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Purpose: A high cardiovascular risk has been described in patients with rheumatoid arthritis (RA); the effects of different biological agents have also been described in these patients. The aim of the present study is to examine the effects of tumor necrosis factor inhibitors (TNFi) in the lipoprotein profile of RA patients using a broad laboratory assessment including a large number of non-routine tests. Patients and Methods: RA patients treated with and without TNFi (70 patients in each group) were cross-sectionally compared regarding a broad spectrum of lipoprotein parameters including serum levels of total and HDL, LDL and VLDL cholesterol triglycerides, lipoprotein A (LpA), apolipoprotein A1 (Apo A), B100 (Apo B) and paroxonase. For each lipoprotein subfraction (HDL, LDL and VLDL), we assess specific concentrations of cholesterol, triglycerides, phospholipids and proteins and total mass of each one. Additionally, HDL Apo A, LDL and VLDL Apo B concentrations and number of particles of LDL and VLDL were also determined. Exploratory univariate and multivariate analyses of the different variables were performed. Results: Seventy patients in each subset were enrolled. Patients on treatment with TNFi showed a trend to be younger and to have a longer disease duration. Regarding the lipoprotein analyses, borderline significant higher levels of serum Apo A were detected and an independent association with lower HDL mass, LDL triglyceride, VLDL cholesterol, VLDL Apo B, VLDL mass, number of VLDL cholesterol molecules and number of particles of VLDL was clearly observed. Conclusion: TNFi treatment was associated with beneficial atherogenic effects at the lipoprotein level especially centered in the VLDL-related parameters consistent with a reduction of the atherogenic risk. Funding: This study was carried out with the support of Instituto de Salud Carlos III (ISCIII) (grant number PI0810119).

We aimed to develop recommendations for the management of methotrexate (MTX) when considering the combination with biological (b) or targeted synthetic (ts) disease modifying drugs (DMARDs) in rheumatoid arthritis (RA). Methods: Eleven experts on RA were selected. Two coordinators formulated 13 questions about the combination therapy of MTX with bDMARDs or tsDMARDs. A systematic review was conducted to answer the questions. Inclusion and exclusion criteria were established as well as the search strategies (Medline, Embase and the Cochrane Library were searched up to January 2019). Two reviewers selected the articles and collected data. Simultaneously, EULAR and ACR meeting abstracts were evaluated. Based on this evidence, the coordinators proposed preliminary recommendations that the experts discussed and voted in a nominal group meeting. The level of evidence and grade of recommendation was established using the Oxford Center for Evidence Based Medicine and the level of agreement with a Delphi. Agreement was established if at least 80% of the experts voted ‘yes’ (yes/no). Results: The systematic review retrieved 513 citations of which 61 were finally included. A total of 10 recommendations were generated, voted and accepted. The level of agreement was very high in all of them and it was achieved in the first Delphi round. Final recommendations cover aspects such as the optimal MTX dosage, tapering strategy or patients’ risk management. Conclusions: This document is intended to help clinicians solve usual clinical questions and facilitate decision making when treating RA patients with MTX in combination with bDMARDs or tsDMARDs, Desarrollar recomendaciones sobre el uso de metotrexato (MTX) en combinación con medicamentos modificadores de la enfermedad (DMARD) biológicos (b) o sintéticos específicos (ts) en la artritis reumatoide (AR). Se seleccionaron 11 expertos en AR. Dos coordinadores formularon 13 preguntas sobre la terapia combinada de MTX con bDMARD o tsDMARD. Se realizó una revisión sistemática para responder las preguntas. Se establecieron criterios de inclusión y exclusión, así como las estrategias de búsqueda (se realizaron búsquedas en Medline, Embase y la Biblioteca Cochrane hasta enero de 2019). Dos revisores seleccionaron los artículos y recopilaron datos. Simultáneamente, se evaluaron los resúmenes de las reuniones EULAR y ACR. Con base en esta evidencia, los coordinadores propusieron recomendaciones preliminares que los expertos discutieron y votaron en una reunión de grupo nominal. El nivel de evidencia y el grado de recomendación se establecieron utilizando el Centro de Oxford para Medicina Basada en Evidencia y el nivel de acuerdo con un Delphi. El acuerdo se estableció si al menos el 80% de los expertos votaron «sí» (sí/no). La revisión sistemática recuperó 513 citas, de las cuales finalmente se incluyeron 61. Se generaron, votaron y aceptaron un total de 10 recomendaciones. El nivel de acuerdo fue muy alto en todas ellas y se logró en la primera ronda de Delphi. Las recomendaciones finales cubren aspectos como la dosis óptima de MTX, la estrategia de reducción o la gestión del riesgo de los pacientes. Este documento está destinado a ayudar a los médicos a resolver preguntas clínicas habituales y facilitar la toma de decisiones al tratar a pacientes con AR con MTX, en combinación con bDMARD o tsDMARD

Objectives: To analyze the prevalence, incidence, survival and contribution on mortality of major central nervous system (CNS) involvement in systemic lupus erythematosus (SLE). Methods: Patients fulfilling the SLE 1997 ACR classification criteria from the multicentre, retrospective RELESSER-TRANS (Spanish Society of Rheumatology Lupus Register) were included. Prevalence, incidence and survival rates of major CNS neuropsychiatric (NP)-SLE as a group and the individual NP manifestations cere-brovascular disease (CVD), seizure, psychosis, organic brain syndrome and transverse myelitis were calculated. Furthermore, the contribution of these manifestations on mortality was analysed in Cox regression models adjusted for confounders. Results: A total of 3591 SLE patients were included. Of them, 412 (11.5%) developed a total of 522 major CNS NP-SLE manifestations. 61 patients (12%) with major CNS NP-SLE died. The annual mortality rate for patients with and without ever major CNS NP-SLE was 10.8% vs 3.8%, respectively. Individually, CVD (14%) and organic brain syndrome (15.5%) showed the highest mortality rates. The 10% mortality rate for patients with and without ever major CNS NP-SLE was reached after 12.3 vs 22.8 years, respectively. CVD (9.8 years) and organic brain syndrome (7.1 years) reached the 10% mortality rate earlier than other major CNS NP-SLE manifestations. Major CNS NP-SLE (HR 1.85, 1.29-2.67) and more specifically CVD (HR 2.17, 1.41-3.33) and organic brain syndrome (HR 2.11, 1.19-3.74) accounted as independent prognostic factors for poor survival. Conclusion: The presentation of major CNS NP-SLE during the disease course contributes to a higher mortality, which may differ depending on the individual NP manifestation. CVD and organic brain syndrome are associated with the highest mortality rates.

Background/objectives: Factors associated with chronic heart failure (CHF) in patients with systemic lupus erythematosus (SLE) have received little attention. Recent data on the use of hydroxychloroquine in the treatment of SARS-CoV-2 infection have cast doubt on its cardiac safety. The factors associated with CHF, including therapy with antimalarials, were analyzed in a large multicenter SLE cohort. Methods: Cross-sectional study including all patients with SLE (ACR-1997 criteria) included in the Spanish Society of Rheumatology Lupus Register (RELESSER), based on historically gathered data. Patients with CHF prior to diagnosis of SLE were excluded. A multivariable analysis exploring factors associated with CHF was conducted. Results: The study population comprised 117 patients with SLE (ACR-97 criteria) and CHF and 3,506 SLE controls. Ninety percent were women. Patients with CHF were older and presented greater SLE severity, organ damage, and mortality than those without CHF. The multivariable model revealed the factors associated with CHF to be ischemic heart disease (7.96 [4.01-15.48], p < 0.0001), cardiac arrhythmia (7.38 [4.00-13.42], p < 0.0001), pulmonary hypertension (3.71 [1.84-7.25], p < 0.0002), valvulopathy (6.33 [3.41-11.62], p < 0.0001), non-cardiovascular damage (1.29 [1.16-1.44], p < 0.000) and calcium/vitamin D treatment (5.29 [2.07-16.86], p = 0.0015). Female sex (0.46 [0.25-0.88], p = 0.0147) and antimalarials (0.28 [0.17-0.45], p < 0.000) proved to be protective factors. Conclusions: Patients with SLE and CHF experience more severe SLE. Treatment with antimalarials appears to confer a cardioprotective effect. (c) 2021 Published by Elsevier Inc.

espanolObjetivos Emitir recomendaciones sobre aspectos practicos de la monitorizacion de los niveles de farmacos biologicos que puedan ser de utilidad para reumatologos. Metodos Se realizo una revision sistematica de la literatura de estudios en los que se determinaron niveles de farmaco y de anticuerpos antifarmaco en pacientes con artritis reumatoide o espondiloartritis para estudiar si podian predecir diferentes desenlaces. Con los resultados de la revision un grupo de expertos discutio bajo que circunstancias podria ser util la solicitud de niveles de farmacos biologicos y sus anticuerpos, lo que se concreto en una serie de preguntas clinicas que fueron respondidas con la evidencia cientifica disponible y creandose algoritmos para facilitar la toma de decisiones. Resultados Se establece que la determinacion de los niveles de farmaco puede ser especialmente util en 2 situaciones clinicas, cuando hay fallo al tratamiento (primario o secundario) y en remision mantenida. Se revisa tambien que tecnica de laboratorio y momento para tomar la muestra son los mas adecuados para la medicion, y se establecen recomendaciones sobre la interpretacion de los niveles de farmaco y sobre factores a tener en cuenta (por ejemplo, indice de masa corporal y farmacos modificadores de la enfermedad). Conclusiones Se han elaborado algoritmos y establecido posibles pautas y directrices para solicitar niveles de farmaco y de anticuerpos antifarmaco en pacientes con artritis reumatoide y espondiloartritis, basados en la evidencia, que pueden ayudar a la toma de decisiones clinicas. EnglishObjectives Issue recommendations on practical aspects of the monitoring of levels of biological drugs that may be useful for rheumatologists. Methods We conducted a systematic review of studies in which drug and anti-drug antibody levels were determined in patients with rheumatoid arthritis (RA) or spondyloarthritis (SpA) to study whether they could predict different outcomes. In light of the results of the review, a group of experts discussed under what circumstances testing biological drug levels and their antibodies could be useful. The discussion resulted in a series of clinical questions that were answered with the scientific evidence collected, and in algorithms that facilitate decision making. Results It was established that the determination of drug levels can be especially useful in two clinical situations, on treatment failure (primary or secondary) and on sustained remission. It is also reviewed which laboratory technique and timing for sample drawing are the most suitable for the measurement. Recommendations are issued on the interpretation of drug levels and on factors to be taken into account (for example, body mass index and disease modifying drugs). Conclusions Evidence-based algorithms and guidelines have been established to test drug levels and anti-drug antibodies in patients with RA and SpA, which can help clinical decision making.

Objective (1) To systematically and critically review the evidence of combined therapy with synthetic disease-modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis (RA) and (2) to design practical recommendations on their use. Methods A systematic literature review (SLR) was performed with a sensitive bibliographic search strategy in Medline, EMBASE and Cochrane Library. We selected randomised clinical trials that analysed the efficacy and/or safety of (1) combined therapy of synthetic compared with sequential therapy of synthetic DMARD in early RA and (2) combination of methotrexate + leflunomide or triple therapy with synthetic DMARD in established RA refractory to synthetic DMARD. Two reviewers made the first selection by title and abstract and 11 performed the selection after detailed review of the articles and data collection. The quality of the studies was evaluated with the Jadad scale. Based on the results, related recommendations were agreed upon in a nominal group meeting. Results Ultimately, no articles were included in the SLR. The analysis of the reviewed articles demonstrated the effectiveness of the treatment with synthetic DMARD following a “treat to target” strategy in early RA patients, and of combination therapy of synthetic DMARD in established RA refractory to synthetic DMARD. This resulted in 6 recommendations concerning combination therapy with synthetic DMARD. Conclusions These recommendations aim to facilitate decision-making with the use of combined therapy with DMARD in RA.

Management of systemic autoimmune diseases is challenging for physicians in their clinical practice. Although not common, they affect thousands of patients in Spain. The family doctor faces patients with symptoms and non-specific cutaneous, mucous, joint, vascular signs or abnormal laboratory findings at the start of the disease process and has to determine when to refer patients to the specialist. To aid in disease detection and better referral, the Spanish Society of Rheumatology and the Spanish Society of Family Medicine has created a group of experts who selected 26 symptoms, key signs and abnormal laboratory findings which were organized by organ and apparatus. Family doctors and rheumatologists with an interest in autoimmune systemic diseases were selected and formed mixed groups of two that then elaborated algorithms for diagnostic guidelines and referral. The algorithms were then reviewed, homogenized and adapted to the algorithm format and application for cell phone (apps) download. The result is the current Referral document of systemic autoimmune diseases for the family doctor in paper format and app (download). It contains easy-to-use algorithms using data from anamnesis, physical examination and laboratory results usually available to primary care, that help diagnose and refer patients to rheumatology or other specialties if needed. (C) 2019 Elsevier Espana, S.L.U. and Sociedad Espanola de Reumatologia y Colegio Mexicano de Reumatologia. All rights reserved.

espanolObjetivo 1) Revisar sistematica y criticamente la evidencia sobre eficacia y seguridad de la terapia combinada con farmacos modificadores de la enfermedad (FAME) sinteticos en la artritis reumatoide (AR); 2) Emitir recomendaciones practicas sobre su uso. Metodos Se realizo una revision sistematica de la literatura con una estrategia de busqueda bibliografica sensible en Medline, Embase y Cochrane Library. Se seleccionaron ensayos clinicos aleatorizados que analizasen la eficacia y/o seguridad de 1) la terapia combinada con FAME sinteticos comparada con la terapia secuencial con FAME sintetico en la AR de inicio; y 2) la combinacion metotrexato + leflunomida o la triple terapia de FAME sinteticos en la AR establecida refractaria a FAME sinteticos. Dos revisores realizaron la primera seleccion por titulo y resumen y 11 la seleccion tras lectura en detalle y la recogida de datos. La calidad se evaluo con la escala de Jadad. En una reunion de grupo nominal en base sus resultados se consensuaron una serie de recomendaciones. Resultados Finalmente no se incluyo ningun articulo en la RSL. Del analisis de los articulos revisados se encontro la eficacia en las AR de inicio del tratamiento precoz con FAME sinteticos siguiendo una estrategia «treat to target» y en AR establecidas refractarias a FAME sinteticos la de la terapia combinada con FAME sinteticos. Con ello se generaron 5 recomendaciones sobre la terapia combinada con FAME sinteticos. Conclusiones Estas recomendaciones pretenden facilitar la toma de decisiones con el uso de la terapia combinada con FAME sinteticos en la AR. EnglishObjective 1) To systematically and critically review the evidence of combined therapy with synthetic disease-modifying antirheumatic drugs (DMARD) in rheumatoid arthritis (RA); 2) To design practical recommendations on their use. Methods A systematic literature review (SLR) was performed with a sensitive bibliographic search strategy in Medline, EMBASE and Cochrane Library. We selected randomized clinical trials that analyzed the efficacy and/or safety of 1) combined therapy of synthetic compared with sequential therapy of synthetic DMARD in early RA; and 2) combination of methotrexate + leflunomide or triple therapy with synthetic DMARD in established RA refractory to synthetic DMARD. Two reviewers made the first selection by title and abstract and 11 performed the selection after detailed review of the articles and data collection. The quality of the studies was evaluated with the Jadad scale. Based on the results, related recommendations were agreed upon in a nominal group meeting. Results Ultimately, no articles were included in the SLR. The analysis of the reviewed articles demonstrated the effectiveness of the treatment with synthetic DMARD following a “treat to target” strategy in early RA patients, and of combination therapy of synthetic DMARD in established RA refractory to synthetic DMARD. This resulted in 6 recommendations concerning combination therapy with synthetic DMARD. Conclusions These recommendations aim to facilitate decision-making with the use of combined therapy with DMARD in RA.

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

Resumen Objetivos 1) Revisar sistematica y criticamente la evidencia sobre las caracteristicas de uso, eficacia y seguridad de los glucocorticoides (GC) en la artritis reumatoide (AR); 2) emitir recomendaciones practicas sobre su utilizacion. Metodos Se realizo una revision sistematica de la literatura con una estrategia de busqueda bibliografica sensible en Medline, Embase y Cochrane Library. Se seleccionaron ensayos clinicos aleatorizados que analizasen la eficacia y/o la seguridad de los GC en pacientes con AR. Dos revisores realizaron la primera seleccion por titulo y abstract y 10, la seleccion tras lectura en detalle y la recogida de datos. La calidad se evaluo con la escala de Jadad. En una reunion de grupo nominal con base en sus resultados se consensuaron una serie de recomendaciones. Resultados Se incluyeron 47 articulos. Los GC, en combinacion con los farmacos antirreumaticos modificadores de la enfermedad, ayudan a controlar la actividad de la enfermedad y a inhibir la progresion radiografica, especialmente en el corto-medio plazo y en las AR de inicio. Los GC pueden mejorar la funcion y el dolor. Distintos tipos y vias de administracion son eficaces, sin que exista un esquema de tratamiento estandarizado (dosis de inicio, desescalada y duracion del tratamiento con los GC) superior a otro. Los acontecimientos adversos de los GC son muy frecuentes, dependientes de la dosis, de gravedad variable, muchos de ellos leves. Se generaron 7 recomendaciones sobre el uso y la gestion del riesgo de los GC. Conclusiones Estas recomendaciones pretenden resolver algunos interrogantes clinicos habituales y facilitar la toma de decisiones con respecto al uso de GC en la AR.

Objectives (1) To systematically and critically review the evidence on the characteristics, efficacy and safety of glucocorticoids (CS) in rheumatoid arthritis (RA); (2) to generate practical recommendations. Methods A systematic literature review was performed through a sensitive bibliographic search strategy in Medline, Embase and the Cochrane Library. We selected randomized clinical trials that analyzed the efficacy and/or safety of CS in patients with RA. Two reviewers performed the first selection by title and abstract. Then 10 reviewers selected the studies after a detailed review of the articles and data collection. The quality of the studies was evaluated with the Jadad scale. In a nominal group meeting, based on the results of the systematic literature review, related recommendations were reached by consensus. Results A total of 47 articles were finally included. CS in combination with disease-modifying antirheumatic drugs help control disease activity and inhibit radiographic progression, especially in the short-to-medium term and in early RA. CS can also improve function and relieve pain. Different types and routes of administration are effective, but there is no standardized scheme (initial dose, tapering and duration of treatment) that is superior to others. Adverse events when using CS are very frequent and are dose-dependent and variable severity, although most are mild. Seven recommendations were generated on the use and risk management of CS. Conclusions These recommendations aim to resolve some common clinical questions and aid in decision-making for CS use in RA.

Resumen Objetivos En el estudio ARCO, la adherencia al biologico subcutaneo en pacientes con artritis reumatoide fue mejor con administracion mensual. Evaluamos si la satisfaccion y el cumplimiento de expectativas pueden relacionarse con la adherencia al tratamiento. Pacientes y metodos La adherencia se evaluo calculando el indice de posesion de medicacion, y satisfaccion y cumplimiento de expectativas mediante el cuestionario «EXPRESAR». Resultados En 346 pacientes, los porcentajes satisfechos/muy satisfechos con eficacia y tolerabilidad fueron ≥ 80 y 64,4%, sin diferencias entre pautas semanal, cada 2 semanas o mensual. Sobre el cumplimiento de expectativas, el 59,9% considero el efecto del tratamiento mayor al esperado, y el 52,6% las molestias bastante/mucho menores a las esperadas, porcentaje mayor en pacientes con administracion mensual (p = 0,049). Los porcentajes de no-adherencia fueron del 15,6% (molestias mayores a las esperadas), 18,5% (molestias esperadas) y 11,1% (menores/sin molestias) (p = 0,189). Conclusiones La satisfaccion y el cumplimiento de expectativas fueron altos. El cumplimiento de expectativas de tolerabilidad fue mejor con administracion mensual, lo que podria contribuir a una mejor adherencia.

Objectives In the ARCO study, adherence to subcutaneous biological agents by patients with rheumatoid arthritis improved with monthly administration. We assess whether adherence can be related to fulfilment of expectations and satisfaction with treatment. Patients and methods Adherence was assessed by calculating the Medication Possession Ratio, and satisfaction and fulfilment of expectations using the EXPRESAR group questionnaire. Results In 346 patients, those who were satisfied/very satisfied with efficacy and tolerability were ≥80% and 64.4%, with no differences between weekly, biweekly or monthly administration regimens. Regarding the fulfilment of expectations, 59.9% considered the effect of the treatment greater than expected and 52.6% reported lower/much lower than expected discomfort; the latter percentage was higher in patients with monthly administration (P = .049). The percentages for nonadherence were 15.6% (discomfort greater than expected), 18.5% (expected discomfort) and 11.1% (lower than expected or no discomfort) (P = .189). Conclusions Satisfaction and fulfilment of expectations were high. Fulfilment of expectations of tolerability was better with monthly administration, which could contribute to better adherence.

Objective To evaluate the budget impact and the direct costs of the introduction of subcutaneous belimumab (SC) into the Spanish National Health Service (NHS) for patients with systemic lupus erythematosus (SLE) in Spain. Methods This study was conducted from the Spanish NHS perspective with a time horizon of 3 years. The budget impact analysis compared the cost difference between two scenarios: current market (standard therapy (ST) and intravenous belimumab (IV)) and other market in which patients switched from belimumab IV to belimumab SC until reaching 17% of the total market share. The eligible population was calculated to receive treatment with belimumab, applying the EPISER (study of the prevalence of rheumatic diseases in adult population in Spain) prevalence (91 per 100,000 inhabitants), Autoimmune Systemic Diseases Study Group (GEAS) incidence (2 per 100,000 inhabitants), and the risk of annual mortality to the Spanish adult population. Patients with severe active lupus nephritis and with severe active CNS lupus were excluded. Patients' characteristics, flare rates and severity, and healthcare resource consumption were evaluated based on data from the literature and interviews with an expert panel. A sensitivity analysis was performed. Results Currently, there is an estimated 34,697 adult patients with SLE in Spain and 3849 patients who are eligible to be treated with belimumab. The introduction of belimumab SC into the Spanish NHS could generate savings in direct healthcare costs of 6 million euros over the 3 years. Conclusion The introduction of belimumab SC shows direct savings for the Spanish NHS. These savings could contribute to sustainability and decision-making.

Patients with rheumatoid arthritis (RA) have a significantly increased risk of sexual dysfunction. However, it is not properly included in commonly used questionnaires to assess health-related quality of life in RA. Qualisex is a questionnaire developed in France to assess the impact of RA on patients´ sexual function. Our aim was to adapt and validate this questionnaire for use with Spanish RA patients. Two independent translations and a backward translation were obtained. The final version was tested in a pilot study with 10 RA patients to detect any aspects that could hinder interpretation. The validity and reliability of the linguistically validated questionnaire were studied in a multicenter cross-sectional study, with a longitudinal component for reliability estimation. 125 RA patients were included. The response process, discrimination, internal consistency, internal structure, convergent validity (correlation with MGH-SFQ questionnaire, DAS-28, physician global assessment, patient global health assessment, RAID, HAQ, HADS and SF-12©) and reliability were analyzed. The inclusion of two extra items was proposed in the pilot study. The validity analysis detected responses for item 10 that were not coherent with responses for the rest of items. The Cronbach alpha coefficient was 0.971. The highest correlation (0.665) was obtained with MGH-SFQ (questionnaire measuring sexual functioning), followed by RAID (0.516). The intra-class correlation was 0.880 (95% CI 0.815; 0.923), higher than 0.85, which indicates excellent reliability. All parameters used to assess this questionnaire show highly acceptable values. Qualisex allows for a global score of RA patients’ sexual functioning and can be self-administered.

Resumen Objetivos Describir pacientes con aortitis no infecciosa y su respuesta al tratamiento de un hospital comarcal. Metodos Revision de pacientes con aortitis no infecciosa, tecnica diagnostica utilizada y tratamiento inmunosupresor recibido. Resultados Se encontraron 8 pacientes (7 mujeres y un hombre) diagnosticados de aortitis mediante tomografia por emision de positrones (PET). La mediana de edad fue de 69 anos (IQR 62-72,2). Tocilizumab (TCZ) mejoro los sintomas, la VSG y la PCR a los 3 meses del tratamiento (p Conclusion TCZ fue eficaz y seguro en los pacientes que fueron refractarios a esteroides y a otros tratamientos inmunosupresores.

Adiponectin is an adipokine that plays a relevant role in the development of metabolic syndrome (MetS), a complication that increases the risk of cardiovascular (CV) disease in patients with rheumatoid arthritis (RA). Accordingly, we assessed for the first time the short-term effect of anti-IL-6 receptor tocilizumab (TCZ) administration on adiponectin serum levels in RA patients and explored the potential association of adiponectin levels with MetS features, other CV risk factors and demographic and clinical characteristics of these patients.Adiponectin serum levels were evaluated in 50 non-diabetic RA patients, undergoing TCZ treatment, immediately prior to (pre-infusion) and 60 minutes after the end of a TCZ intravenous infusion (post-infusion).No significant differences in adiponectin levels pre- and post-TCZ infusion were found in RA patients (p=0.69). Patients with obesity exhibited decreased basal levels of adiponectin with respect to those non-obese (p=0.03). Additionally, a negative association of adiponectin basal levels with body mass index, insulin, insulin/glucose index, C-peptide and leptin levels (p0.01; p=0.02; p=0.03; p=0.03 and p=0.01, respectively), as well as a positive correlation with HDL-cholesterol levels (p0.001) was seen.Our results support the claim that low adiponectin may contribute to the development of MetS and, consequently, CV disease in RA. Anti-IL-6 therapy does not seem to exert a short-term effect on adiponectin levels.

Objectives: To explore current evidence on the management of poor prognostic factors in rheumatoid arthritis (RA) and to investigate whether this evidence is taken into account by clinicians when deciding on treatment in daily clinical practice. Methods: We performed a systematic literature review (SLR) to analyse the effects of currently available biologic disease-modifying antirheumatic drugs (bDMARDs) and Janus kinase inhibitors (JAKi) on the classically accepted poor prognostic factors of RA. All randomized controlled trials reporting subgroup analyses about effects on prognostic factors were identified and synthesized. In a second phase, a two-round Delphi survey was carried out to contrast the SLR results with the grade of agreement of a large group of rheumatologists about the effectiveness of each drug class on each prognostic factor. Results: According to the Delphi results, the only prognostic factor that significantly influenced the selection of treatment was the presence of interstitial lung disease (ILD), being the preferred treatment in this scenario abatacept or rituximab. The rest of the poor prognostic factors (including high disease activity at baseline, disability as measured by the Health Assessment Questionnaire index, seropositivity, elevated acute-phase reactants, and evidence of erosions based on plain radiography or ultrasonography) did not seem to significantly influence rheumatologists when choosing a treatment. The results of the SLR results did not show solid evidence regarding the use of any specific therapy in the management of patients with specific poor factors, except in the case of RA-ILD, although the data in the literature in this regard are not free of bias. Conclusions: The only prognostic factor that seems to significantly influence the selection of treatment is the presence of RA-ILD. Bristol-Myers Squibb 5.263 JCR (2021) Q2, 11/34 Rheumatology 0.798 SJR (2021) Q2, 21/61 Rheumatology No data IDR 2020 UEM

Objective To investigate the human leukocyte antigen (HLA) association with anti-synthetase syndrome (ASSD). Methods We conducted the largest immunogenetic HLA-DRB1 and HLA-B study to date in a homogeneous cohort of 168 Caucasian patients with ASSD and 486 ethnically matched healthy controls by sequencing-based-typing. Results A statistically significant increase of HLA-DRB1*03:01 and HLA-B*08:01 alleles in patients with ASSD compared to healthy controls was disclosed (26.2% versus 12.2%, P = 1.56E–09, odds ratio–OR [95% confidence interval–CI] = 2.54 [1.84–3.50] and 21.4% versus 5.5%, P = 18.95E–18, OR [95% CI] = 4.73 [3.18–7.05]; respectively). Additionally, HLA-DRB1*07:01 allele was significantly decreased in patients with ASSD compared to controls (9.2% versus 17.5%, P = 0.0003, OR [95% CI] = 0.48 [0.31–0.72]). Moreover, a statistically significant increase of HLA-DRB1*03:01 allele in anti-Jo-1 positive compared to anti-Jo-1 negative patients with ASSD was observed (31.8% versus 15.5%, P = 0.001, OR [95% CI] = 2.54 [1.39–4.81]). Similar findings were observed when HLA carrier frequencies were assessed. The HLA-DRB1*03:01 association with anti-Jo-1 was unrelated to smoking history. No HLA differences in patients with ASSD stratified according to the presence/absence of the most representative non-anti-Jo-1 anti-synthetase autoantibodies (anti-PL-12 and anti-PL-7), arthritis, myositis or interstitial lung disease were observed. Conclusions Our results support the association of the HLA complex with the susceptibility to ASSD.

Objective The aim of the present study was to describe the demographic, clinical and immunological characteristics of patients with late-onset (≥50 years) SLE vs patients with early-onset SLE ( Methods We performed a cross-sectional retrospective study of 3619 patients from the RELESSER database (National Register of Patients with Systemic Lupus Erythematosus of the Spanish Society of Rheumatology). Results A total of 565 patients (15.6%) were classified as late-onset SLE and 3054 (84.4%) as early-onset SLE. The male-to-female ratio was 5:1. Mean (s.d.) age at diagnosis in the late-onset group was 57.4 (10.4) years. At diagnosis, patients with late-onset SLE had more comorbid conditions than patients with early-onset SLE; the most frequent was cardiovascular disease (P Conclusion Late-onset SLE is insidious, with unusual clinical manifestations that can lead to diagnostic errors. Clinical course is generally indolent. Compared with early-onset disease, activity is generally reduced and immunosuppressants are less commonly used. Long-term prospective studies are necessary to determine whether the causes of death are associated with clinical course or with age-associated comorbidities in this population.

Background The International Consensus on Antinuclear Antibody (ANA) Patterns (ICAP) has recently proposed nomenclature in order to harmonize ANA indirect immunofluorescence (IIF) pattern reporting. ICAP distinguishes competent-level from expert-level patterns. A survey was organized to evaluate reporting, familiarity, and considered clinical value of ANA IIF patterns. Methods Two surveys were distributed by European Autoimmunity Standardization Initiative (EASI) working groups, the International Consensus on ANA Patterns (ICAP) and UK NEQAS to laboratory professionals and clinicians. Results 438 laboratory professionals and 248 clinicians from 67 countries responded. Except for dense fine speckled (DFS), the nuclear competent patterns were reported by > 85% of the laboratories. Except for rods and rings, the cytoplasmic competent patterns were reported by > 72% of laboratories. Cytoplasmic IIF staining was considered ANA positive by 55% of clinicians and 62% of laboratory professionals, with geographical and expertise-related differences. Quantification of fluorescence intensity was considered clinically relevant for nuclear patterns, but less so for cytoplasmic and mitotic patterns. Combining IIF with specific extractable nuclear antigens (ENA)/dsDNA antibody testing was considered most informative. Of the nuclear competent patterns, the centromere and homogeneous pattern obtained the highest scores for clinical relevance and the DFS pattern the lowest. Of the cytoplasmic patterns, the reticular/mitochondria-like pattern obtained the highest scores for clinical relevance and the polar/Golgi-like and rods and rings patterns the lowest. Conclusion This survey confirms that the major nuclear and cytoplasmic ANA IIF patterns are considered clinically important. There is no unanimity on classifying DFS, rods and rings and polar/Golgi-like as a competent pattern and on reporting cytoplasmic patterns as ANA IIF positive.

Background:Factors associated with the development of chronic heart failure (CHF) in systemic lupus erythematosus (SLE) have received little attention. On the other hand, recent data from the use of hydroxychloroquine in the treatment of SARS-CoV-2 infection during the COVID19 pandemic have cast some doubts on its cardiological safety.Objectives:To identify factors associated to CHF in SLE.Methods:Retrospective cross-sectional study, including all patients with SLE (≥4 ACR-1997 criteria) recruited in RELESSER registry. The objectives and methodology of the registry have been described previously (1). CHF was defined according to the Charlson index item. Patients with CHF before diagnosis of SLE were excluded. Cumulative damage was measured with the SLICC/ACR index, excluding cardiovascular (CV) items (mSDI). Multivariate analysis exploring factors associated with CHF was carried out.Results:117 patients (3% of the entire cohort) with SLE and CHF and 3,506 controls with SLE without CHF were included. 90% were women. Disease duration: mean (SD), 120.2 (87.7) months. CHF appeared after a median (P25-P75) of 9.40 (4.2-18.3) years from SLE diagnosis. Patients with CHF were older (59.8 ± 18.2 vs. 46.2 ± 4.3). In the bivariate analysis, the association of CHF with greater severity [Katz severity index: median (IQR): 4 (3-5) vs. 2 (1-3)], damage [mSDI: 3 (2-4) vs 0 (0-1)], comorbidity [modified Charlson- excluding CV items: 4 (3-6) vs 1(1-3)] and both CV (37.5% vs 6.7%) and overall mortality (43.2% vs 4.7%) (pTable 1.Congestive heart failure associated factors (multivariable analysis)Odds Ratio95% CIP-valueSex (female)0.460.25 - 0.880.0147Ischaemic cardiopathy7.964.01 - 15.48Cardiac arrhythmia7.384.00 - 13.42Pulmonary hypertension3.711.84 - 7.250.0002Cardiac valvulopathy6.333.41 - 11.62Hospitalization (due to SLE)3.741.81 - 8.650.0008Calcium or vitamin D5.292.07 - 16.860.0015Antimalarials0.280.17 - 0.45mSDI *1.291.16 - 1.44*mSDI = modified SLICC/ACR damage index (without cardiovascular items)Conclusion:- CHF is a rather late complication of SLE.- Patients with SLE and CHF have more severe SLE, with greater refractoriness to SLE treatments and higher overall mortality.- Treatment with antimalarials, as routinely used in SLE patients, is not only safe to heart, but even appears to have a cardioprotective effect.References:[1]Rúa-Figueroa I, López-Longo FJ, Calvo-Alén J, et al. National registry of patients with systemic lupus erythematosus of the Spanish Society of Rheumatology: objectives and methodology. Reumatol Clin. 2014;10(1):17-24.Acknowledgements:Research Unit of Spanish Society of RheumatologyDisclosure of Interests:None declared

BackgroundThe International Consensus on Antinuclear Antibody (ANA) Patterns (ICAP) has recently proposed nomenclature in order to harmonize ANA indirect immunofluorescence (IIF) pattern reporting. ICAP distinguishes competent-level from expert-level patterns. A survey was organized to evaluate reporting, familiarity, and considered clinical value of ANA IIF patterns. MethodsTwo surveys were distributed by European Autoimmunity Standardization Initiative (EASI) working groups, the International Consensus on ANA Patterns (ICAP) and UK NEQAS to laboratory professionals and clinicians. Results438 laboratory professionals and 248 clinicians from 67 countries responded. Except for dense fine speckled (DFS), the nuclear competent patterns were reported by >85% of the laboratories. Except for rods and rings, the cytoplasmic competent patterns were reported by >72% of laboratories. Cytoplasmic IIF staining was considered ANA positive by 55% of clinicians and 62% of laboratory professionals, with geographical and expertise-related differences. Quantification of fluorescence intensity was considered clinically relevant for nuclear patterns, but less so for cytoplasmic and mitotic patterns. Combining IIF with specific extractable nuclear antigens (ENA)/dsDNA antibody testing was considered most informative. Of the nuclear competent patterns, the centromere and homogeneous pattern obtained the highest scores for clinical relevance and the DFS pattern the lowest. Of the cytoplasmic patterns, the reticular/mitochondria-like pattern obtained the highest scores for clinical relevance and the polar/Golgi-like and rods and rings patterns the lowest. ConclusionThis survey confirms that the major nuclear and cytoplasmic ANA IIF patterns are considered clinically important. There is no unanimity on classifying DFS, rods and rings and polar/Golgi-like as a competent pattern and on reporting cytoplasmic patterns as ANA IIF positive.

Background: Hemophagocytic Syndrome (HPS) is an uncommon disorder with high mortality. HPS is reported to be usually related to some underlying conditions; autoimmune (AI) and hematological malignancies (HM) are two main underlying conditions. Here, we attempted to determine the clinical characteristics/differences of HPS according to underlying conditions; AI vs. HM, based on our experience. Methods: We studied all adult patients with HPS diagnosed at our institution from 2005 to 2019. Demographic, clinical characteristics, laboratory findings, underlying disorders, hospital stay and prognosis variables were examined and related to the underlying conditions. Results: 30 patients (median age of 55 years and male/female of 14/16) met the inclusion criteria which we analyzed: HM: 12 (40%), AI: 10 (33%), and others: 8 (27%). HM group, compared with AI group, showed a significantly longer length hospital stay (HM vs AI: 61.5 vs 30.5 (median)), more severe thrombocytopenia, leukocytopenias, and neutropenia, and importantly, higher mortality (with overall mortality and HM-related HPS-mortality being 43.3 and 66.7%, respectively). Contrarily, HM group, compared with AI group, showed less severe liver abnormalities (AST; 106 vs 457 (median): ALT; 109 vs 457 (median)). Conclusions : The HM subgroup presented a greater mortality and a higher number and severe cytopenias but lower elevation of transaminases.

Background/Purpose Ultraviolet radiations act by modifying DNA in sun-exposed skin of lupus patients. We develop a study to analyze the association between climatological conditions and cutaneous manifestations in systemic lupus erythematosus (SLE). Methods Patients data from Spanish Rheumatology Society Lupus Registry (RELESSER) cohort were retrospectively analyzed for presence of cutaneous lesions (alopecia, photosensitivity, malar rash, discoid lesions, oral ulcers and subacute lesions). We included patients who were assessed in rheumatology services from January 2011 to December 2012. Data of climatological conditions throughout the Spanish geography were provided by the Spanish Meteorological Agency. Results A total of 2919 patients were included, 87.3% female. Others biological and clinical data are showed in table 1. In the multivariable model, positive associations were observed between coastal regions OR 1.470 (95% CI:1.080–2.001 p=0,014), anti-DNA OR 1.806 (95% CI:1.276–2.556, p=0.001), antiphospholipids antibodies OR 1.428 (95% CI:1.093–1.864 p=0.009), serositis OR 1.557 (95% CI:1.181–2.053 p=0.002) and arthritis OR 1.804 (95% CI:1.258–2.587 p=0,001). Negative associations were observed between females OR 0.412 (95% CI:0.284–0.599, p=0.000) and antimalarial drugs OR 0.469 (95% CI:0.327–0.671, p=0.000). Conclusion Although the influence of global and ultraviolet radiations on the development of cutaneous lesions in SLE have been suggested, the results of our study does not support an association between the diverse climatological conditions and cutaneous manifestations in SLE. However we observed an independent association with living in coastal areas.

Objective: To describe the incidence of bacteremia in a large multicentric cohort of patients with systemic lupus erythematosus (SLE) and their clinical characteristics and to identify risk factors. Methods: All bacteremic episodes from the Spanish RELESSER registry were included. Clinical and laboratory characteristics concerning bacteremia and SLE status, as well as comorbidities at the time of infection, were retrospectively collected. A comparison with sex- and age-matched SLE controls without bacteremia was made. A logistic regression was conducted. Results: The study included 114 episodes of bacteremia in 83 patients. The incidence rate was 2.7/1000 patient-years. At the time of bacteremia, the median age was 40.5 (range: 8-90) years, and 88.6% of patients were female. The Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index was 4 [interquartile range (IQR) 8]; 41% had an SLE flare (66% severe); Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index was 3 (IQR 4). A comorbidity was recorded in 64% of cases. At the time of bacteremia, 88.6% received corticosteroids (68.6% > 10 mg/day) and 57% immunosuppressors. Gram-negative bacilli, most frequently Escherichia coli (29.8%), caused 52.6% of the episodes. The bacteremia-related mortality was 14% and bacteremia was recurrent in 27.2% of cases. A dose-response relationship was found between corticosteroids and bacteremia risk. In the multivariate analysis, these factors were associated with bacteremia: elevated creatinine (OR 1.31, 95% CI 1.01-1.70; p = 0.045), diabetes (OR 6.01, 95% CI 2.26-15.95; p < 0.001), cancer (OR 5.32, 95% CI 2.23-12.70; p < 0.001), immunosuppressors (OR 6.35, 95% CI 3.42-11.77; p < 0.001), and damage (OR 1.65, 95% CI 1.31-2.09; p < 0.001). Conclusion: Bacteremia occurred mostly in patients with active SLE and was frequently associated with severe flares and corticosteroid use. Recurrence and mortality were high. Immunosuppressors, comorbidities, and disease-related damage were associated with bacteremia. This work was supported by the Spanish Foundation of Rheumatology. JMPR is supported by grant 316265 (BIOCAPS) from the European Union 7th Framework Programme (FP7/ REGPOT-2012-2013.1) and FIS/ISCIII-Fondo Europeo de Desarrollo regional (FEDER) (Grant number PI11/02857).

Introduction Antiphospholipid antibodies (aPL) have been associated with organ damage and certain features in systemic lupus erythematosus(SLE) patients. Our aim was to investigate the differences between SLE patients according to the presence of aPL and/or clinical antiphospholipid syndrome (APS). Materials and methods Patients from the RELESSER-T registry were included. RELESSER-T is a Spanish multicenter, hospital-based, retrospective, SLE registry. Results We included 2398 SLE patients, 1372 of whom were positive for aPL. Overall 1026 patients were classified as SLE, 555 as SLE-APS and817 as SLE-aPL. Regarding cardiovascular risk factors, SLE-APS patients had higher rates of hypertension, dyslipidemia and diabetes than those with SLE-aPL and SLE ( p Conclusions SLE-APS patients exhibited more severe clinical profiles with higher frequencies of major organ involvement, greater damage accrual and higher mortality than SLE-aPL and SLE patients.

El diagnóstico y tratamiento de las enfermedades autoinmunes sistémicas (EAS) constituye un reto. Aunque infrecuentes, afectan a cientos de miles de pacientes en España. El médico de familia (MF) se enfrenta a síntomas o signos inespecíficos que hacen sospechar EAS al inicio del proceso, y tiene que decidir a quiénes debería derivar. Para facilitar su reconocimiento y mejorar su derivación, expertos de la Sociedad Española de Medicina de Familia y Comunitaria y de la Sociedad Española de Reumatología seleccionaron 26 síntomas/signos-guía y alteraciones analíticas. Se escogieron parejas de MF y reumatólogo para elaborar algoritmos diagnósticos y de derivación. Posteriormente se revisaron y adaptaron al formato de aplicación para móviles (app) descargable. El resultado es el presente documento de derivación de EAS para MF en formato de papel y app. Contiene algoritmos de fácil manejo utilizando datos de la anamnesis, exploración física y pruebas analíticas accesibles en atención primaria para orientar el diagnóstico y facilitar la derivación a reumatología o a otras especialidades. Management of systemic autoimmune diseases is challenging for physicians in their clinical practice. Although not common, they affect thousands of patients in Spain. The family doctor faces patients with symptoms and non-specific cutaneous, mucous, joint, vascular signs or abnormal laboratory findings at the start of the disease process and has to determine when to refer patients to the specialist. To aid in disease detection and better referral, the Spanish Society of Rheumatology and the Spanish Society of Family Medicine has created a group of experts who selected 26 symptoms, key signs and abnormal laboratory findings which were organized by organ and apparatus. Family doctors and rheumatologists with an interest in autoimmune systemic diseases were selected and formed mixed groups of two that then elaborated algorithms for diagnostic guidelines and referral. The algorithms were then reviewed, homogenized and adapted to the algorithm format and application for cell phone (apps) download. The result is the current Referral document of systemic autoimmune diseases for the family doctor in paper format and app (download). It contains easy-to-use algorithms using data from anamnesis, physical examination and laboratory results usually available to primary care, that help diagnose and refer patients to rheumatology or other specialties if needed. Sin financiación No data JCR 2020 0.271 SJR (2020) Q4, 50/58 Rheumatology No data IDR 2020 UEM

MUC5B rs35705950 (G/T) is strongly associated with idiopathic pulmonary fibrosis (IPF) and also contributes to the risk of interstitial lung disease (ILD) in rheumatoid arthritis (RA-ILD) and chronic hypersensitivity pneumonitis (CHP). Due to this, we evaluated the implication of MUC5B rs35705950 in antisynthetase syndrome (ASSD), a pathology characterised by a high ILD incidence. 160 patients with ASSD (142 with ILD associated with ASSD [ASSD-ILD+]), 232 with ILD unrelated to ASSD (comprising 161 IPF, 27 RA-ILD and 44 CHP) and 534 healthy controls were genotyped. MUC5B rs35705950 frequency did not significantly differ between ASSD-ILD+ patients and healthy controls nor when ASSD patients were stratified according to the presence/absence of anti Jo-1 antibodies or ILD. No significant differences in MUC5B rs35705950 were also observed in ASSD-ILD+ patients with a usual interstitial pneumonia (UIP) pattern when compared to those with a non-UIP pattern. However, a statistically significant decrease of MUC5B rs35705950 GT, TT and T frequencies in ASSD-ILD+ patients compared to patients with ILD unrelated to ASSD was observed. In summary, our study does not support a role of MUC5B rs35705950 in ASSD. It also indicates that there are genetic differences between ILD associated with and that unrelated to ASSD, This study was partially supported by grants from the Foundation for Research in Rheumatology (FOREUM). RL-M is a recipient of a Miguel Servet type I programme fellowship from the ‘Instituto de Salud Carlos III’ (ISCIII), cofunded by the European Social Fund (ESF, ‘Investing in your future’) (grant CP16/00033). SR-M is supported by funds of the RETICS Program (RD16/0012/0009), co-funded by the European Regional Development Fund (ERDF). VP-C is supported by a pre-doctoral grant from IDIVAL (PREVAL 18/01). VM is supported by funds of a Miguel Servet type I programme (grant CP16/00033) (ISCIII, co-funded by ESF). LL-G is supported by funds of PI18/00042 (ISCIII, co-funded by ERDF). OG is Staff Personnel of Xunta de Galicia (Servizo Galego de Saude, SERGAS) through a research-staff stabilization contract (ISCIII/SERGAS). OG,is member of RETICS Programme, RD16/0012/0014 (RIER: Red de Investigación en Inflamación y Enfermedades Reumáticas) via Instituto de Salud Carlos III (ISCIII) and FEDER. The work of OG (PI17/00409), was funded by Instituto de Salud Carlos III and FEDER. OG is a beneficiary of a project funded by Research Executive Agency of the European Union in the framework of MSCA-RISE Action of the H2020 Programme (Project number 734899). OG is beneficiary of a grant funded by Xunta de Galicia, Consellería de Educación, Universidade e Formación Profesional and Consellería de Economía, Emprego e Industria (GAIN), GPC IN607B2019/10

The aim of the study is to benchmark the use and attributed importance of well-established prognostic factors in rheumatoid arthritis (RA) in daily clinical practice, and to contrast the use of factors with their ability to predict outcome. Medline was searched (inception-Sep. 2016) for systematic reviews on factors predicting death, disability, structural damage or remission in RA. All factors identified were compiled in a matrix of factors × outcomes, and scoping reviews for each cell were then performed. A survey to 42 rheumatologists randomly selected explored the use of the list of prognostic factors and inquired about the perceived strength of association with poor prognosis. In a second round, participants were exposed to evidence from the matrix and to responses from other participants. Change on perceived strength of association was evaluated. Rheumatologists report using prognostic factors in clinical practice on a daily basis. Very young onset, joint counts at diagnosis, rheumatoid factor, ACPA, and radiographic erosions are used frequently and correctly recognized as strong predictors. Comorbidities and other associated problems, such as obesity, low bone mineral density, cardiovascular disease, or extra-articular manifestations, are perceived as moderately associated to prognosis but, nevertheless, rheumatologists also use them profusely. Genetic and other biomarkers and osteitis by magnetic resonance are less accessible in daily practice and they obtained better results on second round (probably after knowing the strength of association with prognosis). Rheumatologists use widely most prognostic factors with a strong predictive value. However, factors with low evidence of prognostic value are also used and some factors are not used despite good evidence. Sin financiación 2.200 JCR (2018) Q3, 21/31 Rheumatology 0.830 SJR (2018) Q2, 23/66 Rheumatology No data IDR 2018 UEM

Leptin is an adipokine that participates in the regulation of the immune and inflammatory response. Chronic systemic inflammation contributes to the development of cardiovascular (CV) disease in rheumatoid arthritis (RA). In this study, we aimed to assess the short-term effect of the anti-IL-6 receptor tocilizumab (TCZ) administration on circulating leptin concentrations in patients with RA, as well as the potential association of leptin with CV risk factors and demographic and clinical characteristics of these patients.We recruited 50 consecutive non-diabetic patients with RA undergoing periodic treatment with TCZ. Leptin serum levels were determined by a commercial immunoassay kit in samples obtained immediately prior to (pre-infusion) and 60 minutes after the end of a TCZ intravenous infusion (post-infusion).A significant reduction of leptin levels was observed following the TCZ infusion (9.24±7.98 ng/mL vs. 7.92±7.32 ng/mL, pre- and post-infusion, respectively, p=0.002). Additionally, there was a strong positive correlation between body mass index of RA patients and basal levels of leptin (r=0.56; p=0.0001). Moreover, high basal levels of leptin in RA patients were associated with female sex (p=0.006), obesity (p0.001) and rheumatoid factor negative status (p=0.006).Our study disclosed a short-term effect of anti-IL-6 therapy on leptin serum levels in RA patients. Decreased leptin levels may explain the beneficial effect of anti-IL-6 blockade on CV disease associated to RA.

Resumen Objetivos Desarrollar recomendaciones sobre el uso de metrotexato (MTX) parenteral en pacientes con enfermedades reumaticas, fundamentalmente en la artritis reumatoide, basadas en la mejor evidencia y experiencia. Metodos Se selecciono un grupo de 21 expertos reumatologos en el manejo de MTX. El coordinador genero 13 preguntas sobre el uso de MTX parenteral (perfiles de indicacion, eficacia, seguridad, costo-eficacia y biodisponibilidad) para ser contestadas mediante una revision sistematica de la literatura. Con base en las preguntas se definieron los criterios de inclusion y exclusion, y las estrategias de busqueda (en Medline, EMBASE y la Cochrane Library). Tres revisores seleccionaron los articulos resultantes de la busqueda. 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 genero 13 recomendaciones preliminares que se evaluaron, discutieron y votaron en una reunion del grupo nominal con los expertos. Para cada recomendacion se establecio el nivel de evidencia y grado de recomendacion, y el grado de acuerdo mediante un Delphi. Se definio acuerdo si al menos el 80% de los participantes contestaron si a la recomendacion (si o no). Resultados La mayoria de la evidencia proviene de la artritis reumatoide. De las 13 recomendaciones preliminares se aceptaron 11 recomendaciones sobre el uso de MTX parenteral en reumatologia. Dos no se llegaron a votar y se decidio no incluirlas, pero se comentan en el texto final. Conclusiones Este documento pretende resolver algunos interrogantes clinicos habituales y facilitar la toma de decisiones con el uso de MTX parenteral.

Objective To date, between 17% and 35% of patients with rheumatoid arthritis (RA) do not respond as expected to the initial biological therapy. The objective of this project is to recognize and weigh the attributes of biologic DMARD (bDMARD) to identify the most appropriate for each case, in the first lines of treatment of RA (after inadequate response to at least one synthetic DMARD or previous bDMARD). Methods To recognize the possible attributes that could define the bDMARD, we performed a systematic search of the literature that recognized the possible attributes involving general aspects, pharmacology, efficacy, safety, management, and cost. Then a Delphi process was conducted with two rounds among a group of selected expert rheumatologists in the management of RA indicating the degree of agreement with the attributes identified in the literature. The project was completed between February and September 2015, indicating the degree of importance that was ascribed to each attribute. Two criteria were applied to determine the consistency of results: (1) based on the median and interquartile range; and (2) on the simultaneous compliance with mean, median, standard deviation, interquartile range and coefficient of variation. The agreement and final ratification of the expert panel were also determined. Results Eighty-three Spanish rheumatologists participated and completed both rounds of the Delphi process. In no case was the importance of the 77 attributes identified considered to be low; 75 of 77 (97.4%) were considered highly important and 76 of 77 (98.7%) were ratified. Fifteen attributes had the support of 100% of the working group. Conclusions There was a high degree of agreement concerning the selected attributes. Fifteen of them had the support of 100% of the working group and could be considered the definition of the ideal bDMARD in the first lines of RA treatment.

Objective: To compare the prevalence of the main comorbidities in two large cohorts of patients with Primary Sjogren's Syndrome (pSS) and Systemic Lupus Erythematosus (SLE), with focus on cardiovascular (CV) diseases. Methods: Cross-sectional multicenter study where the prevalence of more relevant comorbidities in two cohorts was compared. Patients under follow-up from the SJOGRENSER (Spanish Rheumatology Society Register of pSS) and RELESSER (Spanish Rheumatology Society Register of SLE) registries, and who fulfilled the 2002-AECG and 1997-ACR classification criteria, respectively, were included. A binomial logistic regression analysis was carried out to explore potential differences, making general adjustments for age, sex and disease duration and specific adjustments for each variable, including CV risk factors and treatments, when it was judged appropriate. Results: A total of 437 pSS patients (95% female) and 2,926 SLE patients (89% female) were included. Mean age: 58.6 (p55-p75: 50.0-69.9) and 45.1 years (36.4-56.3), respectively (p

Objective The objective of this study was to describe the demographic, clinical, and immunological manifestations of systemic lupus erythematosus (SLE) in male patients. Methods A cross-sectional, multicenter study was carried out of 3651 patients (353 men, 9.7%, and 3298 women, 90.2%) diagnosed with SLE, included in the Spanish Rheumatology Society SLE Registry (RELESSER). Results Mean ages (18–92 years) of symptom onset were 37 (SD 17) years (men) and 32 (SD 14) years (women). Male/female ratio was 1/9. Age of onset of symptoms and age at diagnosis were higher in men than in women ( p 50 years had a higher mortality (odds ratios 3.6 and 2.1, respectively). Furthermore, SLE patients who developed pulmonary hemorrhage, pulmonary hypertension, psychiatric involvement, complement deficiency, and hemophagocytic syndrome also had higher mortality, regardless of gender. Conclusion Patients with SLE over the age of 50 years have an increased risk of mortality. In Caucasians, age at diagnosis and symptom onset is higher in men than in women. The diagnostic delay is shorter in men. Male SLE patients present more cardiovascular comorbidities, and also more serositis, adenopathies, splenomegaly, renal involvement, convulsion, thrombosis, and lupus anticoagulant positivity than women.

The objective of this study was to evaluate the impact of digital ulcers (DUs) in daily life of systemic sclerosis (SSc) Spanish patients. We developed a multicenter observational study to compare functional disability in SSc patients with active DUs vs. those without DUs. An additional correlation between perception of patients and physicians on disability due to DUs was performed. A total of 199 patients were enrolled, 70 (35%) with DUs. Patients with DUs were younger (48 vs. 58 years; p

Background Little is known about the patient related outcomes and disease activity in systemic lupus erythematosus. Damage and impact are issues that have not been associated with activity in lupus previously. Objectives In a large cohort of systemic lupus erythematosus (SLE) patients, to evaluate the association between a Patient Acceptable Symptom State (PASS) and three different domains of the disease: activity, damage and impact of SLE on patients’ lives Methods Cross-sectional study of 1,364 SLE (ACR 97 Criteria) patients from the Spanish Society of Rheumatology Lupus Registry (RELESSER). Patients were clinically assessed by the physicians, who collected data about demographics, clinical manifestations, laboratory features and therapies. SLE activity was assessed by using the SLEDAI (SLE Disease Activity Index). The Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR DI) was used to measure damage accrual. The impact of SLE on patients’ lives was evaluated by using the Lupus Impact Tracker (LIT). The PASS question “Considering all the different ways your disease is affecting you, if you would stay in this state for the next months, do you consider that your current state is satisfactory?” was answered in a dichotomized way: yes/no. Measures of central tendency and spread were used to describe responses and T-test was used to evaluate the independence between PASS and the other questionnaires and indices. Results Mean age (years) ± S.D. of the 1,364 patients included in the study was 49.9 ± 13.3; 90.3% were female and 94.9% were Caucasian. In the total of patients, 979 (71.8%) were in PASS. Patients in PASS had significantly lower activity (SLEDAI Score) than those not in PASS (2.4 ± 3.2 vs. 3.0 ± 3.9, respectively; p=0.007). The SLICC/ACR DI was significantly lower in the group of patients in PASS compared to those without PASS (0.64 ± 1.1 vs. 0.81 ± 0.21, respectively; p=0.022). SLE had a significantly lower impact on patients in PASS in comparison to those without PASS (LIT Score: 8.47 ± 7.5 vs. 19.8 ± 8.34, respectively; p=0.001). Conclusion In the largest observational European Registry of SLE patients, PASS was associated with other domains of the disease: activity, damage and impact on patients’ life. PASS is a simple and reliable patient-reported outcome that can be a useful tool to evaluate patients’ well-being. Disclosure of Interests Tomas Vazquez Rodriguez: None declared, Inigo Rua Figueroa: None declared, Victor Del Campo Perez: None declared, J. Narvaez Consultant for: Bristol-Myers Squibb, Francisco J Lopez-Longo: None declared, Maria Galindo-Izquierdo: None declared, Jaime Calvo-Alen: None declared, Antonio Fernandez-Nebro: None declared, Juan Ovalles: None declared, Pilar Rubio Munoz: None declared, Eva Tomero Muriel: None declared, Coral Mourino Rodriguez: None declared, Esther Uriarte Isacelaya: None declared, Angela Pecondon-Espanol: None declared, Mercedes Freire Gonzalez: None declared, Ricardo Blanco Grant/research support from: Abbvie, MSD, and Roche, Consultant for: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen, Speakers bureau: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen, Marian Gantes Mora: None declared, Monica Ibanez Barcelo: None declared, Carlos A. Montilla-Morales: None declared, Jose M Pego-Reigosa: None declared

Objectives: To estimate the incidence of cancer in systemic lupus erythematosus (SLE) patients and to analyze factors associated with cancer differentiating between hormone-sensitive (HS) and non-HS cancers. Methods: Multicenter retrospective study of a cohort of patients included in Spanish Society of Rheumatology Lupus Registry (RELESSER). The first cancer after the diagnosis of SLE, sociodemographic, clinical, activity, cumulative damage, severity, comorbidity, treatments, and refractory disease data were collected. Cancers were classified into HS (prostate, breast, endometrial and ovarian) and non-HS (the rest). Standardized incidence ratio (SIR) was calculated and logistics regression models were constructed to identify factors associated with cancer. Results: We included 3539 patients (90.4% women) with SLE (ACR-97 criteria), of whom 154 had cancer (91% women), and 44 were HS (100% women). The SIR for cancer was 1.37 (95% CI: 1.15-1.59), reaching higher values in women under 65 years [2.38 (95% CI: 1.84-2.91)]. The SIR in women with cancer HS vs. non-HS was 1.02 (95% CI: 0.13-1.91) and 1.93 (95% CI: 0.98-2.89)], respectively. In HS vs. non-HS cancers, age at diagnosis of SLE [Odds ratio (OR) 1.04 (p = 0.002) vs. 1.04 (p = 0.019), respectively] and the evolution time [OR 1.01 (p Conclusion: The incidence of cancer in patients with SLE is increased compared to the Spanish population, specially in younger women. This increase might be due to non-HS cancers. SLE with more cumulative damage and more prescription of ACE inhibitors might associate with non-HS cancers. Disclosure of Interests: Tatiana Cobo-Ibanez: None declared, ANA URRUTICOECHEA-ARANA: None declared, Inigo Rua-Figueroa: None declared, Maria Auxiliadora Martin-Martinez: None declared, Juan Ovalles: None declared, Maria Galindo-Izquierdo: None declared, Jaime Calvo-Alen: None declared, Alejandro Olive: None declared, Antonio Fernandez-Nebro: None declared, Raul Menor-Almagro: None declared, Eva Tomero Muriel: None declared, Loreto Horcada: None declared, Esther Uriarte Isacelaya: None declared, Victor Martinez Taboada: None declared, Jose Luis Andreu: None declared, Alina Boteanu: None declared, J. Narvaez Consultant for: Bristol-Myers Squibb, Cristina Bohorquez: None declared, Carlos A. Montilla-Morales: None declared, Gregorio Santos Soler: None declared, Blanca Hernandez-Cruz: None declared, Paloma Vela-Casasempere Grant/research support from: UCB, Abbvie, Pfizer, Roche, Bristol-Myer-Squibb (another research, not BIOBADASER related), Consultant for: UCB, Lilly, Pfizer, Roche, Bristol-Myer-Squibb, Speakers bureau: Roche, UCB, MSD, Pfizer, GSK, BMS, Lilly, Eva Salgado Perez: None declared, Mercedes Freire Gonzalez: None declared, Jose A Hernandez Beriain: None declared, Elvira Diez Alvarez: None declared, Lorena Exposito: None declared, Olaia Fernandez- Berrizbeitia: None declared, Jose Luis Marenco Speakers bureau: abbie, pfizer, novartis, janmsen, Jose M Pego-Reigosa: None declared

Background Remission and Low Disease activity state (LDAS) are physician assessed treat to target-T2T outcomes for Systemic Lupus Erythematosus (SLE). Lupus Impact Tracker (LIT), a ten-item unidimensional patient reported tool has good psychometric properties and responds to patient reported changes in health, physician based disease activity (DA) and composite response Index (SRI). Herein we report responsiveness of LIT to changes in physician (T2T) and patient assessed outcomes (DA by SLAQ and health status (EQ5D)) among SLE patients from the largest European SLE registry- cohort. Methods One-year longitudinal, observational, multi-center data from 1364 adult patients with SLE meeting 1997 ACR criteria were obtained from baseline and year 1 visit. This included demographics, patient reported tools (LIT, EQ5D VAS, SLAQ), SLE (activity-SLEDAI) and medications. Remission off therapy (ROFT) was defined as SLEDAI=0 without prednisone or Immunosuppressive/s. Remission on-therapy (RONT) was SLEDAI=0 and a prednisone dose 5 mg/day and/or Immunosuppressive/s (maintenance dose). LDAS (modified) was defined as SLEDAI 4, prednisone dose 9 mg/day and/or maintenance immunosuppressive/s. Non-optimal (NO) disease status was SLEDAI >4 and/or prednisone dose >9 mg/day and/or immunosuppressive/s in induction dose. Use of hydroxychloroquine was permitted in all groups. LIT values were compared using mixed models. Responsiveness was evaluated by standard response means (SRM) in groups with changes in DA (T2T, SLAQ) and EQ5D VAS as anchors. We did not have enough observations for stratified analysis for SLE patients with fibromyalgia. Results 1232/1364 (90%) were women, and 95% were Caucasian. Mean (SD) SLEDAI and SDI were 2.6 (3.5) and 0.7 (1.1) respectively. As (i) DA was low (median 2) in LDAS, (ii) steroid use was more prevalent in RONT than LDAS, we combined RONT and LDAS into one category to analyse patient relevant differences in LIT. LIT was responsiveness in the appropriate direction with improvement and worsening in disease activity (T2T and SLAQ) and health status (EQ5D VAS) over time. Mean LIT changes to and from NO to RONT/LDAS ranged from 3–5 (table 1), while it declined by over 8.5 with change from NO to ROFT. We had limited observations for ROFT to NO change. Mean change in LIT ranged from −3 to 3 with improvement and worsening in SLAQ, and from −7.6 to 6 with improvement and worsening in EQ5D VAS. Conclusions LIT responds appropriately in both directions to changes in physician (T2T) as well as patient relevant (DA and health status) outcomes among Spanish SLE patients. Funding Source(s): None

Background The clinical coexistence of Systemic Lupus Erythematosus (SLE) and Sjogrens Syndrome (SS) was recognized in 1959. The prevalence of SS among patients with SLE varies considerably among the published studies (10%–30%). There is still controversy as to whether or not SLE patients with overlapping SS have a distinct and significantly milder lupus. To address the clinical and serologic features of SLE and differences from SLE that occurs in overlap with SS. Methods This is a multicenter, descriptive, cross-sectional study of 3575 patients from the Spanish Society for Rheumatology Lupus Registry (RELESSER). Unselected SLE patients from 45 Rheumatology Departments across Spain were evaluated for the presence of overlapping SS using the American-European consensus criteria. Cumulative clinical data were collected at the moment of the last assessment. Clinical and laboratory parameters in SLE patients with SS (SLEwSS) were compared with those in SLE patients without SS (SLEwoSS). Results SS was identified in 516 SLE patients (14.4%). Compared with the SLEwoSS group, patients with SLEwSS were significantly older, had a higher frequency of mucocutaneous manifestations, Raynauds phenomenon, peripheral neuropathy, anti-Ro/SSA, anti-La/SSB, neoplasia, and older age at death, but had a significantly lower frequency of renal involvement, thrombocytopenia, anti-dsDNA, anti-2-GPI IgM and complement consumption. Both groups displayed a clinically similar presentation of lymphadenopathy, systemic vasculitis, serositis, damage accrual, mortality, musculoskeletal and CNS manifestations. Conclusions SLEwSS appears to constitute a subgroup of SLE patients with distinct clinical and serologic features, in whom SS is expressed as an overlapping entity. A particular cluster of clinical variables, namely, mucocutaneous manifestations, Raynauds phenomenon, peripheral neuropathy, renal involvement and thrombocytopenia, was found to be important overall for discriminating SLE patients with or without SS. SLEwSS patients constitute a subgroup of patients with SLE characterized by milder lupus: older age at death, similar rates of mortality and SLICC-ACR damage index, less renal and immunological manifestations. Funding Source(s): None

To estimate the agreement level between patient and physician assessment of disease activity and to explore whether agreement is associated with adherence to subcutaneous (SC) biological drugs in rheumatoid arthritis (RA). Cross-sectional study of RA patients who had been prescribed a SC biological drug in the past 12–18 months was performed. Patients and physicians global disease activity on visual analogue scale (VAS) were collected. Disagreement was defined as an absolute difference ≥ 3 points between VAS scores. Adherence was assessed by the Medication Possession Ratio (MPR), considering adherence an MPR > 80%. We analysed 360 patients of whom 15.5% presented disagreement with their physicians. The mean patient global VAS was 5.75 ± 1.8 (median 5.5 [5–7]) in the disagreement group versus 2.7 ± 2.2 (median 2 [1–4]) in the agreement group (p

Introduction: The role of the immune response in the pathogenesis of antiphospholipid syndrome (APS) remains elusive. It is possible that differences in the frequencies of Th17 cells and/or defects in the immunoregulatory mechanisms are involved in the pathogenesis of APS. Our aim was to determine the peripheral blood Th cells phenotype and the circulating cytokine profile in patients with primary APS (pAPS) and compare it with systemic lupus erythemathosus (SLE) as disease control group. Methods: The frequencies of circulating regulatory T cells (Tregs) were determined in PBMCs from 36 patients with pAPS by flow cytometry. As control groups we included 21 age- and gender-matched healthy controls (HC) and 11 patients with SLE. The suppressive capacity of Tregs was evaluated in vitro by coculture assay. On the other hand, intracellular cytokine production was assessed in Th1, Th2, and Th17 cells and circulating IL-6, IL-10, and IL-35 were measured by Cytometric Bead Array and ELISA. The quantification of Th master gene expression levels was performed by real time quantitative PCR. Results: pAPS patients and SLE patients did not show differences in the percentage or number of Tregs compared to HC. The suppressive capacity of Tregs was also similar in the three study group. Instead, we found higher FoxP3·mRNA expression levels in pAPS patients and HC than SLE patients. Regarding the Th17 response, patients with pAPS and HC showed a significantly lower frequency of circulating Th17 cells than SLE. However, no differences were observed in the Th1 response between patients and controls. Thus, increased Th17/Th1 and Th17/Treg ratios were found in SLE patients but not in pAPS patients. pAPS and SLE patients had higher serum IL-6 levels than HC but there was not difference between both disease groups. Besides, a significant increase in the immunosuppressive cytokine levels was observed only in pAPS as compared to HC. Conclusions: Our data demonstrate an increased inflammatory profile of peripheral blood CD4+ T cells from SLE as compared with pAPS mostly due to an increased Th17 response. In conclusion, there seems not to be a direct pathogenic role for Th cells in pAPS but in SLE.

Background:Climatological conditions and ethnicity impact on the course of the disease in systemic lupus erythematosus patients.Objectives:We carry out a study to analyze cutaneous manifestations in SLE patients from Argentina and Spain.Methods:Patients data from Spanish Rheumatology Society Lupus Registry (RELESSER) and Argentina Rheumatology Society Lupus Registry (RELESSAR) were retrospectively analyzed for presence of cutaneous lesions (alopecia, photosensitivity, malar rash, discoid lesions, oral ulcers and subacute lesions). RELESSER-T and RELESSAR-T are multicenter, hospital-based registries, with retrospective cross-sectional collection of data about patients with SLE attending Spanish and Argentinian rheumatology services from the public national health system. Data about climatological conditions throughout the Spanish and Argentinian geography were provided by the Spanish Meteorological Agency and Argentine Meteorological Services.Results:A total of 5604 patients were included, median age 44.6 ± 15.3, 90.4 % female. Current smokers were 28,9%. Other climatological, geographical, biological and clinical data are shown in table 1. In the multivariable model, the presence of cutaneous lesion were significantly associated with temperature OR 1.116 (95% CI:1.042-1.196 p=0,002), altitude OR 1.001 (95% CI:1.000-1.001, p=0.012), hemolytic anemia OR 1.401 (95% CI:1.017-1.931 p=0.039) and serositis OR 1.509 (95% CI:1.215-1.875 p=0.000). Negative associations were observed between females OR 0.392 (95% CI:0.297-0.518, p=0.000), latitude OR 0.994 (95% CI:0.988-0.999, p=0.000), oceanic climate OR 0.566 (95% CI:0.381-0.842, p=0.005), leukopenia OR 0.790 (95% CI:0.643-0.970, p=0.025), renal disorder OR 0.761 (95% CI:0.600-0.966, p=0.025), glucocorticoids treatment OR 0.571 (95% CI:0.456-0.715, p=0.000) and antimalarial drugs OR 0.439 (95% CI:0.342-0.563, p=0.000).Table 1.Geographical, climatological and clinical/laboratory variables.No cutaneous manifestationsCutaneous manifestationspLatitude, median (interqualite range)40.47 (38.35-41.63)40.37 (-31.41-41.34)0.001Altitude, median (interqualite range)192.0 (37.0-698.0)156.0 (25.0-609.0)0.000Temperature, mean monthly ± SD15.2 ± 3.515.3 ± 3.60.000Humidity, mean monthly ± SD66.9 ± 7.267.4 ± 7.10.108Oceanic climate, n (%)307 (11)2406 (89)0.000Subhumid/altitude climate, n (%)17 (7)240 (93)0.002Mediterranean climate, n (%)292 (17)1434 (83)0.000Arthritis, n (%)523 (12)3722 (88)0,003Serositis, n (%)254 (16)1368 (84)0,000Renal disorder, ever, n (%)206 (11)1576 (89)0.015Hemolytic anemia, n (%)90 (17)426 (83)0,002Leukopenia, n (%)345 (11)2669 (89)0.000Thrombocytopenia, n (%)170 (15)986 (85)0.076Antiphospholipid antibodies, n (%)293 (15)1606 (85)0.000Anti DNA, n (%)522 (14)3279 (86)0.044Anti-Ro/SSA, n (%)189 (11)1563 (89)0.000Hypocomplementemia, n (%)510 (12)3736 (88)0.000Glucocorticoids mucocutaneous cause, ever, n (%)499 (11)3928 (89)0.000Antimalarial drug: ever, n (%)500 (11)4034 (89)0.000Conclusion:In the current analysis, taking RELESSAR and RELESSER data together, we observe positive association between higher temperature and skin lesion and negative association with living in southern hemisphere latitudes.References:Influence of Solar Radiation in Cutaneous Manifestations of Lupus: Data from the Gladel Cohort [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10).Disclosure of Interests:Raúl Menor-Almagro: None declared, Mercedes Argentina García: None declared, Iñigo Rua-Figueroa: None declared, Guillermo Pons Estel: None declared, Maria Auxiliadora Martin-Martinez: None declared, Alejandro Muñoz Jimenez.: None declared, María Galindo-Izquierdo: None declared, Jaime Calvo-Alen: None declared, Antonio Fernandez-Nebro: None declared, Alejandro Olive: None declared, Bernardo Pons-Estel Grant/research support from: GSK, Janssen, Consultant of: GSK, Janssen, Speakers bureau: GSK, Janssen, Jose M Pego-Reigosa: None declared

Background:Serious infections are one of the most feared adverse events in patients treated with biologics. To this regard data coming from randomized and long-term extension studies may not totally applied to the usual clinical practice due to the different profile of the treated patients. To study the associated factors for serious infections in patients with inflammatory arthritis treated with TNF inhibitorsObjectives:To study the associated factors for serious infections in patients with inflammatory arthritis treated with TNF inhibitorsMethods:All the medical records of the patients with inflammatory arthritis being treated with TNF inhibitors at the beginning of 2016 were retrospectively reviewed. All serious infections suffered for these patients until the end of 2018 were recorded. Serious infections were defined as those which required to admitted at the hospital for intravenous treatment. Potential variables associated with the development of these infections including: demographic and clinical characteristics, concomitant treatments or comorbidity (by Charlson index) were studied. Standard statistical tests for descriptive and univariate analyses were used and a multivariable logistic regression model was built to check independent associations.Results:Overall 334 patients (50.3% women) with a mean age of 56.67 (±12.853) were studied: 140 (41.92%) Rheumatoid arthritis (RA), 55 (16.46%) psoriatic arthritis (PsA) and 138 (41.62%) spondyloarthritis (Sp). Forty-five serious infections were observed in 30 patients, being respiratory (40%) and urinary (8.8%) the most frequent localizations. Only one patient died. By univariate analysis, disease duration, age, concomitan use of glucocorticoids (GC) (but not of synthetic DMARDs), Charlson index and specifically Diabetes Mellitus were associated with infection (p< 0.05). The type of arthritis was not associated and the results in the subset of RA patients were overall similar. In the multivariate analysis the use of GC [OR: 5.31 (1.98.14.26)] and the Charlson index [OR:2.48 (1.70;3.60)] were found to be independently associated to infection.Conclusion:In patients with inflammatory arthritis and treated with TNF inhibitors around a 10% developed any serious infection along three years of follow up. Use of GC and comorbidity emerged as the main risk factors for this complication.Disclosure of Interests:None declared