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Se han estudiado un total de 116 sueros, distribuídos de la siguiente forma: 20 de ellos procedían de personas normales y fueron actualizados con control; los 96 restantes procedían de distintos pacientes afectos de neoplasias pulmonares (22), gástricas (29), hepáticas primitivas (9), hepáticas metastásicas (10), y tumores recto-sigmoideos (26). Los resultados obtenidos permiten establecer las siguientes conclusiones: 1) Los rasgos disproteinémicos más constantes de las neoplasias han sido: hipoalbuminemia, hiper-alfa-2-globulinemia, constante hiperbetaglobulinemia y discreta hipergammaglobulirremia. 2) El estudio de las correlaciones estadísticas entre la cronología evolutiva de las neoplasias y los cambios disproteinémicos ha puesto de manifiesto la estrecha correlación existente entre la cuantía de la alfa 2 globulina y el tiempo de evolución de los tumores pulmonares y hepáticos metastásicos, dando resultados negativos en los restantes grupos. La alfa 2 globulina ha demostrado, igualmente, una correlación estadísticamente significativa, de signo directo, con respecto a la extensión metastática de los tumores gástricos. En ningún otro caso ha podido precisarse tal tipo de correlación con respecto a ninguna otra fracción ni a ningún otro tipo de tumor. 3) Aunque el patrón disproteinémico encontrado en las neoplasias no puede considerarse específico de las mismas, su análisis cuidadoso puede constituir un importante instrumento auxiliar en la valoración clínica y pronóstica de las mismas.

Se estudian 14-pacientes afectos de ACG diagnosticados en los últimos cinco años por biopsia temporal o criterios clínicos. Dos de ellos debutaron con sintomatología atípica. El síntoma más común fue la polimialgia reumática que se encontró en el 71 % de los casos. Dos pacientes ( 14 %) tuvieron pérdida de visión irreversible en un ojo. La biopsia temporal demostró histología de arteritis en 8 casos, uno de los cuales no tenia manifestaciones craneales. El dato de laboratorio más constante fue la elevación de la VSG (100 %), seguido del incremento de la alfa-dos-globulina (93 %) y la anemia (57 %). Un paciente presentó un síndrome del cayado aórtico, rara complicación de la enfermedad. Todos los pacientes respondieron bien al tratamiento. Dos fallecieron durante el seguimiento.

Se estudian un total de 55 enfermos con Artritis Reumatoide (AR) así como 25 personas sanas, tomadas como población control. Se determina en la sangre venosa de todos ellos el porcentaje y valor absoluto de linfocitos T, encontrándose en la AR un nivel de rosetas E similar al de la población control, cuando estos pacientes no están recibiendo esteroides; sin embargo se plantea la posibilidad de que el número absoluto de linfocitos T, sí está descendido. Finalmente se hace una amplia correlación entre la inmunidad celular cuantitativa (rosetas E y valor absoluto de linfocitos T) y diferentes parámetros clínicos y biológicos.

The aim of this article is to evaluate the use of musculoskeletal ultrasound in the daily clinical practice of a rheumatology unit. We conducted a descriptive retrospective analysis of the ultrasound examinations performed during 2011 and a comparison of these examinations with those performed between 1998 and 2003 and between 2007 and 2008. A total of 712 ultrasound examinations performed in 2011 were reviewed. Out of the total, examinations of individual areas of the body represented 11.6% versus 45.9% of the examinations made between 2007 and 2008 and 100% of those performed before 2003. The remaining 88.4% of ultrasound examinations performed in 2011 were intended to investigate inflammation in 25.8%, differential diagnosis of arthralgia in 17.1%, enthesis in 12.6% and temporal arteries in 17.3%, and to conduct ultrasound-guided procedures in 10.6% and study microcrystalline pathologies in 4.7%. In our unit, ultrasonography is evolving from being a mere investigation of individual areas of the body to becoming a clinical information tool, which contributes to the diagnosis and monitoring of the disease activity in the patient as a whole.

Background Subcutaneous tocilizumab (TCZ-SC) has demonstrated non-inferiority to TCZ-IV and superiority to placebo Objectives The primary objective of this study was to assess the 24-week efficacy and safety of subcutaneous (SC) tocilizumab (TCZ) 162 mg weekly (qw) as monotherapy or in combination with methotrexate (MTX) or other synthetic (s) DMARDs in patients with active rheumatoid arthritis (RA) in the real world setting Methods This multinational (Spain, Ireland, Portugal), multicenter, phase IIIb study. Subjects ≥18 years of age with active RA (DAS 28-ESR >3.2) who have had inadequate response or intolerance to sDMARDs or to a first anti-TNF drug. The study comprised a phase 1 with open-label design in which patients received TCZ-SC 162 mg qw (+/- oral/SC MTX or other sDMARDs) for 24-weeks and the main outcome was the percentage of patients achieving sustained clinical remission (DAS 28-ESR Results 401 patients were included in the phase 1, 74 patients received TCZ-SC monotherapy and 327 patients received TCZ-SC in combination with oral/SC MTX or other sDMARDs. Sustained clinical remission rates were comparable between the mono- and combination-therapy groups at 24 week (48.4% vs. 52.9%, p=0.523). Of the 179 patients who achieved sustained clinical remission during the phase 1, 89 were randomly assigned to receive TCZ-SC 162 mg qw and 90 to receive TCZ-SC 162 mg q2w. At the end of phase 2, the percentage of patients who maintained the remission at week 48 was 91.5% with TCZ-SC qw and 73.9% with TCZ-SC q2w (p=0.002). Main efficacy outcomes for both phases of the study are presented in the table. Rates of serious adverse events (AEs) and rates of AEs leading to drug discontinuation were similar in patients treated with mono or combination therapy, and in patients treated with TCZ-SC qw or TCZ-SC q2w. Conclusions In the real world setting, treatment with TCZ-SC 162 mg weekly in patients with active RA is associated with rate of sustained clinical remission of approximately 50% regardless it is administered as monotherapy or in combination with a sDMARD. The proportion of patients who remained in clinical remission at week 48 was significantly higher with TCZ-SC qw than with TCZ-SC q2w. The safety profile of TCZ-SC was consistent with previous studies of TCZ-SC and TCZ-IV Disclosure of Interest R. Sanmarti Grant/research support from: Roche, E. Martin Mola Grant/research support from: Roche, J. Fonseca Grant/research support from: Roche, D. Veale Grant/research support from: Roche, A. Escudero Grant/research support from: Roche, C. Gonzalez Grant/research support from: Roche

Established osteoporosis in women is associated with a higher risk of fractures and poor quality of life. The objective of this study was to determine clinical features that could alert clinicians during diagnosis. Risk factors and quality of life were compared in paired groups. The first group presented clinical features related to increased risk of fracture, while the second, the control group, did not. Although 104 pairs were studied, no differences were found for the majority of osteoporosis risk factors. Nevertheless, the scales used showed a significant reduction in quality of life in the group that presented a higher fracture risk (P < 0.05). The existence of multiple fractures or a history of inadequate response to osteoporosis treatment is related to poorer quality of life.

Etanercept is a dimeric fusion protein based on the p75 TNF-alpha receptor. It binds to TNF-alpha and blocks its biologic activity. In randomized, double-blind, placebo-controlled trials, etanercept has therapeutic activity in rheumatoid arthritis, psoriatic arthritis, polyarticular-course juvenile idiopathic arthritis and ankylosing spondylitis. Etanercept improves joint inflammation, physical function and slows/halts structural damage, especially when combined with methotrexate. A sustained response is observed in a substantial percentage of patients. Although some safety issues should be considered before starting etanercept treatment, in general terms, etanercept is a well tolerated drug with an acceptable safety profile. The use of any TNF-alpha antagonist must be in agreement with the National Recommendations for Biologic Therapy, and in difficult clinical situations, a balance between risk/benefit needs to be obtained.

Introduccion El presente estudio procede de una encuesta europea promovida por el Arthritis Action Group en 8 paises con el objetivo de conocer la prevalencia e impacto en la calidad de vida del dolor musculoesqueletico cronico (DMC). Se muestran los resultados en Espana. Metodos Estudio transversal realizado en Espana mediante encuesta telefonica a 200 medicos de Atencion Primaria y 816 sujetos con DMC. Resultados Un 21% de los sujetos contactados aleatorizados cumplieron criterios de DMC (edad media: 56 anos, 69% mujeres). La artrosis fue la causa mas frecuente de diagnostico de DMC. El 75% de los sujetos con DMC habia consultado a un medico, mayoritariamente de Atencion Primaria, y un 39% habia tomado tratamiento farmacologico en las 4 semanas anteriores a la encuesta. Un 38% considero que no debia molestar al medico con sus dolencias y el 29% que no se podia hacer nada para mejorar su estado de salud. El 49% obtenia informacion sobre su patologia/opciones terapeuticas a traves de fuentes no medicas, y solo el 24% la obtenia de su medico. El 91% de los medicos utilizaban antiinflamatorios no esteroideos (AINE) como farmacos de eleccion. El 42% de los pacientes en tratamiento tomaban un AINE de prescripcion (solo el 19% conocian sus efectos adversos). Conclusiones Aunque el presente estudio muestra una alta prevalencia del DMC en la poblacion espanola, el 25% de los sujetos nunca ha consultado a un medico. Ciertas actitudes y creencias de los sujetos que la padecen, asi como la falta de informacion y comunicacion entre medico y paciente pueden constituir no solo una barrera al diagnostico, sino tambien a la participacion activa del paciente en el manejo de su patologia.

Twin and family studies have demonstrated that a large part of a population's variance in bone mineral density (BMD) is attributable to genetic factors. A polymorphism in the collagen type I alpha1 (COLIA1) gene has recently been associated with low bone mass and fracture incidence. We analyzed the relationship between COLIA1 gene polymorphism, lumbar spine and hip BMD, and fracture prevalence in a population of 319 postmenopausal women classified by WHO standards, including 98 nonosteoporotic women (NOPW) and 221 osteoporotic postmenopausal women (OPW), divided into 139 osteoporotic women without fracture (OPWnF) and 82 osteoporotic women with fracture (OPWwF). The COLIA1 genotype was assessed by polymerase chain reaction and BalI endonuclease digestion. Genotype frequencies for the total group were 49.2% GG homozygotes, 39.5% GT heterozygotes, and 11.3% TT homozygotes. We found significant differences in the percentage of homozygous TT between NOPW and OPW (6.1% and 13.6%, respectively). Significantly, the occurrence of genotype TT in OPWnF was 6.2%, and 28% in OPWwF. We observed no associations between the COLIA1 genotype and lumbar spine and hip BMD. The prevalence of fractures varied significantly by genotype: GG, 26.1%; GT, 15.9%; and TT, 58.3%. Logistic regression analysis of fracture prevalence showed that, for prevalent fractures, the women with the TT genotype had a 5.9-fold increased risk when compared with the other genotypes (GG + GT). When prevalence was adjusted for age, body mass index, and BMD, the fracture risk was 4.8 for the TT group vs. the genotype GG, whereas it was 0.6 for the GT genotype. In conclusion, we found the COLIA1 Sp1 TT genotype to be associated with an increased fracture risk in postmenopausal women. Interestingly, this genotype-dependent risk could not be explained completely by BMD differences.

Resumen La atritis reumatoide es una enfermedad que engloba manifestaciones articulares y extraarticulares como la neumonitis. Igualmente, ciertas medicaciones usadas para su tratamiento, como el metotrexato, se han asociado a neumopatias y a la presencia de atipias epiteliales y bronquiales. Reportamos el caso de una mujer de 63 anos, diagnosticada de artritis reumatoide y con tratamiento con metotrexato, que presento una neumonia intersticial, la cual inicialmente fue etiquetada de carcinoma pulmonar.

Background Tocilizumab (TCZ), a humanized anti-IL-6 receptor antibody, represents a new treatment strategy for RA patients.Several studies have demonstrated the association between high serum levels of TNF-inhibitors and a good clinical response in patients with RA. Little evidence exists on this relationship for other biological therapies. Objectives To evaluate the association between TCZ serum through levels and disease activity in a cohort of RA patients after one year of treatment with TCZ. Methods 34 RA patients treated with Tocilizumab were included. Clinical activity was assessed using the Disease Activity Score 28 (DAS28-ESR) and the Clinical and Simplified Activity Index (CDAI and SDAI), serological improvement by C-Reactive Protein- CRP- and Erythrocyte Sedimentation Rate-ESR, clinical improvement by the delta-DAS 28 and response to treatment using EULAR criteria at baseline and after one year of treatment. We stratified all patients into quartiles according to the tocilizumab levels (μg/ml) as follows: IQR1: 18.5. A last observation carried forward analysis (LOCF) was performed at the first year of treatment, so patients that dropped out of the therapy before this period were included. Blood samples were collected just before intravenous (i.v) infusion. Serum drug levels were determined by a capture enzymelinked immunosorbent assay (ELISA). Results The baseline demographic and clinical characteristics are shown in Table 1. When patients were categorised into quartiles, IQR1 comprised 8 (24,2%) patients; IQR2, 7 (21,2%); IQR3, 8 (24,2%) and IQR4, 10 (30,3%). Clinical activity (DAS28, CDAI and SDAI) was statistically significant higher in patients with lower serum through levels at the first year [DAS28 (IQR1: 4,46 ±1,5, IQR2: 2,58 ± 0,87, IQR 3: 3,6± 0,79; IQR4: 2,17 ± 0,74; p=0,001), CDAI (IQR1: 23±13,9, IQR2: 7,72 ± 4,44, QIR 3: 13,38± 4,35, IQR4: 6,33 ± 4,62; p=0,003) and SDAI (IQR1: 19,46 ±15,5, IQR2: 9,51± 7,4, IQR3: 12,59 ± 6,31, IQR4: 4,55 ± 3,73; p=0,005)] and also was the number of swollen joints (IQR1: 7,5 ± 6,6, IQR2: 2,29 ±2,06, IQR3: 5,63 ± 4,3, IQR4: 1,1 ± 1,6, p=0,013) and tender joints (IQR1: 5,5 ± 5,7, IQR2: 1,71 ± 2,06, IQR3: 3,13 ± 2,8, IQR4: 0,8 ± 0,9, p=0,014). In addition, the EULAR reponse was worse in those patients with lower serum drug levels [non-responders: 4 (66,7%) in IQR1 vs 1 (16,7%) in IQR2 vs 1 (16,7%) in IQ3 vs 0 (0%) in IQR4, moderate responders: 3 (37,5%) in IQR1 vs 0 (0%) in IQR2 vs 4 (50%) in IQR3 vs 1 (12,5%) in IQR4 and good responders: 1 (5,3%) in IQR1 vs 6 (31,6%) in IQR2 vs 3 (37,5%) in IQR3 vs 9 (47,4%) in IQR4, p=0,006]. In terms of acute-phase reactants, the mean ESR tended to be higher in patients with lower TCZ levels (IQR1: 22,6±14,8 vs IQR2: 5,6±1,6 vs IQR 3: 9,4 ±3,5 vs IQR4: 6,4 ± 3,5, p=0,005), and also CRP levels (RIQ1: 10,2±17,4 vs RIQ2: 2,3 ± 3,4 vs RIQ3 0,56 ± 0,4 vs RIQ 4: 0,42 ± 0,66, p=NS)]. Conclusions The presence of low serum Tocilizumab levels correlates with a worse clinical disease activity. Consequently, measurement of Tocilizumab levels is a valuable tool that might help in the clinical management of patients with Rheumatoid Arthritis. Disclosure of Interest C. Tornero Marin Grant/research support from: Funded by an unrestricted medical grant from Pfizer., C. Plasencia: None declared, D. Pascual Salcedo: None declared, T. Jurado: None declared, M. B. Paredes: None declared, I. Monjo: None declared, E. Moral: None declared, A. Pieren: None declared, G. Bonilla Hernan: None declared, D. Peiteado: None declared, P. Bogas: None declared, L. Nuno: None declared, A. Villalba Yllan: None declared, E. Martin Mola: None declared, A. Balsa Criado: None declared

Background The majority of patients with axial spondyloarthritis (SpA) response to anti-TNF therapy. However, discontinuation of this therapy due to different reasons is still a relevant problem. Currently, there is not enough data to know exactly which is the prevalence and causes of interruption of anti-TNF therapies in clinical practice. Objectives First, to evaluate the frequency and causes of discontinuating adalimumab or infliximab as the first anti-TNF in patients with axial SpA in clinical practice. Second, to investigate the influence of anti-drug antibodies (ADA) on these causes. Methods A total of 326 patients with axial SpA who had received adalimumab (34%) or infliximab (66%) as a first anti-TNF therapy were included in this retrospective, observational study performed in a tertiary hospital. Disease activity (BASDAI, ASDAS, CRP and ESR) was measured before starting anti-TNF therapy, after 6 months and when interrupting the therapy to assess properly whether the reason for discontinuation was primary or secondary failure. Serum drug levels and/or ADA were measured at 6 months visit and at the end of anti-TNF treatment. Results A total of 99 (30.4%) patients discontinued treatment. Mean (SD) under anti-TNF therapy until discontinuation was 2.5 (2.9) years. Characteristics of these patients when initiating anti-TNF therapy are shown in Table 1. The reason to interrupt treatment was: primary failure in 22.2%, secondary failure in 36.4%, side effects 32.3%), and other reasons in 9.1%. Serum drug levels and ADA were available in 83 patients. In most patients with ADA positive (14/17), the reason for discontinuation was secondary failure. Out of those patients who discontinued due to secondary failure, 38.9% had ADA positive. Conclusions In our cohort of patients with axial SpA treated with adalimumab/infliximab, 30% of patients discontinued anti-TNF therapy. The main reason to discontinue treatment was secondary failure, which was related to the presence of ADA in almost 40% of patients. Disclosure of Interest E. Moral Grant/research support from: Funded by an unrestricted medical grant from Pfizer, C. Plasencia: None declared, V. Navarro-Compan: None declared, D. Pascual Salcedo: None declared, T. Jurado: None declared, C. Tornero: None declared, A. Pierens: None declared, M. B. Paredes: None declared, P. Bogas: None declared, I. Monjo: None declared, E. Martin Mola: None declared, A. Balsa: None declared

Background Loss of response of TNFα inhibitors (TNFi) over time resulting in discontinuing of this therapy is a major issue in RA, but underlying reasons for this remains unknown. A few studies suggest the influence of BMI on serum levels of subcutaneous TNFi. However, there is no available data on the possible influence of BMI on infliximab (IFX) serum levels, which is intravenously administred and adjusteing the dose according to patient weight. Objectives To determine the possible influence of BMI on serum IFX levels in patients with RA. Methods Retrospective observational study incluiding 72 patients with RA treated with infliximab, at 3 mg/kg dose in a standard regimen, in our department between 2000 and 2015. Serum IFX levels were determined by ELISA in 3 visits: i)2 weeks, ii)six months and iii)one year after treatment onset. BMI (kg/m 2 ) was classified in four categories: underweight ( Results Characteristics of patients included in the study when initiating IFX therapy were: 88% female, median (range) age 52 (21–82) years, 71% RF+, 79% ACPA+, disease duration 10,4 (1,0–39,0) years, 79% with concomitant methotrexate and 57% with other DMARDs. Median (range) BMI was 25,5 (16,7–40,2) kg/m 2 . According to BMI, patients with underweight, normal, overweight and obesity were 2 (2,7%), 35 (48,6%), 23 (31,9%) and 12 (16,7%), respectively. Median (range) IFX serum levels, in ng/ml, for each of the four BMI categories,and for each of the visits, are presented in Table 1. In the longitudinal analysis, an inverse statistically significant relationship between BMI and drug serum levels was observed: β: -441,7; 95%CI (-829,7 to -53,8). This relationship remained despite of adjusting the model for potential confounders: β: -457,3; 95%CI (-858,8 to -55,8). Conclusions BMI influences serum IFX levels in patients with RA treated with infliximab. Higher BMI values are associated with lower serum drug levels. Acknowledgement Unrestricted grants from Pfizer Disclosure of Interest None declared

To assess long-term safety and clinical efficacy of etanercept 25 mg subcutaneously twice weekly up to 5 years in subjects with ankylosing spondylitis (AS).An open-label (OL), multicentre, phase 4, 156-week extension study of subjects with AS who had completed a 12-week randomised, placebo-controlled study (N=84; n=45 etanercept, n=39 placebo) followed by a 96-week OL study (n=81; n=42 etanercept/etanercept; n=39 placebo/etanercept); 59 subjects who completed the 96-week OL extension enrolled in the current OL trial and continued etanercept 25 mg BIW for an additional 156 weeks (total duration: 264 weeks, original etanercept group; 252 weeks, original placebo group). Safety was based on spontaneous reports of adverse events (AEs). Last observation carried forward was used for imputation of missing values.Thirty-seven of 59 subjects (63%) completed 5 years of etanercept treatment. Serious non infectious AEs and serious infections occurred at a rate of 0.17 and 0.03 events per subject years, respectively; inflammatory bowel disease and uveitis (including iritis and iridiocyclitis) occurred at 0.01 and 0.14, respectively. No cases of tuberculosis or opportunistic infections were reported. Assessment in Ankylosing Spondylitis (ASAS) responses and improvements in Bath Ankylosing Spondylitis Functional Index and spinal mobility were sustained from week 108 through week 264.Etanercept was well tolerated with no new safety signals detected in subjects with AS over 5 years. Clinical efficacy and improvements in function and mobility seen during the double-blind and first OL study were sustained. These results support etanercept therapy for the long-term management of this chronic disease.

Summary Aim To conduct a multi-language translation and cross-cultural adaptation of the Intermittent and Constant OsteoArthritis Pain (ICOAP) questionnaire for hip and knee osteoarthritis (OA). Methods The questionnaires were translated and cross-culturally adapted in parallel, using a common protocol, into the following languages: Czech, Dutch, French (France), German, Italian, Norwegian, Spanish (Castillan), North and Central American Spanish, Swedish. The process was conducted following five steps: (1) – independent translation into the target language by two or three persons; (2) – consensus meeting to obtain a single preliminary translated version; (3) – backward translation by an independent bilingual native English speaker, blinded to the English original version; (4) – final version produced by a multidisciplinary consensus committee; (5) – pre-testing of the final version with 10–20 target-language-native hip and knee OA patients. Results The process could be followed and completed in all countries. Only slight differences were identified in the structure of the sentences between the original and the translated versions. A large majority of the patients felt that the questionnaire was easy to understand and complete. Only a few minor criticisms were expressed. Moreover, a majority of patients found the concepts of constant pain and pain that comes and goes to be of a great pertinence and were very happy with the distinction. Conclusion The ICOAP questionnaire is now available for multi-center international studies.

Objective. To analyse the relationship between the presence of auto-antibodies [rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP)], HLA-DRB1 alleles and PTPN22 1858 C/T polymorphism and test the value of their combination as susceptibility markers for rheumatoid arthritis (RA). Methods. Patients with early arthritis were included. At entry in the cohort or during follow-up, 191 patients fulfilled the criteria for RA and 184 individuals suffered from other arthropathies. RF was measured by nephelometry and anti-CCP antibody by enzyme-linked immunosorbent assay. HLA class II alleles were determined by polymerase chain reaction. Samples were genotyped for PTPN22 1858C/T variants using a TaqMan 5 0 -allele discrimination assay. Results. The presence of shared epitope (SE) alleles was strongly associated with anti-CCP and RF-positive RA [P ¼ 7.05 � 10 � 10 , odds ratio (OR) 4.57, 95% confidence interval (CI) 2.76–7.57 and P ¼ 1.68 � 10 � 6 , OR 2.99, 95% CI 1.89–4.74, respectively). The combination of the PTPN22 1858T variant and anti-CCP antibodies gave a high specificity for the disease, and was significantly associated with RA (P ¼ 8.86 � 10 � 5 , OR 10.05, 95% CI 1.88–53.73). Conclusion. The combination of the T variant of the 1858 polymorphism of the PTPN22 gene in combination with the presence of anti-CCP antibodies, preferentially in a SE-positive individual, is associated with the development of RA.

To determine if adding etanercept (ETN) to methotrexate (MTX) or MTX to ETN for 52 weeks in rheumatoid arthritis (RA) patients with moderate disease activity provides higher efficacy.All patients (n = 227) received open-label ETN 25 mg subcutaneously twice-weekly and MTX orally up to 20 mg weekly for 52 weeks and had completed a 3-year study in which patients received MTX, ETN or combination therapy. Endpoints were based on Disease Activity Score (DAS) and European League Against Rheumatism (EULAR) responses.Patients previously receiving combination therapy (Combination group; n = 96) had a lower disease activity at baseline. The mean DAS for those previously receiving MTX (ETN-added group; n = 55) and previously receiving ETN (MTX-added group; n = 76) were in the moderate disease activity range at baseline; Combination patients had a low disease activity. The greatest increase in DAS remission rates from baseline to week 52 was in the ETN-added group (23.6% to 41.8%, p0.01), although Combination (37.6% to 50.0%, p0.01) and MTX-added (26.7% to 36.8%, p = NS) also demonstrated improvements. DAS low disease activity and EULAR responses showed similar results. No new safety issues were identified.RA patients who were partial responders to long-term MTX or etanercept monotherapy obtained a higher efficacy with combination therapy. Responses achieved by patients with combination therapy after 3 years in the previous study were sustained or improved during the fourth year of treatment. This trial supports the higher therapeutic effect of combination treatment with etanercept and MTX in RA patients with moderate disease activity despite monotherapy with one of the two agents.

Objectives To analyze the impact of smoking through time in the clinical characteristics and disease activity in a cohort of rheumatoid arthritis (RA) patients from an Early Arthritis Clinic (EAC). Methods We studied a cohort of patients from an EAC, followed up between January 1993 and December 2014. All patients gave informed consent. Patients with early arthritis (less than one year of disease duration), who met the 1987 criteria of the American College of Rheumatology (ACR) for rheumatoid arthritis (RA)1 at some time during the disease course were included and followed up for two years. Microcrystalline and infectious arthritis were excluded, as well as patients who previously had been treated with disease modifying antirheumatic drugs. Patients were assessed for clinical and analytical data using standardized protocols every six months, that included:number of tender joints (out of 28) (NTJ), number of swollen joints (out of 28) (NSJ), DAS28, erythrocyte sedimentation rate (ESR), rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA). Disease activity in different periods of time (first from 01/01/1993 to 31/12/2000, second from 01/01/2001 to 31/12/2007, third from 01/01/2008 to 31/12/2014), as well as the influence of smoking were studied. Data was analyzed with the statistical program SPSS 11.5. Results Out of 1144 patients included in the cohort, 480 patients fulfilling RA classification criteria were included in this study. The age of onset was similar between the 3 periods (52,5±16,3 years in the first period vs. 53,2±17,1 years in the second vs. 51,8±16,4 years in the third; p=NS). In spite of the fact that RA is a predominant women's disease, the frequency of female sex increased significantly in the last periods (66,7% vs. 81,1% vs. 81,4% respectively; p=0,007) and also an increase of smoking habit in women was observed (proportion of smoking or ex-smoking women for periods: 40% vs. 67,4% vs. 68,1% respectively; p=0,003). In the last period, patients were first seen in our EAC with a longer disease duration (15,4±8,3 vs. 16,2±11,5 vs. 25,5±20,5 weeks respectively; p

Background In spondyloarthritis (SpA) patients in low disease activity (LDA) treated with biologics it is possible to decrease dose or increase the interval of administration (tapering strategy: TS) It is hypothesized whether the use of the TS could increase the development of anti-drug antibodies (ADA) with the consequent secondary inefficacy. Objectives To analyze the influence of the TS of TNF inhibitors (TNFi) in a cohort of SpA patients at least in LDA on the clinical activity (Bath Ankylosing Spondylitis Disease Activity Index: BASDAI and incidence of flares) and serum drug and ADA levels. Methods Retrospective observational study of a cohort of SpA patients under TNFi: Infliximab (Ifx), Adalimumab (Ada), Etanercept (Etn) and Golimumab (Gol)] on a TS. Sixty two out of 148 SpA patients under TS treated with the first anti-TNF were included. All included patients had to be at least 6 months in LDA (defined by BASDAI 5mg/L) and/or Delta-BASDAI ≥2. Clinical activity (BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS), serological data of disease activity (CRP) were measured at baseline, prior starting the TS (pre-visit) and last visit available in the first 2 years after TS (final-visit). Results 62 patients: 44 males (71%) and 82.2% of patients were HLA B27 positive. the subtypes of SpA are shown in the tables. No differences in clinical activity by ASDAS (p=0.219), BASDAI (p=0.271) or CRP levels (0.051) were detected between pre-visit and final-visit (see tables). Nine (14.52%) patients were ADA positive: 5 with Ifx, 3 with Ada and 1 with Gol. Two patients were already ADA positive in the pre-visit and 7 were ADA positive at final-visit. During follow-up only 8 patients (12.9%) experienced a flare and 80% recovered the LDA after shortening the interval of administration. Patients without detectable drug levels at flare visit, developed ADA at the end of follow up (p=0.035), reaching statistical significance. None ADA positive results were found in patients with use of concomitant methotrexate (MTX) at baseline. Conclusions In SpA patients in LDA, the tapering strategy of TNFi seems to be feasible in most patients without a relevant clinical worsening and with a low incidence of flares. Monitoring drug and ADA levels could help to predict patients with flares. Furthermore, the use of concomitant MTX seem to have a protective effect on ADA development. Disclosure of Interest I. Monjo Henry Grant/research support from: This study has received unrestricted grants from Pfizer, C. Plasencia: None declared, D. Pascual-Salcedo: None declared, B. Paredes: None declared, A. Pieren: None declared, C. Tornero: None declared, E. Moral: None declared, G. Bonilla: None declared, L. Nuno: None declared, D. Peiteado: None declared, A. Villalba: None declared, T. Jurado: None declared, C. Diego: None declared, J. Diez: None declared, E. Martin Mola: None declared, A. Balsa: None declared

To evaluate the efficacy and tolerability of aceclofenac, 200 mg/day, and paracetamol, 3000 mg/day, in the treatment of osteoarthritis (OA) of the knee.This was a double-blind, parallel-group, multicentre clinical trial involving patients with symptomatic OA of the knee, conducted in Spain. Patients were randomly allocated to aceclofenac 100 mg twice daily (n=82) or paracetamol 1000 mg three times daily (n=86). Patients were assessed at baseline and 6 weeks. Primary efficacy measures were severity of pain (visual analogue scale, VAS), Lequesne OA knee index, and patient's and physician's global assessment of disease activity. Severity of knee pain at rest or walking, stiffness, knee swelling and tenderness, and assessment of health-related quality of life (Health Assessment Questionnaire, Western Ontario and McMaster Universities Osteoarthritis Index, and Short Form 36) were included as secondary endpoints.Both treatment groups showed significant improvement compared with their baseline values in the four primary endpoints. Mean between-treatment differences favoured aceclofenac over paracetamol on pain (VAS, 7.64 mm [95% confidence interval (CI), 0.44-14.85 mm]), Lequesne OA index (1.41 [95% CI, 0.45-2.36]), and patient's (0.33 [95% CI, 0.06-0.61]) and physician's (0.23 [95% CI, 0.01-0.47]) global assessments. Adverse events were similar for both drugs (paracetamol, 29% patients vs aceclofenac, 32%; P=0.71). Four patients withdrew in each group due to adverse events. Patients tended to prefer aceclofenac to paracetamol (P=0.001), and more treated with paracetamol withdrew from the study due to lack of efficacy (n=8 vs n=1, P=0.035, for paracetamol and aceclofenac, respectively).At 6 weeks, patients with symptomatic OA of the knee showed a greater improvement in pain and functional capacity with aceclofenac than paracetamol with no difference in tolerability.

SummaryObjectivesTo determine clinical and sonographic factors associated with painful episodes in patients with knee osteoarthritis (OA).MethodsIn this cross-sectional controlled study, patients with primary knee OA (ACR criteria) were prospectively placed into two groups. Group A: 81 patients with knee pain during physical activity ≥30mm in visual analogue scale (VAS) for pain for at least 48h prior to inclusion; Group B: 20 patients without knee pain from at least 1 month prior to inclusion. Clinical parameters, knee radiographic and ultrasonographic findings were collected. The sonographic study assessed joint effusion in the suprapatellar pouch, infrapatellar superficial and deep bursitis, meniscal lesions, anserine tendinobursitis, and Baker's cyst.ResultsGroup A patients tended to be older and heavier women than group B (P

To evaluate bone mineral metabolism in HIV infected and asymptomatic patients receiving highly active antiretroviral therapy (HAART) containing protease inhibitors (PI) and naive patients. We studied 30 asymptomatic HIV infected male patients, 13 in the naive group and 17 in the IP group, both without differences in demographics characteristics. We excluded women and patients with any known factor associated to osteopenia. We did a nutritional questionnaire, a DEXA scan in lumbar spine and femur, a study of CD4 lymphocytes, viral load and an analysis of bone formation and resorption markers in all patients. We compared vitamin D and PTH levels with a control group of healthy male volunteers age-pareated. For the statistical analysis we used the SPSS program. Osteopenia was present in 17/30 (57%), 8/13 (61.5%) in the naive group and 9/17 (53%) in the PI group (not significant differences). We found a vitamin D deficiency in 86% of patients, with mean serum levels that was found to be significantly lower than those from a healthy control group (p=0.04). Testosterone level was significantly related to bone mineral density in lumbar spine (p≤0.05). HIV may be an individual risk factor in bone disorders, requiring calcium and vitamin D supplementation.

Adult Still's disease is a systemic inflammatory disorder of unknown etiology. First-line treatment for Still's disease includes nonsteroidal anti-inflammatory drugs and corticosteroids. In refractory cases o when the dose of corticosteroid is unacceptably high, other disease modifying antirheumatic drugs have been used. But recent study showed the efficacy anti-TNF therapy in adult Sill's disease refractory to conventional therapy. We report a favourable response to infliximab in two patients who has proved resistant to conventional therapy.

La enfermedad de Still del adulto es una enfermedad inflamatoria crónica de etiología desconocida. Los antinflamatorios no esteroideos (AINEs) y los glucocorticoides son la base del tratamiento, pero en casos refractarios o cuando la dosis de esteroides es muy elevada es necesario recurrir al tratamiento con fármacos antireumáticos modificadores de la enfermedad (FAME). Ultimamente se ha comenzado a utilizar tratamientos biológicos como alternativa terapéutica a los casos de enfermedad de Still del adulto refractaria al tratamiento convencional. Presentamos nuestra experiencia satisfactoria del tratamiento con infliximab en dos pacientes con esta enfermedad.

Background Denosumab is the first biological treatment for osteoporosis in postmenopausal women at high risk of fracture or who have failed, or are intolerant to other osteoporosis treatment. Objectives To compare the effect of the treatment with denosumab to alendronate in postmenopausal women with osteoporosis and at high risk of fractures with regard to the variation of bone mineral density (BMD) and the incidence of new fractures. Methods This is a longitudinal and prospective study conducted at an outpatient rheumatology division of La Paz University Hospital, Madrid, Spain. Between 126 postmenopausal women ≥65 of age, with severe osteoporosis and history of fractures in most of them, who received 70mg alendronato (ALN) every week for more than two years, 75 patients suspended ALN for different reasons and they signed an informed consent to continue treatment with 60mg denosumab subcutaneously every 6 months. The other patients (n=51) decided to continue with 70 mg ALN every week. All patients received supplements of calcium and vitamin D, according to the individual levels. End points included percentage change from the beginning of the study in lumbar spine (LS) and femoral neck (FN) BMD at month 12 and new fractures incidence by dorsolumbar x-ray and clinic history. Results Denosumab-treated women and ALN-treated women were similar age: 73.8±7.1 and 71.7±6.0 years old, respectively. At month 12, significantly greater BMD increase from baseline were observed with denosumab compared with alendronate at LS (6.2±5.7% compared with 3.5±1.6%; p Conclusions In postmenopausal women with severe osteoporosis previously treated with alendronate, denosumab treatment resulted in greater BMD increases in lumbar spine and femoral neck than alendronate, probably associated with the better adherence due to the highest degree of satisfaction of the patients manifest to receive a six-monthly injection treatment. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.2881

Background The spondyloarthritis (SpA) patients treated under TNF inhibitors (TNFi) with detectable antidrug antibodies (ADA) often develop loss of efficacy. Concomitant therapy with methotrexate (MTX) appears to reduce the the immunogenicity of biological drugs. Objectives To analyze if the use of combined therapy with MTX and TNFi can reduce the incidence of ADA and whether its effect is MTX dose dependent in SpA patients. Methods In this retrospective observational study, 162 SpA patients (including ankylosing spondylitis, Psoriatic SpA, SpA associated with inflammatory bowel disease and undifferentiated SpA) were included. The patients are treated with infliximab (Ifx) or adalimumab (Ada). The presence of ADA were measured at baseline and before each administration by ELISA to complete a follow up of 3 years. The patients were divided in two groups [MTX-15 (dose Results Eighty nine out of 162 (54,9%) patients were male. Eighty five out of 162 (52,5%) patients received Ifx and 77 out of 162 (47,5%) Ada. The mean duration of treatment was 13.38±9.19 years to Ifx and 12.71±10.46 years for Ada. Forty five patients received MTX weekly at baseline [25/85 (29.4%)in Ifx and 20/77 (26%)in Ada]. The mean dose of MTX was 15,9±4.76 mg/week. Twenty nine out of 162 (17,9%) patients developed ADA, and ADA presence was significantly higher in SpA patients on Ifx therapy [21/85 (24.7%) in Ifx vs 8/77 (10.4%) in Ada, p=0.018)]. The presence of ADA was less frequent in SpA patients taking MTX [3/162 (1.8%) with MTX vs 26/162 (16%) without MTX, p=0.021]. No statistically differences were observed in the influence of baseline MTX dose on the ADA appearance (in Ifx: 2/18 (11,1%) in MTX+15 vs 1/9 (11,1%)in MTX-15, p=1,0; in Ada: 1/17 (5,9%) in MTX+15 vs 0/4 (0,0%)in MTX-15, p=1,0). Conclusions In this cohort of SpA patients treated with Ifx and Ada, the use of MTX has a preventive effect on the ADA development. However, the baseline MTX dose is not a determinant factor to get this effect. Further prospective studies are needed to confirm these data. Disclosure of Interest A. Villalba Yllan: None declared, C. Plasencia Grant/research support: Pfizer, D. Pascual-Salcedo Grant/research support: Pfizer, Speakers bureau: Pfizer, D. Peiteado: None declared, L. Nuno: None declared, G. Bonilla: None declared, R. del Moral: None declared, A. Balsa Grant/research support: Pfizer, Speakers bureau: Pfizer, Roche, Abbvie, E. Martin Mola Speakers bureau: Pfizer, Roche, Abbvie, Amgen DOI 10.1136/annrheumdis-2014-eular.5819

Background Spondyloarthritis (SpA) is a group of disorders that are characterized by inflammatory involvement of the enthesis and the adjacent bone. The importance of enthesis has increased over the last years as a result of their inclusion in the recent developed Assessment of SpondyloArthritis International Society (ASAS) new classification criteria for axial and peripheral SpA. Ultrasound is superior to clinical examination for detecting early signs of enthesitis and enthesopathy and improve the knowledge about enthesis pathology. The positivity of HLA B27 has a strong association with ankylosing spondylitis and male sex is associated with X-Rays progression, but today there is few information about presence and progression of entheseal lesions in SpA. Objectives To evaluate the influence of HLA B27 and gender on ultrasound enthuses affectation and progression in early spondyloarthritis. Methods Longitudinal, prospective, blinded ultrasound study in patients diagnosed with early spondyloarthritis that fulfilled ASAS classification criteria. All patients underwent ultrasound MASEI index at baseline, at 6 and 12 months. Inter-reader ICC was 0,83. Results One hundred and forty-six early SpA patients (68 females and 78 males) were examined. HLA B27 positive was present in 32% of the male patients and 16.51% of the female patients. The diagnostics, according to the order of frequency were: non-radiological spondyloarthritis (65.83%), psoriatic arthritis (17%), ankylosing spondylitis (8.33%), spondyloarthritis associated with intestinal inflammatory disease (4.17%) and reactive arthritis (4.17%). The mean ASDAS value during the first visit was 2.39 (high activity). Baseline mean visual analogic scale for pain and patient global disease assessment were 5.15±2.5 and 2.98±1.56, respectively. The mean BASFI was 2.37±2.1. The baseline mean (range) BASDAI, ASDAS, ESR and CRP measurements were 4.60±2.07, 2.41±1.17, 15.0±16.99 mm/h and 8.67±16.98 mg/l, respectively. As shown in the table, the male patients scored higher in the MASEI index during the first visit and at the 12-month visit, reaching statistical significance in both global indices and in almost all elemental lesions explored. When we analyse HLA B27 positive patients, the only significance in the MASEI index was found at the 12-month visit, and at the basal visit and the 12-month visit for thickness. After analyzing the data we estimates that the highest score in this ultrasound index was mainly influenced by the male and the positivity of HLA B27 was probably due to the greater frequency of males in this group (66.04%). Conclusions Male gender determines a higher enthesis involvement in early spondyloarthritis while the HLA B27 seems to have a less pathogenic fact. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.4444

Background Relationship between knee osteoarthritis (OA) and bone mass has brought a great interest. Serum calcidiol (CS) low level has been associated with a higher incidence and faster progression of OA in elderly women, but this relation has not been defined in young postmenopausal women. Objectives The aim of the study was to determine the prevalence of knee OA in postmenopausal women and its relationship with bone density and CS levels. Methods Prospective study realised in 89 women (mean age ± 5 years: range:47–66), all of them being diagnosed of natural menopause for at least 2 years before they were included in this study.(mean value of 7.9 ± 2). They were recruited at a rheumatology consultory. CS levels were determined by RIA, along the winter time because of the lest sunny hours during that period. Two critical values were established ( 2 in Kellgren-Lawrence radiologic scale. Prevalence difference was analysed by contingency tables. Results A total of 58 women had OP while 31 had normal BMD. SC mean value was 13 ± 7.1 ng/ml and there were no significant differences comparing osteoporotic (OP) women with non-OP women. Knee OA prevalence was 65 (73%). In the OP. group and 80.6 in the non-OP. group. Conclusion No inverse relationship was found between OP and knee OA in our group. CS deficit was not associated with a higher prevalence of knee OA in young postmenopausal women.

Background Objectives To validate the efficiency of the application of a diagnostic protocol based on the patterns of presentation of uveitis to establish the diagnosis. Methods Our Uveitis Clinic is composed of a multidisciplinary team of Ophatalmologists and Rheumatologist. We defined a clinical diagnostic protocol for the uveitis, based on the frequency of syndromes found in the literature in each clinical pattern of uveitis and the symptoms of the patients. We routinarelly performed a careful history, a complete ophtalmologic examination, hemogram, biochemistry, ESR, a fluorescent treponemal antibody absorption test, an urinary test and a chest X Ray. Other diagnostic procedures were ordered according to a established protocol based on the clinic patterns of presentation of uveitis. Data from the patients were prospectively recorded from June of 1997 to October 2000. Results 366 patients were included, 40 of them (10.7%) were lost of follow-up,146 of the 336 who completed the study were diagnosed of idiopahatic uveitis (43.4%),70 (21%) had some type of spondyloarthopaty (30 patients were diagnosed in our uveitis clinic), 33 (9.8%) were secondary to infections (23 herpes, 6 toxoplasmosis,3 tuberculosis, 1 candida), 3 were masquerade syndromes (1 lung cancer and 2 linphoproliferative diseases), 6 (1.7%) were traumatic, 47 (14%) were ophtalmologic syndromes, 21 (6.25%) uveitis were secondary to other rheumatic diseases (8 Behcet diseases,8 Sarcoidosis,4 Sjogren’s syndrome and one juvenile chronic arthritis) and 2 were TINU syndromes. Conclusion We have achieved the etyology of the uveitis in 56.6%. A greater percentage than those found in other series in which the diagnostic procedures have not been prestablished. In addition, it could have a better cost-effective impact and avoid the number of consultations between different specialists. We believe that this is the first study in which a clinical protocol of diagnostic procedures has been validated in patients with uveitis.

To determine which activity indices better correlate with assessor's (AGA) and patient's (PGA) global assessment of disease activity and to compare the improvement with American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria and their association with PGA and AGA of overall improvement.Seventy-five patients with rheumatoid arthritis (RA) were studied. Swollen and tender joints, morning stiffness, grip strength, pain, AGA, PGA, Health Assessment Questionnaire (HAQ) score, erythrocyte sedimentation rate (ESR), C-reactive protein (CPR), and hemoglobin were determined before and 6 months after treatment. Several activity indices were calculated: Disease Activity Score (DAS), DAS 3, DAS 28, DAS '28,' ACRor = 20%, Mallya, Riel, IDA, and a modification of the Stoke index.All indices correlated with PGA and AGA before and after treatment (r0.38, p0.01), but better results were obtained with AGA than PGA. DAS, DAS 3, DAS 28, and modified Stoke had the best correlation with AGA (ror = 0.77, p0.01). The indices that better detected the differences after treatment for AGA were DAS, DAS 3, DAS 28, and modified Stoke (ror = -0.42, p0.01). The level of agreement between EULAR and ACR improvement classifications with both reduced and extensive joint counts was comparable and its association with PGA and AGA overall improvement was significant (p0.01).All activity indices correlated with PGA and AGA, although the best results were obtained with AGA. Although indices' correlations were similar, the DAS group and the modified Stoke seemed to be the most useful indices to measure disease activity in RA. The discriminating potential between ACR and EULAR improvement classification was comparable, as was the association with PGA and AGA overall improvement.

Vitamin D deficiency has been frequently observed in the elderly population in Europe. However few information is available about the vitamin D status in postmenopausal women in the Mediterranean countries. The aim of this study was to evaluate the vitamin D status assessed by serum 25(OH)D3 (calcidiol) in postmenopausal women who attended a Rheumatology practice in Madrid area, and to evaluate calcidiol serum levels through one year after two forms of vitamin D administration.Calcidiol serum levels were measured in 171 postmenopausal women (111 with osteoporosis and 60 without osteoporosis). 82 women with calcidiol serum levels10 ng/ml were distributed in two groups: Group I received 800 U/day of vitamin D3 associated with calcium (1 g/day) and group II, one dose of 80,000 U vitamin D orally as calcidiol and latter a daily dose of 800 U vitamin D3 plus 1 g calcium. Calcidiol serum levels were measured by RIA in both groups at basal condition and after three, six and twelve months under treatment.Three cut-offs were considered: 10, 15 and 20 ng/ml of calcidiol. Percentages of postmenopausal women with vitamin D deficiency for such cut-offs were: 35.3%, 64.1% and 87.1%, respectively. After three months of treatment, women from group II showed calcidiol serum levels higher than group I. At six and twelve months calcidiol serum levels were similar in both groups.A high prevalence of vitamin D deficiency was observed in a group of postmenopausal women who attended a rheumatology practice in Madrid area. Both forms of vitamin D administration seem not sufficient to maintain the adequate calcidiol serum levels in postmenopausal deficient women. A dose of 80,000 U of calcidiol twice a year should be considered.

Conflicting results have been reported on the association between restriction fragment length polymorphism at the vitamin D receptor (VDR) gene locus and bone mineral density (BMD). Population differences in environmental factors, such as calcium intake and calcidiol levels which have strong influence in BMD, may alter this association.We analyzed the Bsml RFLP at the eight introm of the VDR gene in a population sample (n = 204) of postmenopausal Spanish women aged 50-65 years being seen clinically and studied calcium intake (dietetic questionnaire) and biochemical parameters (PTH and calcidiol). In parallel bone densitometry were measured in lumbar spine and proximal femur.We identified low BMD of the proximal femur in the BB group. This effect was not observed at other body locations. The calcium intake was lees than 500 mg/day in 60% of the studied population as calcidiol levels were lower than 10 ng/l in 36% of it. The total group population with normal calcium intake (1,000 mg/day) showed higher BMD (proximal femur and spine) than the group with low calcium intake, this variation not being observed in group BB alleles. Interestingly, we observed significant differences in BMD proximal femur between genotype groups BB versus Bb + bb when calcidiol levels were10 ng/l. Moreover, within the BB subgroup, those subjects with normal calcidiol levels have higher proximal femur BMD compared with those with low calcidiol levels.Our results indicate an effect of the VDR genotype on BMD proximal femur which is clearly influenced by calcium intake and calcidiol serum levels.

We studied interleukin 6 (IL-6) and soluble IL-6 receptor (sIL-6R) in serum and synovial fluid (SF) to investigate their role in different arthropathies.IL-6 was measured by ELISA and bioassay and sIL-6R by ELISA, in 210 sera and 73 SF samples from 49 patients with rheumatoid arthritis (RA), 20 crystal deposition disease, 17 osteoarthritis (OA), 24 with other inflammatory arthropathies, and 100 controls. In all patients, disease activity was assessed by erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP); in patients with RA and other arthropathies pain, tender and swollen joints, and Ritchie index were also evaluated. Total leukocyte count in SF was determined.There was good correlation between IL-6 ELISA and bioassay levels both in serum (r = 0.62, p = 0.0001) and in SF (r = 0.72, p = 0.0001). Serum IL-6 was detected only in patients with inflammatory arthritis and SF IL-6 was detected in all patient groups. Serum IL-6 correlated with swollen joints (r = 0.35, p = 0.05), ESR (r = 0.46, p = 0.001), and CRP (r = 0.46, p = 0.001) in RA; and with CRP (r = 0.89, p = 0.0001) in crystal deposition disease. SF IL-6 correlated with ESR (r = 0.54, p = 0.007) and CRP (r = 0.42, p = 0.04) in RA; with SF total leukocyte count (r = 0.61, p = 0.004) in crystal deposition disease; and with SF total leukocyte count (r = 0.61, p = 0.009) in OA. No correlations were found in the group with other inflammatory diseases. No correlations were found between sIL-6R and IL-6 or between sIL-6R and disease activity variables in any group of patients.Unlike IL-6, sIL-6R is not produced at the site of inflammation and is not related to clinical or biological disease activity variables. Only in RA are both IL-6 and sIL-6R levels increased, suggesting that sIL-6R may reinforce the systemic effects of IL-6.

Background The FRAX index is a tool developed by the WHO that estimates the 10-year probability of hip fracture and a major osteoporotic fracture. It is calculated using an algorithm that includes clinical risk factors and can be calculated with or without densitometry data (femoral neck T-score). Its usefulness in patients with Early Arthritis (EA) is poorly studied Objectives To evaluate if there is a difference between estimated 10-year fracture risk using the FRAX index, calculating it with and without densitometry data in patients with EA Methods This is a prospective study of 101 patients from our EA Unit. At the baseline visit, a protocol was carried out which registered the following: sociodemographic data, anthropometric data, osteoporosis (OP) risk factors, bone metabolism laboratory parameters, rheumatoid factor and Anti-CCP, clinical disease activity (patient and physician scoring, pain, HAQ, number of tender and swollen joints, acute phase reactants), radiography of the dorsolumbar spine, hands and feet and bone densitometry (Hologic). The FRAX Index was calculated with and without densitometry data in patients over 40 years of age. Statistical analysis: descriptive and kappa index concordance test Results At the initial visit, 39 patients were diagnosed with rheumatoid arthritis (ACR 1987 criteria) and the remainder were classified as undifferentiated arthritis. 84 women (83.2%) were studied, 40 premenopausal (pre-M) and 44 postmenopausal (post-M), as well as 17 (16.8%) men. The mean age was 52.7±16.6 years. The mean disease duration was 17.97±18.94 weeks with DAS28 mean 6.64±6.74. 12.9% had a family history of hip fracture, 10.9% had morphometric vertebral fractures, 75.2% started corticosteroid therapy after the initial visit, 41.3% were smokers or ex-smokers and 9.9% consumed alcohol. The prevalence of densitometric OP was 22.4% (7.8% pre-M, 34.9% post-M, 25% men) and the osteopenia 44.9% (43.6% pre-M, 46.5% post-M, 43.8% men). 22.1% of patients (20.45% post-M, 17.64% men, 1.25% pre-M) had a hip fracture risk greater than 3% according to the FRAX index calculated with densitometry and 27.8% without densitometry, which implies a concordance of 85% (p Conclusions In our patients with EA, the concordance observed when calculating the FRAX index with and without bone densitometry is very high, which makes it unlikely that performing densitometry would change the clinical risk of fracture and the indication for treatment. However, in a subgroup of our patients, introducing densitometry of the femoral neck only modified the clinical risk of fracture downwards Disclosure of Interest None Declared

Background There is wide scientific evidence about the involvement of smoking in the susceptibility to rheumatoid arthritis. However, the effect of smoking on the activity of the disease and its clinical course is controversial. Objectives To analyze the impact of smoking on disease activity in a cohort of patients with recent onset rheumatoid arthritis. Methods We included a cohort of patients from an Early Arthritis Clinic (EAC), followed up between January 1993 and December 2012. All patients gave informed consent to the study. Patients were included with early arthritis (less than one year of disease duration to the onset), who met the criteria of the American College of Rheumatology (ACR) 1987 for RA at some time during the disease course, and were followed up for two years. Microcrystalline and infectious arthritis were excluded, as well as patients who previously had been treated with disease modifying antirheumatic drugs. Patients were monitored for clinical and analytical data using standardized protocols every six months. The influence of active smoking in disease activity, functional disability and serological variables were studied. Every six months we assessed: number of tender (out of 68) joints (NTJ), number of swollen (out of 68) joints (NSJ), DAS, change in DAS (ΔDAS), HAQ, erythrocyte sedimentation rate (ESR), rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA). Results 398 patients were included in the study, with a mean age at onset of 51.8 years (± 16.1 SD) and a predominance of women (77.6%). Patients were referred to the EAC with a mean of 17.7 weeks (± 13.1 SD) from the onset of symptoms. Active smokers were 27.6% of the patients. At baseline most patients had a subacute (88.7%), symmetrical (88.9%), RF-positive (81.3%), ACCP-positive (67, 5%) polyarthritis (83.1%). Smokers were younger at disease onset (49 ± 13.4 years smokers vs. 52.9 ± 13.4 in nonsmokers, p = 0.022), with a predominance of males (43% males vs. 23% women, p Conclusions Active smoking has a negative impact on the activity of patients with recent onset rheumatoid arthritis, with less improvement as compared to non-smokers. Disclosure of Interest None Declared

Background Patients reaching remission for joint counts and CRP according to the ACR/EULAR Boolean definition fo remission (value Objectives To assess whether psychological components of the RAID score explain the elevated PGA for patients in near-remission. Methods The RAID database, based on an international multicenter cross-sectional study of consecutive RA patients from 12 European countries, was used (3). Each component of the RAID score ranges from 0 (no impact) to 10 (high impact). Patients in near-remission were compared to those in remission and not in remission for the proportion of patients with a score Results In total, 359 patients had complete data for this analysis: mean (±standard deviation) age 55.8±13.0 yrs, disease duration 12.6±10.5 yrs, 76.4% women. Mean RAID score was 4.3±2.2. With the ACR/EULAR Boolean definition, only 22 (6.1%) were in remission and 53 (14.8%) were in near-remission. In near-remission patients, the mean PGA was 3.3±1.5, and the mean RAID score was 3.6±1.8. The components of the RAID were mostly all >1/10 but specifically, physical well-being, fatigue, pain and functional assessment were more frequently >1/10 (94%, 89%, 87%, 83%) than sleep, coping or emotional well-being in these patients (79%, 79%, 74%, all p Conclusions The new definition of remission is extremely stringent and rarely attained for patients with long-standing RA. Near-remission is a more frequently achieved status. In this sample, psychological distress and lack of coping did not explain the raised PGA of near-remission, which was better explained by higher physical components of the RAID score. More work is needed to understand the patient perspective regarding remission. References Studenic P, et al. Ann Rheum Dis. 2012;71(10):1702-5. Sanderson T, et al. J Rheumatol 2011;38;191-194. Gossec L, et al. Ann Rheum Dis. 2011;70(6):935-42. Disclosure of Interest None Declared