Janus kinase inhibitors and tumour necrosis factor inhibitors show a favourable safety profile and similar persistence in rheumatoid arthritis, psoriatic arthritis and spondyloarthritis: real-world data from the BIOBADASER registry.

OBJECTIVES: To compare the safety of Janus kinase inhibitors (JAKi) with that of tumour necrosis factor inhibitors (TNFi) and determine drug persistence among patients with rheumatoid arthritis (RA) and spondyloarthritis (SpA). METHODS: We analysed data from patients included in BIOBADASER 3.0 and treated with JAKi or TNFi from 2015 to 2023 and estimated the incidence rate ratio (IRR) of adverse events and persistence. RESULTS: A total of 6826 patients were included. Of these, 52% had RA, 25% psoriatic arthritis and 23% axial SpA. Treatment was with TNFi in 86%. The mean duration of treatment was 2.2±2.0 years with TNFi versus 1.8±1.5 with JAKi. JAKis were prescribed in older patients with longer term disease, greater comorbidity and later treatment lines and more frequently as monotherapy. The IRR of all infections and gastrointestinal events was higher among patients with RA treated with JAKi. Drug persistence at 1, 2 and 3 years was 69%, 55% and 45% for TNFi and 68%, 54% and 45% for JAKi. Multivariate regression models showed a lower probability of discontinuation for JAKi (HR=0.85; 95% CI 0.78-0.92) and concomitant conventional synthetic disease-modifying antirheumatic drugs (HR=0.90; 95% CI 0.84-0.96). The risk of discontinuation increased with glucocorticoids, comorbidities, greater disease activity and later treatment lines. CONCLUSIONS: Infections, herpes zoster and gastrointestinal adverse events in patients with RA tended to be more frequent with JAKi. However, prognosis was poor in patients receiving JAKi. Persistence was similar for TNFi and JAKi, although factors associated with discontinuation differed by diagnostic group.

Patient-Reported Outcomes (PROs) and PRO Remission Rates in 12,262 Biologic-Naïve Patients With Psoriatic Arthritis Treated With Tumor Necrosis Factor Inhibitors in Routine Care.

OBJECTIVE: To evaluate patient-reported outcomes (PROs) after initiation of tumor necrosis factor inhibitor (TNFi) treatment in European real-world patients with psoriatic arthritis (PsA). Further, to investigate PRO remission rates across treatment courses, registries, disease duration, sex, and age at disease onset. METHODS: Visual analog scale or numerical rating scale scores for pain, fatigue, patient global assessment (PtGA), and the Health Assessment Questionnaire-Disability Index (HAQ-DI) from 12,262 patients with PsA initiating a TNFi in 13 registries were pooled. PRO remission rates (pain ≤ 1, fatigue ≤ 2, PtGA ≤ 2, and HAQ-DI ≤ 0.5) were calculated for patients still on the treatment. RESULTS: For the first TNFi, median pain score was reduced by approximately 50%, from 6 to 3, 3, and 2; as were fatigue scores, from 6 to 4, 4, and 3; PtGA scores, from 6 to 3, 3, and 2; and HAQ-DI scores, from 0.9 to 0.5, 0.5, and 0.4 at baseline, 6, 12, and 24 months, respectively. Six-month Lund Efficacy Index (LUNDEX)-adjusted remission rates for pain, fatigue, PtGA, and HAQ-DI scores were 24%, 31%, 36%, and 43% (first TNFi); 14%, 19%, 23%, and 29% (second TNFi); and 9%, 14%, 17%, and 20% (third TNFi), respectively. For biologic-naïve patients with disease duration < 5 years, 6-month LUNDEX-adjusted remission rates for pain, fatigue, PtGA, and HAQ-DI scores were 22%, 28%, 33%, and 42%, respectively. Corresponding rates for patients with disease duration > 10 years were 27%, 32%, 41%, and 43%, respectively. Remission rates were 33%, 40%, 45%, and 56% for men and 17%, 23%, 24%, and 32% for women, respectively. For patients aged < 45 years at diagnosis, 6-month LUNDEX-adjusted remission rate for pain was 29% vs 18% for patients ≥ 45 years. CONCLUSION: In 12,262 biologic-naïve patients with PsA, 6 months of treatment with a TNFi reduced pain by approximately 50%. Marked differences in PRO remission rates across treatment courses, registries, disease duration, sex, and age at onset of disease were observed, emphasizing the potential influence of factors other than disease activity on PROs.

Associated factors to non-medical and medical use of psychoactive medication among Mexican adolescents and adults in a national household survey.

BACKGROUND: Non-medical use of psychoactive medication is a public health problem. Studies in other contexts indicate that individual sociodemographic characteristics are associated with non-medical use, but these associations have not been assessed in the Mexican context. OBJECTIVES: To estimate the prevalence non-medical and medical use of psychoactive medication among Mexican adolescents and adults' medication users and to estimate the associations between sociodemographic characteristics and non-medical use of psychoactive medication, using data from a nationally representative sample. METHODS: Secondary analysis of data collected from the National Survey of Drug, Alcohol, and Tobacco Consumption (ENCODAT) 2016 to 2017. The analytical sample included people aged 12 to 65 years. The sample was stratified into two age categories: adolescents (12-17 years) and adults (18-65 years). Sub-analyses were performed to describe prevalence of use and non-medical use of psychoactive medication at the state-level. Descriptive statistics and multinomial logistic regression models were used to estimate associations between sociodemographic characteristics and medical, non-medical, and non-use of psychoactive medication in adolescents and adults. RESULTS: Among Mexican medication users in 2016, the national prevalence of non-medical use of psychoactive drugs was 19.6%; 22.2% among adolescents and 19.4% among adults. States adjacent to the US-Mexico border reported the highest levels of non-medical use of psychoactive medication. Illicit drug consumption was associated with non-medical use. Sociodemographic characteristics associated with non-medical use varied between adolescents and adults. CONCLUSIONS: There is a high proportion of non-medical use of psychoactive drugs among Mexican medication users, especially among young people. Understanding factors associated with the misuse of psychoactive medications in Mexico can inform policy for prevention and treatment.

Cyclosporine A in hospitalized COVID-19 pneumonia patients to prevent the development of interstitial lung disease: a pilot randomized clinical trial.

Post-COVID-19 interstitial lung disease (ILD) is a new entity that frequently causes pulmonary fibrosis and can become chronic. We performed a single-center parallel-group open-label pilot randomized clinical trial to investigate the efficacy and safety of cyclosporine A (CsA) in the development of ILD in the medium term among patients hospitalized with COVID-19 pneumonia. Patients were randomized 1:1 to receive CsA plus standard of care or standard of care alone. The primary composite outcome was the percentage of patients without ILD 3 months after diagnosis of pneumonia and not requiring invasive mechanical ventilation (IMV) (response without requiring IMV). The key secondary composite outcomes were the percentage of patients who achieve a response requiring IMV or irrespective of the need for IMV, and adverse events. A total of 33 patients received at least one dose of CsA plus standard of care (n = 17) or standard of care alone (n = 16). No differences were found between the groups in the percentage of patients who achieved a response without requiring IMV or a response requiring IMV. A higher percentage of patients achieved a response irrespective of the need for IMV in the CsA plus standard of care group although the RR was almost significant 2.833 (95% CI, 0.908-8.840; p = 0.057). No differences were found between the groups for adverse events. In hospitalized patients with COVID-19 pneumonia, we were unable to demonstrate that CsA achieved a significant effect in preventing the development of ILD. (EU Clinical Trials Register; EudraCT Number: 2020-002123-11; registration date: 08/05/2020).

Drug effectiveness of 2nd and 3rd TNF inhibitors in psoriatic arthritis - relationship with the reason for withdrawal from the previous treatment.

OBJECTIVE: To investigate real-world retention and remission rates in PsA patients initiating a 2nd or 3rd TNFi and the association with reason for discontinuation from the previous TNFi-treatment. METHODS: Prospectively collected routine care data from 12 European registries were pooled. Retention rates (Kaplan-Meier estimation) and crude/LUNDEX-adjusted rates of Disease Activity Score 28 and Disease Activity index for PSoriatic Arthritis (DAS28 and DAPSA28) remission were calculated and compared with adjusted Cox regression analyses and Chi-squared test, respectively). RESULTS: We included 5233 (2nd TNFi) and 1906 (3rd TNFi) patients. Twelve-month retention rates for the 2nd and 3rd TNFi were 68% (95%CI: 67-70%) and 66% (64-68%), respectively. Patients who stopped the previous TNFi due to AE/LOE had 12-month retention rates of 66%/65% (2nd TNFi), and 65%/63% (3rd TNFi), respectively. Patients who stopped the previous TNFi due to LOE after less vs more than 24 weeks had 12-month retention rates of 54%/69% (2nd TNFi), and 58%/65% (3rd TNFi). Six-month crude/LUNDEX-adjusted DAS28 remission rates were 48%/35% and 38%/27%, and DAPSA28 remission rates were 19%/14% and 14%/10%, for the 2nd and 3rd TNFi. CONCLUSION: Two-thirds of patients remained on TNFi at 12months for both the 2nd and 3rd TNFi, while one-third and one-quarter of patients were in DAS28 remission after 6months on the 2nd and 3rd TNFi. While drug effectiveness was similar in patients who stopped the previous TNFi due to AE compared to overall LOE, drug effectiveness was better in patients who had stopped the previous TNF due to secondary LOE compared to primary LOE.

Effect of prevalence of alcohol consumption and tobacco use in Mexican municipalities on early childhood development / Efecto de la prevalencia del consumo de alcohol y tabaco en municipios mexicanos sobre el desarrollo durante la primera infancia / Efeito da prevalência do consumo de álcool e tabaco em municípios mexicanos sobre o desenvolvimento durante a primeira infância

Abstract: One of the most critical time periods in childhood is from birth to five years of age. Children exposed to alcohol and/or tobacco via family members and neighborhood are at risk for childhood developmental delays. This study evaluated the association of early childhood development with the prevalence of alcohol consumption and tobacco use in Mexican municipalities. This is a cross-sectional study. Early childhood development information from 2,345 children aged from 36 to 59 months was obtained from the 2015 Mexican National Survey of Boys, Girls, and Women (ENIM). Data on alcohol consumption and tobacco use come from the 2016 Mexican National Survey on Drugs, Alcohol, and Tobacco Consumption (ENCODAT). Multilevel logistic models were fitted to evaluate the association of the prevalence of alcohol consumption and tobacco use with the inadequacy of early childhood development. Children living in municipalities with high prevalence of alcohol consumption (OR = 13.410; 95%CI: 2.986; 60.240) and tobacco use (OR = 15.080; 95%CI: 2.040; 111.400) were less likely to be developmentally on track regarding early childhood development after adjustment for individual variables related to the child's development and other environmental variables at municipal level. Childhood exposure to alcohol and tobacco in the neighborhood may directly contribute to inadequate early childhood development. These findings suggest that there is an urgent need to develop effective interventions aimed at reducing alcohol consumption and tobacco use in municipalities to ensure adequate early childhood development.

Resumen: El grupo de edad que se extiende desde el nacimiento hasta los 5 años es uno de los periodos más críticos en la infancia. Niños expuestos al alcohol y/o al tabaco a través de la familia y vecinos corren el riesgo de sufrir un retraso en el desarrollo infantil. Este estudio evaluó la asociación del desarrollo durante la primera infancia con la prevalencia del consumo de alcohol y tabaco en municipios mexicanos. Se trata de un estudio transversal. Las informaciones sobre el desarrollo durante la primera infancia de 2.345 niños de 36 a 59 meses se obtuvieron a través de la Encuesta Nacional de los Niños, Niñas y Mujeres en México (ENIM) de 2015. Los datos sobre el consumo de alcohol y tabaco son de la Encuesta Nacional de Consumo de Drogas, Alcohol y Tabaco en México (ENCODAT) de 2016. Se ajustaron los modelos logísticos multiniveles para evaluar la asociación de la prevalencia de consumo de alcohol y tabaquismo con desarrollo durante la primera infancia inadecuado. Los niños que viven en municipios que tienen una alta prevalencia de consumo de alcohol (OR = 13,410; IC95%: 2,986; 60,240) y tabaquismo (OR = 15,080; IC95%: 2,040; 111,400) se asociaron con la probabilidad más alta de tener un desarrollo durante la primera infancia inadecuado tras el ajuste de las variables individuales relacionadas al desarrollo del niño y a otras variables ambientales en nivel municipal. La exposición infantil al alcohol y al tabaco en la vecindad puede contribuir directamente a un desarrollo durante la primera infancia inadecuado. Estos hallazgos indican una necesidad urgente de desarrollar intervenciones eficaces destinadas a reducir el consumo de alcohol y tabaquismo en los municipios para asegurar un desarrollo durante la primera infancia adecuado.

Resumo: A faixa etária que se estende do nascimento aos 5 anos de idade é um dos períodos mais críticos na infância. Crianças expostas ao álcool e/ou tabaco por meio de familiares e vizinhos estão em risco de atraso no desenvolvimento infantil. Este estudo avaliou a associação do desenvolvimento durante a primeira infância com a prevalência do consumo de álcool e tabaco em municípios mexicanos. Trata-se de um estudo transversal. As informações sobre o desenvolvimento durante a primeira infância de 2.345 crianças de 36 a 59 meses foram obtidas pela Pesquisa Nacional Sobre Crianças e Mulheres no México (ENIM) de 2015. Os dados sobre consumo de álcool e tabaco são da Pesquisa Nacional sobre Consumo de Drogas, Álcool e Tabaco no México (ENCODAT) de 2016. Modelos logísticos multiníveis foram ajustados para avaliar a associação da prevalência de consumo de álcool e tabagismo com desenvolvimento durante a primeira infância inadequado. Crianças que vivem em municípios com alta prevalência de consumo de álcool (OR = 13,410; IC95%: 2,986; 60,240) e tabagismo (OR = 15,080; IC95%: 2,040; 111,400) foram associadas à maior probabilidade de ter um desenvolvimento durante a primeira infância inadequado após ajuste às variáveis individuais relacionadas ao desenvolvimento da criança e a outras variáveis ambientais em nível municipal. A exposição infantil ao álcool e tabaco na vizinhança pode contribuir diretamente para o desenvolvimento durante a primeira infância inadequado. Estas descobertas demonstram uma necessidade urgente de desenvolver intervenções eficazes destinadas a reduzir o consumo de álcool e tabagismo nos municípios para garantir um desenvolvimento durante a primeira infância adequado.

Myo-Spain: Registro de pacientes con miopatía inflamatoria idiopática de España. Metodología / Myo-Spain: Spanish Registry of Patients with Idiopathic Inflammatory Myopathy. Methodology

Objetivos: Describir la metodología del Registro de pacientes con miopatía inflamatoria idiopática (MII) de España (Myo-Spain), así como sus fortalezas y limitaciones. El objetivo principal del proyecto es analizar la evolución y el manejo clínico de una cohorte de pacientes con MII. Material y método: Estudio observacional, longitudinal, ambispectivo y multicéntrico de una cohorte de pacientes con MII atendidos en servicios de reumatología de España. Se incluirán todos los pacientes con diagnóstico de MII en seguimiento habitual por los centros participantes, sin tener en cuenta la edad de inicio del proceso. Los casos incidentes serán todos los pacientes que al inicio del estudio en cada centrosu estén diagnosticados desde hace menos de 12 meses y casos prevalentes desde hace más de 12 meses. Se construirá un registro en el que se incluirán los datos de la visita basal, del año y dos años. Se recogerán variables sociodemográficas, clínicas, analíticas, complicaciones, comorbilidad, asociación con otras enfermedades reumáticas, ingresos hospitalarios, mortalidad y tratamientos. Además, se determinarán índices, escalas y cuestionarios de actividad, afectación muscular, daño, discapacidad y calidad de vida. El periodo de reclutamiento será de 23 meses. El propósito es conseguir una cohorte de 400 pacientes con MII. Conclusion: esEl estudio Myo-Spain constituye la oportunidad para desarrollar una cohorte de pacientes incidentes y prevalentes con MII en España. Myo-Spain permitirá evaluar en detalle, las características clínicas de la enfermedad en diferentes momentos. Se espera que la información exhaustiva recogida en las visitas suponga una amplia fuente de datos para futuros análisis.(AU)

Objectives: To describe the methods of the Spanish Registry of patients with idiopathic inflammatory myopathy (IIM) (Myo-Spain), as well as its strengths and limitations. The main objective of the project is to analyse the evolution and clinical management of a cohort of patients with IIM. Methods: Observational, longitudinal, ambispective and multicentre study of a cohort of patients with IIM seen in rheumatology units in Spain. All patients with a diagnosis of IMM will be included in the regular follow-up of the participating centres, regardless of age on initiation of the process. Incident cases will be all patients who at the beginning of the study have been diagnosed for less than 12 months and prevalent cases for more than 12 months. The registry will include data from the visit at baseline, one year and two years. Socio-demographic, clinical, analytical variables, complications, comorbidities, association with other rheumatic diseases, hospital admissions, mortality and treatments will be collected. In addition, indices, scales and questionnaires of activity, muscle involvement, damage, disability, and quality of life will be determined. The recruitment period will be 23 months. The purpose is to obtain a cohort of 400 patients with IMM. Conclusions: Myo-Spain registry provides the opportunity to develop a cohort of incident and prevalent patients with IMM in Spain. Myo-Spain will be able to assess in detail the clinical characteristics of the disease at different times. The comprehensive information collected during the visits is expected to provide a broad source of data for future analysis.(AU)

Frecuencia de consulta médica por problemas osteoarticulares en población general adulta en España. Estudio EPISER2016 / Frequency of medical visits due to osteoarticular problems of the adult general population in Spain. EPISER2016 Study

OBJETIVO: Estimar la prevalencia de consultas médicas por problemas osteoarticulares en población general adulta en España y su asociación con variables sociodemográficas, antropométricas y de hábitos de vida. MÉTODO: Estudio transversal de base poblacional. Muestra de 4916 sujetos de 20 o más años de edad. Se realizó un cuestionario telefónico que incluía una pregunta sobre consulta médica por problemas osteoarticulares. Para la estimación de la prevalencia y su intervalo de confianza del 95% (IC95%) se calcularon los pesos en función de la probabilidad de selección en cada una de las etapas del muestreo. RESULTADOS: El 28,9% (IC95%: 27,6-30,2) de las personas encuestadas refirieron haber consultado a algún médico por problemas osteoarticulares en el último año. Se ha observado una asociación con la edad, el sexo, el nivel de estudios y el índice de masa corporal

OBJECTIVE: To estimate the prevalence of medical visits due to osteoarticular problems by the adult general population in Spain and its association with sociodemographic, anthropometric and lifestyle variables. METHOD: Cross-sectional population-based study. Sample with 4916 subjects aged 20 years and over. A telephone questionnaire, with a question about medical visits due to osteoarticular problems, was used. To estimate the prevalence and its 95% confidence interval (95%CI), weights were calculated according to the probability of selection in each of the sampling stages. RESULTS: 28.9% (95%CI: 27.6-30.2) of the people reported having consulted a doctor in the last year because of osteoarticular problems. We observed an association with age, sex, level of education, and body mass index

Características clínicas, serológicas e imagenológicas de los pacientes con úlcera del pie diabético complicada con osteomielitis / Clinical, serological and imaging features of patients with diabetic foot ulcer complicated with osteomyelitis

Objetivo: Determinar las características clínicas, serológicas e imagenológicas presentes en los pacientes con úlcera del pie diabético complicada con osteomielitis. Métodos: Estudio observacional prospectivo, en 280 pacientes ingresado en el servicio de Angiología del Hospital Provincial Universitario Comandante Faustino Pérez Hernández de Matanzas por presentar úlceras del pie diabético, con sospecha de infección y de osteomielitis de las úlceras. La osteomielitis se diagnosticó mediante histología del hueso. El período de estudio osciló entre enero de 2013 y diciembre de 2017, ambos incluidos. Resultados: Se encontraron los siguientes elementos clínicos en los pacientes diagnosticados con osteomielitis: proceder de una zona rural, edad mayor de 59 años, tiempo de evolución de la diabetes mayor a los 14 años, glucemia al ingreso mayor de 10 mmol/L, área de la lesión mayor de 5,4 cm2, infección severa según la Infectious disease Society of America, test de contacto óseo con sonda acanalada (positivo), velocidad de sedimentación globular mayor de 90 mm y rayos X positivo del pie. Conclusiones: Existen características clínicas, serológicas e imagenológicas predominantes en los pacientes con úlceras del pie diabético y diagnóstico histopatológico de osteomielitis(AU)

Objective: To determine clinical, serologic and imageonology characteristics that are present in osteomyelitis of these ulcers which are diagnosed by means of histopathological studies and bones histology. Methods: Prospective, observational study in a cohort of 280 patients with diabetic foot ulcer, with suspicious of infection and osteomyelitis of the ulcers that were attended in the Provincial Service of Angiology of Matanzas. Osteomyelitis was diagnosed by bone histology. The study period oscillated between January 2013 to December 2017, both included. Results: The following clinical elements were predominat: rural zone procedence, older than 59 years, time of evolution of the diabetes mellitus bigger than 14 years, fast plasmatic glucose of more than 10 mmol/l , wound area bigger than 5.4 cm2, severe infection according to criteria of the Infectious Disease Society of America (IDISA), probing to bone test (positive), VSG > 90 mms; and positive result in the foot´s X Ray. Conclusions: There are clinical, serological and imagenology characteristics that are predominant in the patients with diabetic foot ulcers and histopathological diagnosis of osteomyelitis(AU)

Evaluation of the effect of hospitalization on mortality in patients with heart failure followed in primary care / Evaluación del efecto de las hospitalizaciones sobre mortalidad en pacientes con Insuficiencia cardíaca seguidos en atención primaria

Abstract Background: Heart failure (HF) is a serious health-care problem. The aim of this study is to evaluate the effect of the first acute episode of decompensated HF that requires a hospitalization on the survival of newly diagnosed cases of HF with follow-up for 5 years in primary care (PC). Methods: This was a longitudinal observational study of a retrospective cohort of patients with information extracted from electronic medical records of PC. Incident cases of HF from 2006 to 2010 or until death were studied through a survival analysis with Kaplan–Meier and Cox proportional hazards multivariate regression, after applying the propensity score matching technique (PSM). Results: A total of 3061 new cases of HF were identified. The PSM analysis was performed with 529 couples, with a total of 1058 patients. 5-year survival was 65% in no hospitalized and 53% in hospitalized patients. Factors with an increased risk of mortality were having prescribed nitrates (heart rate [HR] = 1.56; 1.08-2.24). Factors with protective effect were having received the annual influenza vaccine (HR = 0.04; 0.01-0.15) and having been indicated X-rays by PC physician (HR = 0.76; 0.67-0.88). Conclusions: The findings indicate that hospitalizations are associated with a significant increase in mortality in patients recently diagnosed with HF. It is important to reinforce the need for the prevention of acute decompensated HF and for strategies to improve post-discharge outcomes.

Resumen Antecedentes: La insuficiencia cardiaca (IC) es un serio problema de asistencia médica. El objetivo de este estudio es evaluar el efecto del primer episodio de IC aguda descompensada que requiere una hospitalización en la supervivencia de los casos de IC recientemente diagnosticados con un seguimiento de 5 años en Atención Primaria (AP). Métodos: Estudio observacional longitudinal de una cohorte retrospectiva de pacientes con información extraída de la historia clínica electrónica de AP. Se estudiaron los casos incidentes de IC desde 2006 a 2010 o hasta su fallecimiento con un análisis de supervivencia de Kaplan-Meier y un modelo de regresión de Cox, después de aplicar la técnica del Propensity Score Matching (PSM). Resultados: Se identificaron 3.061 casos nuevos de IC. El análisis PSM se realizó con 529 pareja, con un total de 1.058 pacientes. La supervivencia a los cinco años fue del 65% en pacientes no hospitalizados y del 53% en pacientes hospitalizados. Los factores con mayor riesgo de mortalidad fueron tener prescritos nitratos (HR = 1,56; 1,08-2,24). Los factores con efecto protector fueron haber recibido la vacuna anual de la gripe (HR = 0,04; 0,01-0,15) y haber sido indicadas radiografías por el médico de AP (HR = 0,76; 0,67-0,88). Conclusiones: Los hallazgos indican que las hospitalizaciones se asocian con un aumento significativo de la mortalidad en pacientes diagnosticados recientemente con IC. Es importante reforzar la necesidad de prevenir la IC descompensada aguda y las estrategias para mejorar los resultados posteriores al alta.

Objetivos y metodología de la fase III de BIOBADASER / Objectives and methodology of BIOBADASER phase III

Objetivo: Describir los objetivos, la metodología y los resultados del primer año de la nueva versión del registro español de acontecimientos adversos de terapias biológicas y fármacos sintéticos con diana identificable en enfermedades reumáticas (BIOBADASER III). Metodología: Registro prospectivo multicéntrico de pacientes con enfermedades inflamatorias reumáticas en tratamiento con terapia biológica o fármacos sintéticos con diana identificable y atendidos en servicios de Reumatología en España. El objetivo principal de BIOBADASER Fase III es la recogida y análisis de acontecimientos adversos al que se ha añadido como objetivo secundario la evaluación de la efectividad mediante la recogida de índices de actividad. Los pacientes que entran en el registro son evaluados al menos una vez cada año y cada vez que presenten un acontecimiento adverso o se produzcan modificaciones en el tratamiento. La recogida de datos de la fase iii se inició el 17 de diciembre del 2015. Resultados: Durante el primer año han participado 35 centros. El número de pacientes incluidos en esta nueva fase en diciembre del 2016 era de 2.664. La edad media era de 53,7 años, con una mediana de duración de la enfermedad hasta el inicio de tratamiento de 8,1 años. Un 40,4% de los pacientes estaban diagnosticados de artritis reumatoide. Los acontecimientos adversos más frecuentes eran las infecciones e infestaciones. Conclusiones: La fase iii de BIOBADASER se ha puesto en marcha para responder a un entorno farmacológico cambiante con la aparición de los biosimilares y las pequeñas moléculas en el tratamiento de la patología reumática. Esta nueva etapa se adapta a los cambios normativos en la comunicación de acontecimientos adversos y amplía la información recogida incluyendo los índices de actividad

Objective: Describe the objectives, methods and results of the first year of the new version of the Spanish registry of adverse events involving biological therapies and synthetic drugs with an identifiable target in rheumatic diseases (BIOBADASER III). Methodology: Multicenter prospective registry of patients with rheumatic inflammatory diseases being treated with biological drugs or synthetic drugs with an identifiable target in rheumatology departments in Spain. The main objective of BIOBADASER Phase III is the registry and analysis of adverse events; moreover, a secondary objective was added consisting of assessing the effectiveness by means of the registry of activity indexes. Patients in the registry are evaluated at least once every year and whenever they experience an adverse event or a change in treatment. The collection of data for phase iii began on 17 December 2015. Results: During the first year, 35 centers participated. The number of patients included in this new phase in December 2016 was 2,664. The mean age was 53.7 years and the median duration of treatment was 8.1 years. In all, 40.4% of the patients were diagnosed with rheumatoid arthritis. The most frequent adverse events were infections and infestations. Conclusions: BIOBADASER Phase III has been launched to adapt to a changing pharmacological environment, with the introduction of biosimilars and small molecules in the treatment of rheumatic diseases. This new stage is adapted to the changes in the reporting of adverse events and now includes information related to activity scores

Prevalencia de enfermedades reumáticas en población adulta en España (estudio EPISER 2016). Objetivos y metodología / Prevalence of rheumatic diseases in adult population in Spain (EPISER 2016 study): Aims and methodology

Objetivos: Describir la metodología del estudio de prevalencia de las enfermedades reumáticas en la población adulta en España, EPISER 2016, así como sus fortalezas y limitaciones. El objetivo del proyecto es estimar la prevalencia de artritis reumatoide (AR), artropatía psoriásica (APs), espondilitis anquilosante (EA), lupus eritematoso sistémico (LES), síndrome de Sjögren (SS), artrosis (de rodilla, cadera, manos, columna cervical y lumbar), fibromialgia, gota y fractura osteoporótica clínica. Material y método: Estudio transversal multicéntrico de base poblacional en el que participan 45 municipios de las 17 comunidades autónomas. La población de referencia está compuesta por adultos de 20 o más años residentes en España. La recogida de información se llevará a cabo mediante encuesta telefónica empleando el sistema Computer Assisted Telephone Interview (CATI). Las sospechas diagnósticas y los diagnósticos autorreferidos serán estudiadas por reumatólogos del hospital de referencia de los municipios seleccionados. Análisis estadístico: se calcularán las prevalencias de enfermedades reumáticas mediante estimadores y sus IC del 95%. Se calcularán factores de ponderación en función de la probabilidad de selección en cada una de las etapas del muestreo. Se tendrá en cuenta la distribución de la población en España según datos del Instituto Nacional de Estadística. Conclusiones: Los cambios sociodemográficos y en hábitos de vida durante los últimos 16 años justifican la realización de EPISER 2016. El estudio ofrecerá datos actualizados de prevalencia en AR, EA, APs, LES, SS, artrosis, fibromialgia, gota y fractura osteoporótica clínica. Los resultados permitirán comparar los datos con estudios de otros países y con el EPISER 2000

Aims: To describe the methodology of the EPISER 2016 (study of the prevalence of rheumatic diseases in adult population in Spain), as well its strengths and limitations. The aim of this study is to estimate the prevalence of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), Sjögren's syndrome (SS), osteoarthritis (knee, hip, hands, and cervical and lumbar spine), fibromyalgia, gout and clinical osteoporotic fracture. Material and method: Population-based, multicenter, cross-sectional study, with the participation of 45 municipalities in the 17 Spanish autonomous communities. The reference population will consist of adults aged 20 years and over residing in Spain. A computer-assisted telephone interview (CATI) system will be used for data collection. Diagnostic suspicions and diagnoses received by the participants will be studied by rheumatologists in the referral hospitals in the selected municipalities. Statistical analysis: the prevalence of the rheumatic diseases will be calculated using estimators and their 95% confidence intervals. Weights will be calculated in each of the sampling stages in accordance with the probability of selection. The distribution of the population in Spain will be obtained from the Spanish Statistics Institute. Conclusions: Sociodemographic and lifestyle changes over the last 16 years justify EPISER 2016. This study will provide current data about the prevalences of RA, AS, PsA, SLE, SS, osteoarthritis, fibromyalgia, gout and clinical osteoporotic fracture. The results will allow comparisons with studies from other countries and EPISER 2000

Respuesta a la estimulación multisitio del ventrículo izquierdo en un paciente con terapia de resincronización y fibrilación auricular permanente / Multi-site stimulation of the left ventricle in a patient with dilated cardiomyopathy and permanent atrial fibrillation on resynchronization therapy

Resumen: Se presenta el caso de un hombre de 79 años con miocardiopatía dilatada severa, disfunción ventricular izquierda, fibrilación auricular permanente y portador de un resincronizador ventricular. Al efectuar un recambio del resincronizador se implantó un electrodo adicional para estimulación multisitio del ventrículo izquierdo. Ello condujo a significativa mejoría clínica y de la fracción de eyección del ventrículo izquierdo.

Abstract: A 79-year-old man with dilated cardiomyopathy and atrial fibrillation undergoing resynchronization therapy had and additional electrode implanted in the left ventricle. Multi-site stimulation led to an improved functional class and left ventricular ejection fraction.

Effectiveness of natriuretic peptide-guided treatmen of chronic heart failure. A meta-analysis / Efectividad del tratamiento guiado por el péptido natriurético para la insuficiencia cardiaca crónica. Meta-análisis

Abstract Objective: To evaluate the efficacy of natriuretic peptide (NP)-guided therapy compared to clinically-guided therapy in reducing mortality and hospital admissions in chronic heart failure (HF) patients. Methods: Randomised clinical trials (RCT) were selected through a systematic review. Four meta-analyses were conducted for the outcomes of overall mortality, HF-related mortality, overall hospital admissions, and HF-related hospital admissions. Heterogeneity between studies and publication bias were also assessed. Results: Nine RCTs were found with a total of 1914 patients. NP-guided therapy significantly reduced overall mortality and HF-related hospital admissions. No significant results were found for HF-related mortality and overall hospital admissions. Some clinical heterogeneity regarding interventions performed was found between studies. Publication bias was found for HF-related and overall hospital admissions. Conclusions: NP-guided therapy seems to improve outcomes compared to clinically-guided therapy. However, heterogeneity found between interventions might reduce the generalisation of these results. Specific interventions of the clinical trials should be examined when making recommendations regarding NP-guided therapy. © 2017 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/).

Resumen Objetivo: Evaluar la eficacia de la terapia guiada por el péptido natriurético (PN) en comparación con la terapia guiada clínicamente para reducir la mortalidad y la hospitalización de la insuficiencia cardiaca (IC) crónica. Métodos: Los ensayos clínicos aleatorizados fueron seleccionados a través de una revisión sistemática. Cuatro metaanálisis se realizaron para los resultados de mortalidad general, mortalidad por IC, hospitalización general y la hospitalización por IC. Se evaluó la heterogeneidad entre los estudios y el sesgo de publicación. Resultados: Nueve ensayos clínicos aleatorizados se encontraron con un total de 1,914 pacientes. La terapia guiada con el PN reduce significativamente la mortalidad general y la hospitalización por IC. No se encontraron resultados significativos para la mortalidad por IC y la hospitalización general. El sesgo de publicación se encontró para las hospitalizaciones por IC y globales. Conclusiones: La terapia guiada por PN parece mejorar los resultados en comparación con la terapia guiada clínicamente. Sin embargo, la heterogeneidad encontrada entre las intervenciones podría reducir la generalización de estos resultados. Las intervenciones específicas de los ensayos clínicos deben ser analizadas al hacer recomendaciones con respecto a la terapia de guiada por PN. © 2017 Instituto Nacional de Cardiología Ignacio Chávez. Publicado por Masson Doyma México S.A. Este es un artículo Open Access bajo la licencia CC BY-NC-ND (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Estado de la reumatología en España en 2017: 2.0 reumatólogos por 100.000 habitantes / Status of Rheumatology in Spain in 2017: 2.0 Rheumatologists per 100.000 Population

No disponible

Safety and effectiveness of bDMARDs during pregnancy in patients with rheumatic diseases: Real-world data from the BIOBADASER registry / Seguridad y efectividad de los FAME biológicos durante el embarazo en pacientes con enfermedades reumáticas: datos del mundo real procedentes del registro BIOBADASER

Introduction: Inflammatory rheumatic diseases usually affect women of childbearing age treated with biologic drugs. However, there is a lack of literature on the efficacy and toxicity of biologic disease-modifying drugs during pregnancy. The aim of this study was to determine the presence of pregnant patients treated with bDMARDs in a real-world dataset and to examine the impact of pregnancy and lactation on the evolution of rheumatic disease in a registry of Spanish patients.Method: This was a multicentre prospective study with a real-world setting. Information was obtained from BIOBADASER registry. Patients included are women who got pregnant until November 2020 from 19 rheumatology units. We conducted proportions, means, and standard deviations (SD) to describe the study population and the use of treatments. T-test and Chi-square test were applied to assess differences between groups.Result: Ninety cases of pregnancy were registered (n=68 full-term pregnancies; n=22 spontaneous miscarriages). Most of the cases discontinued bDMARDs during pregnancy (78.9%) but 13 cases continued treatment during pregnancy, mainly using certolizumab pegol. These cases were obtaining better management of rheumatic disease, although the differences were not statistically significant [DAS28-CRP, 2.9 (SD: 1.6) vs. 2.0 (1.2), p=.255; DAS28-ESR, 2.2 (1.0) vs. 1.7 (.5), p=.266]. No serious adverse events were reported during pregnancy and lactation.Conclusion: Being pregnant is still an uncommon condition in patients with rheumatic diseases and using bDMARDs. Our results show that rheumatic disease tended to progress better during pregnancy in patients who continued to take bDMARDs.(AU)

Introducción: Las enfermedades reumáticas inflamatorias afectan normalmente a mujeres en edad fértil tratadas con fármacos biológicos. Sin embargo, escasea la literatura sobre la eficacia y la toxicidad de los fármacos modificadores de la enfermedad (FAME) biológicos durante el embarazo. El objetivo de este estudio fue determinar la presencia de pacientes embarazadas tratadas con FAME biológicos en un conjunto de datos del mundo real y examinar el impacto del embarazo y la lactancia en la evolución de la enfermedad reumática en un registro de pacientes españoles.Método: Estudio prospectivo multicéntrico en un entorno del mundo real. La información se obtuvo del registro BIOBADASER. Los pacientes fueron mujeres embarazadas hasta el mes de noviembre del 2020, de 19 unidades de Rreumatología. Obtuvimos proporciones, medias y desviaciones estándar (DE) para describir la población de estudio y el uso de tratamientos. Se realizaron las pruebas t y χ2 para evaluar las diferencias entre grupos.Resultado:Se registraron 90 casos de embarazo (n=68 embarazos a término; n=22 abortos espontáneos). La mayoría de los casos suspendieron el tratamiento con FAME biológicos durante el embarazo (78,9%), pero 13 casos prosiguieron el tratamiento durante el embarazo, utilizando principalmente certolizumab pegol. Dichos casos obtuvieron un mejor manejo de la enfermedad reumática, aunque las diferencias no fueron estadísticamente significativas (DAS28-CRP, 2,9 [DE 1,6] vs. 2 [1,2], p=0,255; DAS28-ESR, 2,2 [1] vs. 1,7 [0,5], p=0,266). No se reportaron episodios adversos graves durante el embarazo y la lactancia.Conclusión: La situación de embarazo sigue siendo infrecuente en las pacientes con enfermedades reumáticas que utilizan FAME biológicos. Nuestros resultados reflejan que la enfermedad reumática tendió a progresar mejor durante el embarazo en las mujeres tratadas con FAME biológicos.(AU)

Realidad de la Reumatología en España y sus comunidades autónomas antes de la pandemia / The reality of Rheumatology in Spain and its autonomous communities before the pandemic

Objetivo: Determinar el número de reumatólogos por 100.000 habitantes en activo en centros públicos o privados en el conjunto de España, por comunidades autónomas y su distribución por edad y sexo. Material y método: Estudio transversal utilizando la información contenida en la base de datos de la Sociedad Española de Reumatología, con datos confirmados por los responsables de los servicios clínicos de cada uno de los hospitales (públicos y privados) disponibles en la base de datos. Se analizó edad, sexo y lugar de trabajo de los reumatólogos en activo en febrero de 2020. Se calcularon tasas de reumatólogos por 100.000 habitantes a partir de datos de población del Instituto Nacional de Estadística. Resultados: Se estimó una tasa de especialistas en reumatología por 100.000 habitantes en España de 2,17. El porcentaje de mujeres fue del 59,7%, siendo superior la proporción mujer/hombre en edades más jóvenes. La menor relación de especialistas por 100.000 habitantes se registró en la Comunidad Valenciana (1,6), y la mayor en Cantabria (3,2). Conclusiones: Se encontraron variaciones en la tasa de reumatólogos por 100.000 habitantes entre comunidades autónomas. La distribución por sexo mostró una tendencia a un incremento de mujeres reumatólogas.(AU)

Objectives: To determine the number of rheumatologists per 100,000 inhabitants working in public or private centres in Spain as a whole, and by Autonomous Community and their distribution by age and sex. Material and method: Cross-sectional study based on the information contained in the database of the Spanish Society of Rheumatology. Quality control was performed by contact (e-mail and telephone call) with the heads of the clinical services of each of the hospitals (public and private). The information analysed was the age, sex and place of work of active rheumatologists in February 2020. The rates of rheumatologists per 100,000 inhabitants were calculated from population data from the National Institute of Statistics. Results: The rate of rheumatology specialists per 100,000 inhabitants in Spain was estimated at 2.17. The percentage of women was 59.7%, with a higher female/male ratio at younger ages. The lowest proportion of specialists per 100,000 inhabitants was in the community of Valencia (1.6), and the highest in Cantabria (3.2). Conclusions: Variations were found in the rate of rheumatologists per 100,000 inhabitants among the Autonomous Communities. The distribution by age and sex showed a tendency towards female rheumatologists, especially in the younger age strata.(AU)

Comparación de métodos para modelizar los factores asociados con los ingresos hospitalarios en casos incidentes de insuficiencia cardíaca / A comparison of methods for modeling factors associated with hospital admissions in incident cases of heart failure

Fundamento: La insuficiencia cardiaca (IC) es un importante problema de salud pública debido a su creciente prevalencia y la descompensación que conlleva un ingreso hospitalario representa un aumento del riesgo de muerte. El objetivo de este trabajo fue comparar varios métodos para modelizar la variable hospitalizaciones y determinar el efecto de los factores asociados con los ingresos hospitalarios en casos incidentes de IC. Método: Se realizó un estudio de cohortes restrospectivo con información extraída de la historia clínica electrónica de Atención Primaria (AP). Se incluyeron pacientes mayores de 24 años que habían realizado al menos 1 consulta en AP durante el año 2006. Se analizaron las hospitalizaciones registradas de casos incidentes de IC entre 2006 y 2010 o hasta su fallecimiento y se compararon modelos de regresión de Poisson, Binomial Negativa (BN), inflados con ceros y de Hurdle para identificar factores asociados a las hospitalizaciones. Resultados: Se identificó a 3.061 personas con IC en una cohorte de 227.984 pacientes. Respecto a los factores asociados con las hospitalizaciones y según el modelo de regresión BN inflado con ceros, los pacientes con valvulopatías (OR=2,01; IC95%: 1,22-3,30) o en tratamiento con antitrombóticos (OR=3,45; IC95%: 1,61-7,42) o diuréticos (OR=2,28; IC95%:1,13-4,58) tuvieron mayor probabilidad de hospitalización. Los factores asociados a una mayor tasa de ingresos fueron tener valvulopatías (IRR=1,37; IC95%: 1,03-1,81) o diabetes mellitus (IRR=1,38, 1,07-1,78) y estar en tratamiento con calcioantagonistas (IRR=1,35; IC95%: 1,05-1,73) o IECAS (IRR=1,43; IC95%:1,06- 1,92). Haber tenido derivaciones a cardiología tuvo efecto protector (IRR=0,86; IC95%: 0,76-0,97). Conclusión: El modelo de regresión que tiene mejor ajuste es el BN inflado con ceros. Según este modelo los factores asociados con un incremento en los ingresos hospitalarios son las valvulopatías, la diabetes mellitus y el tratamiento con calcioantagonistas (AU)

Background: Heart failure (HF) is an important public health problem due to its increasing prevalence, and the decompensation associated with hospital admission represents an increased risk of death. The objective of this study was to compare several methods to model the variable hospitalizations and to determine the effect of factors associated with hospital admissions in incident cases of HF. Methods: Study of a retrospective cohort of patients with information extracted from electronic medical records of PC was performed. Patients 24 year and older with at least 1 visit to PC in 2006 were included. Registered hospital admissions of HF incident cases between 2006 and 2010 or until death were analyzed and comparison of Poisson, Negative Binomial (NB), zero-inflated and Hurdle regression models were conducted to identify factors associated con hospitalizations. Results: 3,061 patients were identified in a cohort of 227,984. Regarding the factors associated with hospitalizations and according to the zero inflated NB regression model, patients who presented valvular disease (OR=2.01; CI95% 1.22-3.30), or were being treated with antithrombotics (OR=3.45; CI95%: 1.61-7.42) or diuretics (OR=2.28; CI95% 1.13-4.58) had a lower likelihood of hospitalization. Factors associated with a higher rate of hospital admissions were having valvular disease (IRR=1.37; CI95% 1.03-1.81) or diabetes mellitus (IRR=1.38; 1.07-1.78), and being treated with calcium antagonists (IRR=1.35; CI95% 1.05- 1.73) or ACE inhibitors (IRR=1.43; CI95% 1.06- 1.92). Having being referred to a cardiologist had a protective effect (IRR=0.86; CI95% 0.76- 0.97). Conclusion: The regression model that obtained the best adjustment was the zero inflated NB. According to this model, the factors associated with an increase in hospital admissions were valvulopathies, diabetes and treatment with calcium antagonists (AU)

Variabilidad en los hospitales de día de Reumatología en España: proyecto VALORA / Variability in Rheumatology day care hospitals in Spain: VALORA study

Objetivos. Describir la variabilidad de las unidades de hospitalización de día (UHdD) de Reumatología en España, en términos de recursos estructurales y procesos de funcionamiento. Material y métodos. Estudio descriptivo, multicéntrico, con evaluación de las UHdD mediante cuestionario autocumplimentado a partir de estándares de calidad de la Sociedad Española de Reumatología. Se analizaron recursos estructurales y procesos de las UHdD estratificados por complejidad del hospital (comarcal, general, mayor y complejo), y se determinó la variabilidad mediante el coeficiente de variación (CV) de la variable con relevancia clínica que presentara diferencias estadísticamente significativas al comparar por centros. Resultados. Un total de 89 centros (16 comunidades autónomas y Melilla) se incluyeron en el análisis. El 11,2% de los hospitales son comarcales; el 22,5%, generales; el 27%, mayores, y el 39,3%, complejos. El 92% de las UHdD son polivalentes. El número de tratamientos aplicados, la coordinación entre las UHdD y farmacia hospitalaria y la presencia de formación posgrado fueron las variables de proceso que presentaron diferencias estadísticamente significativas en función del nivel de complejidad del hospital. La tasa de tratamientos más alta se halló en hospitales complejos (2,97 por 1.000 habitantes), y la más baja, en hospitales generales (2,01 por 1.000 habitantes). El CV fue de 0,88 en hospitales mayores, de 0,86 en comarcales, de 0,76 en generales y de 0,72 en los complejos. Conclusiones. Existe una mayor variabilidad en el número de tratamientos de UHdD en los hospitales mayores, seguido de los comarcales. Sin embargo, la variabilidad en estructura y funcionamiento no parece deberse a diferencias de complejidad de los centros (AU)

Objective. To describe the variability of the day care hospital units (DCHUs) of Rheumatology in Spain, in terms of structural resources and operating processes. Material and methods. Multicenter descriptive study with data from a self-completed questionnaire of DCHUs self-assessment based on DCHUs quality standards of the Spanish Society of Rheumatology. Structural resources and operating processes were analyzed and stratified by hospital complexity (regional, general, major and complex). Variability was determined using the coefficient of variation (CV) of the variable with clinical relevance that presented statistically significant differences when was compared by centers. Results. A total of 89 hospitals (16 autonomous regions and Melilla) were included in the analysis. 11.2% of hospitals are regional, 22,5% general, 27%, major and 39,3% complex. A total of 92% of DCHUs were polyvalent. The number of treatments applied, the coordination between DCHUs and hospital pharmacy and the post graduate training process were the variables that showed statistically significant differences depending on the complexity of hospital. The highest rate of rheumatologic treatments was found in complex hospitals (2.97 per 1,000 population), and the lowest in general hospitals (2.01 per 1,000 population). The CV was 0.88 in major hospitals; 0.86 in regional; 0.76 in general, and 0.72 in the complex. Conclusions. there was variability in the number of treatments delivered in DCHUs, being greater in major hospitals and then in regional centers. Nonetheless, the variability in terms of structure and function does not seem due to differences in center complexity (AU)

SJÖGREN-SER: Registro nacional de pacientes con síndrome de Sjögren primario de la Sociedad Española de Reumatología: objetivos y metodología / Sjögren SER: National registry of the Spanish Society of Rheumatology of patients with primary Sjögren syndrome: Objectives and methodology

Objetivo. Describir los objetivos y metodología del registro de síndrome de Sjögren primario (SSp) de la Sociedad Española de Reumatología (SJOGREN-SER). Métodos. Estudio transversal descriptivo multicéntrico de pacientes con SSp que cumplen los criterios de clasificación del consenso europeo-americano del 2002 atendidos en servicios de reumatología españoles. Cohorte elaborada a partir de la selección al azar de pacientes con SSp. Los datos se obtuvieron de la historia clínica y por entrevista médica al paciente el día de la inclusión en el estudio. Se recogieron 298 variables agrupadas en características epidemiológicas, clínicas, serológicas y terapéuticas, así como diferentes desenlaces reportados por el paciente. El estudio fue aprobado por los CEIC locales y los pacientes firmaron un consentimiento informado. Para el análisis de los datos se utilizó estadística descriptiva, se analizaron medias, medianas y frecuencias, con sus respectivas desviaciones y rangos intercuartílicos de las variables recogidas (p25-p75). Resultados. Han participado 33 centros españoles. El número de pacientes incluidos es de 437, la mayoría mujeres (95%), con una mediana de edad al diagnóstico de SSp de 50 años. La mediana de edad de esta cohorte es de 58 años. La mayoría de los pacientes (95%) presenta síndrome seco y hasta el 94% anti-Ro positivo. Un total de 119 pacientes (27%) cumplen los nuevos criterios de clasificación SICCA-ACR de 2012. Conclusiones. SJOGREN-SER ha sido diseñado con el fin de caracterizar una cohorte representativa de pacientes con SSp en nuestro país, en situación de práctica clínica habitual, para analizar la magnitud y distribución de sus manifestaciones, la actividad, el daño acumulado y el manejo terapéutico de la enfermedad. Esto nos permitirá ampliar y actualizar el conocimiento sobre esta enfermedad y planificar estrategias de actuación en el SSp (AU)

Objective. To describe the objectives and methods of the Spanish Society of Rheumatology primary Sjögren syndrome (pSS) registry (SJOGREN-SER) Methods. This is a multicenter descriptive transversal study of a cohort of pSS patients fulfilling European/American consensus criteria collected from Rheumatology clinics all over Spain. Patients were included by randomisation from an anonymised list provided by every department. Data were collected by reviewing clinical records and an interviewing the patients. Two hundred and ninety eight variables were investigated: epidemiological, clinical, serological characteristics, treatments and complications. Informed consent was obtained and local ethics committees approved the study. Variables were analysed by descriptive statistical methods, using means, medians, and rates, with their deviations and interquartile ranges (p25-p75). Results. A total of 3 rheumatology departments participated in the registry. A total of 437 patients were included. And 95% of them were women, with a median age of 58. Median age at pSS ‘s diagnosis was 50 years. Dryness symptoms (95%) were the most frequent complaint and anti-Ro/SS-A were present in 94% of the cases. Only 27% of the patients fulfilled the new 2012 SICCA-ACR classification criteria. Conclusions. SJOGREN-SER has been designed in order to characterize a representative pSS Spanish cohort, in clinical daily practice, to analyze the magnitude and distribution of its manifestations, activity, accumulated damage and therapeutic management of the disease. This will allow broadening the knowledge of this disease and plan strategies of action in pSS (AU)