient's home (369). Among diagnostic techniques, biopsies were prominent, those with the highest score were: bone biopsy (465), sural nerve biopsy (416) and synovial biopsy (380). Ultrasound scan scored 204, capillaroscopy 113 and densitometry 112. Among therapeutic techniques, infiltration/ arthrocentesis/articular injection in children reached the highest difficulty (388). The score for ultrasound-guided articular injection was 163. The score for clinical report on disability was 323 and expert report 370. CONCLUSIONS: A nomenclature of 54 actions in Rheumatology was compiled. Biopsies (bone, sural nerve, synovial), inpatient visits, visits to the patient's home, infiltrations in children, and the preparation of the expert report were identified as the most complex actions. Musculoskeletal ultrasound is twice as complex as subsequent visits, capillaroscopy or bone densitometry.

Recomendaciones sobre el uso de metrotexato parenteral en enfermedades reumáticas / Recommendations for the use of parenteral methotrexate in rheumatic diseases

Objetivos. Desarrollar recomendaciones sobre el uso de metrotexato (MTX) parenteral en pacientes con enfermedades reumáticas, fundamentalmente en la artritis reumatoide, basadas en la mejor evidencia y experiencia. Métodos. Se seleccionó un grupo de 21 expertos reumatólogos en el manejo de MTX. El coordinador generó 13 preguntas sobre el uso de MTX parenteral (perfiles de indicación, eficacia, seguridad, costo-eficacia y biodisponibilidad) para ser contestadas mediante una revisión sistemática de la literatura. Con base en las preguntas se definieron los criterios de inclusión y exclusión, y las estrategias de búsqueda (en Medline, EMBASE y la Cochrane Library). Tres revisores seleccionaron los artículos resultantes de la búsqueda. Se generaron tablas de evidencia. Paralelamente se evaluaron abstracts de congresos de la European League Against Rheumatism (EULAR) y del American College of Rheumatology (ACR). Con toda esta evidencia el coordinador generó 13 recomendaciones preliminares que se evaluaron, discutieron y votaron en una reunión del grupo nominal con los expertos. Para cada recomendación se estableció el nivel de evidencia y grado de recomendación, y el grado de acuerdo mediante un Delphi. Se definió acuerdo si al menos el 80% de los participantes contestaron sí a la recomendación (sí o no). Resultados. La mayoría de la evidencia proviene de la artritis reumatoide. De las 13 recomendaciones preliminares se aceptaron 11 recomendaciones sobre el uso de MTX parenteral en reumatología. Dos no se llegaron a votar y se decidió no incluirlas, pero se comentan en el texto final. Conclusiones. Este documento pretende resolver algunos interrogantes clínicos habituales y facilitar la toma de decisiones con el uso de MTX parenteral

Objective. To develop recommendations for the use of parenteral methotrexate (MTX) in rheumatic diseases, mainly rheumatoid arthritis, based on best evidence and experience. Methods. A group of 21 experts on parenteral MTX use was selected. The coordinator formulated 13 questions about parenteral MTX (indications, efficacy, safety and cost-effectiveness). A systematic review was conducted to answer the questions. Using this information, inclusion and exclusion criteria were established, as were the search strategies (involving Medline, EMBASE and the Cochrane Library). Three different reviewers selected the articles. Evidence tables were created. Abstracts from the European League Against Rheumatism (EULAR) and American College of Rheumatology (ACR) were evaluated. Based on this evidence, the coordinator proposed preliminary recommendations that the experts discussed and voted in a nominal group meeting. The level of evidence and grade of recommendation were established using the Oxford Center 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. Most of the evidence involved rheumatoid arthritis. A total of 13 preliminary recommendations on the use of parenteral MTX were proposed; 11 of them were accepted. Two of the 13 were not voted and are commented on in the main text. Conclusions. The manuscript aims to solve frequent questions and help in decision-making strategies when treating patients with parenteral MTX

Recommendations for the use of parenteral methotrexate in rheumatic diseases. / Recomendaciones sobre el uso de metrotexato parenteral en enfermedades reumáticas.

OBJECTIVE: To develop recommendations for the use of parenteral methotrexate (MTX) in rheumatic diseases, mainly rheumatoid arthritis, based on best evidence and experience. METHODS: A group of 21 experts on parenteral MTX use was selected. The coordinator formulated 13 questions about parenteral MTX (indications, efficacy, safety and cost-effectiveness). A systematic review was conducted to answer the questions. Using this information, inclusion and exclusion criteria were established, as were the search strategies (involving Medline, EMBASE and the Cochrane Library). Three different reviewers selected the articles. Evidence tables were created. Abstracts from the European League Against Rheumatism (EULAR) and American College of Rheumatology (ACR) were evaluated. Based on this evidence, the coordinator proposed preliminary recommendations that the experts discussed and voted in a nominal group meeting. The level of evidence and grade of recommendation were established using the Oxford Center 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: Most of the evidence involved rheumatoid arthritis. A total of 13 preliminary recommendations on the use of parenteral MTX were proposed; 11 of them were accepted. Two of the 13 were not voted and are commented on in the main text. CONCLUSIONS: The manuscript aims to solve frequent questions and help in decision-making strategies when treating patients with parenteral MTX.

Estado de la reumatología privada en España / Status of private rheumatology in Spain

Introducción. El Sistema Nacional de Salud ofrece en España la atención reumatológica. Más de una cuarta parte del gasto sanitario se realiza en medicina privada. En la actualidad no existen datos sobre el número de reumatólogos con actividad privada en España. Objetivos. Evaluar los reumatólogos con actividad privada en España describiendo su perfil y localización. Material y métodos. Desde la Comisión de Práctica Privada de la SER, se elaboró una encuesta que se envió a todos los socios reumatólogos en activo. La recogida de datos finalizó en diciembre del 2014. Se analizaron los datos mediante estadística descriptiva y se realizó una comparación de los resultados. Resultados. Se obtuvieron 759 respuestas de un total de 980 encuestas enviadas (77,45%). El 38% de los reumatólogos españoles tienen actividad privada; el 13% en exclusiva (privada) y el 25% compartida con su actividad pública (mixta). El perfil del reumatólogo que trabaja en la medicina privada es: género masculino, 49 años de edad con 19 años de experiencia, su jornada laboral es de 42h semanales. Existe un claro predominio de la práctica privada en la CC.AA. de Cataluña (28% del total), seguida por las CC.AA. de Madrid con un 18%, Andalucía con un 12% y Valencia con un 8%. Conclusiones. El 38% de los reumatólogos españoles trabajan en la medicina privada. El perfil profesional en reumatología privada es distinto del que trabaja exclusivamente en la sanidad pública. Existe reumatología privada en todas las CC.AA, aunque la mayoría de reumatólogos privados se localizan en las CC.AA. de Cataluña, Madrid, Valenciana y Andalucía, representando más del 50% del total (AU)

Introduction. Rheumatologic care is offered by the National Health System in Spain. However, more than a quarter of health spending is carried out in private medicine. Currently, there are no data about the number of rheumatologists with private activity in Spain. Objectives. To evaluate the number of rheumatologists with private activity in Spain and to describe the profile and location of these professionals. Material and methods. A survey was developed and sent from the SER Commission on Private Practice to all SER active members. Data collection ends in December 2014. A descriptive statistical analysis and comparison of results was done. Results. 759 answers from a total of 980 surveys sent (77.45%) were obtained; 38% of Spanish rheumatologists have private activity; 13% exclusively private practice and 25% private practice shared with his or her public activity. The private practice rheumatologist profile is: male, 49 years old with 19 years of experience after finishing the specialty and with a working day of 42hours per week. There is a clear predominance of private practice in the Autonomous Community of Catalonia with 28% of the total, followed by Madrid 18%, Andalusia 12% and Valencia 8%. Conclusions. 38% of Spanish rheumatologists are working in private practice. The profile of professionals working in private practice is different from that of those who work exclusively in public health. Private rheumatology is located in all regions, although most private rheumatologists are located in the regions of Catalonia, Madrid, Valencia and Andalusia, representing more than 50% of the total (AU)

Status of private rheumatology in Spain. / Estado de la reumatología privada en España.

INTRODUCTION: Rheumatologic care is offered by the National Health System in Spain. However, more than a quarter of health spending is carried out in private medicine. Currently, there are no data about the number of rheumatologists with private activity in Spain. OBJECTIVES: To evaluate the number of rheumatologists with private activity in Spain and to describe the profile and location of these professionals. MATERIAL AND METHODS: A survey was developed and sent from the SER Commission on Private Practice to all SER active members. Data collection ends in December 2014. A descriptive statistical analysis and comparison of results was done. RESULTS: 759 answers from a total of 980 surveys sent (77.45%) were obtained; 38% of Spanish rheumatologists have private activity; 13% exclusively private practice and 25% private practice shared with his or her public activity. The private practice rheumatologist profile is: male, 49 years old with 19 years of experience after finishing the specialty and with a working day of 42hours per week. There is a clear predominance of private practice in the Autonomous Community of Catalonia with 28% of the total, followed by Madrid 18%, Andalusia 12% and Valencia 8%. CONCLUSIONS: 38% of Spanish rheumatologists are working in private practice. The profile of professionals working in private practice is different from that of those who work exclusively in public health. Private rheumatology is located in all regions, although most private rheumatologists are located in the regions of Catalonia, Madrid, Valencia and Andalusia, representing more than 50% of the total.

Documento de posicionamiento de la Sociedad Española de Reumatología sobre fármacos biosimilares / Position paper from the Spanish Society of Rheumatology on biosimilar drugs

Un biosimilar (BS) es un fármaco biológico que contiene una versión de la sustancia activa de un producto biológico original ya autorizado. Los BS se comercializan al terminar el periodo de patente del fármaco original y tras demostrar que las diferencias con respecto al medicamento innovador no tienen ningún efecto relevante sobre su seguridad y su eficacia clínica. La Sociedad Española de Reumatología, en consonancia con la Agencia Europea del Medicamento, considera que por su naturaleza y complejidad de producción no se puede equiparar un BS a un genérico. La Sociedad Española de Reumatología manifiesta un compromiso inequívoco con la sostenibilidad del sistema sanitario y apoya medidas que, sin reducir la calidad asistencial, estén encaminadas a asegurar su continuidad. Por esto considera que, probablemente, la llegada de los BS mejorará el acceso de los pacientes con enfermedades reumáticas a los fármacos biológicos. Este artículo revisa la normativa de la Agencia Europea del Medicamento, el marco legal español y las controversias sobre los BS, y presenta el posicionamiento de la Sociedad Española de Reumatología sobre estos fármacos (AU)

A biosimilar (BS) is a biological drug that contains a version of the active substance of an already authorized original biological product. The BSs are marketed after patent period of the original drug has ended and once it has been demonstrated that the differences regarding the innovative medicine have no relevant effect on its safety or clinical efficacy. The Spanish Society of Rheumatology, in line with the European Medicines Agency, considers that because of its nature and complexity of production, a BS cannot be considered to be the same as a generic drug. The Spanish Society of Rheumatology expresses an unequivocal commitment to the sustainability of the health system in our country and our steadfast alignment with all measures designed to ensure continuity, without reducing the quality of care. Therefore, we believe that the advent of BSs will likely facilitate access of patients with rheumatic diseases to the biological drugs. This article reviews the European Medicines Agency requirements for authorization, the Spanish legal framework and controversies on BS and presents the position paper of the Spanish Society of Rheumatology on these drugs (AU)

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)

2014 update of the Consensus Statement of the Spanish Society of Rheumatology on the use of biological therapies in rheumatoid arthritis.

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.

Position paper from the Spanish Society of Rheumatology on biosimilar drugs.

A biosimilar (BS) is a biological drug that contains a version of the active substance of an already authorized original biological product. The BSs are marketed after patent period of the original drug has ended and once it has been demonstrated that the differences regarding the innovative medicine have no relevant effect on its safety or clinical efficacy. The Spanish Society of Rheumatology, in line with the European Medicines Agency, considers that because of its nature and complexity of production, a BS cannot be considered to be the same as a generic drug. The Spanish Society of Rheumatology expresses an unequivocal commitment to the sustainability of the health system in our country and our steadfast alignment with all measures designed to ensure continuity, without reducing the quality of care. Therefore, we believe that the advent of BSs will likely facilitate access of patients with rheumatic diseases to the biological drugs. This article reviews the European Medicines Agency requirements for authorization, the Spanish legal framework and controversies on BS and presents the position paper of the Spanish Society of Rheumatology on these drugs.

Recomendaciones para el uso del metotrexato en artritis reumatoide: incremento y reducción de dosis y vías de administración / Recommendations for the use of methotrexate in rheumatoid arthritis: up and down scaling of the dose and administration routes

Objetivos. Describir la estrategia terapéutica óptima de uso de metotrexato en AR sobre dosis inicial, vía de administración, incremento y disminución de dosis, seguimiento del paciente y uso de ácido fólico/folínico. Material y método. Once expertos plantearon los interrogantes clínicos a resolver. Se realizó una búsqueda bibliográfica sistemática. Los contenidos fueron seleccionados en una sesión de trabajo y el nivel de acuerdo se estableció posteriormente en una ronda de consenso vía correo. Resultados. La dosis de inicio de metotrexato no debe ser < 10 mg/semana, preferentemente por vía oral, considerando la vía parenteral como alternativa según el cumplimento, ineficacia o efectos secundarios gastrointestinales, polimedicación, obesidad (si requiere dosis > 20 mg/semana), preferencias del paciente, enfermedad muy activa o para evitar errores de medicación. Se cambiará a la vía parenteral cuando haya ineficacia, toxicidad gastrointestinal, incumplimiento o por coste-efectividad antes de pasar a fármacos más caros; y a la inversa, según preferencias del paciente, intolerancia a inyectables, reducción de dosis < 7,5 mg/semana, ineficacia, bajo cumplimiento o efectos adversos gastrointestinales. Se realizará escalada rápida de dosis si la respuesta es inadecuada hasta los 15-20 o, incluso, 25 mg/semana en unas 8 semanas, con incrementos de 2,5-5 mg. La reducción se realizará según la dosis a la que estuviera el paciente, con disminuciones de 2,5-5 mg cada 3-6 meses. El seguimiento del paciente deberá realizarse cada 1-1,5 meses hasta la estabilidad y luego cada 1-3 meses. Conclusiones. Este documento pretende resolver algunos interrogantes clínicos habituales y facilitar la toma de decisiones en la AR tratada con metotrexato (AU)

Objectives, To describe the optimal therapeutic strategy for use of methotrexate in RA patients over the initial dose, route of administration, dose increase and decrease, patient monitoring, and use of folic/folinic acid. Materials and methods. Eleven clinical experts proposed some questions to be solved. A systematic literature search was conducted. The contents were selected in a work session and subsequently validated via email to establish the level of agreement. Results. The initial dose of methotrexate should not be <10 mg/week, preferably orally, but the parenteral route is considered as an alternative due to compliance, non-effectiveness of treatment or gastrointestinal side effects, polypharmacy, obesity (if required doses are >20 mg/week), patient preference, very active disease or to avoid administration errors. Changing to a parenteral administration is proposed when the oral route is not effective enough, gastrointestinal toxicity appears, there is non-compliance or due to cost-effectiveness reasons before using more expensive drugs. On the contrary, due to patient preferences, intolerance to injections, dose reduction <7.5 mg/week, non-effectiveness of the route, poor compliance or gastrointestinal side effects. There should be a rapid dose escalation if inadequate responses occur up to 15–20 or even 25 mg/week in about 8 weeks, with increments of 2.5–5 mg. The reduction will be carried out according to the dose the patient had, with decreases of 2.5–5 mg every 3–6 months. Patient monitoring should be performed every 1–1.5 months until stability is reached and then for every 1–3 months. Conclusions. This document pretends to solve some common clinical questions and facilitate decision-making in RA patients treated with methotrexate (AU)

Recommendations for the use of methotrexate in rheumatoid arthritis: up and down scaling of the dose and administration routes.

OBJECTIVES: To describe the optimal therapeutic strategy for use of methotrexate in RA patients over the initial dose, route of administration, dose increase and decrease, patient monitoring, and use of folic/folinic acid. MATERIAL AND METHOD: Eleven clinical experts proposed some questions to be solved. A systematic literature search was conducted. The contents were selected in a work session and subsequently validated via email to establish the level of agreement. RESULTS: The initial dose of methotrexate should not be <10mg/week, preferably orally, but considering the parenteral route as an alternative due to compliance, non effectiveness of treatment or gastrointestinal side effects, polypharmacy, obesity (if required doses are >20mg/week), patient preference, very active disease or to avoid administration errors. Changing to a parenteral administration is proposed when the oral route is not effective enough, gastrointestinal toxicity appears, there is non-compliance or due to cost-effectiveness reasons before using more expensive drugs. On the contrary, due to patient preferences, intolerance to injections, dose reduction <7.5mg/week, non effectiveness of the route, poor compliance or gastrointestinal side effects. There should be a rapid dose escalation if inadequate responses occurr up to 15-20 or even 25mg/week in about 8 weeks, with increments of 2.5-5mg. The reduction will be carried out according to the dose the patient had, with decreases of 2.5-5mg every 3-6 months. Patient monitoring should be performed every 1-1.5 months until stability and then every 1-3 months. CONCLUSIONS: This document pretends to solve some common clinical questions and facilitate decision-making in RA patients treated with methotrexate.