Gender biases in Spanish rheumatology: Perception and facts.

OBJECTIVE: To identify perceptions of gender bias in Spanish rheumatology and to quantify the involvement of both sexes in all areas of the specialty. METHODS: A survey was sent to all members of the SER on participation and perception of biases and of their own competencies, and actual data on participation in governing bodies, congresses, committees, and Spanish rheumatology departments in the last 5 years were reviewed. RESULTS: The survey was answered by 95 rheumatologists, 4.8% of SER members (14 men and 81 women), both groups being similar in terms of age, academic level, and position and work centre. No differences were detected in the distribution of work and non-work tasks between sexes, nor in invitations to positions of power in the last five years, nor in the perception of capacity to occupy the different positions of power, which was high for both sexes. Male respondents more frequently consider that activities such as participating in a scientific committee or giving a conference are not empowering. A third of both sexes consider that the SER should review its processes with a gender perspective but less than a third believe that this should be done by quotas. The reality of the last 5 years is that 1) there is a male to female ratio of 3:2 on SER boards of directors and in this period there has been no female president or treasurer; 2) in the scientific committees of the congresses men predominate (2:1) although slightly less in the local organizing committee; 3) there are more male speakers and moderators than women (very striking in satellite symposia, 4: 1); 4) 9 out of 10 editors-in-chief are men; 5) in academic positions there are 3 men for every 2 women, 9 to 1 in professorships or emeritus positions; although more women supervise residents; and 6) there are more women (60%) than men (40%) in Spanish rheumatology departments, although 75% of department chiefs are men. CONCLUSION: Although not perceived by either the men or the women, there are biases in the involvement of women in important and leadership positions in the specialty.

Effectiveness and safety of tocilizumab in monotherapy in biologic-naïve and non-naïve patients with rheumatoid arthritis in a real-world setting.

OBJECTIVE: 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. MATERIALS AND METHODS: 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. RESULTS: 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%). CONCLUSIONS: 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.

Adalimumab in Elderly Patients with Non-Infectious Uveitis. Safety and Efficacy.

Purpose: To assess the efficacy and safety of adalimumab in elderly patients with noninfectious uveitis (NIU).Methods: An observational, retrospective, multicenter study was done. Changes in best-corrected visual acuity (BCVA), inflammatory activity parameters, central retinal thickness (CRT), and the occurrence of adverse events (AE) developed during follow-up were recorded.Results: A total of 82 eyes from 41 patients 60 years of age and older with noninfectious uveitis treated with adalimumab were included. A significant improvement in BCVA (71.5 to 75.4 letters, p = .001) and in CRT (311.1 µm to 265 µm, p = .001) was observed. Moreover, a significant decrease from baseline in the rate of patients with anterior chamber cell (ACC) >0+ (34.6% to 5.7%, p = <0.001) or vitreous haze>0+ (21.3% to 4.3%, p = .002) was determined. AEs were observed in 11 patients (26.8%).Conclusion: Adalimumab can be safe and efficacious for the treatment of NIU in patients 60 years of age and older.

Impact of Comorbidity on Physical Function in Patients With Ankylosing Spondylitis and Psoriatic Arthritis Attending Rheumatology Clinics: Results From a Cross-Sectional Study.

OBJECTIVE: To evaluate the impact of comorbidities on physical function in patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA). METHODS: This was a cross-sectional analysis of the baseline visit from the Cardiovascular in Rheumatology study. Multivariate models with physical function as the dependent variable (Bath Ankylosing Spondylitis Functional Index and Health Assessment Questionnaire for AS and PsA, respectively) were performed. Independent variables were a proxy for the Charlson Comorbidity Index (CCIp; range 0-27), sociodemographic data, disease activity (erythrocyte sedimentation rate [ESR] and Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] in AS; Disease Activity Score in 28 joints [DAS28] using the ESR in PsA), disease duration, radiographic damage, and treatments. Results were reported as beta coefficients, 95% confidence intervals (95% CIs), and P values. RESULTS: We included 738 patients with AS and 721 with PsA; 21% of patients had >1 comorbidity. Comorbidity burden (CCIp) was independently associated with worse adjusted physical function in patients with PsA (ß = 0.11). Also, female sex (ß = 0.14), disease duration (ß = 0.01), disease activity (DAS28-ESR; ß = 0.19), and the use of nonsteroidal antiinflammatory drugs (ß = 0.09), glucocorticoids (ß = 0.11), and biologics (ß = 0.15) were associated with worse function in patients with PsA. A higher education level was associated with less disability (ß = -0.14). In patients with AS, age (ß = 0.03), disease activity (BASDAI; ß = 0.81), radiographic damage (ß = 0.61), and the use of biologics (ß = 0.51) were independently associated with worse function on multivariate analyses, but CCIp was not. CONCLUSION: The presence of comorbidities in patients with PsA is independently associated with worse physical function. The detection and control of the comorbidities may yield an integral management of the disease.

Launch and preliminary analysis of Hospital de La Princesa's inter-specialists biological therapies unit.

We herein describe an inter-specialists unit for the monitoring and management of biological therapies and analyze the utilization of biological agents across specialties and diseases. Protocols and therapeutic objectives, as well as outcomes and protocol deviations, are shared and discussed periodically between specialists. All patients treated at one centre with any biological treatment from January 2000 by rheumatology, gastroenterology, dermatology, or neurology, regardless diagnosis, are identified by Clinical Pharmacy and included in an ongoing database that detects use and outcome. The drugs, survival, and reasons for discontinuation differ significantly across specialties. This approach has helped us recognizing the challenges and size of the problem of sharing expensive medications across specialties, and has served as a starting point to contribute to the better use of these compounds.

Launch and preliminary analysis of Hospital de La Princesa's inter-specialists biological therapies unit / Lanzamiento y análisis preliminar de la Unidad de Terapias Biológicas interespecialistas del Hospital de La Princesa

We herein describe an inter-specialists unit for the monitoring and management of biological therapies and analyze the utilization of biological agents across specialties and diseases. Protocols and therapeutic objectives, as well as outcomes and protocol deviations, are shared and discussed periodically between specialists. All patients treated at one centre with any biological treatment from January 2000 by rheumatology, gastroenterology, dermatology, or neurology, regardless diagnosis, are identified by Clinical Pharmacy and included in an ongoing database that detects use and outcome. The drugs, survival, and reasons for discontinuation differ significantly across specialties. This approach has helped us recognizing the challenges and size of the problem of sharing expensive medications across specialties, and has served as a starting point to contribute to the better use of these compounds

A continuación describimos una unidad interservicios para el seguimiento y la gestión de las terapias biológicas, y analizamos la utilización de los agentes biológicos en las distintas especialidades y enfermedades. Los protocolos y los objetivos terapéuticos, así como los resultados y las desviaciones de los protocolos, se comparten y debaten periódicamente entre los especialistas. Todos los pacientes tratados en el centro con cualquier terapia biológica desde enero de 2000 por reumatología, gastroenterología, dermatología o neurología, independientemente del diagnóstico, son identificados por Farmacia Clínica e incluidos en una base de datos continua, que detecta el uso y los resultados. Los medicamentos, la supervivencia y las razones de interrupción del tratamiento difieren significativamente entre especialidades. Este enfoque nos ha ayudado a reconocer los retos y la magnitud del problema de compartir medicamentos costosos entre especialidades, y ha servido como punto de partida para contribuir a un mejor uso de los mismos

Influence of the structure of mood in the assessment of rheumatoid arthritis through the visual analog scale for pain, HAQ and DAS28.

OBJECTIVE: To analyze the effect of the structure of mood over the following assessment tools for rheumatoid arthritis: visual analog scale (VAS) for pain, HAQ and DAS28. PATIENTS AND METHODS: We studied 86 patients with recent onset rheumatoid arthritis, of which 75.7% were female, with a mean age at disease onset of 55 years. All patients were administered the Spanish version of the PANAS questionnaire that evaluates the components of positive (PA) and negative mood (AN). Patients belonged to the registry of new-onset arthritis in our center so clinical information was available for 282 patients visits. To determine the effect of PA and AN on each of the dependent variables we performed three multivariate linear regression models using generalized linear models through the Stata glm command 10.1. RESULTS: The mean score for PA and AN in our patients was similar to that described for the healthy Spanish population. The high scores on the subscale of AN were associated with worse scores in both the VAS for pain and the HAQ. By contrast, high scores on PA were associated with better outcomes of disease activity measured by DAS28. CONCLUSION: The structure of mood may influence the tools we use for evaluating patients with rheumatoid arthritis, so it might be advisable to include the PANAS questionnaire as part of that assessment.

Effectiveness and safety of tocilizumab in monotherapy in biologic-naïve and non-naïve patients with rheumatoid arthritis in a real-world setting / Eficacia y seguridad de tocilizumab en monoterapia en pacientes con artritis reumatoide naive y no naive a biológicos en un entorno del mundo real

Objective: 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. Materials and methods: 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. Results: 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%). Conclusions: 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.(AU)

Objetivo: Evaluar la efectividad y seguridad de la monoterapia con tocilizumab (TCZ) en pacientes con artritis reumatoide (AR) sin tratamiento biológico en comparación con pacientes con exposición previa a biológico en un entorno real.Materiales y métodos: Ensayo clínico no controlado, estudio multicéntrico prospectivo de 32 semanas que incluyó pacientes con AR con actividad de la enfermedad moderada-grave que comenzaron con TCZ en monoterapia y que tuvieron una respuesta inadecuada previa o fueron intolerantes al metotrexato. La eficacia de acuerdo con la respuesta EULAR fue evaluada a las 24 semanas y la seguridad a las 32 semanas. Resultados: De los 93 pacientes seleccionados, 84 (90%) fueron elegibles para el análisis de efectividad. Los pacientes sin tratamiento biológico previo (n=46, 54,8%) eran más jóvenes (51,5 frente a 57,9 años), con una duración más corta de la enfermedad (6,4 frente a 13,3 años), pero presentaban comorbilidades similares en comparación con los pacientes con tratamiento previo. La remisión de DAS28 se logró en un mayor porcentaje en el grupo de pacientes con tratamiento biológico previo. Se registraron 89 eventos adversos en 50 pacientes, la mayoría de ellos no graves (86,3%). Conclusiones: En un entorno del mundo real, TCZ exhibe una eficacia y seguridad similares en monoterapia en pacientes con AR, independientemente de la exposición previa a otras terapias biológicas. Este estudio proporciona hallazgos adicionales y valiosos en el contexto del mundo real sobre el uso de TCZ en pacientes con AR.(UA)

[Consensus statement of the Spanish Society of Rheumatology on the management of biologic therapies in psoriatic arthritis]. / Documento SER de consenso sobre el uso de terapias biológicas en la artritis psoriásica.

OBJECTIVE: Due to the amount and quality variability regarding the use of biologic therapy (BT) in psoriatic arthritis (PsA) patients, the Spanish Society of Rheumatology (SER) has promoted the generation of recommendations based on the best evidence available. These recommendations should serve as reference to rheumatologists and those involved in the treatment of patients with PsA, who are using, or about to use BT. METHODS: Recommendations were developed following a nominal group methodology and based on systematic reviews. The level of evidence and degree of recommendation was classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through Delphi technique. RESULTS: We have produced recommendations for the use of TB currently available for PsA in our country. These recommendations include disease assessment, treatment objectives, therapeutic scheme and switching. CONCLUSIONS: We present an update on the SER recommendations for the use of BT in patients with PsA.

[Consensus Statement of the Spanish Society of Rheumatology on the management of biologic therapies in spondyloarthritis except for psoriatic arthritis]. / Documento SER de consenso sobre el uso de terapias biológicas en la espondilitis anquilosante y otras espondiloartritis, excepto la artritis psoriásica.

OBJECTIVE: Due to the amount and variability in quality regarding the use of biologic therapy (BT) in patients with spondyloarthritis (SpA), except for psoriatic arthritis (PsA) patients, the Spanish Society of Rheumatology has promoted the generation of recommendations based on the best evidence available. These recommendations should be a reference for rheumatologists and those involved in the treatment of patients with spondyloarthritis (SpA), except for psoriatic arthritis (PsA), who are using, or about to use BT. METHODS: Recommendations were developed following a nominal group methodology and based on systematic reviews. The level of evidence and grade of recommendation were classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through Delphi technique. RESULTS: We have produced recommendations on the use of BT currently available for SpA (but not PsA) in our country. These recommendations include disease assessment, treatment objectives, therapeutic scheme and switching. CONCLUSIONS: We present an update on the SER recommendations for the use of BT in patients with SpA, except for PsA.

[Consensus statement of the Spanish Society of Rheumatology on risk management of biologic therapy in rheumatic patients]. / Consenso SER sobre la gestión de riesgo del tratamiento con terapias biológicas en pacientes con enfermedades reumáticas.

OBJECTIVE: Due to the increasing use of biologic therapy in rheumatic diseases and the importance of its risk management, the Spanish Society of Rheumatology (SER) has promoted the development of recommendations based on the best evidence available. These recommendations should be a reference to rheumatologists and those involved in the treatment of patients who are using, or about to use biologic therapy irrespectively of the rheumatic disease. 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 the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through a Delphi technique. Evidence from previous consensus and clinical guidelines was used. RESULTS: We have produced recommendations on risk management of biologic therapy in rheumatic patients. These recommendations include indication risk management, risk management before the use of biologic therapy, risk management during follow-up, attitude to adverse events, and attitude to special situations. CONCLUSIONS: We present the SER recommendations related to biologic therapy risk management.

[Recommendations for the management of influenza A (H1N1) in rheumatic patients with immunosuppression]. / Recomendaciones de manejo de la gripe A (H1N1) en pacientes reumáticos con inmunosupresión.

The Spanish Society of Rheumatology (SER), through a multidiscipline task force, has elaborated a document with specific recommendations for specialists in Rheumatology, emphasizing the special needs of patients with rheumatic diseases, with the objective of informing and orienting health professionals about the current influenza A/H1N1 virus pandemic. All of the recommendations are based on prior documents elaborated by the Ministry of Health and Social Policy task forces, as well as those from the autonomous communities, which are themselves based on the guidelines and documents routinely published by the Centers for Disease Control (CDC) in the US, this being the center designated by WHO for the coordination of efforts against the pandemic. All rheumatologists and potential users of these recommendations are encouraged to consult the original documents, as well as the general guidelines established at each health center.

Influencia de la estructura de los afectos en la evaluación de la artritis reumatoide mediante la escala visual analógica de dolor, el HAQ y el DAS28 / Influence of the structure of mood in the assessment of rheumatoid arthritis through the visual analog scale for pain, HAQ and DAS28

Objetivo: Analizar el efecto de la estructura del afecto en las siguientes herramientas de evaluación de la artritis reumatoide: escala visual analógica (EVA) de dolor, HAQ y DAS28. Pacientes y métodos: Se estudiaron 86 pacientes con artritis reumatoide de reciente comienzo, de los que el 75,7% eran mujeres, con una mediana de edad al inicio de la enfermedad de 55 años. A todos los pacientes se les aplicó la versión adaptada a población española del cuestionario PANAS que evalúa las componentes de afecto positivo (AP) y negativo (AN). Los pacientes pertenecían al registro de artritis de reciente comienzo de nuestro centro por lo que se disponía de información clínica de los enfermos en 282 visitas. Para determinar el efecto de AP y AN en cada una de nuestras variables dependientes se estimaron 3 modelos de regresión lineal multivariable mediante modelos lineales generalizados usando el comando glm del programa Stata 10.1. Resultados: El promedio de la puntuación de AP y AN en nuestros pacientes fue similar al descrito para la población española sana. Las puntuaciones elevadas en la subescala de AN se asociaron a peores puntuaciones, tanto en la EVA de dolor, como en el HAQ. Por el contrario, puntuaciones elevadas en AP se asociaron con una mejor evolución de la actividad de la enfermedad medida por el DAS28. Conclusión: La estructura del afecto puede influir en las herramientas que utilizamos para la evaluación de los pacientes con artritis reumatoide, por lo que podría ser recomendable incluir la realización del PANAS como parte de dicha evaluación (AU)

Objective: To analyze the effect of the structure of mood over the following assessment tools for rheumatoid arthritis: visual analog scale (VAS) for pain, HAQ and DAS28. Patients and methods: We studied 86 patients with recent onset rheumatoid arthritis, of which 75.7% were female, with a mean age at disease onset of 55 years. All patients were administered the Spanish version of the PANAS questionnaire that evaluates the components of positive (PA) and negative mood (AN). Patients belonged to the registry of new-onset arthritis in our center so clinical information was available for 282 patients visits. To determine the effect of PA and AN on each of the dependent variables we performed three multivariate linear regression models using generalized linear models through the Stata glm command 10.1. Results: The mean score for PA and AN in our patients was similar to that described for the healthy Spanish population. The high scores on the subscale of AN were associated with worse scores in both the VAS for pain and the HAQ. By contrast, high scores on PA were associated with better outcomes of disease activity measured by DAS28. Conclusion: The structure of mood may influence the tools we use for evaluating patients with rheumatoid arthritis, so it might be advisable to include the PANAS questionnaire as part of that assessment (AU)

Documento SER de consenso sobre el uso de terapias biológicas en la artritis psoriásica / Consensus statement of the Spanish Society of Rheumatology on the management of biologic therapies in psoriatic arthritis

Objetivo. Dada la gran cantidad de información actual sobre el uso de terapias biológicas (TB) en la artritis psoriásica (APs), y la variabilidad de la misma en cuanto a su calidad, desde la Sociedad Española de Reumatología (SER) se ha impulsado la generación de recomendaciones basadas en la mejor evidencia posible. Éstas deben de servir de referencia para reumatólogos e implicados en el tratamiento de APs que vayan a utilizar o consideren la utilización de TB. 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 las TB disponibles en la actualidad en nuestro país para el tratamiento de la APs. Estas recomendaciones incluyen la evaluación de la enfermedad, objetivos del tratamiento, esquema terapéutico y cambios en el mismo. Conclusiones. Se presentan las actualizaciones a las recomendaciones SER para el uso de TB en pacientes con APs (AU)

Objective. Due to the amount and quality variability regarding the use of biologic therapy (BT) in psoriatic arthritis (PsA) patients, the Spanish Society of Rheumatology (SER) has promoted the generation of recommendations based on the best evidence available. These recommendations should serve as reference to rheumatologists and those involved in the treatment of patients with PsA, who are using, or about to use BT. Methods. Recommendations were developed following a nominal group methodology and based on systematic reviews. The level of evidence and degree of recommendation was classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through Delphi technique. Results. We have produced recommendations for the use of TB currently available for PsA in our country. These recommendations include disease assessment, treatment objectives, therapeutic scheme and switching. Conclusions. We present an update on the SER recommendations for the use of BT in patients with PsA (AU)

Documento SER de consenso sobre el uso de terapias biológicas en la espondilitis anquilosante y otras espondiloartritis, excepto la artritis psoriásica / Consensus statement of the Spanish Society of Rheumatology on the management of biologic therapies in spondyloarthritis except for psoriatic arthritis

Objetivo. Dada la gran cantidad de información sobre las terapias biológicas (TB) en las espondiloartritis (EspA), excepto la artritis psoriásica (APs), y la variabilidad en cuanto a su calidad, desde la Sociedad Española de Reumatología (SER) se ha impulsado la generación de recomendaciones basadas en la mejor evidencia posible. Estas deben de servir de referencia para reumatólogos e implicados en el tratamiento de estos pacientes. Métodos. Las recomendaciones se emitieron siguiendo la metodología de grupos nominales. 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 las TB para el tratamiento de las EspA (excepto la APs). Incluyen la evaluación de la enfermedad, objetivos del tratamiento, esquema terapéutico y cambios en éste. Conclusiones. Se presentan las actualizaciones a las recomendaciones SER para el uso de TB en pacientes con EsA, excepto la APs(AU)

Objective. Due to the amount and variability in quality regarding the use of biologic therapy (BT) in patients with spondyloarthritis (SpA), except for psoriatic arthritis (PsA) patients, the Spanish Society of Rheumatology has promoted the generation of recommendations based on the best evidence available. These recommendations should be a reference for rheumatologists and those involved in the treatment of patients with spondyloarthritis (SpA), except for psoriatic arthritis (PsA), who are using, or about to use BT. Methods. Recommendations were developed following a nominal group methodology and based on systematic reviews. The level of evidence and grade of recommendation were classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through Delphi technique. Results. We have produced recommendations on the use of BT currently available for SpA (but not PsA) in our country. These recommendations include disease assessment, treatment objectives, therapeutic scheme and switching. Conclusions. We present an update on the SER recommendations for the use of BT in patients with SpA, except for PsA(AU)

Consenso SER sobre la gestión de riesgo del tratamiento con terapias biológicas en pacientes con enfermedades reumáticas / Consensus statement of the spanish society of rheumatology on risk management of biologic therapy in rheumatic patients

Objetivo: Dado el creciente uso de las terapias biológicas en distintas enfermedades reumatológicas, y la importancia de la gestión de riesgo de las mismas, desde la Sociedad Española de Reumatología (SER) se ha impulsado el desarrollo de recomendaciones basadas en la mejor evidencia posible. Estas deben de servir de referencia para reumatólogos e implicados en el tratamiento de pacientes en tratamiento o en los que se quiere indicar la terapia biológica independientemente de su enfermedad de base. Métodos: Las recomendaciones se emitieron siguiendo la metodología de grupos nominales. 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. Se utilizó toda la información de consensos y guías de práctica clínica previas. Resultados: Se realizan recomendaciones sobre la gestión del riesgo del uso de las terapias biológicas en pacientes con enfermedades reumática. Incluyen la gestión del riesgo de la indicación, gestión del riesgo antes de iniciar el tratamiento, gestión del riesgo durante el seguimiento, actitud ante acontecimientos adversos, y actitud en situaciones especiales. Conclusiones: Se presentan las recomendaciones SER sobre la gestión del riesgo del tratamiento con terapias biológicas (AU)

Objective: Due to the increasing use of biologic therapy in rheumatic diseases and the importance of its risk management, the Spanish Society of Rheumatology (SER) has promoted the development of recommendations based on the best evidence available. These recommendations should be a reference to rheumatologists and those involved in the treatment of patients who are using, or about to use biologic therapy irrespectively of the rheumatic disease. 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 the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through a Delphi technique. Evidence from previous consensus and clinical guidelines was used. Results: We have produced recommendations on risk management of biologic therapy in rheumatic patients. These recommendations include indication risk management, risk management before the use of biologic therapy, risk management during follow-up, attitude to adverse events, and attitude to special situations. Conclusions: We present the SER recommendations related to biologic therapy risk management (AU)

Recomendaciones de manejo de la gripe A (H1N1) en pacientes reumáticos con inmunosupresión / Recommendations for the management of influenza A (H1N1) in rheumatic patients with immunosuppression

La Sociedad Española de Reumatología (SER), a través de una comisión multidisciplinar, ha elaborado un documento con recomendaciones específicas para los profesionales de Reumatología, atendiendo a las características propias de estos pacientes, con el objetivo de informar y orientar a los profesionales ante la situación actual de pandemia por gripe A/H1N1. Todas las recomendaciones están basadas en documentos previos elaborados por grupos de trabajo del Ministerio de Sanidad y Política Social y de comunidades autónomas, los cuales a su vez se basan en las guías y documentos que elaboran periódicamente el Center for Disease Control (CDC) de EEUU, como centro designado por la Organización Mundial de la Salud para la coordinación de la pandemia. Se insta a todos los reumatólogos y potenciales usuarios de estas recomendaciones a que consulten los documentos originales, así como las directrices generales que se establezcan en cada centro sanitario(AU)

The Spanish Society of Rheumatology (SER), through a multidiscipline task force, has elaborated a document with specific recommendations for specialists in Rheumatology, emphasizing the special needs of patients with rheumatic diseases, with the objective of informing and orienting health professionals about the current influenza A/H1N1 virus pandemic. All of the recommendations are based on prior documents elaborated by the Ministry of Health and Social Policy task forces, as well as those from the autonomous communities, which are themselves based on the guidelines and documents routinely published by the Centers for Disease Control (CDC) in the US, this being the center designated by WHO for the coordination of efforts against the pandemic. All rheumatologists and potential users of these recommendations are encouraged to consult the original documents, as well as the general guidelines established at each health center(AU)