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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.

BackgroundSerum calprotectin (SC) is an emerging biomarker in the measurement of inflammation. It can be determined by different techniques, such as enzyme immunoassay (EIA) or chemiluminescence (CLIA). However, there are no studies comparing whether there is a correlation between the two diagnostic methods in paediatric rheumatologic diseases.Objectives(i) To assess whether there are differences between serum calprotectin (SC) levels determined by EIA (Bühlmann) method and CLIA (QUANTA Flash) in pediatric age patients with systemic autoimmune rheumatic disease (SARD). (ii) To evaluate which clinical and analytical variables are associated with an increase of SC in each method.MethodsAnalytical cross-sectional study that included patients from a pediatric rheumatology specialized unit between 02/2017 and 05/2021. We included 41 patients with SARD who had at least one SC analysis determined by EIA in their routine controls (144 serum) and afterwards had SC determined again, this time using the CLIA method.The collected variables were sex, age, remission according to clinical judgment, swollen joint count according to physical examination (PE Count) and ultrasound (US Count), Juvenile Arthritis Disease Activity Score according to physical examination (PE JADAS-27) and ultrasound (US JADAS-27), C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR).As for the statistical analysis, intraclass correlation (ICC) and paired samples t-test were performed to compare the two methods. Univariate linear regression was performed to study the association between EIA, CLIA and both clinical and analytical variables.ResultsWe included 41 patients, 50.1% were women with a mean age (± SD) of 13.1 (± 3.8) years. The details of their descriptive characteristics were: mean SC (EIA) of 3.1 (±1.8) µg/ml, mean SC (CLIA) of 2.5 (±1.6) µg/ml, mean CRP of 2.6 (± 6.5) mg/l, mean ESR of 10.1 (± 11) mm/h, and mean PE JADAS-27 of 2.8 (± 8). Most frequent diagnosis was oligoarticular juvenile idiopathic arthritis (JIA) (24.4%), followed by enthesitis-related (ERA) JIA (12.2%) and polyarticular JIA (12.2%), familial Mediterranean fever (FMF) (9.8%), psoriatic JIA (4.9%), systemic JIA (4.9%) and syndrome of periodic fever, aphtous stomatitis, pharyngitis, and cervical adenitis (PFAPA) (4.9%), vasculitis (4.8%), and undifferentiated JIA (2.4%). Clinical diagnosis was unspecific in 9.8% of the patients. In our sample, 66.7% were in clinical remission at the discretion of the specialist.A statistically significant Pearson’s CCI of 0.77 (95%CI 0.70-0.83; p=0.00) was observed as a single measure between EIA and CLIA and with an average of 0.87 (95%CI=0.82-0.91; p=0.000). Figure 1 shows the dispersion of this correlation.On the other hand, we observed a statistically significant difference in the mean between both methods of 0.58 (95%CI=0.40-0.77; p=0.000), observing a greater difference in SC (EIA) > 4 µg/ml.A significant association was observed between EIA and clinical remission, joint count, JADAS and CRP; and also between CLIA and clinical remission, JADAS and CRP. The analysis performed is shown in Table 1.Table 1.Association between EIA and CLIA with clinical and analytical variables.RemissionPE CountUS CountPE JADASUS JADASbpbpbpbpbpSC(EIA)0.430.0110.140.0270.080.0240.090.0000.060.000SC(CLIA)0.530.000-0.000.9450.310.3200.050.0210.040.015SexGenderESRCRPbpbpbpbpSC(EIA)0.000.9970.050.2070.000.4870.050.027SC(CLIA)-0.240.3620.010.7950.020.1050.080.000b, regression coefficient; p, statistical significance.ConclusionThere is a good correlation between EIA and CLIA methods to determine SC in pediatric patients with SARD. Significant differences were observed between both methods above the value of 4 µg/ml. This fact could be explained by methodological differences, since CLIA discriminates better at higher values than EIA.An association was observed between both methods and variables of remission or disease activity.Disclosure of InterestsNone declared

Resumen Objetivo Elaborar recomendaciones SER sobre el uso de agentes biologicos en el sindrome de Sjogren primario (SSp). Metodos Se identificaron preguntas clinicas de investigacion relevantes sobre el uso de agentes biologicos en el SSp. Las preguntas clinicas se reformularon en 4 preguntas PICO. Se diseno una estrategia de busqueda y se realizo una revision de la evidencia cientifica de estudios publicados hasta mayo de 2017. Se reviso sistematicamente la evidencia cientifica disponible. Se evaluo el nivel global de la evidencia cientifica utilizando los niveles de evidencia del SIGN. Tras ello, se formularon recomendaciones especificas. Resultados Se recomienda rituximab como el farmaco biologico de eleccion para las manifestaciones extraglandulares refractarias al tratamiento convencional. Se desaconseja el uso de agentes anti-TNF. La evidencia cientifica es escasa con belimumab y abatacept, por lo que deberian considerarse solamente en los casos resistentes a rituximab. Conclusiones El rituximab es el farmaco biologico de eleccion en las manifestaciones graves extraglandulares del SSp. Belimumab o abatacept podrian ser de utilidad en casos seleccionados.

Resumen Objetivo El paradigma actual en el tratamiento de la artritis reumatoide (AR) contempla el diagnostico temprano y el uso precoz de farmacos modificadores de enfermedad (FAME) para alcanzar la remision o baja actividad inflamatoria, lo cual, se conoce como «treat to target» (T2T). El objetivo del trabajo es desarrollar un indicador compuesto (IC) para evaluar la calidad asistencial en el manejo de los pacientes con AR atendiendo a la estrategia T2T y a otras recomendaciones generales para la atencion de estos pacientes. Material y metodo La construccion del IC siguio las fases: 1) seleccion de los criterios de calidad mediante un juicio de expertos ; 2) priorizacion de los criterios, a partir de un Delphi con 20 expertos; 3) diseno de los indicadores de calidad, y 4) calculo del IC ponderado. La fuente de informacion para el calculo del IC son las historias clinicas de los pacientes con AR. Resultados De los 37 criterios seleccionados, 12 necesitaron una segunda ronda Delphi. Se priorizaron 31 criterios, los cuales presentaron una mediana en relevancia y factibilidad, en las rondas Delphi, mayor o igual a 7,5, con un rango intercuartilico inferior a 3,5, y un grado de acuerdo (puntuacion mayor o igual a 8) igual o superior al 80%. Conclusiones El IC construido, consensuado y ponderado, permite evaluar la calidad asistencial de los pacientes con AR, en las Unidades de Reumatologia de hospitales espanoles, ofreciendo una medida resumen valida y facilmente interpretable.

Background Vagus nerve stimulation delivered with an implanted device has been shown to improve rheumatoid arthritis severity. We aimed to investigate the safety and efficacy of non-invasive stimulation of the auricular branch of the vagus nerve for the treatment of patients with moderately to severely active rheumatoid arthritis. Methods This prospective, multicentre, open-label, single-arm proof-of-concept study enrolled patients aged 18-80 years with active rheumatoid arthritis who had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and up to one biological DMARD. Biological DMARDs were stopped at least 4 weeks before enrolment and concomitant use was not allowed during the study. All eligible participants were assigned to use a non-invasive, wearable vagus nerve stimulation device for up to 30 min per day, which delivered pulses of 20 kHz. Follow-up visits occurred at week 1, week 2, week 4, week 8, and week 12 after the baseline visit. The primary endpoint was the mean change in Disease Activity Score of 28 joints with C-reactive protein (DAS28-CRP) at week 12 compared with baseline. Secondary endpoints included the mean change in the Health Assessment Questionnaire-Disability Index (HAQ-DI), the proportion of patients with a minimal clinically important difference of 0 center dot 22 on HAQ-DI, the proportion achieving American College of Rheumatology (ACR) 20, ACR50, and ACR70 response, and safety analysis. This study is registered with ClinicalTrials.gov (NCT04116866). Findings Of 35 patients screened for eligibility, 30 (86%) were enrolled at six centres in Spain between Dec 27, 2018, and Oct 24, 2019, of whom 27 (90%) completed the week 12 visit. The mean change in DAS28-CRP at 12 weeks was -1 & middot;4 (95% CI -1 & middot;9 to -0 & middot;9; p

BackgroundCurrent pharmacological treatments remain inadequate for a significant proportion of patients with rheumatoid arthritis (RA), and thus alternative treatment approaches are needed. Prior results from the first 12 weeks of a proof-of-concept (POC) study showed that ATHENS, a non-invasive high-frequency vagus nerve therapy, was well-tolerated with meaningful reductions in RA disease severity as measured by the American College of Rheumatology response criteria (ACR) and the Disease Activity Score using 28 joints (DAS28)[1].ObjectivesThe current analysis assessed long-term changes (52 weeks total follow-up) in disease activity as measured by ACR, DAS28, and the following MRI-assessed changes: synovitis, osteitis, bone erosion, and cartilage loss.MethodsFollowing the completion of the 12-week POC study, patients achieving a reduction in DAS28-CRP of ≥1.2 were given the option to enroll in the 9-month open-label extension (OLE) study. During the extension phase, patients were to use the wearable device for 15 minutes per day. Adjustment of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or biologic disease-modifying antirheumatic drugs (bDMARDs) were allowed during the OLE. Changes from baseline were assessed at 12 weeks (end of initial POC) and 52 weeks (end of the OLE). Structural damage and disease progression were evaluated by standardized MRI of the wrist and hand, with and without intravenous gadolinium-based contrast. MRIs were evaluated by two independent, central readers, blinded to clinical information and visit-order of the images, and were scored for synovitis, osteitis and bone erosion using the OMERACT-RAMRIS method. Cartilage loss was also determined using the 9-point cartilage loss scale (CARLOS).ResultsTwenty-seven of 30 patients completed the initial 12-week study, of whom 19 consented and entered the OLE. Of those 19 patients, 4 (21%) discontinued due to lack of efficacy, while the remaining 15 completed the 9-month extension. Due to the COVID-19 pandemic, 7 patients were unable to complete a 52-week MRI scan; MRI evaluations at baseline, 12 weeks, and 52 weeks were available for 8 patients.DAS28-CRP mean (standard deviation [SD]) change from baseline was -1.78 (1.01) at 12 weeks (n=19; pTable 1.Change in MRI OMERACT-RAMRIS from baseline to week 52ScoreBaseline (n=8)Week 12 (n=8)Week 52 (n=8)Change Week 12 vs BL (n=8)Change Week 52 vs BL (n=8)CARLOS, mean (SD)3.9 (5.6)3.9 (5.6)3.9 (5.6)0.0 (0.0)0.0 (0.0)Erosion, mean (SD)10.8 (10.3)10.5 (10.3)10.6 (10.3)-0.3 (0.4)-0.1 (0.8)Osteitis, mean (SD)2.8 (4.1)2.3 (3.7)1.0 (1.1)-0.5 (1.1)-1.8 (3.1)Synovitis, mean (SD)4.0 (4.2)4.1 (4.7)3.3 (4.0)0.1 (0.6)-0.7 (1.0)CARLOS = Cartilage loss score; OMERACT = Outcome Measures in Rheumatology; RAMRIS = Rheumatoid Arthritis Magnetic Resonance Imaging Scoring SystemDuring the 9-month extension study, two new adverse events were reported (cornea transplant and right hand dysesthesia) in 2 (11%) patients; neither was treatment-related and both resolved without intervention. No serious adverse events were reported.ConclusionIn patients with an initial treatment response to the Nēsos ATHENS therapy in the 12-week POC study, reductions in DAS28-CRP were sustained through 52 weeks. Although results should be interpreted cautiously given the small sample size and lack of control arm, MRI evaluation of synovitis, osteitis, bone erosion, and cartilage loss suggested no disease progression.References[1]Marsal, S., The Lancet Rheumatology, 2021. 3(4): p. e262-e269.Disclosure of InterestsCharles Peterfy Consultant of: Nesos Corp, Employee of: Spire Sciences, Héctor Corominas: None declared, Juan Jose de Agustin: None declared, Carolina Perez-Garcia: None declared, Maria Lopez Lasanta: None declared, Helena Borrell Paños: None declared, D Reina-Sanz: None declared, Raimón Sanmartí: None declared, J. Narváez: None declared, Jose Antonio Narvaez: None declared, Vivek Sharma Shareholder of: Nesos Corp., Employee of: Nesos Corp., Konstantinos Alataris Shareholder of: Nesos Corp., Employee of: Nesos Corp., Mark C. Genovese Shareholder of: Nesos Corp. and Gilead, Employee of: Gilead, Matthew Baker Shareholder of: Nesos Corp., Consultant of: Nesos Corp., Sara Marsal Consultant of: Nesos, Pfizer, Sandoz, Novartis, Gilead, Grant/research support from: Nesos, BMS, Celgene, Merck Sharp and Dohme, Pfizer, Sandoz, Novartis, Sanofi, Janssen, Union Chimique Belge Pharma

BackgroundInflammation of the valve attachment site may produce tissue degeneration near the atrioventricular node, which may lead to electrical conduction disturbances, that is to say atrioventricular block (AVB) and bundle branch block (BBB).ObjectivesTo evaluate the evidence regarding the prevalence and risk of BB, AVB and pacemaker implantation (PMI) in patients with spondyloarthritis (SpA) compared to a control group without SpA.MethodsA systematic review of the literature was performed using Pubmed (Medline), EMBASE (Elsevier) and Cochrane Library (Wiley) databases until December 2021. The risk for AVB, BBB and PMI were analyzed. Cohort, case control and cross-sectional studies in patients ≥18 years meeting the classification criteria for SpA were included. The Odds ratio (OR), risk ratio (RR) or Hazard ratio (HR) were considered as outcomes. Data was synthesized in a previously defined extraction form. The risk of bias was assessed by the Newcastle-Ottawa Scale.ResultsIn total, eight out of 374 studies were included. As for low grade AVB and BBB, only indirect results comparing prevalences from low to medium quality studies were found. According to population based registries, the sex and age adjusted HR of AVB was 2.3 (95% CI 1.6 - 3.3) in ankylosing spondylitis, 2.9 (95% CI 1.8 - 4.7) in undifferentiated spondyloarthritis and 1.5 (95% CI 1.1 a 1.9) in psoriatic arthritis. The RR for PMI was 1.3 (95% CI 1.16 - 1.46) for groups aged between 65-69 years, 1.33 (95% CI 1.22 - 1.44) for 70-75 years, 1.24 (95% CI 1.55 - 1.33) for 75-79 years and 1.11 (95% CI 1.06 - 1.17) for groups older than 80 years.AuthorStudy designPopulationSample numberTestOutcomesAdjustmentBaniaamam 2021[6]Cross sectionalAS and osteoarthritis between 50-75 years267ECGPrevalence of AVB, BBB and PMIControls matched for age, sex and smoking statusBengtsson 2017[12]CohortAS, uSpA, PsA, GPfrom the Swedish national registry294136ICD-10Prevalence, Incidence, HR, for AVB and PMI compared to GPAge, sexDik 2010[9]Cross sectionalAS131ECGPrevalence of AVB and BBB Association of PR interval with AS disease related variablesAge, sex, disease durationFeld 2008[10]Case controlPsA compared to non psoriatic nor arthritic patients184ECGPrevalence of AVB, BBB Correlation of PR interval with AS disease related variablesNoneFu 2016[8]Cross sectionalAS between 18-50y without cardiac disease122ECGPrevalence of AVB, BBB AS without kyphosisNoneGoulenok 2010[13]Cross sectionalSpA, RA and control group without known CV disease288ECGPrevalence AVB, BBNoneWard 2018[7]CohortAS from Medicare database older than 6542,327ICD-9Prevalence, incidence, OR of PMIAge, sex, raceYildrir 1999[11]Case controlAS88Holter and ECGPrevalence of AVBNoneConclusionThe differences of prevalence in AVB and BBB were similar in SpA and control groups even though studies lacked the power. According to population registries there was an two fold-increased risk of high grade AVB in SpA patients. RR for PMI was higher in younger age groups.Disclosure of InterestsHye Sang Park: None declared, Ana Laiz Speakers bureau: A.L. has received speaker fees/honoraria from Abbvie, Lilly, Novartis, Pfizer and UCB, Petra Díaz del Campo Fontecha: None declared, Mª Auxiliadora Martín Martínez: None declared, Mercedes Guerra-Rodriguez: None declared, Concepción Alonso Martín: None declared, Jesus Sanchez-Vega: None declared, Hector Corominas Speakers bureau: H.C. has received speaker fees/honoraria from BMS, Gebro, MSD, Lilly, Novartis, Pfizer, Roche, Sanofi, and UCB, Consultant of: H.C. has participated in consulting for Abbvie, Amgen, Biogen, Celgene, Gilead, Kern, Pfizer and Sanofi.

BackgroundGiven the progressive change in the management of inflammatory diseases,an observational study was conducted on the management of Early Rheumatoid Arthritis (ERA) in Catalonia.ObjectivesTo know the management of ERA in Catalonia, to assess whether the recommendations of the EULAR/ACR guidelines are followed and to study the causes of management variability,to set improvement objectives.MethodsAn observational,descriptive,and cross-sectional study was conducted,with data collection from June 15 to 30, 2021.The rheumatologists’ partners of the Catalan Society of Rheumatology were the object of study. An online survey was conducted with 304 members on the management of the ERA. Variables related to the characteristics of the respondents,the derivation and variables of the disease including clinical variables,type of treatment and outcomes used for follow-up including the impact of the SARS-CoV2 pandemic were included.The univariate study was performed using a study of proportions with Pearson’s correlation.ResultsA total of 105 members (34.5%) responded to the survey.11.6%>60 y, only 7.8% Characteristics of ERA:77.5% are derived from primary care(PC),52% have been between 6 weeks,42.1%>3 months.54.9% make a first visit within 2-4 weeks of PC referral and 14.7%> 8 weeks.100%provide previous analysis,only 47% had had RX performed.98% were previously treated(50.4%NSAIDs + CG,36.1%NSAIDs,12.3% CG).4.3% had GC doses>10 mg/day,11.3%> to 20mg/day.The treatment:DMARDs of choice in 100% is MTX,44.1% start doses of 10mg/week and 3.9%7.5 mg/week.The route of choice is oral(55.9% vs 44.1%).92.2% associate GC and 31.7% have not withdrawn them after 6 m.57.8% consider the maximum of MTX 25mg/W.87.1% use dosesPROs(HAQ 83.3%,RAPID 3 14.3%).The use of systematic ultrasound is collected in 33%, being himself who performs it in 59.9% and an expert rheumatologist in 46.1%.Finally, when asked about incidence of pandemic in the follow-up,53.3% consider that it is doing the same as before. 46.1% consider that telephone visits are not suitable for the follow-up of the ERAvs14.7% who consider that Yes.When questioning the situations in which they consider them to be appropriate,75.9% that it was adequate in the control after the beginning of the DMARDs.Regarding the treatment of ERA, 66% delayed the onset of biological DMARDs, 72.1% due to difficulty of follow-up and only 8.8% due to an increased risk of infection. When performing the univariate analysis, it is evident that having a monographic dispensary is associated with earlier onset of MTX(p< 0.001)and at doses≥15 mg/W(p = 0.05),greater nursing intervention(p< 0.001),greater use of PROs(p = 0.008)and there is a tendency to a shorter waiting time for first visits(p = 0.07).It is also associated with not considering telephone visits(p< 0.001), making them in less than 25%(p< 0.0001).Similarly,hospital level is directly proportional to initiation at higher doses of MTX(p< 0.0001),lower use of GCConclusionThe recommendations of EULAR/ACR in the treatment and follow-up of ERA are consistently followed,although the wide use of MTX orally is striking.It is evident that the variable that most influences the early onset of FAME and at higher doses,is a monographic dispensary,as well as greater presence of nursing and performance of PROs.AcknowledgementsThanks to all the members of the Catalan society of reuamtology who participated in the surveyDisclosure of InterestsNone declared

BackgroundIn Diffuse idiopathic Skeletal Hyperostosis (DISH) o Forestier-Rotés disease the enthesis is also the hallmark of extraspinal manifestations. Despite being a characteristic hallmark of the disease, it has been poorly investigated.ObjectivesTo assess the usefulness of the Madrid Sonographic Enthesitis Index (MASEI) to classify patients with DISH and to analyse the ultrasound findings in hyperostotic entheses.MethodsWe recruited 35 patients with DISH, according to Resnick classification criteria, who were compared with 33 healthy patients age, sex and body mass index-matched. An ultrasound was performed strictly following the MASEI protocol. The ultrasound examiners, with extensive experience in musculoskeletal ultrasound (ECOCAT group), were blinded to the diagnosis of the patients. The interobserver reliability of MASEI index measured by an ICC was 0.97 (95%, CI 89-99) [1]. Demographic, cardiovascular risk factors, clinical, radiological and MASEI-related variables were collected. We categorized into MASEI- inflammatory (MASEI-I) and MASEI-damage (MASEI-D) as previously published [2]but also into MASEI-DISH, which included the variables of thickness, structure and calcification. In the statistical analysis, patients’ data were depicted by using descriptive statistics and the comparison between groups with the Chi-square test for categorical variables and the T-Student test for numerical variables. The validity of the index was examined using the area under the ROC curve and its corresponding 95% confidence interval (CI). The optimal cut-off point was defined as the one that maximizes sensitivity (S) and specificity. (Spe). The statistical program used was R software.ResultsIn the analysis of the elemental lesions, the alterations in structure, thickness and calcification of the distal quadriceps (DQT) and Achilles tendons (AQT) stood out (p ConclusionEntheses lesions of the AQT and the DQT mark the differences between DISH and healthy patients. The optimal cut-off point was 16.50, and we did not observe any advantages in establishing MASEI categorizations that could be useful in clinical practice. Although the MASEI is an index designed to classify patients with spondyloarthritis, our study shows that it also allows differentiating DISH patients from healthy subjects. It would also be interesting to analyse the capacity of the MASEI to distinguish DISH from spondyloarthritis.References[1]Moya Alvarado P, et al. Rheumatol Int. 2020.[2]Eder L et al. J Rheumatol. 2014; 41(3): 466-72.This study has received a grant from the Catalan Rheumatology Society (2019)AcknowledgementsInvestigation Unit Sociedad Española de ReumatologíaCatalan Rheumatology Society (Grant)Disclosure of InterestsTeresa Clavaguera Speakers bureau: 2021 Jansen, UCB, Novartis, Marta Valls Speakers bureau: 2021 Lilly, Nordic, Maria Buxó: None declared, MANEL PUJOL BUSQUETS Speakers bureau: abbvie, pfizer, lilly, UCB, Janssen, Novartis, Georgina Salvador Alarcon Speakers bureau: Lilly, Novartis, Roche, abbvie, Sanofi, Eulàlia Armengol Speakers bureau: Novartis, Jansen, Xavier González-Giménez: None declared, Mireia Moreno Speakers bureau: Many: Novartis, MSD, Marta Arévalo: None declared, Vicenç Torrente: None declared, Lourdes Mateo: None declared, Susana Holgado: None declared, Xabier Michelena: None declared, Juan José De Agustín De Oro: None declared, Meritxell Sallés Lizarzaburu Speakers bureau: Lilly, Sanofi, Sonia Mínguez: None declared, ANDRES PONCE FERNANDEZ: None declared, Rosa Morlà: None declared, Paula Estrada: None declared, D Reina-Sanz Speakers bureau: Novartis, UCB, Patricia Moya: None declared, Hector Corominas Speakers bureau: Gebro, Abbvie, Fresenius, Judith Font Urgellés: None declared, Patricia Reyner Speakers bureau: Lilly, Sanofi, Nordic

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.

Resumen Objetivos Describir la variabilidad de las unidades de hospitalizacion de dia (UHdD) de Reumatologia en Espana, en terminos de recursos estructurales y procesos de funcionamiento. Material y metodos Estudio descriptivo, multicentrico, con evaluacion de las UHdD mediante cuestionario autocumplimentado a partir de estandares de calidad de la Sociedad Espanola de Reumatologia. Se analizaron recursos estructurales y procesos de las UHdD estratificados por complejidad del hospital (comarcal, general, mayor y complejo), y se determino la variabilidad mediante el coeficiente de variacion (CV) de la variable con relevancia clinica que presentara diferencias estadisticamente significativas al comparar por centros. Resultados Un total de 89 centros (16 comunidades autonomas y Melilla) se incluyeron en el analisis. 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 numero de tratamientos aplicados, la coordinacion entre las UHdD y farmacia hospitalaria y la presencia de formacion posgrado fueron las variables de proceso que presentaron diferencias estadisticamente significativas en funcion del nivel de complejidad del hospital. La tasa de tratamientos mas alta se hallo en hospitales complejos (2,97 por 1.000 habitantes), y la mas 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 numero 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.

Background:Systemic lupus erythematosus (SLE) is an autoimmune disease with variable clinical features and a complex physiopathology. In 2019, EULAR and ACR have jointly developed new classification criteria with both high sensitivity and specificity. These criteria have the particularity of including the presence of ANA as an obligatory entry criterion and the existence of clinical and immunological domains with weighted scores.Objectives:To evaluate the performance and characteristics of the ACR/EULAR 2019, SLICC 2012 and ACR 1997 classification criteria in a cohort of SLE patients with longstanding disease.Methods:Descriptive observational study that enrolled a cohort of SLE patients with longstanding disease followed in a tertiary level hospital. Demographic and clinical data were gathered along with the fulfillment of classification criteria. The sensitivity of each classification criteria and the statistically significant associations between criteria fulfillment and clinical and immunological data were calculated. Statistical analyses were performed using the Chi2, T-student and ANOVA tests. Statistical significance was assumed in p values Results:A total of 79 patients (88.6% women) with a mean age of 51.8±14 years, disease duration of 15.2±11.5 years and SLEDAI of 2.65±2.1 were included. The sensitivity of the different classification criteria was 51.9% for ACR 1997, 87.3% for SLICC 2012 and 86.1% for ACR/EULAR 2019 (Table 1).Table 1.Sensitivity and average scores.ACR/EULAR 2019SLICC 2012ACR 1997Sensitivity (%)86.187.351.9Average score of patients classified as SLE(±SD)18.6±5.85.3±1.45±0.9Average score of patients NOT classified as SLE(±SD)6.1±2.52.8±0.42.8±0.851.9% of patients met all three classification criteria, 29.1% met SLICC 2012 and ACR/EULAR 2019, 5% only met SLICC 2012 and 3.7% exclusively met ACR/EULAR 2019. 11.4% of patients did not meet any classification criteria and were characterized by having a low SLEDAI (0.6±0.9) and fulfilling only skin domains (alopecia or oral ulcers), antiphospholipid antibodies or hypocomplementemia.Statistically significant associations were found between meeting ACR/EULAR 2019 classification criteria and the presence of low C3 and C4 (pIn the SLICC 2012 evaluation, significant associations were found between meeting these criteria and the presence of arthritis (pFullfilment of ACR 1997 was associated to the presence of malar rash (pThe Kappa concordance coefficient among classification criteria is detailed in Table 2.Table 2.Kappa concordance coefficient.ACR/EULAR 2019 - SLICC 2012ACR/EULAR 2019 - ACR 1997SLICC 2012 - ACR 1997Kappa concordance coefficient0.610.270.30Conclusion:The ACR/EULAR 2019 classification criteria maintain a high sensitivity similar to the SLICC 2012 in SLE patients with longstanding disease, both of which are much higher than ACR 1997. Patients with serological, articular or renal involvement are more likely to meet SLICC 2012 or ACR/EULAR 2019 criteria. It is noteworthy the relevance of dermatological manifestations in ACR1997 classification criteria against the increased weight that a better understanding of SLE physiopathology has provided to analytic and immunological criteria in the subsequent classification criteria.Disclosure of Interests:David Lobo Prat: None declared, Berta Magallares: None declared, Ivan Castellví Consultant of: Boehringer Ingelheim, Actelion, Kern Pharma, Speakers bureau: Boehringer Ingelheim, Actelion, Bristol-Myers Squibb, Roche, HyeSang Park: None declared, Patricia Moya: None declared, Ignasi Gich: None declared, Ana Laiz: None declared, Cesar Díaz-Torné: None declared, Ana Milena Millán Arciniegas: None declared, Susana P. Fernandez-Sanchez: None declared, Hector Corominas: None declared

Background:GCA is characterized by cranial symptoms but imaging techniques show that patients with non-specific symptoms such as systemic inflammation or PMR may have undiagnosed large vessel (LV) GCA1. Although silent GCA in patients with clinically isolated PMR may have consequences for patients’ outcome, little is known about its prevalence and characteristics of affected patients.Objectives:To review data on the prevalence of silent GCA in newly diagnosed PMR patients without cranial GCA symptoms and to analyze which characteristics are associated with vascular involvement among PMR patients.Methods:We systematically screened PubMed, Embase and Web of Science databases and included studies screening for GCA in steroid naïve PMR patients without cranial symptoms consistent with GCA. Authors of the publications that used PET for vasculitis screening were invited to share their individual patient data (IPD) for a meta-analysis. We sought to define patient characteristics that were associated with vasculitis using univariable mixed effects logistic regression models with vascular involvement as the outcome, missing values were imputed using multilevel joint modeling multiple imputation. To fit a multivariable model with the candidate predictors we excluded variables that were hypothesized to have less medical relevance for the outcome and highly correlated inflammation markers (ESR, Lc).Results:Out of the 3047 studies screened independently by 2 authors (DG and TD), 13 fulfilled the inclusion criteria. These studies (published 1963-2019) reported on 543 PMR patients examined by temporal artery biopsy (n=175), ultrasound (n=110), PET or PET-CT (n=258). 115 PMR patients were diagnosed with GCA (21.2%), with prevalence ranging from 0-92%.We collected IPD for 243 patients from 4 cohorts using PET and 3 using PET/CT for GCA diagnosis. The overall median age of patients was 72.3 years (IQR 66.4-78.0) and vasculitis was found in 65 patients (26.7%) (table 1).Table 1.OverallPMRPMR+GCAn (%)243178 (73.3)65 (26.7)Female sex (%)146 (60.1)98 (55.1)48 (73.8)Shoulder girdle pain (%)236 (97.1)174 (97.8)62 (95.4)Pelvic girdle pain (%)174 (71.6)127 (71.3)47 (72.3)Inflammatory back pain (%)No107 (44.0)83 (46.6)24 (36.9)Yes106 (43.6)70 (39.3)36 (55.4)Lower limb pain (%)No87 (35.8)61 (34.3)26 (40.0)Yes81 (33.3)68 (38.2)13 (20.0)Weight loss (%)112 (46.1)78 (43.8)34 (52.3)CRP (mg/l) (median [IQR])46.0 [19.0, 77.7]44.0 [16.9, 74.2]52.0 [27.9, 85.0]ESR (mm/h) (mean (SD))65.2 (30.3)62.7 (30.2)72.3 (29.7)Hemoglobin (g/dl) (mean (SD))12.1 (1.5)12.2 (1.5)11.7 (1.6)Thrombocytes (1e+09/ml) (mean (SD))341.9 (106.3)323.9 (103.2)375.8 (104.6)In the univariable analyses the following factors were most strongly associated with vasculitic PET findings: female sex (OR 2.31, CI 1.17-4.58), inflammatory back pain (OR 2.73, CI 1.32-5.64), temperature >37° (OR 1.83, CI 0.90-3.7), weight loss (OR 1.83, CI 0.96-3.51), thrombocytosis (i.e., patients with a thrombocyte count 1 SD above mean have an OR of 1.51, CI 1.05-2.18), anemia (i.e., 1 g/dl decrease in Hb below mean corresponds to an OR of 1.25, CI 1.00-1.56). Patients with lower limb pain were less likely to have vasculitis (OR 0.43, CI 0.19–0.95). The estimated ORs were very similar in the multivariable model although the 95%CIs became wider.Conclusion:Although the prevalence across published studies showed substantial variation, 6 out of 13 studies reported a prevalence of silent GCA in 18-40% of all PMR patients. The exploratory analysis of the collected IPD identified female sex, inflammatory back pain, fever, weight loss, absence of lower leg pain, thrombocytosis and anemia as factors associated with LV-GCA. These findings should be validated in future prospective cohort studies. The presence or absence of these factors may further aid in diagnosing LV-GCA in PMR patients.References:[1]Buttgereit F, Dejaco C, Matteson EL, Dasgupta B. Polymyalgia Rheumatica and Giant Cell Arteritis: A Systematic Review. JAMA. 2016 Jun 14;315(22):2442–58.Acknowledgements:The study is funded by the “Schweizerische Stiftung für die Erforschung der Muskelkrankheiten (SSEM)”.Disclosure of Interests:Daniele Silvio Gozzoli: None declared, Andrea Hemmig: None declared, Lars Hemkens: None declared, Laura Werlen: None declared, Hannah Ewald: None declared, Christoph Berger: None declared, Diego Kyburz Grant/research support from: DK reports personal fees from Abbvie, Gilead, Lilly, Novartis and Pfizer, outside of the submitted work, Stephan Imfeld: None declared, Markus Aschwanden: None declared, Mihaela Stegert: None declared, Dario Camellino: None declared, Marco Amedeo Cimmino: None declared, Corrado Campochiaro Grant/research support from: personal fees from Roche, Alessandro Tomelleri: None declared, Liesbet Henckaerts: None declared, Daniel Blockmans Speakers bureau: Paid speaker for Roche, Consultant of: Paid consultant for Roche, Patricia Moya: None declared, Hector Corominas: None declared, Russell Buchanan: None declared, Claire Owen Speakers bureau: CO has received speaking honoraria from Roche, Janssen, Novartis and Pfizer, and meeting sponsorship from Roche, UCB and Janssen, Yannick van Sleen: None declared, Elisabeth Brouwer Speakers bureau: E. Brouwer as an employee of the UMCG received speaker fees and consulting fees from Roche in 2017, 2018 which were paid to the UMCG, Consultant of: E. Brouwer as an employee of the UMCG received speaker fees and consulting fees from Roche in 2017, 2018 which were paid to the UMCG, Hiroyuki Ymashita: None declared, Thomas Daikeler: None declared

Background:Despite the clinical benefits of current pharmacological treatments for rheumatoid arthritis (RA), there remains an unmet need for alternative treatment approaches. Initial results of a 12-week proof-of-concept study of non-invasive, vagus nerve stimulation (VNS) of the auricular branch of the vagus nerve from a wearable device to treat RA showed the device to be well-tolerated with significant reductions in the DAS28-CRP and RA disease severity1.Objectives:This analysis presents data from the 9-month extension of the original proof-of-concept study.Methods:Following the completion of the 12-week proof-of-concept study, responding patients (defined as achieving a reduction in DAS28-CRP of ≥1.2 from baseline and/or achievement of ACR20) were given the option to enroll in a 9-month extension study. Use of the wearable device continued daily for up to 30 minutes as in the first 12 weeks of the study. Alteration of baseline medication and addition of conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and biologic DMARDs were allowed during the extension phase.Results:20/27 patients who completed the initial 12-week study met the enrollment criteria for the extension phase; 19 of those patients consented to participate. 4/19 patients (21%) discontinued the extension study due to lack of efficacy (1 patient after 1 month, 2 patients after 3 months, and 1 patient after 6 months in the extension); 15 patients completed the extension phase. 2/15 patients (13%) added biologic therapy to their treatment regimen. Mean DAS28-CRP reduction from baseline to the end of the extension (12 months total) in all patients completing the extension was 2.23 (95% CI: -1.60, -2.86). For patients who did and did not add biologic therapy, mean DAS28-CRP reduction was 2.98 and 2.11, respectively. Individual DAS28-CRP reductions are shown in the figure 1. Mean HAQ-DI reduction from baseline to the end of the extension in all patients was 0.70. 2 non-device related adverse events were reported in the study extension: one related to cornea transplant and one related to dysesthesia. No serious adverse events were reported during the study extension phase.Conclusion:Benefits from the use of the wearable device were maintained over longer periods of time from the initial 12-week proof-of-concept study, with few safety concerns as no additional side effects were observed.References:[1]Marsal S et al. Non-invasive Vagus Nerve Stimulation Improves Signs and Symptoms of Rheumatoid Arthritis: Results of a Pilot Study [in press]. The Lancet Rheumatol, 2021Disclosure of Interests:Sara Marsal Speakers bureau: BMS, Pfizer, UCB, Celgene, Roche, Sanofi, Consultant of: Pfizer, Abbvie, Roche, Celgene, Galapagos, MSD, UCB, BMS, Sanofi, Grant/research support from: Pfizer, Abbvie, Roche, Celgene, MSD, UCB, BMS, Novartis, Janssen, Sanofi, Héctor Corominas: None declared, Juan Jose de Agustin: None declared, Carolina Perez-Garcia: None declared, Maria Lopez Lasanta: None declared, Helena Borrell Paños: None declared, D Reina-Sanz: None declared, Raimón Sanmartí: None declared, J. Narváez: None declared, Clara Franco-Jarava: None declared, Charles Peterfy Speakers bureau: Novartis, Bristol Myers Squibb, Amgen, Consultant of: Multiple companies on behalf of Spire Sciences Inc., Jose Antonio Narvaez: None declared, Vivek Sharma Shareholder of: Nēsos Corp, Employee of: Nēsos Corp, Konstantinos Alataris Shareholder of: Nēsos Corp, Employee of: Nēsos Corp, Mark C. Genovese Shareholder of: Gilead Sciences, Nēsos Corp, Employee of: Gilead Sciences, Matthew Baker Shareholder of: Nēsos Corp, Consultant of: Nēsos Corp

Background:Cryoglobulinemia (CG) is a rare phenomenon, which is defined as the persistent presence in serum of abnormal immunoglobulins (Igs) that precipitate in vitro at less than 37°C and dissolve when the temperature rises again. Is related to hematological disorders, infections and autoimmunes diseases.Objectives:To describe the differential clinical features, serological and demographics in a cohort of patients diagnosed with CG.Methods:We describe a retrospective cohort of 252 cryoglobulin (Cg) positive samples, obtained from a database from the immunology laboratory of a tertiary hospital (November 2018-November 2019). We obtained 182 patients with CG, classified according to their etiology into 4 groups: 1)Rheumatic diseases (RD) that includes rheumatoid arthritis, Systemic lupus erythematosus, Sjögren´s syndrome and Systemic scleroderma, 2)Hepatotropic viruses (HV) with patients diagnosed with Hepatitis C virus, B virus and both, 3)Hematological diseases (HD) and 4)Essential cryoglobulinemia (CGE). Demographic variables, clinical and serological data were collected. A comparative analysis was performed with the Mann-Whitney U test and the multivariate Kruskal-Wallis test, nonparametric variables were compared using a Wilcoxon test. Ten patients, with more than one disease from 4 groups, were excluded from the study.Results:Out of 182 reviewed patients, 172 were included in the study. Mean age at diagnosis was 59.7(±14.0). Demographic, clinical and laboratory characteristics are described in table 1. Mixed CG was the predominant subtype, in 116 (67.4%) patients. The most prevalent CG-associated diseases were HV infection with 91(53%) patients. CGE mostly presented with cutaneous manifestations (p=0.0001), particularly purpura. In RD group the presence of Raynaud and non-erosive arthritis (p=0.0001) was relevant. Laboratory findings showed that CG titration varies according to the etiology, being HD the one with the highest values with 292.2 (±546.2). There is significant difference in terms of the average of rheumatoid factor (RF) being higher in the group by CGE. On other hand, the group HV presented more consumption of complement, and showed the lowest average p=0.0001, without more severe clinical manifestations.RD (n=47)HV (n=91)HD (n=17)CGE (n=17)Gender,n(%) F42 (89.4)57 (62.6)7 (41.2)11 (64.7)Age at dg, years, (± SD)60.6 (±14)59.6 (±13.1)61.1(±16.6)56.3(±20.8)p=0.8CLINICAL CHARACTERISTICSSkin n (%)18 (38.3)10 (11.0)2 (11.8)9 (52.9)pRaynaud n (%)14 (29.8)1 (5.9)3 (17.6)pPurpura n (%)6 (12.8)9 (9.9)2 (11.8)6 (35.3)p=0.04Acrocyanosis n (%)6 (12.8)1 (5.9)p=0.0033Ulcers n (%)3 (6.4)2 (2.2) -2 (11.8)p=0.19Peripheric Neuro n (%)10 (21.3)9 (9.9)1 (5.9)4 (23.5)p=0.13N-E arthritis n (%)22 (46.8)8 (8.8)1 (5.9)4 (23.5)pGMN n (%)5 (10.6)3 (3.3)1 (5.9)3 (17.6)p=0.11LABORATORYCg (mg/dL) x (± SD)26.7 (±63.2)65.8 (±256.5)292.4 (±546.2)47.59 (±79.1)pIsotype IgG, n (%)G+M 26 (55.3)G+M 72 (79.1)M 8 (47.1)G+M 12 (70.6)β2M (≥1.8 mg/L), n (%)7/40 (17.5%)1/5 (20.0%)3/12 (25.0%)-p= 0.44RCP (mg/L) p 5010.3 (±26.2)3.9 (±3.0)13.4 (±18.3)8.5 (±12.0)p= 0.47ESR (mm/h) p5040.0 (±28.5)20.3 (±20.2)35.4 (±35.1)24.5 (±25.0)p= 0.0003RF + (>20UI/mL), n (%)19/46 (41.3)44/86 (51.2)5/11 (45.5)7/17 (41.2)p= 0.09p5090.6 (±175.9)161.0 (±219.5)94.8 (±135.6)284.5 (±619.3)pC3 ()20 (42.6)47 (51.6)3 (17.6)3 (17.6)p= 0.13x (± SD)90.1 (±28.6)68.5 (±10.8)99.1 (±29.0)114.8 (±12.7)pC4 ()17 (36.2)36 (39.6) -3 (17.6)p= 0.02x (± SD)15.6 (±9.0)7.6 (±3.5)20.4 (±7.4)21.1 (±9.5)pConclusion:In our cohort, not all patients with CG presented clinical manifestations being those associated with CGE and RD those with the highest skin and joint expression. The most prevalent association of CG continues to be the HV and we confirmed the characteristic decrease in C3 and C4 complement levels, together with the positivity for RF.Disclosure of Interests:None declared

Background:Patients with autoimmune inflammatory rheumatic diseases (AIIRD) have a higher burden of infectious diseases compared to the general population. This could be explained by the disturbances in their immune system response, comorbidities and immunosuppressive treatment.Vaccination is the most effective measure to prevent infections.Objectives:To describe a cohort of patients with AIIRD referred to the infectious disease´s unit according to the vaccination protocol.Methods:Restrospective and descriptive study of a cohort of 286 patients with AIIRD who were evaluated in the rheumatology service of a tertiary hospital in Barcelona and referred to the infectious disease´s unit according to the vaccination protocol among 1 year,between January 1rst December 31st, 2019. The vaccination protocol included serologies of human immunodeficiency virus,hepatitis A,B and C, varicella zoster,tuberculosis,measles,mumps and rubella virus.The recommended vaccines were H.influenzae b,S.pneumonia,influenza,hepatitis A and B(immunity absence),meningococcus c,tetanus – diphtheria (low antigenic load),poliomyelitis and human papillomavirus (not vaccinated).The patients included were diagnosed with a rheumatologic condition under immunosuppressive therapy. Demographic variables,diagnosis,treatment,vaccines administered,infections and adverse effects were collected.Results:Of 286 patients reviewed the mean age was 61, 4 (±14.4) years. The characteristics of the cohort are shown in Table 1. Most of the patients used csDMARDs 149 (52.1%), 77(26.9%) patients used combined treatment. Measles and rubella are part of the triple virus vaccines included in the systematic Spanish vaccination schedule, in our cohort 20 (7%) patients had negative serologies for measles and 26 (9%) for rubella. 57 (20%) patients had latent TB with positive Quantiferon.Forty-one (14.3%) were vaccinated before receiving immunosuppressive treatment. The less administered vaccine was influenza with 44.9% (vaccination rate in Spain in healthy population, in 2019-2020 was 51.2%).No serious adverse effects were reported in relation to the vaccination. The infectious complications during the follow-up period were bronchopneumonia in a patient with RA treated with certolizumab (1), herpes zoster infection in RA on adalimumab(1), recurrent otitis in RA on adalimumab(1), mycobacterium avium infection in RA on etanercept(1), TB reactivation in RA with GCs and csDMARDs(1) and Papilloma virus infection in SpA on ustekinumab (1).Table 1.CHARACTERISTICS OF COHORT OF PATIENTSSex n % (women/men)193/93 (67,5/32,5)Age, years ± DE61.4 ± 14.4Diagnoses AIIRD, n (%)Rheumatoid arthritis n (%)164 (57.3)Systemic lupus erythematosus n (%)6 (2.1)Sjögren´s syndrome n (%)9 (3.1)Systemic sclerosis n (%)1 (0.35)Inflammatory myopathie n (%)5 (1.7)Vasculitis n (%)36 (12.6)Polymyalgia rheumatica n (%)4 (1.4)Spondyloarthropathy n (%)46 (16.1)Others n (%)15 (5.2)Treatment AIIRDGCs n (%)116 (40.7)csDMARDs n (%)149 (52.1)bDMARDs n (%)80 (27.8)tsDMARDs n (%)7 (2.4)Others1 n (%)12 (4.2)GCs + csDMARDs n (%)59 (21)GCs + bDMARDs n (%)14 (4.9)GCs + csDMARDs + bDMARDs n (%)4 (1.4)VaccinesPCV 13 n (%)283 (99)PPSV23 n (%)265 (93)HiB n (%)265 (93)NM n (%)247 (86.7)Influenza n (%)128 (44.9)HBV n (%)121 (42.3)Vaccination before IS n (%)41 (14.3)Vaccination with IS n (%)244 (85.3)Other: Behcet,Adult Stills,Relapsing polychondritis,IGg4 related disease,SarcoidosisOthers1: Mycophenolic acid,cyclosporine and tacrolimusConclusion:In our cohort, the vaccination protocol proved to be a good tool to improve the vaccination rate of rheumatological patients, despite this, the vaccination of Hepatitis B and specially of influenza, continues to have a lower prevalence to general population.The vaccines were effective since none of the preventable infections occurred during follow up, despite the use of an immunosuppressant. Vaccination showed a good safety profile, without reported serious adverse effects or worsening of the underlying disease.Disclosure of Interests:None declared

Background:Giant cell arteritis (GCA) is the most common primary systemic vasculitis in adults over 50 years of age. Its incidence increases with age, with a peak between 70-80 years and predominates in women, 3:1. It is a medical emergency that, if not diagnosed, can lead to irreversible complications. The delay in time from diagnosis to start of treatment is crucial to avoid possible serious outcomes on short, medium and long term. Survival in GCA is estimated between 60-90% at 5 years and 48-81% at 10 years. Efforts have been made to implement rapid diagnostic circuits to assess patients and initiate treatment without delay with good results both in reducing permanent vision loss and in reducing the costs of these patients due to emergency visits and admissions. The morbidity and mortality of this disease is high, but the use of efficient diagnostic strategies, such as ultrasound of superficial temporal arteries, has proven to be a useful, practical, cost-effective and, above all, quick tool to make the diagnostic approach.Objectives:Analyze the impact of early temporal artery ultrasound on survival for patients with GCA.Methods:Survival study of 48 patients with GCA, in two different “stages” in terms of diagnostic approach: Group A (n = 27), patients diagnosed between 2002 - 2011 using only ACR 1990 criteria and Group E (n = 21) diagnosed between 2010-2015 using ACR criteria and TAUS. TAUS was performed by Rheumatologists with extensive experience in ultrasound and within a period of no more than 7 days for these patients. The definitive diagnosis of GCA was based on the clinical criteria of the Rheumatologist within the clinical and analytical context and with the specific complementary examinations for each case (Ultrasound, PET-CT, biopsy). Demographic data, comorbidities, signs and symptoms at debut, analytical data, complementary examinations, treatment and evolution were obtained retrospectively through the electronic medical record of the patient, based on the database of our GCA cohort. A survival analysis was performed considering death as the main outcome. The statistic used was the Kaplan-Meier test. In addition, other complications related to treatment or pathology are collected.Results:The mean age at diagnosis of our patients was 79 + - 6 years, with a female: male ratio of 3: 1. The follow-up was between 2 and 16 years with a mean of 5.8 + - 3 years, until the last visit collected or until the outcome of death. Group A had a survival at 5 and 10 years of 53.4% and 36.7% respectively, while group E of 79.5% at both cut-off points. (Figure 1).There is a significant difference between the survival of both groups, p Figure 1.Group A (red line) according to ACG 1990 criteria and Group B (green line) according to ACG criteria and implementing TAUS for rapid diagnosisConclusion:The implementation of temporal artery ultrasound (TAUS) is associated with a significant improvement in the survival rate of patients with GCA and a reduction in treatment-related complications in patients who were diagnosed with ultrasound in less than 7 days compared to those diagnosed by the conventional healthcare attention routes.References:[1]Gonzalez-Gay MA, et al. Giant cell arteritis: epidemiology, diagnosis, and management. DOI: 10.1007/s11926-010-0135-9[2]Patil P, et al. Fast track pathway reduces sight loss in giant cell arteritis: results of a longitudinal observational cohort study. PMID: 26016758[3]Breuer GS, et al. Survival of patients with giant cell arteritis: a controversial issue. PMID: 31969222[4]Diamantopoulos AP, et al. The fast-track ultrasound clinic for early diagnosis of giant cell arteritis significantly reduces permanent visual impairment: towards a more effective strategy to improve clinical outcome in giant cell arteritis? 10.1093/rheumatology/kev289Disclosure of Interests:None declared

Background:Gout is the most prevalent inflammatory arthritis. Gout is chronic inflammatory deposition disease related to an increase of cardiovascular (CV) events and mortality. Subclinical chronic inflammation has been demonstrated in this patients but not its relation with the monosodium urate (MSU) crystal deposit size and the number of CV risk factors.Objectives:To study the subclinical inflammation in intercritical gout patients and its possible relation to the estimated size of the crystal deposition and the number of CV risk factors.Methods:To analyze subclinical inflammation we performed a secretome analysis and a cytokine and adiponektine plasma levels quantification (IL-1β, IL-18, IL-6, sIL-6R, TNFα, CXCL-5, RANTES, leptin, resistin and adiponectin) in a cohort of gout patients. As nowadays it is not feasible to determinate the whole body deposit of MSU crystals we created three different MSU crystal deposit size patient groups using an indirect clinical and analytical classification to estimate it. Then we compared cytokine levels between healthy donors and gout patients. We also compared cytokine levels between the different crystal size deposition groups and studied its association to the number of CV risk factors.Results:Ninety consecutive patients attending a Crystal Arthritis Unit were studied. Mean age was 68.27 (28-101) years. 81.1% were male. Clinical gout evolution was of 10.1±9.8 years. 77.5% were on urate lowering treatment. 24% had tophaceous gout. Mean uric acid was 6.3±2.1 mg/dl with 47.1% of them being on target. Hypertension was present in 68.9%, diabetes mellitus in 18.9%, dislipemia in 48.9%, BMI>30 in 32.9%, abdominal obesity in 50% and 16.1% suffered from ischemic heart disease. From the 102 molecules studied in the secretome analysis in 56 there was at least a 20% difference between donors group and any of the deposition groups. In 74% of them gout patients secreted lower levels. IL-18, sIL-6R, RANTES, leptin and adiponectin were higher in patients than in healthy donors. IL-18, sIL6-R, RANTES and CXCL5 levels were associated to the size of the crystal deposits. IL-18, sIL-6R, RANTES and leptin were higher in gout groups with CV risk factors. IL-18, sIL6-R, RANTES and leptin were higher in gout patients with no risk factors when compared to healthy donors with no risk factors. We found no differences when comparing urate lowering treated and non-treated patients.Conclusion:Our results demonstrate that some proinflammatory cytokines and metabolic proteins are raised in intercritical gout patients. Some of them are different from the flare/inflammasome expected ones. In some cytokines this elevation is related to the size of the monosodium urate crystal deposit and/or to the number of cardiovascular risk factors. This cytokine changes could help to explain the increase of the cardiovascular events in gout patients.Disclosure of Interests:Cesar Diaz-Torne Grant/research support from: Received a grant from Grünenthal, Maria Angels Ortiz: None declared, Sicylle Jeria Navarro: None declared, Andrea Garcia-Gullien: None declared, Lluis Sainz: None declared, Hector Corominas: None declared, Silvia Vidal: None declared

Background:Currently, there are no biomarkers to predict respiratory worsening in patients with Coronavirus infectious disease, 2019 (COVID- 19) pneumonia.Objectives:We aimed to determine the prognostic value of Krebs von de Lungen-6 circulating serum levels (sKL-6) predicting COVID- 19 evolving trends.Methods:We prospectively analyzed the clinical and laboratory characteristics of 375 COVID- 19 patients with mild lung disease on admission. sKL-6 was obtained in all patients at baseline and compared among patients with respiratory worsening.Results:45.1% of patients developed respiratory worsening during hospitalization. Baseline sKL-6 levels were higher in patients who had respiratory worsening (median [IQR] 303 [209-449] vs. 285.5 [15.8-5724], P=0.068). The best sKL-6 cut-off point was 408 U/mL (area under the curve 0.55; 33% sensitivity, 79% specificity). Independent predictors of respiratory worsening were sKL-6 serum levels, age >51 years, time hospitalized, and dyspnea on admission. Patients with baseline sKL-6 ≥ 408 U/mL had a 39% higher risk of developing respiratory aggravation seven days after admission. In patients with serial determinations, sKL-6 was also higher in those who subsequently worsened (median [IQR] 330 [219-460] vs 290.5 [193-396]; pConclusion:sKL-6 has a low sensibility to predict respiratory worsening in patients with mild COVID-19 pneumonia. Baseline sKL-6 ≥ 408 U/mL is associated to a higher risk of respiratory worsening. sKL-6 levels are not useful as a screening tool to stratify patients on admission but further research is needed to investigate if serial determinations of sKL-6 may be of prognostic use.References:[1]Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020;395(10229):1054-62. 5.[2]Tian W, Jiang W, Yao J, Nicholson CJ, Li RH, Sigurslid HH, et al. Predictors of mortality in hospitalized COVID-19 patients: A systematic review and meta-analysis. J Med Virol. 2020.[3]Wang D, Li R, Wang J, Jiang Q, Gao C, Yang J, et al. Correlation analysis between disease severity and clinical and biochemical characteristics of 143 cases of COVID-19 in Wuhan, China: a descriptive study. BMC Infect Dis. 2020;20(1):519.Disclosure of Interests:None declared.

Resumen Los pacientes con artritis reumatoide (AR) tratados con farmacos modificadores del curso de la enfermedad estan expuestos a desarrollar infecciones potencialmente graves como la leishmaniasis. L. infantum es endemica en el Mediterraneo, hecho que obliga ante un paciente con AR que presenta fiebre y pancitopenia, a descartar este proceso. Un diagnostico de sospecha precoz, puede evitar un curso y pronostico fatal.

Background:Obesity is a predictor for the development of psoriatic arthritis (PsA) with a negative prognostic impact.Objectives:We aimed to describe and characterize patients with PsA according to the Body Mass Index (BMI) in a joint Rheumatology-Dermatology unit (PAIDER).Methods:We retrospectively reviewed patients diagnosed with PsA according to CASPAR criteria visited between May 2012 and May 2019 at the PAIDER clinic of our center. Data on demographic and anthropometric features, serologic findings, source of referral, cardiovascular risk factors and biological treatment were collected from clinical records. Patients were classified according to the WHO International Classification of nutritional status in normal weight (BMI 18.5-24.9 Kg/m2), overweight (BMI 25-29.9 Kg/m2) and obesity (BMI≥30 Kg/m2). A descriptive analysis was performed, and the differences between groups were evaluated using Chi2, T-Student and ANOVA tests. P-values Results:During the study period 393 patients (50.6% women) with a mean age of 52.47 ± 13.21 years were evaluated. Baseline characteristics are shown in table 1.Table 1.Baseline characteristicsTotaln=393Female, n (%)199 (50,6)Age, yrs, mean ±SD52,47 (13,21)Source of referral, n (%) Dermatology117 (29,8) Rheumatology219 (55,7) Primary Care and Others22 (5,6)Smoker, n (%)97 (25,8)High Blood Pressure (HBP), n (%)106 (27,7)Diabetes, n (%)48 (12,5)Hypercholesterolemia, n (%)98 (25,8)Hyperuricemia, n (%)32 (8,6)HLA-B27 positive, n (%)68 (21,6)BMI, Kg/m2, mean ±SD28,15 (5,87)Biological treatment, n (%)166 (43,2)The mean BMI was 28.15 ± 5.87 kg/m2. 112 patients (32%) were overweight with a mean BMI of 27.46 ± 1.55 kg/m2and 118 patients (34%) were obese with a mean BMI of 34.42 ± 5.08 kg/m2. Of the obese patients, 80 (67.8%) had obesity grade 1, 28 (23.7%) grade 2 and 10 (8.5%) grade 3.Characteristics of the patients according to BMI categories are shown in Table 2.Table 2.Characteristics according to BMINormal weightn= 118Overweightn= 112Obesityn=118P valueFemale, n (%)66 (55,9)52 (46,4)62 (52,5)nsAge, yrs, mean ±SD47,92 (14,08)54,71 (11,75)54,48 (11,54)Source of referral, n (%)Ns Dermatology35 (33,7)37 (35,2)34 (30,9) Rheumatology63 (60,6)61 (58,1)70 (63,6) Primary Care and Others6 (5,8)7 (6,7)6 (5,5)Smoker, n (%)37 (33)23 (21,1)31 (26,7)nsHigh Blood Pressure (HBP), n (%)12 (10,5)37 (34,3)41 (35)Diabetes, n (%)7 (6)9 (8,3)30 (25,6)Hypercholesterolemia, n (%)19 (17)24 (22,2)45 (38,5)0,001Hyperuricemia, n (%)5 (4,4)7 (6,8)19 (16,7)0,004HLA-B27, n (%)27 (28,7)17 (17,9)13 (12,6)0,016BMI, Kg/m2, media ±DE22,58 (1,78)27,46 (1,55)34,42 (5,08)-Biological treatment, n (%)47 (41,2)45 (40,9)66 (55,9)0,032We observed that mean age was significantly higher in obese patients (p Conclusion:- Almost 70% of patients with PsA visited in the PAIDER clinic of our center have a BMI above normal and more than a third of them are obese, mostly grade 1.- In our joint clinic there are no differences in BMI regarding the source of referral of the patients.- Patients with obesity are older, have more cardiovascular comorbidities and receive more biological treatment significantly, which increases the complexity of their management and worsens the prognosis.Disclosure of Interests:Andrea García-Guillén: None declared, Ana Laiz: None declared, Anna Lopez-Ferrer: None declared, HyeSang Park: None declared, Patricia Moya: None declared, Berta Magallares: None declared, Ivan Castellví Consultant of: Boehringer Ingelheim, Actelion, Kern Pharma, Speakers bureau: Boehringer Ingelheim, Actelion, Bristol-Myers Squibb, Roche, Ana Milena Millán Arciniegas: None declared, Cesar Díaz-Torné: None declared, Sicylle Jeria: None declared, Hector Corominas: None declared

Background:Positivity of dense fine speckles antibodies (anti-DFS70) has been associated with antinuclear antibodies positivity in people with no evidence of systemic autoimmune disease. They could be useful to distinguish patients with these characteristics that do not meet diagnostic and/or classifying criteria for any systemic autoimmune disease (SAD).Objectives:To evaluate the use of anti- DFS70 in patients with suspicion of SAD.Methods:A cross-sectional observational study was conducted at 2 tertiary-level hospitals. We included a cohort of patients visited in the last year by either rheumatology or other specialties, under suspicion of SAD, in which the IgG isotype anti-DFS70 was obtained by recombination with the Euroline Immunoblot of Euroimmun. Demographic, clinical and immunological variables were collected.Results:102 patients (78% women) were included, median age of 49 years old. The descriptive statistics are summarized in Table 1. All patients had ANA titters > 1/80. 37% were positive for anti-DFS70, with homogeneous, speckled and other patterns in 36%, 72% and 15% respectively.74% were visited by rheumatologists under the suspicion of systemic lupus erythematosus (SLE) in 27%, other SAD 25%, arthralgia 36% and fibromyalgia 12%. 13% presented high DNA titters, low C3/C4 levels in 14% and 9%. SLE’s symptoms were: arthritis 21%, arthralgia 41%, cutaneous 20% and oral ulcers 8%. Anti-DFS70(+) was related to the speckled pattern in 46% compared to other patterns (p=0,009), which had a negative association with anti-DFS70(p=0,003). Regarding the diagnoses, there was a negative association with SLE, other SAD and other rheumatologic diagnoses in 88%, 75% and 55% respectively(p=0,006). Anti-DFS70(-) was associated with oral ulcers (p=0,024), decreased C3/C4 levels (p=0,007/p=0,018), psoriatic arthritis (p=0,024) and cutaneous lupus (p=0,008), but not with drug-induced SLE (p=0,48) or lupus nephritis (p=0,067). There was no statistical significance between anti-DFS70(+) and arthralgia or fibromyalgia, but these patients don’t have a SAD diagnosis.Table 1.RHEUMATOLOGY(n=75)OTHER SPECIALTIES(n=27)antiDFS70(+)n=25(100%)antiDFS70(-)n=50(100%)antiDFS70(+)n=13(100%)antiDFS70(-)n=14(100%)Women20(80)43(86)8(62)9(64)Age years (ED)47,1(±20,1)50,4(±15,5)45,1(±26,7)54,7(±15,6)ANAHomogeneous8(32)23(46)2(15)4(29)PatternSpeckled22(88)*30(60)12(92)9(64)IIFOther010(20)1(8)4(29)Final diagnosisArthralgia12(48)15(30)SpecialityFibromyalgia3(12)6(12)Dermatology4(31)7(49)Drug-induced SLE2(8)2(4)Gastroenterology3(23)3(21)SLE3(12)17(34)*Hematology1(8)2(14)Cutaneous lupus08(16)*Other5(38)2(14)PsA06(12)*Other6(25)16(32)SLEArthritis3(12)13(26)Arthralgia13(52)18(36)Cutaneous3(12)12(24)Oral ulcers0(0)6(12)*Leukopenia0(0)4(8)Thrombocytopenia0(0)1(2)Fever1(4)1(2)Pleuritis0(0)1(2)Pericarditis0(0)1(2)Nephritis0(0)4(8)Myositis1(4)0(0)ANA (antinuclear antibody), IIF (indirect immunofluorescence), SLE (systemic lupus erythematosus), PsA (psoriatic arthritis), *pConclusion:Our results suggest that patients with suspicion of SAD, especially SLE, presented a greater proportion of negative anti-DFS70 compared to other diagnoses, including SAD, along with a decrease in complement levels and the presence of oral ulcers, being useful at the initial study of these patients. More studies are needed to characterize this association.Disclosure of Interests:Jose Luis TANDAIPAN JAIME: None declared, Berta Magallares: None declared, Julia Bernardez: None declared, ELENA RIERA ALONSO: None declared, FRANCISCO PUJALTE: None declared, Laura Martínez-Martínez: None declared, ANDRES BAUCELLS: None declared, Ivan Castellví Consultant of: Boehringer Ingelheim, Actelion, Kern Pharma, Speakers bureau: Boehringer Ingelheim, Actelion, Bristol-Myers Squibb, Roche, Hector Corominas: None declared, Silvia Martinez Pardo: None declared

Background:Joint damage is the pathological hallmark of rheumatoid arthritis (RA). To identify the genetic variation associated with a higher level of erosions has proven elusive.Objectives:The objective of the present study was to perform a genome-wide association study on joint damage in a cohort of RA patients of the Spanish population. Our aims were to provide independent validation of previously reported variants and to identify new candidate risk loci. A stratified analysis was performed based on positivity to ACPA status.Methods:A total of 1,135 patients diagnosed with RA using the ACR-EULAR criteria recruited by the IMID Consortium were genotyped using a 550,000 single-nucleotide polymorphism array. Additional SNPs were imputed using the 1KG genome data. Joint damage was performed using the S-score, a simplified radiographic erosion score that has a high correlation with the Sharp-van der Hejde score (1). Association testing of SNPs with joint damage was performed via linear regression with the addition of the years of evolution as covariate. The two main components of genetic variation were also added to adjust for potential population stratification. A total of 50 SNPs representing previously reported loci associated with joint damage were selected. Genetic association was also performed at the pathway level using Pascal.Results:45 out of 50 SNPs representing 31 previously reported loci for joint damage could be satisfactorily imputed. Association testing of the whole patient cohort replicated the association withIL2RAandTRAF1. Of relevance, after stratifying for anti-CCP five new loci were replicated:KIF5AandSOSTin ACPA-positive RA andCD40, DKK1andTNFin ACPA-negative RA.IL2RAwas only significant in the ACPA-positive group andTRAF1was not significant in either strata. GWAS on the ACPA-positive cohort and on the ACPA-negative group identified n=7 and n=18 loci with P-values < 1x10-5, respectively. From these, however, only 1 SNP showed nominal significant association in the other patient group. Based on this evidence, we performed a pathway-based analysis to understand the biological mechanisms underlying this difference. Pathway analysis showed 52 biological processes associated with joint damage in ACPA-negative RA and 32 pathways in the ACPA-positive group, with only two shared biological processes between the two groups. Fc Gamma receptor mediated phagocytosis was the topmost biological process associated with erosions specifically in ACPA-negative RA and Signalling by Fibroblast Growth Factor mutants was the top process specific for ACPA-positive patients.Conclusion:The results from our study provide suggestive evidence that the genetic basis for joint damage is different according to the presence of ACPA. Replication of the new candidate loci in an independent patient cohort is underway.References:[1]Lopez-Lasanta, M., Julià, A., Maymó, J., Fernández-Gutierrez, B., Ureña-Garnica, I., Blanco, F. J., ... & Tornero, J. (2015). Variation at interleukin-6 receptor gene is associated to joint damage in rheumatoid arthritis.Arthritis research & therapy,17(1), 242.Disclosure of Interests:Antonio Julià: None declared, Francisco Blanco: None declared, Benjamin Fernandez: None declared, Antonio Gonzalez: None declared, Juan D: None declared, Joan Maymó: None declared, Mercedes Alperi-López: None declared, Alejandro Olive: None declared, Héctor Corominas Speakers bureau: Abbvie, Lilly, Pfizer, Roche, Victor Martinez Taboada: None declared, Isidoro González-Álvaro Grant/research support from: Roche Laboratories, Consultant of: Lilly, Sanofi, Paid instructor for: Lilly, Speakers bureau: Abbvie, MSD, Roche, Lilly, Antonio Fernandez-Nebro: None declared, Alba Erra: None declared, Simon Sánchez Fernandez: None declared, Núria Palau: None declared, Maria Lopez Lasanta: None declared, Adrià Aterido: None declared, Jesús Tornero: None declared, Sara Marsal: None declared

Background:Despite the clinical benefit of current pharmacological treatments for rheumatoid arthritis (RA), there remains an unmet need for alternative treatment approaches. Vagus nerve stimulation (VNS) via an implanted device has been shown to attenuate RA disease severity in patients resistant to therapy,1as evidenced by a reduction in the DAS28-CRP score following a month of daily stimulation.Objectives:This pilot study investigated the safety and efficacy of a wearable (non-invasive) device that attaches to the outer ear to treat RA via electrical stimulation of the auricular branch of the vagus nerve.Methods:Patients with active RA (≥4 tender/swollen joints based on a 28-joint count, Disease Activity Score-28 with C-reactive protein (DAS28-CRP) >3.8, active synovitis detected on ultrasound and MRI) and inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), or csDMARD and biologic DMARDs (bDMARDs), were enrolled in this open-label study. Patients used the device for up to 30 minutes daily over the course of the 12-week study. The primary endpoint was the change in DAS28-CRP score at Week 12. Secondary endpoints included a safety analysis, proportion of patients achieving ACR20/50/70, the mean change in HAQ-DI and the proportion of patients achieving a HAQ-DI MCID of at least 0.22 over 12 weeks. Additionally, sleep scores were assessed using a visual analogue scale (0-100) at baseline and 12 weeks.Results:Thirty patients with active RA were enrolled, of which 27 patients completed the 12-week protocol. Three patients dropped out of the study: two patients decided to seek other treatment and one patient moved out of the country. Data for three additional patients was not included in this dataset as it was still being collected. Of the 24 patients with complete 12-week datasets, 88% were female, the average age was 54.9 years, mean disease duration was 7.3 years, and four patients had an inadequate response to one or two bDMARDs.The mean change in DAS28-CRP from baseline to Week 12 was -1.43 (pFigure 1Figure 2Average DAS28-CRP is shown for each study visit. Error bars indicate standard error of mean. Percentage of subjects meeting ACR20/50/70 at 12 weeks.Conclusion:In this pilot study, auricular stimulation was well tolerated and daily use over 12 weeks attenuated RA disease severity. Further evaluation in larger controlled studies are needed to confirm whether a non-invasive wearable device might offer an alternative approach for the treatment of RA.References:[1]Koopman FA, et al. (2016) Vagus nerve stimulation inhibits cytokine production and attenuates disease severity in rheumatoid arthritis. Proc Nat Acad Sci 2016; 113: 8284–9.Disclosure of Interests:Sara Marsal: None declared, Héctor Corominas Speakers bureau: Abbvie, Lilly, Pfizer, Roche, Maria Lopez Lasanta: None declared, D Reina-Sanz: None declared, Carolina Perez-Garcia: None declared, Helena Borrell Paños Speakers bureau: Lilly, Novartis, MSD and Janssen, Raimón Sanmartí Speakers bureau: Abbvie, Eli Lilly, BMS, Roche and Pfizer, J. Narváez: None declared, Clara Franco-Jarava: None declared, Jose Antonio Narvaez: None declared, Juan Jose de Agustin: None declared, Vivek Sharma Shareholder of: Vorso Corp., Konstantinos Alataris Shareholder of: Vorso Corp., Mark C. Genovese Grant/research support from: Abbvie, Eli Lilly and Company, EMD Merck Serono, Galapagos, Genentech/Roche, Gilead Sciences, Inc., GSK, Novartis, Pfizer Inc., RPharm, Sanofi Genzyme, Consultant of: Abbvie, Eli Lilly and Company, EMD Merck Serono, Genentech/Roche, Gilead Sciences, Inc., GSK, Novartis, RPharm, Sanofi Genzyme, Matthew Baker Consultant of: Gilead, Vorso, Paid instructor for: Gilead

Background:Lyme disease (LD) is a multisystemic animal-borne disease caused by spirochetes of theBorrelia burgdorferi s.lcomplex and transmitted by ticks of the speciesIxodes ricinus. In Spain, most cases occur in rural areas of the north-east region with a peak of maximum incidence between spring and early autumn. The diagnosis is based on a history of potential exposure to ticks, the recognition of characteristic clinical manifestations and serological testing.Objectives:To assess the suitability of serological study for the diagnosis of LD in an urban area.Methods:Retrospective observational study that included all LD serology tests made between April 2017 and September 2019 at a tertiary hospital in Barcelona covering a population of 450,000 people. Demographic data and the medical department that requested the serology test were collected along with serology test results. The medical records of patients with positive serology were consulted to identify which patients were finally diagnosed with LD along with their clinical manifestations, treatment and outcome.Results:A total of 574 serological tests were included and 78 (13.59%) of them were positive. Only 1.04% (6) of all serological tests belonged to patients finally diagnosed with LD. The department that made most requests was Neurology (37.3%) followed by Infectious Diseases (21%), Internal Medicine (14.5%), Emergency Medicine (4.7%), Dermatology (4.5%), Critical Care Medicine (2.3%) and Rheumatology (2.1%). 50% of the diagnosed patients were women with a mean age of 57.7±7.7DE years. In 50% of diagnosed cases, patients remembered a tick bite during activities in the mountain or rural areas. The most common clinical manifestations were erythema migrans (67%), non-inflammatory arthralgias (50%), fatigue and malaise (67%), together with one case of meningoencephalitis and one of knee monoarthritis. All diagnosed patients received antibiotic treatment with ceftriaxone (33%) or doxycycline (66%). Only one patient presented post-Lyme syndrome.The serological test for LD in our center had a total individual cost of 15.75 eur, so the cost of the 574 requests was 9,040.5 eur. 7,812 eur corresponded to negative results and 1,134 eur to false positive results.Conclusion:Our study indicates the overuse of diagnostic testing for LD with implications for patient care and cost-effective health management. In the absence of a history of potential exposure to infected vector ticks or characteristic clinical manifestations, unnecessary microbiological tests should not be performed.Disclosure of Interests:David Lobo Prat: None declared, Luís Sainz Comas: None declared, Virginia Pomar: None declared, Ana Milena Millán Arciniegas: None declared, HyeSang Park: None declared, Andrea García-Guillén: None declared, Sicylle Jeria: None declared, Ana Laiz: None declared, Berta Magallares: None declared, Ivan Castellví Consultant of: Boehringer Ingelheim, Actelion, Kern Pharma, Speakers bureau: Boehringer Ingelheim, Actelion, Bristol-Myers Squibb, Roche, Patricia Moya: None declared, Cesar Díaz-Torné: None declared, Susana P. Fernandez-Sanchez: None declared, Hector Corominas: None declared

Background:Gout has a prevalence >2.5% in the Spanish adult population. It is a chronic disease that without proper treatment causes pain, joint deformity and increased cardiovascular risk and mortality. Recent advances have demonstrated that if correctly treated the disease can be controlled and even ‘cured’. Most gouty patients are diagnosed and treated by general practitioners (GPs). There is evidence that the management if these patients is not good neither at Rheumatology Units nor at Primary Healthcare (PHC) centers.Several causes of this mismanagement can be found in the literature.Objectives:Design and evaluation of the results of a questionnaire created from a bibliographic search focused on areas of improvement of gout management in PHC.Methods:A search was made in Pubmed to identify the main barriers described in the management of patients with gout in primary care. The terms used were: “Gout”, “primary healthcare” and “education”. A Google Form of gout knowledge and management questionnaire was designed, taking into account what is described in the literature. The Google Form was sent to all GP from an urban area via mail and to other contacts via WhatsApp and twitter.Results:Responses were obtained from 224 GPs; 69.5% were women; 73.1% had between 11 and 30 years of professional experience; 96.4% answered that gouty are mostly controlled in primary care; 99.6% performs the diagnosis of gout without analysis of synovial fluid and 17% diagnosed only by clinics without urate levels; 55.9% of GPs do not use any reference guide. Of those who use, the 73% use GUIPCLINGOT and 40% use SEMGs one; 80.5% have not done any gout course in the last 5 years; 26% did not have access to a rheumatologist to confirm the gout diagnosis; only 30.8% knew the therapeutic objective of the urate lowering therapy (ULT); 28.6% considered the beginning of ULT after the first attack; 62% believed that the most important part of the treatment was changing diet and lifestyles; 88.8% did not perform any specific education for these patients by the nurse; just 37.2% carried out a treat-to-target strategy to lower urate levels.Conclusion:The questionnaire identifies multiple points of improvement for the management of this pathology in accordance with the described in the literature. Most GPs are unaware of the therapeutic objective of the ULT.Disclosure of Interests:None declared

Background:Cryoglobulinemia (CG) is a rare phenomenon related to haematological disorders, infections and autoimmune diseases. Age and renal involvement are known prognostic markers.Objectives:To describe the differential clinical features and the prognostic factors in a cohort of patients diagnosed with CG non-associated with hepatotropic viruses.Methods:A descriptive, retrospective study of a cohort comprised of 252 cryoglobulin positive samples, obtained from the immunology laboratory database of a tertiary hospital attending 450,000 people over 1 year. 186 patients with CG positive samples were included, 87 of which were not associated with neither hepatitis B nor C virus. Demographic, clinical, serological and pathological data were collected. Nonparametric variables were compared using a Wilcoxon test.Results:Out of 186 reviewed patients, 87 (46.7%) are included in this study. The mean age at CG diagnosis was 60 (± 16) years. Mixed CG was the predominant subtype, detected in 66 (75.9%) patients, 10 of which (11.5%) were associated with glomerulonephritis (GN) with compatible biopsy, 17 (19.5%) with peripheral neuropathy (PN), 29 (33.3%) with non-erosive arthritis and 10 (11.5%) with leukocytoclastic vasculitis confirmed by skin biopsy. The clinical, epidemiological and serological characteristics of the sample are summarized in Table 1.Figure 1.Ing et al’s Nomogram of parsimonious model.Table 1.Clinical, epidemiological and serical characteristics of patients with CGSex, female / male, n (%)65/22 (74.7/25.3)Age at diagnosis, years ± SD60 ± 16CG subtype, n (%)- Type 1, n (%)27 (30)- Mixed, n (%)61 (70)ASSOCIATED DISEASES- pSS, n (%)37 (42,5)- LES, n (%)9 (10,3)- SSc, n (%)7 (8,05)CLINICAL CHARACTERISTICS- Skin, n (%)30 (34,5)- Purpura, n (%)14(16)- Ulcers, n (%)5 (5,7)- Acral ischemia, n (%)2 (2,3)- Acrocyanosis by cold, n (%)7 (8)- Raynaud, n (%)19 (21,8)- Peripheric Neuropathy, n (%)17 (19,5)- Non-erosive arthritis, n (%)29 (33,3)- Glomerulonephritis, n (%)10 (11,5)LABORATORY- β2M +(>1.8 mg/L) mean3.9- RCP (mg/L) p503.7- ESR (mm/hour) p5028- RF + (>20 UI/mL) p50124- Anti Ro52 + /Anti Ro60 + n, (%)42 (48.3)- Low C3 n, (%)48 (55.1)- Low C4 n, (%)36 (41.4)In the comparative analysis of patients with CG and Beta 2 microglobulin (β2M), CG and rheumatoid factor (RF), those with high β2M (>1.8 mg / L) presented significantly more GN (p0.016) and PN (p0.013). However, the association of RF with either GN (p0.948) or PN (p0.645) was not significant. Also, high β2M was significantly related to complement consumption of C4 (p: 0.015) but not of C3 (p: 0.063). In the 30 (34.5%) patients with skin manifestations, high β2M showed no statistically significant association. The main systemic autoimmune diseases associated were primary Sjögren’s Syndrome (pSS) 37 (42.5%), Systemic Lupus Erythematosus (SLE) 9 (10.3%) and Systemic Sclerosis (SSc) 7 (8.05%).Conclusion:A direct association between presence of elevated levels of β2M and the existence of progression to glomerulonephritis and peripheral neuropathy is found in our cohort. No correlation is found between the presence of CG and other serological markers of autoimmunity except low C4. CG with elevated β2M does not associate with greater skin involvement or arthritis.References:[1]A.C. Desbois et al. Cryoglobulinemia: An update in 2019. Joint Bone Spine (2019)[2]Cacoub P, Cryoglobulinemia Vasculitis, The American Journal of Medicine (2015)Disclosure of Interests:None declared

Background Positive minor salivary gland biopsy(MSGB) is a major criteria for the diagnosis of primary Sjogren’s Syndrome (PSS). In our centre the MSGB analysis is carried out by Immunology and Pathology Department in parallel. The immunological analysis identifies the lymphocytic composition of the inflammatory infiltrate. Their results show: the number of T and B cells, the ratio between CD4 and CD8 T lymphocytes and other non infiltrating lymphocytes. Objectives The goal of our study was to evaluate whether there is an association between the lymphocytic composition of the MSGB with the clinical and serological findings of PSS patients. Methods Patients diagnosed of PSS according American-European criteria(2002) underwent . MSGB between February and November of 2017 Demographic (sex and age), clinical (disease duration, xerostomia, queratoconjuctivitis sicca, Schirmer test, systemic disease) data were collected. Present or previous treatment with steroids and/or immunosuppressive therapy, serological studies such as ANA, RF, anti Ro and anti La were also included. MSGB data with the number of infiltrates, quantitative composition of T and B lymphocytes, CD4/CD8 ratio and presence of other non infiltrating lymphocytes were registered. Pathology data concerning Chisholm-Mason scale, presence of fibrosis, atrophy and size of infiltrate (small, moderate and severe) were also registered. A multiple logistic regression for each item of the immunological analysis adjusted for sex and age was made. We also measured the odds ratio and performed correlation test for all variables included. Results Table 1 and 2 summarise our cohort characteristics. The presence of T lymphocyte was associated with B lymphocyte, OR 99.21 (IC95% 5.12–1921, p=0.002) and with higher CD4/CD8 ratio, OR 17.34 (IC95% 1.45–206.15, p=0.024). CD4/CD8 ratio was also associated with the presence of T lymphocytes OR 10.54 (IC95% 2.16–51.50, p=0.004) and B lymphocytes were associated with the presence of T lymphocytes as well OR 5.38 (CI95% 1.63–17.72, p=0.006). Other non infiltrating lymphocytes were composed of CD8 T cells and were associated with a positive Schirmer test OR 17.47(IC95% 1.62–188.13, p=0.018) but inversely associated with Chisholm-Mason grade ≥3 OR 0.09(IC95% 0.014–0.58, p=0.011). There was no other association observed with clinical or analytical parameters. Colinearity test between pathological and immunological analysis was negative. Conclusions MSGB in our PSS patients demonstrated an association between T lymphocytes, B lymphocytes and CD4/CD8 ratio. The infiltrate is mostly based on CD4 more than CD8 T cells. Other significant findings were the association between CD8 T lymphocytes and Chisholm-Mason scale grade ≥3, regardless of the number of infiltrates. No correlation or colinearity was observed with the number of infiltrates by immunological analysis and the Chisholm-Mason grade reported by the pathology analysis. Disclosure of Interest None declared

Objectives To describe and characterise the patient group defined as complex in a joint Rheumatology/Dermatology clinic (PAIDER). Methods We performed a retrospective chart review of patients evaluated between May 2012 and November 2017 at a weekly joint Rheumatology/Dermatology clinic at Hospital de Sant Pau (Autonomous University of Barcelona), Spain. We reviewed the medical records for demographic information, source of referral, complexity, cardiovascular risk factors and the number of visits. Complexity or complex patient was defined by at least one of the following characteristics: liver disease, neoplastic disease, psychiatric disorders, communication difficulties, adverse drug reactions to previous treatment, or paradoxical effects of biological therapy. The degree of complexity was a number (from 1 to 6) resulting from the sum of the previous characteristics. A descriptive analysis was carried out and the correlation between variables was studied through the application of nonparametric tests. The statistical package SPSS v. 21 was used to analyse the data. Results 494 patients were evaluated (52% women) with a total of 1110 visits. The mean age was 53 years. Patients were referred from Rheumatology, Dermatology, primary care physicians and other specialties in 47%, 40%, 6.5% and 5.5% of cases, respectively. The average number of visits per patient was 2.25. 164 patients (33%) were defined as complex with a total of 546 visits. 48.8% were women. The mean age was 55 years. They were referred from Rheumatology, Dermatology, primary care physicians and other specialties in 50.6%, 35.4%, 7.3% and 6.7% of cases, respectively. The mean number of following-up visits for the complex patients was 3.33. The features that defined complexity and the number of visits required are shown in table 1. The number of visits according to the degree of complexity is shown in table 2. Conclusions A third of the patients visited in our joint clinic were defined as complex, although the great majority showed a low level of complexity. Of all the features used to define complexity, only a few were associated with a greater number of visits. However, the degree of complexity of the patients was associated with an increased number of visits. Disclosure of Interest None declared

Background It has been demonstrated that hyperuricemia protects from Parkinson’s disease (PD), but this relation is controversial in patients with gout. Inflammatory properties of urate monosodium(UMS) crystals deposition that appears when uric acid(UA) levels exceed its solubility faces antioxidant and neuroprotective features of soluble UA. Both, UMS crystals deposition and hyperuricemia coexist in gouty patients. There is several data that demonstrates that hyperuricemia protects from Parkinson’s disease (PD). Results from different studies about the relation between them are controversial. Inflammatory properties of the urate crystals faces antioxidant and neuroprotective features of soluble UA. Both, UMS crystals and hyperuricemia coexist in gouty patients. Objectives To study if gout protects from Parkinson disease in a mediterranean urban population. Methods Primary care based matched case-control study. It has been carried out using the electronic clinical record database from the public health (Institut Catala de la Salut) of the city of Barcelona. The database contains anonymous data from almost 1 million and a half people. Just people that were 40 years or older were studied. Were considered cases patients with a PD diagnose, or taking high specific anti-Parkinson’s drugs (like l-dope, rasagiline, selegiline…), between 2006 and 2016. For every case we randomly selected four controls matched by gender and age. Data on risk factors was also collected for each individual (diabetes mellitus, hypertension, hypercholesterolemia and tobacco consumption before the PD diagnose), as well as age and gender. A multivariate logistic regression model was used to study the association of gout and PD adjusted by the presence of other risk factors. Adjusted Odds Ratios (aOR) and their 95% CI are provided. Results 21 789 persons with a PD diagnose and 87 156 controls were included. Mean age was 75.5 (SD 10.9) years. 55.6% were females. 2.5% of PD patients had a previous gout diagnose, compared to 4.8% of controls (p Conclusions Gout shows a protective effect on the development of Parkinson’s disease, pointing that the antioxidant and neuro protective effect of UA seems to overcome its inflammatory properties in gouty patients. Gout shows a protective effect on the development of Parkinson’s disease, pointing that the antioxidant and neuro protective effect of UA seems to overcome itsinflammatory properties in gouty patients. Disclosure of Interest None declared

Background Tocilizumab (TCZ) is a humanised antibody that blocks IL-6 receptor. Despite its effectiveness in rheumatoid arthritis (RA), there are patients that do not respond to the IL-6R blockade. The immune characteristics that would explain this lack of response are not known. Objectives Our aim was to determine the tocilizumab-induced changes in CD4 +T cells of patients that achieve, or not, remission at 12 m. Methods Prospective, multicenter study in 47 RA patients treated with TCZ during one year following standard clinical practice. Demographic, disease and treatment characteristics were collected at each visit. Ultrasound (US) grey scale and power doppler were assessed for joints and tendons using a semiquantitative scale from 0–3 points. Phenotyping of T lymphocytes was determined by flow cytometry and the plasma cytokine concentration was quantified by ELISA. Results Forty seven patients were treated with a mean age of 54±11 y and 85% were women. Years of disease were 13±8. We segregated patients according to the DAS28-remission. 44% achieved remission at month 12. We observed that absolute counts of neutrophils and CD4 +T lymphocytes decreased significantly in the remission group but not in the other one. Both memory and naive CD4 +T cells decreased in the remission group. The analysis of T cells classified according to chemokine receptors showed that memory (29.1±4.0 vs 22.7±2.7 × 10 4 cells/mL; p=0.06) and naive (22.6±4.1 vs 17.2±2.8; p=0.04) CD4 +with CXCR3 +and with CCR4 +were the subsets that decreased significantly in the remission group but not in the non-remission group. Since the expression of chemokine receptors defines the different Th subpopulations, we analysed them in the two groups of patients. Th1 tended to decreased in the remission group (3.5±0.7 vs 2.5±0.4; p=0.06) and Th9 decreased significantly in both groups (R: 5.0±0.8 vs 2.5±0.3; p=0.006 and Non R 5.5±0.8 vs 3.1±0.4; p=0.001). In regard to the cytokines produced by CD4 +T lymphocytes, IL-17 (2.1±1.1 vs 1.2±0.5 ng/ml; p=0.04) and VEGF (0.5±0.2 vs 0.3±0.1 ng/ml; p=0.05) but not IL-6 and IL-22 changed significantly in the remission group. Interestingly, IL-17 and VEGF correlated with US findings before the initiation of the treatment (grey scale R=0.378, p=0.01 and R=0.322, p=0.03; power Doppler R=0.415, p=0.004 and R=0.320, p=0.03 respectively). Conclusions Tocilizumab induced changes in specific subsets of CD4 +T cells and their inflammatory associated cytokines in the remission group. Disclosure of Interest None declared

Background Serum Calprotectin is a new biomarker of clinical activity in Rheumatology, especially in Juvenile Idiopathic Arthritis (JIA) Objectives To assess the use of serum Calprotectin in paediatric patients with inflammatory/Rheumatic diseases in clinical practice Methods We retrospectively collected Demographic and Clinical data from patients of our Paediatric Rheumatology Clinic, in which serum Calprotectin levels were determined. The determination of serum Calprotectin was carried out using the ELISA technique. Diagnostic and Inflammatory activity data were also collected: RCP, ESR and Clinical Assessment of the patients Results We present 28 patients, 61% females, with an average age of 11 (3–23 years) The diagnoses were as follows: 16 JIA (57% of the total), of which 8 were of the Oligoarticular type, 3 were Polyarticular, 3 were Arthritis related to Enthesitis, 1 was Psoriatic and 1 Systemic. Other diagnoses were: Behcet,1 Autoinflammatory Diseases: 4 (2 ADA2 Deficit, 1 Familial Mediterranean Fever, 1 PFAPA) and 7 patients had suspected rheumatological/inflammatory diseases in study 17 patients were considered clinically inactive, 6 with inflammatory activity and 3 doubtful at the time of blood test. The mean values of Calprotectin, RCP and ESR can be seen in Table 1. Calprotectin was statistically correlated with Clinical Activity (p=0.018), however, neither ESR (p=0.539) nor RCP (p=0.059) did, although in RCP there was a clinical trend, (ANOVA) Calprotectin, RCP and ESR were negative in 91%, 80% and 76% respectively of Inactive patients; and positive in 43%, 100% and 33% of the Active ones The analysis of the ROC curves in our sample showed that the value that allows to discriminate between active and non-active disease with a Sensitivity of 80% and a Specificity of 69% is 2’07 µg/mL Serum Calprotectin was 2 points higher in the group of patients with Autoinflammatory diseases than in the group of JIA, with a mean of 4.91 compared to 2.90 (p=0.002). However, since it is a retrospective study, we must bear in mind that this can be influenced by the reasons for the test request, being in the group of Autoinflammatory Disease the suspicion of active disease, and in the AIJ simply monitoring or assessment of treatment optimisation. It should be noted that, in the patients in diagnostic process that did not present any rheumatological disease (final diagnoses of: arthralgias in 3 cases and glomerulonephritis not associated to rheumatologic/autoimmune disease in 1), serum Calprotectine did not exceed in any case the 1.15 µg/mL Conclusions Serum Calprotectin is emerging as a useful marker, not only in the field of JIA, but also in other diagnostic groups such as Autoinflammatory Diseases. Prospective and larger studies are needed to determine its role Disclosure of Interest None declared

Background Serum Calprotectin (MPR8/MPR14) is a promising biomarker in the management of juvenile idiopathic arthritis (JIA), mainly as a predictor of flare, especially in treatment de-escalation Objectives To describe the evolution of serum Calprotectin in patients with JIA, their clinical evolution and its impact on therapeutic decisions Methods Demographic, clinical and inflammatory activity data (RCP and ESR) were retrospectively collected in patients with JIA of any subtype in whom serum Calprotectin had been determined at least once Results We present the data of 15 children, 7 with Oligoarticular subtype JIA, 1 Systemic, 3 Polyarticular, 1 Psoriasic and 3 Enthesitis Related Arthritis (ERA) The average age was 11 years, 66% female. The characteristics of each patient can be seen in table 1, together with the first determination of serum Calprotectin, CRP and ESR. It also shows the physiscan’s decision, and the outcome, obtained from the assessment in the next visit Considering the cutoff point of serum Calprotectin in our sample of: 2.2 µg/mL (80% sensitivity and 69% specificity), 9 of 15 patients presented high values, 2 of them presented a flare (1 Oligo and 1 Poly), both had maintained the same treatment, because they were considered inactive. There were no flares in patients with negative Calprotectin The evolution of serum Calprotectin, together with the clinical decisions (based on clinical and analytical assessment) are described in table 1 In most of stable patients in whom serum calprotectin was high, it was decided not to lower treatment, and only in one case it was de-escalated. There were no flares in any of them Conclusions Serum Calprotectin is a useful biomarker in routine clinical practice, together with other markers such as CRP and ESR, and our clinical judgment, it helps us to make therapeutic decisions Disclosure of Interest None declared

Background Musculoskeletal (MS) ultrasound (US) is used for diagnosing and managing gout in clinical practice and has the potential to become an outcome measure for clinical trials. Cartilage double contour sign (DC) and tophi(T) are elementary US lesions of urate crystal deposits. OMERACT MSUS Working Group developed the first consensus-based definitions for DC and T and showed that the reliability of the definitions ranged from moderate to excellent in static images and somewhat lower in patients when tested in highly experienced MS ultrasonographers.1 Objectives To compare the agreement between a group of rheumatologist-ultrasonographers (RU) with a variable experience in MSUS with the agreement between rheumatologist-ultrasonographers highly experienced in MSUS and teachers (ExRU) for detecting DC and T in in patients. Methods 16 RU with a variable experience in MSUS were trained in the OMERACT U definitions for DC and T. Next, as a preliminary reliability exercise, they read 30 different US joint static images from gout patients and healthy subjects for the presence or absence of DC or T. Afterwards the RU group and a group of 5 ExRU consecutively, independently and blindly carried out each a reliability exercise in 5 subjects (3 crystal proven gout patients and 2 healthy controls) for the presence or absence of DC or T. Both groups performed a standardised 8 min bilateral grey-scale UU examination of the following: the suprapatellar knee recess for T, femoral knee cartilage for DC, medial and lateral knee compartments for T and dorsal first metatarsal phalangeal for T and metatarsal head for DC. Fleiss kappa was used to assess interobserver reliability. K values 0–0.20 were considered poor; 0.20–0.40 fair;0.40–0.60 moderate;0.60–0.80 good and 0.80–1 excellent. Results Kappa values were moderate for the RU group inter-reader agreement in static US images (K 0.514 for DC and 0.465 for T). However, there were significant differences between the interobserver agreement from both groups in patients, being kappa values fair (K 0.344 for DC and 0.305 for T) for the RU group while good for the ExRU group (K 0.674 for DC and 0. 673 for T) (p Conclusions This study showed that although inter-reader agreement for gout lesions can be acceptable in static US images, interobserver agreement in patients is highly dependent on the experience of the ultrasonographers. Reference [1] Terslev L, Gutierrez M, Schmidt WA, Keen HI, Filippucci E, Kane D, et al. Ultrasound as an Outcome Measure in Gout. A Validation Process by the OMERACT Ultrasound Working Group. J Rheumatol2015;2149–54. Acknowledgements Carlos Salgado from GE heathcare, Ultrasonidos Iberia. Disclosure of Interest None declared

Background Giant cell arteritis (GCA) is the most frequent vasculitis in adulthood. The delay in diagnosis sets back treatment and can lead to serious consequences. Diagnosis is complex, and is followed by the classification criteria according to the American College of Rheumatology (ACR). The is an increasing interest on the utility of temporal artery ultrasound (TAUS) as a tool to evaluate inflammation on the vessel wall. Objectives to evaluate the utility of TAUS in GCA. Methods During 2016, 120 TAUS were carried out in 60 patients with clinical suspicion for GCA. The TAUS was carried to completion by rheumatologist with experience. The symptoms that lead to a TAUS was either one or more of these clinical scenarios: 1) cranial symptoms (recent onset headache, mandibular claudication, visual disturbances) 2) polymyalgic syndrome 3) toxic o febril unspecific syndrome 4) vertebrobasilary (VB) stroke. Demographic and laboratory data were collected, and a follow-up was done to learn the final diagnosis. As for TAUS, the “halo” sign was considered positive if an anechoic image surrounded the vessel was present, and measured >0,30 mm in both, longitudinal and transverse cuts. Other more unspecific signs as stenosis or occlusion were also registered. A temporal artery biopsy was performed whenever the physicians considered necessary, based on clinical criteria, every case in no more than 30 days. Results Fifty-two percent were women, mean age 76±7.8 years old. Mean laboratory parameters: eritrosedimentation rate 85±41.9 mm/h, C-reactive protein 77±80 mg/L, Haemoglobin 11.4±2.2 g/L, white blood count 10,228±3,520, platelet count 310,603±123,918. The symptoms that motivated requesting the TAUS were: cranial symptoms (62.2%), toxic, unspecific, febrile syndrome (44%), polymyalgic syndrome (30%), VB stroke (5%). A temporal artery biopsy was carried out in 45% of patients (N=27); it was positive in 40.7%, negative in 40.7% and unspecific (given it reported an inflammatory histologic pattern, but without the characteristic giant cells) in 18.5%. From all 60 patients in whom a TAUS was performed, 36% were diagnosed with GCA, based on ACR criteria. The sensibility and specificity for TAUS was 80% and 94% respectively, with a posivite predictive value of 88.9% and a negative predictive value of 89.2% Conclusions TAUS is a useful, non-invasive, fast, accessible tool for evaluating temporal arteries with a great diagnostic valu Disclosure of Interest None declared

Existen pacientes con artritis reumatoide (AR) que no responden de la forma deseada a la terapia biológica. Nuestro objetivo fue reconocer los atributos del FAME biológico (FAMEb) que podrían identificar al más adecuado en las primeras líneas de tratamiento de la AR. Métodos Para reconocer los atributos que podrían definir el FAMEb, se realizó una búsqueda sistemática de la literatura acerca de aspectos generales, farmacología, eficacia, seguridad, administración y coste. A continuación, se realizó un proceso Delphi a 2 rondas entre un grupo de reumatólogos expertos en el manejo de la AR para determinar el grado de acuerdo con los atributos identificados, indicando el grado de importancia que se le daba a cada atributo. Se aplicaron 2 criterios para determinar la consistencia de los resultados: 1) sobre la base de la mediana y el rango intercuartílico, y 2) el cumplimiento simultáneo de media, mediana, desviación estándar, rango intercuartílico y coeficiente de variación. Se determinaron también la concordancia y la ratificación final del panel de expertos. Resultados Ochenta y tres reumatólogos españoles completaron las 2 circulaciones del proceso Delphi. Ninguno de los 77 atributos identificados se consideró de baja importancia, 75 de los 77 (97,4%) se consideraron de alta importancia y 76 de los 77 (98,7%) fueron ratificados. Quince tuvieron el apoyo del 100% del grupo de trabajo. Conclusiones Quince atributos tuvieron el apoyo del 100% del grupo de trabajo y podrían considerarse los que definirían el FAMEb ideal en las primeras líneas de tratamiento de la AR. 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. Sin financiación No data JCR 2018 0.363 SJR (2018) Q3, 38/66 Rheumatology No data IDR 2018 UEM

Resumen Antecedentes y objetivos La encefalopatia posterior reversible es una entidad clinicoradiologica caracterizada por cefalea, obnubilacion y ceguera cortical asociada a edema cerebral en neuroimagen, cuyas causas clasicas son: eclampsia, encefalopatia hipertensiva y agentes inmunosupresores. Metodos Mujer de 33 anos afecta de lupus eritematoso sistemico traida a urgencias por cefalea, agitacion y amaurosis. Resultados A su llegada PA: 205/139 mmHg. No signos meningeos ni focalidad motora. Examen cardiopulmonar y ECG normales. Analitica anodina excepto proteinuria. RMN craneal: lesiones simetricas corticosubcorticales bioccipitales, hiperintensas en T2. Estos hallazgos sugerian lesiones tipo encefalopatia posterior reversible. Se administro labetalol i.v. como tratamiento de la emergencia hipertensiva con evolucion favorable, consiguiendose cifras de normotension en dias posteriores con valsartan y lercanidipino. La paciente quedo asintomatica en 24 h, RM craneal de control a las 2 semanas: normal. Se instauro tratamiento con prednisona y azatioprina orientando el episodio como complicacion de su lupus eritematoso sistemico. Conclusiones La encefalopatia posterior reversible no es una condicion excepcional en pacientes con lupus eritematoso sistemico. La clinica debe diferenciarse de un neurolupus y de posibles causas infecciosas en relacion con la inmunosupresion. La evolucion clinica y radiologica de este sindrome es generalmente rapidamente favorable.

Objective: To assess effectiveness and safety of certolizumab PEGol (CZP) in Rheumatoid Arthritis (RA) patients after 12 months of treatment and to detect predictors of response.Methods: Observational longitudinal prospective study of RA patients from 35 sites in Spain. Variables (baseline, 3- and 12-month assessment): socio-demographics, previous DMARD and previous Biological Therapies (BT) use; TJC, SJC, ESR, CRP, DAS28, SDAI. Response variables: TJC, SJC, CRP, ESR and steroids dose reductions, EULAR Moderate/Good Response, SDAI response and remission, DAS28 remission. Safety variables: discontinuation due to side-effects. Descriptive, comparative and Logistic regression analyses were performed.Results: We included 168 patients: 79.2% women, mean age 54.5 years (±13.2 SD), mean disease duration 7.5 years (±7.3 SD). Mean number of prior DMARD: 1.4 (±1.2 SD), mean number of prior BT was 0.8 (±1.1). Mean time on CZP was 9.8 months (±3.4 SD). A total of 71.4% were receiving CZP at 12-month assessment. Baseline predictors of response: lower prior number DMARD; low number prior BT; higher CRP, ESR, TJC, SJC, DAS28 and SDAI (pConclusions: CZP showed benefit in severe RA patients, with significant reduction of all effectiveness parameters, despite the high prevalence of previous BT exposure in our series. We found CRP, ESR, prior DMARD/BT number, TJC, SJC, DAS28, and SDAI as baseline predictors of response. CZP was mostly well tolerated.

Background The current paradigm of optimal clinical management of patients with rheumatoid arthritis (RA) recommends reaching a state of remission or low activity of the disease, assessed by composite indexes of activity, by means of a tight control and a dynamic adjustment of available therapeutic options, using a “treat to target” strategy. Objectives The aim of this study is to assess the level of implementation of the “treat to target” strategy and other parameters of medical quality in clinical records (CRs) of RA patients in Spanish rheumatology departments. Methods Adult RA patients fulfilling 2010 ACR-EULAR criteria for RA and diagnosed between January 1st, 2010 and December 31st, 2013 in Spanish rheumatology departments were included. From every centre, 19 patients were randomly chosen from a computerized anonymized list provided by every department. Independent auditors assessed the CRs, verifying the fulfilling of the quality criteria included in an assessment tool specifically developed for this project. The study was approved by the ethic committees of every participant hospital. Descriptive statistics was used for the presentation of the results. Results A total of 856 CRs from 46 rheumatology departments were included. Patients9 mean age was 54 years and 71% of patients were women. Mean duration of RA was 2 years. During the follow-up, 38% of patients reached a state of low disease activity, defined by DAS28 and/or SDAI. An explicit assessment of the disease activity as a determinant element considered to choose the therapy was recorded in 32% of the CRs. An optimal escalation of methotrexate dose was registered in 72% of the cases. Use of a composite disease activity score (DAS28, SDAI, CDAI) was reported in 61% of the cases. Disease activity monitoring every 6–8 months after reaching the therapeutic target was recorded in 73% of the cases. In 99% of the cases, the clinicians had registered patient9s comorbidities and these associated conditions had been considered in planning the therapeutic approach and objective. In only 4% of the CRs, visits every 4 weeks using a composite activity score had been reported during the early stage while trying to reach remission after diagnosis. Starting a DMARD in the first two weeks after the first appointment with the rheumatologist was recorded in only 35% of the cases. Conclusions Currently, the implementation of the “treat to target” strategy is scarcely registered in clinical records of patients diagnosed with RA in Spanish rheumatology departments. A minority of patients is treated according to the “Treat to target” recommendations. Disclosure of Interest None declared

Background Genome-wide association studies (GWAS) in Psoriatic Arthritis (PsA)patients and controls have allowed the identification of multiple variants associated with disease risk. To date, however, no GWAS for PsA phenotypes has been reported. Objectives The main objective of this study was to identify new genetic variation associated with clinical phenotypes in PsA. Methods A total of n=835 patients diagnosed with PsA using CASPAR criteria were recruited in the discovery stage and genotyped for >600,000 single nucleotide polymorphisms. GWAS were performed for clinical and biological phenotypes associated with joint and skin disease. After allelic association analysis, those SNPs with highest level of significance were analyzed in an independent cohort of n=414 PsA patients. Results In the GWAS stage, several genomic regions showing high evidence of association with different PsA phenotypes (P Conclusions Usign a GWAS approach, new loci associated with axial and peripheral disease in PsA have been identified. Disclosure of Interest None declared

Background According to clinical guidelines, treatment with a DMARD should be initiated as soon as possible, and any patient who does not improve with at least one relevant synthetic DMARD is a candidate for a biological one. However, up to one third of the patients treated with a biological DMARD do not accomplish the therapeutic objective. Objectives To identify and assess the attributes of the biological DMARDs which determine the most suitable treatment of patients with RA. Methods We performed a systematic search with the following MeSH terms: rheumatoid arthritis, biologic, DMARD, characteristic, efficacy, safety, side effects, pharmacology, route–administration, adherence y cost. More than 500 publications were reviewed, from which we selected 77 attributes: 7 about general aspects, 5 about pharmacological aspects, 18 about efficacy, 31 about safety, 6 administration aspects and 10 related with cost. Between May and September 2015, 12 meetings were held, followed by a Delphi process of 2 rounds in which the degree of importance was awarded to each attribute on a Likert scale from 1 (minimum) to 9 (maximum). The consistency and concordance of the agreement were determined and they were circulated, obtaining the percentage supported for each one of them. Results 83 Spanish rheumatologists participated, reaching a high degree of agreement with the attributes, 75 with a high importance (97.4%) and none of low importance. Fifteen attributes were ratified by all the participants: –Product with approved indication in RA as first-line biological. –Product recommended in the guidelines as first-line biological. –Product that shows efficacy following the failure of another biological. –Treatment accompanied by a reduction in articular damage progression. –Treatment that reduces comorbidities associated with RA. –Treatment characterised by a sustained long-term response. –Safe product (globally). –Proven long-term safety. –Treatment with a low incidence of serious infections. –Product that does not increase the incidence of solid malignancies. –Product that does not increase the incidence of haematological neoplasms. –Safe product in patients with cardiovascular pathology. –Safe product in patients with interstitial pulmonary disease. –Product that has demonstrated a reduction in mortality. –Product that presents a scant incidence of serious adverse events. Conclusions There was a high degree of agreement with the selected attributes, none of which were regarded as being of low importance; 15 of them received the full support of the work group. These attributes would help to define the ideal profile of the biological DMARD following the failure of a synthetic or previous biological DMARD. Acknowledgement Financing: Bristol-Myers Squibb Disclosure of Interest None declared