Search

In 2015 the Spanish Society of Rheumatology (Sociedad Espanola de Reumatologia [SER]) published its position paper on biosimilar drugs. In this update, the SER, continues to manifest its unequivocal commitment to the sustainability of the health system of our country and is aligned with the measures that, without reducing quality of care, are aimed at ensuring its continuity. Since the publication of the previous position paper, the European Commission has authorized new biosimilar drugs, which provides an excellent opportunity to advance the efficiency of health care. In this new scenario of increased therapeutic offer of biologics, the SER considers it crucial to preserve the freedom of prescription of physicians who prescribe drugs based exclusively on the characteristics and individual circumstances of each patient, without forgetting the economic aspects there of.

espanolObjetivos Analizar las caracteristicas clinicas y de metabolismo oseo de una serie de pacientes con fracturas vertebrales tras la suspension de denosumab (DMab). Metodos Estudio observacional retrospectivo de 10 pacientes con fracturas vertebrales tras suspender DMab atendidas en el Servicio de Reumatologia de un hospital espanol de tercer nivel entre 2015 y 2018. Resultados Se registraron un total de 49 fracturas espontaneas tras una media de 6 dosis de DMab y transcurridos 10,9 meses desde la suspension del farmaco. El 90% habia recibido tratamiento previo, 7 de 10 bisfosfonatos orales. Tras la suspension, CTX y P1NP estaban elevados y la media de T-score en cuello femoral y columna lumbar fue menor que previo a DMab. Las vertebras mas afectadas fueron L3, L5, D6, D7, D9 y D11. Conclusion La descripcion de nuevos casos de fracturas vertebrales multiples en los meses posteriores a la suspension de DMab subraya la preocupacion emergente en la comunidad cientifica siendo preciso apoyar en evidencias solidas las nuevas recomendaciones sobre su manejo. EnglishObjectives Analyse clinical and bone metabolism features in a case series of patients with multiple vertebral fractures after discontinuation of denosumab (DMab). Methods An observational descriptive study analysing data from ten patients with multiple vertebral fractures after DMab discontinuation that were admitted to our rheumatology department between 2015 and 2018. Results There were a total of 49 spontaneous fractures after an average of 6 DMab doses and 10.9 months from discontinuation. Ninety percent had already received treatment other than DMab 7 of 10 oral bisphosphonates. After discontinuation, CTX and P1NP remained elevated and mean T-score for femoral neck and lumbar spine was lower than before treatment. The most affected vertebrae were L3, L5, D6, D7, D9 and D11. Conclusion This report of ten new cases suffering multiple vertebral fractures early after discontinuation of DMab highlights the emerging concern on the subject in the scientific community and the need to clarify its pathogenic mechanism, and to support by solid evidence the new recommendations on its management.

Introduction During the last years, regulatory agencies raised some relevant concerns with regard to the possibility of administrating biological therapy (BT) to non-SpA patients. Especially, the possibility of treating women with fibromyalgia as non-radiographic axSpA (nr-axSpA) was mentioned. Objectives To evaluate if the gender distribution and clinical pattern of patients with axSpA initiating biological therapy (BT) was modified in clinical practice after its approval for non radiographic-axSpA (nr-axSpA). Methods Baseline dataset from a prospective ongoing cohort including all patients with axSpA treated with BT at the Rheumatology Department of University Hospital La Paz, Madrid, Spain, was analysed. Patient's characteristics and disease activity parameters were collected. Based on the approval indication date of BT for nr-axSpA, patients were classified in two periods according to the starting date for the first BT: period 1 (before 2013) and period 2 (during or after 2013). Gender distribution and disease’ characteristics were compared between both groups using Chi-square and Student-t tests. Results In total, 385 patients initiated BT: 266 (69%) in period 1 and 119 (31%) in period 2. No significant differences between both periods were observed regarding gender distribution (38% and 39% of women; p = 0.8). Out of those patients with nr-axSpA initiating BT in period 2, the majority (60%) were men. Women starting BT in period 2 had significantly higher systemic inflammation and mobility restriction compared with women in period 1 [median (interquartile range) CRP 10.2 mg/l (3.0–24.9) vs 3.2 mg/l (2.0–9.4); p = 0.02 and BASMI 2.7 (1.8–3.5) vs. 2.0 (1.2–2.6); p = 0.01, respectively]. In addition, they also presented significantly higher disease activity [BASDAI 6.5 (5.4–8.0) vs. 5.8 (4.6–6.8); p = 0.02; ASDAS, mean (SD) 3.6 ± 3.4 vs. 3.2 ± 1.0; p = 0.02, respectively] and more functional limitation [BASFI 5.7 (3.8–6.7) vs. 4.3 (2.0–6.1); p = 0.01, respectively] than men treated in period 2. Conclusions In our clinical practice, the frequency of women who started BT did not increase since their approval for nr-axSpA. Women treated with BT after 2012 had more objective disease activity parameters than before their approval for nr-axSpA treatment.

Methotrexate (MTX) is a remarkable drug with a key role in the management of rheumatoid arthritis (RA) at every stage of its evolution. Its attributes include good overall efficacy for signs and symptoms, inhibition of structural damage and preservation of function with acceptable and manageable safety, a large dose-titratable range, options for either an oral or parenteral route of administration, and currently unrivalled cost-effectiveness. It has a place as a monotherapy and also as an anchor drug that can be safely used in combination with other conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or used concomitantly with biological DMARDs or targeted synthetic DMARDs. MTX is not without potential issues regarding toxicity, notably hepatotoxicity and bone marrow toxicity, as well as tolerability problems for some, but not all, patients. But many of these issues can be mitigated or managed. In the face of a welcome expansion in available targeted therapies for the treatment of RA, MTX looks set to remain at the foundation of pharmacotherapy for the majority of people living with RA and other inflammatory rheumatic diseases. In this article, we provide an evidence-based discussion as to how to achieve the best outcomes with this versatile drug in the context of a treat-to-target strategy for the management of RA.

Objective To evaluate the responsiveness in terms of correlation of the Hospital Universitario La Princesa Index (HUPI) comparatively to the traditional composite indices used to assess disease activity in rheumatoid arthritis (RA), and to compare the performance of HUPI-based response criteria with that of the EULAR response criteria. Methods Secondary data analysis from the following studies: ACT-RAY (clinical trial), PROAR (early RA cohort) and EMECAR (pre-biologic era long term RA cohort). Responsiveness was evaluated by: 1) comparing change from baseline (Delta) of HUPI with Delta in other scores by calculating correlation coefficients; 2) calculating standardised effect sizes. The accuracy of response by HUPI and by EULAR criteria was analyzed using linear regressions in which the dependent variable was change in global assessment by physician (Delta GDA-Phy). Results Delta HUPI correlation with change in all other indices ranged from 0.387 to 0.791); HUPI's standardized effect size was larger than those from the other indices in each database used. In ACT-RAY, depending on visit, between 65 and 80% of patients were equally classified by HUPI and EULAR response criteria. However, HUPI criteria were slightly more stringent, with higher percentage of patients classified as non-responder, especially at early visits. HUPI response criteria showed a slightly higher accuracy than EULAR response criteria when using Delta GDA-Phy as gold standard. Conclusion HUPI shows good responsiveness in terms of correlation in each studied scenario (clinical trial, early RA cohort, and established RA cohort). Response criteria by HUPI seem more stringent than EULAR's., Our study was supported by grants RD16/0012/0011 and PI14/00442 from the Ministerio de Economia y Competitividad (Instituto de Salud Carlos III; Spain) and cofunded by the Fondo Europeo de Desarrollo Regional (FEDER). Data from ACT-RAY clinical trial were kindly provided by Hoffmann-La Roche Ltd. No financial support was received from Hoffmann-La Roche Ltd Data from EMECAR and PROAR cohorts were provided by the Spanish Society of Rheumatology. No financial support was received from the Spanish Society of Rheumatology. None of these institutions played any role in the analysis or interpretation of data, nor were they involved in the writing of the manuscript. Roche and Sociedad Espanola de Reumatologia were involved in the collection of data from ACT-RAY, and EMECAR and PROAR, respectively. However, these funders had no role in study design, analysis, decision to publish, or preparation of the manuscript.

Background Gout is the most common inflammatory articular disease in adults concerning a 1%–2% of the general population, and even a 4%–5% in older than 70 years. Recently, it has been reported an increase of the prevalence of gout, especially in developed countries. Objectives The principal purpose of our study is to describe the clinical and epidemiological characteristics of hospitalised patients with diagnosis of gout in Spain including mortality, comorbidities and healthcare costs in the last decade Methods Retrospective observational study based on data from the Database of Hospital from the Spanish National Health Service. The study was conducted in patients over eighteen years old with any gout diagnosis as principal or other diagnosis, who were admitted in the hospital between the years 2005–2015. The clinical characteristics analysed were sex, age, costs and length of hospital stay. Comorbidities as diabetes, congestive heart failure, acute myocardial infarction and cerebrovascular disease were identified with International Classification of Diseases, ninth revision, common modification (ICD-9-CM). Results The study cohort included 192.037 patients with gout, 82.6% of those were males. There was a progressive increase in the number of hospitalised patients with gout from 12 851 patients in 2005 to 23 318 in 2015; this was associated with an increase in mortality, reaching its highest value in 2015 with a 4.9% of gout hospitalised patients. The average age at dead in 2015 was 79.2 years and 85.16 years in male and female respectively, an age slightly lower than in the general population. The average cost in these hospitalised patients was 4931 €, reaching a peak of 5384 € in the last year. The hospital stay reached its lowest numbers in 2015 with an average of 8.9 days per patient. These comorbidities had statistical association with an added mortality risk in cerebrovascular disease (odds ratio [OR] 1.57, 95% confidence interval [CI]1.46–1.49), liver disease (OR 2.61 95% CI 2.34–2.9), kidney disease (OR 1.34 95% CI 1.28–1.41), dementia (OR 2.13 95% CI 1.88–2.42). On the contrary, in type 2 diabetes (OR 0.92 95% CI 0.87–0.96), we found a statistically significant lower mortality risk. Furthermore, it was found a statistically reduced mortality risk in females (OR 0.85 95% CI 0.8–0.9) Conclusions In Spain we have a progressive increase in the hospital admissions for gout, higher mortality rates and higher healthcare costs. This shows the need for changes in prevention and management of gout disease. Disclosure of Interest None declared

Background Gout is the most common inflammatory articular disease in adults concerning a 1%–2% of the general population, and even a 4%–5% in older than 70 years. Recently, it has been reported an increase of the prevalence of gout, especially in developed countries. Objectives The main objective of this study is to describe the clinical and epidemiological characteristics of gout hospitalised patients in Spain (as the main reason of admission) and the economic outcomes of its management by the main care departments in charge when this disease is the principal diagnosis. Methods The main objective of this study is to describe the clinical and epidemiological characteristics of gout hospitalised patients in Spain (as the main reason of admission) and the economic outcomes of its management by the main care departments in charge when this disease is the principal diagnosis. Results From the whole 192.037 patients we have with gout diagnosis we performed a sub-analysis of 10.512 patients with gout as the main cause of hospitalisation, from witch the 85.9% are males. The admission number for this cause has remained constant or with a slight increase, with an average of 956 patients per year (equivalent to a 5.5% of gout total admissions). The average male age was 64.02 years (standard deviation (SD) 14.43) and 73.9 years (SD 13.69) for women (p Regarding the average of hospital stay of these patients, it was 6.71±6.8 days with an average cost of 3471±2678 €. Three medical specialities (Internal Medicine with 3852 hospital admissions (36.6%), Rheumatology with 2600 (24.7%) and Traumatology with 2033 (19.3%)), attended to an 80.6% of the total gout patients as main diagnosis for admission. It was noticed that the hospital stay was lower in the Traumatology Department with an average of 4.85±6.78 days compared with the Rheumatology and Internal Medicine departments, which had an average of 6.52±5.65 days and 7.76±6.83 days respectively. However, it was found the lowest cost in the Rheumatology Department, with an average of 2892 €. Conclusions Only 24.7% of hospitalised patients with gout as main diagnosis are attended by Rheumatology Departments. However, Rheumatology was the most efficient clinical department in the care of this pathology. This conclusion should be considered in order to improve the management of gout in the health system Disclosure of Interest None declared

Background Despite the fact that genetic and serological risk factors have been studied in rheumatoid arthritis (RA), the symptoms phase of preclinical RA is poorly characterised. Taking into account the importance of early diagnosis and effective treatment for the prevention of structural damage and long-term disability in RA, it is important to find clinical or image variables that identify patients with clinically suspected arthralgias at risk of developing a chronic arthritis (CSA). Objectives To identify baseline clinical, immunological and ultrasound variables in patients with arthralgias clinically suspected of progression to chronic arthritis. Methods Longitudinal prospective study of patients with CSA and follow-up from November 2015 in pre-arthritis clinics. Patients were assessed at baseline and every 6 months until 2 years, with clinical, laboratory and ultrasound data using standardised protocols. The criteria for eligible patients for inclusion in the study were:≤12 months of symptoms onset, inflammatory arthralgias (predominance in nights or mornings, improvement during the day or with movement, and morning stiffness of ≥30 min), and the involvement of small joints of hands or feet. Patients with clinical synovitis at baseline visit, patients with fibromyalgia or osteoarthritis were excluded. Results Twenty-six patients were recruited in 26 months of the study (1 male, 25 female), with an average baseline age of 44.7±12.6 years, an average delay time of symptoms to first visit of 8.7±3.3 months, a mean follow-up time of 7.7±8.1 months an average body mass index (BMI) of 27.7±7.2. Five patients had familial background of autoimmune diseases in first degree relatives (RA, psoriasis, inflammatory bowel disease), 6 (23.1%) were seropositive (RF and/or ACPA), 7 (26.9%) had increased baseline acute-phase reactants (PAR), and 11 (47.8%) were smokers or former smokers. Most of the patients reported a progression of the arthralgias (55%) and a subjective joint swelling at some point (70%). Of 24 patients, 8 (33.3%) developed clinical arthritis (7 RA, 1 undifferentiated arthritis), with a longer follow-up (15.7±7.4 vs. 7.5±7.2 months, p=0.016), greater baseline HAQ (11.8±8.3 vs. 3.9±4.8, p=0.033) and higher percentage of moderate inflammatory activity in the baseline ultrasound (83.3% vs. 8.3%, p=0.004), compared to patients that didn’t develop arthritis. There was a trend towards a higher seropositivity, (37.7% vs. 18.8%), a higher patient global disease assessment (45±29 vs. 30±27 on a 100 mm scale), higher patient pain scores (using a visual analogue pain 100 mm scale) (58±41 vs. 34±23) among patients who eventually developed arthritis, although not statistically significant. No differences were found with PAR, BMI, age, smoking habit or painful joint count at baseline visit. Conclusions In our pre-arthritis clinics of patients with clinically suspicious arthralgias, 33% progressed to arthritis, underlying the importance of these clinics. Functional disability and ultrasound at baseline visit are especially useful in predicting future progression to arthritis. It is necessary to recruit more patients in order to obtain more robust conclusions. Disclosure of Interest None declared

OBJECTIVE: To draft recommendations on interleukin 6 (IL-6) blockade in rheumatoid arthritis (RA), based on best evidence and experience.; METHODS: A group of 10 experts on IL-6 blockade in RA was selected. The 2 coordinators formulated 23 questions about IL-6 blockade (indications, efficacy, safety, etc.). A systematic review was conducted to answer the questions. Using this information, inclusion and exclusion criteria were established, as were the search strategies (Medline, EMBASE and the Cochrane Library were searched). Two different reviewers selected the articles. Evidence tables were created. At the same time, European League Against Rheumatism and American College of Rheumatology abstracts were evaluated. Based on this evidence, the coordinators proposed preliminary recommendations that the experts discussed and voted on in a nominal group meeting. The level of evidence and grade of recommendation were established using the Oxford Centre for Evidence Based Medicine and the level of agreement with the Delphi technique (2 rounds). Agreement was established if at least 80% of the experts voted yes (yes/no).; RESULTS: The 8 preliminary recommendations were accepted after the Delphi process. They covered aspects such as the use of these therapies in monotherapy, in combination, in patients with refractory disease or intolerant patients, response evaluation, optimization and risk management.; CONCLUSIONS: The manuscript aims to solve frequently asked questions and aid in decision making strategies when treating RA patients with IL-6 blockade. Copyright © 2018 Elsevier Espana, S.L.U. and Sociedad Espanola de Reumatologia y Colegio Mexicano de Reumatologia. All rights reserved.

Background The use of biological therapy (BT) in rheumatoid arthritis (RA) has supposes a very important change in the disease9s treatment and prognosis. Drugs like Anti-TNFα have proven unquestionable effectiveness. However, the lack or loss of such effectiveness over time raises the dilemma of what factors may influence it. There are studies that suggest the influence of BMI on the efficacy of these drugs and therefore on the control of the disease. Objectives To determine the influence of BMI on disease activity and response to treatment with infliximab (ifx) in patients with RA. Methods A retrospective observational study of a population of 76 patients with RA who received infliximab treatment, in a standard guideline of 3 mg/kg, in our service between 2000 and 2016 inclusive. The BMI was classified for some sub-studies in four categories: low ( 1.2, or>0.6 and DAS28 Results Characteristics of the 76 patients included in the study when initiating IFX therapy were: 66 (86.8%) were women, median (range) age 54 (21–83) years, 77,% RF+, 81% ACPA+, disease duration 10,8 (1,0–39,0) years, 59% with concomitant methotrexate and 55% 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 0 (0,0%), 41 (53,9%), 22 (28,9%) and 13 (17,2%), respectively. The association between BMI and disease activity (median DAS28 (p25-p75)) is shown in Table 1: The association between BMI and treatment response (median deltaDAS28 (p25-p75) and EULAR response (%)) is shown in Table 2: In the longitudinal analysis, a trending but not statistically significant relationship between adjusted BMI and DAS28 was observed at six month and at one year of treatment onset: β: 0,051; 95% CI (-0,06 to 0,109) and β: 0,037; 95% CI (-0,022 to 0,097) Conclusions BMI seems to influence, in a non significantly manner, in disease activity and in treatment response in RA treated with infliximab. Obesity BMI values are associated with increased activity and a lower response to this treatment than lower BMI values. Disclosure of Interest None declared

Disseminated gonococcal infection is a rare presentation of the sexually transmitted pathogen, Neisseria gonorrhoeae. Here, we report the case of a 64-year-old woman with disseminated gonococcal infection, which started with symptoms of oligoarthritis and malaise. Neisseria gonorrhoeae was identified in the carpal synovial fluid. The follow-up study revealed an absence of total hemolytic complement and complement C2 was not detected. Being relatively common, C2 deficiency has been associated with disseminated gonococcal infection in a few cases. We present a new case and discuss those previously published.

We describe a case of septic arthritis in a native knee due to Corynebacterium striatum, gram-positive bacilli that are usually commensal organisms of skin and mucosal membranes, but are seldom implicated in native septic arthritis. An 84-year-old man with Corynebacterium striatum septic arthritis of his native left knee and no response to conventional antibiotic therapy. Thus, the patient was allowed to take dalbavancin for compassionate use, with an excellent clinical outcome. This case emphasizes de role of Corynebacterium striatum in native joint infections and highlights the importance of early detection and appropriate treatment in improving the clinical outcome.

Time is a crucial dimension in most chronic diseases, especially in inflammatory rheumatic disease, which it affects in many ways. Early treatment in rheumatoid arthritis (RA) is an essential issue, as joint damage occurs within the first weeks or months of the disease process and inflammatory activity maintained over time is responsible for all of the consequences of the disease. The introduction of new drugs with faster and more effective action, such as tumor necrosis factor (TNF) inhibitors, has represented a major shift in the strategy of RA treatment, allowing the clinician to aim for remission and prevention of structural damage as realizable goals.

a b s t r a c t Time is a crucial dimension in most chronic diseases, especially in inflammatory rheumatic disease, which it affects in many ways. Early treatment in rheumatoid arthritis (RA) is an essential issue, as joint damage occurs within the first weeks or months of the disease process and inflammatory activity maintained over time is responsible for all of the consequences of the disease. The introduction of new drugs with faster and more effective action, such as tumor necrosis factor (TNF) inhibitors, has represented a major shift in the strategy of RA treatment, allowing the clinician to aim for remission and prevention of structural damage as realizable goals.

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 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

Objective To provide a reference to rheumatologists and to those involved in the treatment of RA who are using, or about to use biologic therapy. Methods Recommendations were developed following a nominal group methodology and based on systematic reviews. The level of evidence and grade of recommendation were classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through Delphi technique. Results We have produced recommendations on the use of the seven biologic agents available for RA in our country. The objective of treatment is to achieve the remission of the disease as quickly as possible. Indications and nuances regarding the use of biologic therapy were reviewed as well as the evaluation that should be performed prior to administration and the follow up of patients undergoing this therapy. Conclusions We present an update on the SER recommendations for the use of biologic therapy in patients with RA.

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

Se trata de un varon de 68 anos con historia de artritis reumatoide, en tratamiento con metotrexate (7,5 mg/semana) y prednisona (5 mg/dia). Cinco anos antes de la consulta presento dolor continuo, que no cedia con el reposo, progresivo y tumefaccion de tobillo izquierdo con impotencia funcional. En la exploracion fisica se evidencia dolor en la interlinea articular a la palpacion, que aumenta con la flexoextension del pie del mismo lado. En el estudio analitico se objetivan: velocidad de sedimentacion en la primera hora, 31 mm; factor reumatoide, 438 U/ml, y proteina C reactiva, 1,3 mg/dl. Se realizan estudios radiologico y tomografico simples de tobillo izquierdo (figs. 1 y 2) y posteriormente resonancia magnetica con secuencias spin-eco potenciada en T1 y turbo-spin-eco potenciada en T2 con supresion grasa (figs. 3 y 4). MEDICINA EN IMAGENES

Relapsing polychondritis is a rare disease characterized by recurrent inflammatory lesions involving cartilaginous structures, the eyes, the ears and the cardiovascular system. Valvar insufficiency represents the most common of the cardiac abnormalities and appears in 8 percent of patients. We describe two patients having relapsing polychondritis with cardiac involvement. One of them required valvar substitution and died 6 months after surgery.