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Objective To develop and validate the prognostic prediction model DU-VASC to assist the clinicians in decision-making regarding the use of platelet inhibitors (PIs) for the management of digital ulcers in patients with systemic sclerosis. Secondly, to assess the incremental value of PIs as predictor. Methods We analysed patient data from the European Scleroderma Trials and Research group registry (one time point assessed). Three sets of derivation/validation cohorts were obtained from the original cohort. Using logistic regression, we developed a model for prediction of digital ulcers (DUs). C-Statistics and calibration plots were calculated to evaluate the prediction performance. Variable importance plots and the decrease in C-statistics were used to address the importance of the predictors. Results Of 3710 patients in the original cohort, 487 had DUs and 90 were exposed to PIs. For the DU-VASC model, which includes 27 predictors, we observed good calibration and discrimination in all cohorts (C-statistic = 81.1% [95% CI: 78.9%, 83.4%] for the derivation and 82.3% [95% CI: 779.3%, 85.3%] for the independent temporal validation cohort). Exposure to PIs was associated with absence of DUs and was the most important therapeutic predictor. Further important factors associated with absence of DUs were lower modified Rodnan skin score, anti-Scl-70 negativity and normal CRP. Conversely, the exposure to phosphodiesterase-5 inhibitor, prostacyclin analogues or endothelin receptor antagonists seemed to be associated with the occurrence of DUs. Nonetheless, previous DUs remains the most impactful predictor of DUs. Conclusion The DU-VASC model, with good calibration and discrimination ability, revealed that PI treatment was the most important therapy-related predictor associated with reduced DU occurrence.

Background Off-label (OL) drug use is the prescription of a drug for indications other than those authorised in its technical datasheet. The objective of this study was to identify drugs recommended in rheumatology but considered for off-label use in Argentina. Methods A list of medications for certain selected rheumatic conditions was compiled. A drug was considered recommended if it was endorsed by a) at least one Argentine or Pan-American treatment guideline or consensus, or b) two international treatment guidelines, or c) one international treatment guideline and one selected textbook. Approval of these drugs for any condition in Argentina until December 31st, 2018 was explored, and medicines were divided into those with on-label indications and those considered for OL use. Results One hundred and thirty-six medications were analysed in 13 clinical conditions. Sixty-seven OL recommendations (49%) were found, and several drugs had more than one. All the conditions included the recommendation of at least 1 OL drug except osteoporosis and rheumatoid arthritis. The frequency of OL recommendations for the following conditions was 100%: calcium pyrophosphate dihydrate crystal deposition disease, polymyalgia rheumatica, Sjogren syndrome, and systemic sclerosis. The drugs with the highest number of OL recommendations were methotrexate (in 7 conditions), and glucocorticoids and mycophenolate (in 4). There were 2 OL recommendations for rituximab and 1 for abatacept. Conclusions Almost all the rheumatic disorders analysed involved the recommendation of at least 1 OL medication, and in 4 conditions all the recommendations were OL. Most OL drugs recommended in rheumatology are neither biological nor small-molecule therapies.

Objectives To characterize patients with positive anti-topoisomerase I (ATA) in lcSSc. Methods SSc patients enrolled in the EUSTAR cohort with a disease duration of ≤3 years at database entry were considered. We assessed the risk of major organ involvement in the following groups: ATA-lcSSc vs ACA-lcSSc and vs ANA without specificity (ANA)-lcSSc, and ATA-lcSSc vs ATA-dcSSc. Cox regression models with time-dependent covariates were performed with the following outcomes: new-onset interstitial lung disease (ILD), ILD progression [forced vital capacity (FVC) decline ≥10% and ≥5% vs values at ILD diagnosis), primary myocardial involvement (PMI), pulmonary hypertension (PH), any organ involvement and all-cause mortality. Results We included 1252 patients [194 ATA-lcSSc (15.5%)], with 7.7 years (s.d. 3.5) of follow-up. ILD risk was higher in ATA-lcSSc vs ACA- and ANA-lcSSc and similar to ATA-dcSSc, although with less frequent restrictive lung disease. The risk of FVC decline ≥10% (35% of ATA-lcSSc) was lower in ATA-lcSSc than in ATA-dcSSc, whereas FVC decline ≥5% occurs similarly between ATA-lcSSc (58% of patients) and other SSc subsets, including ATA-dcSSc. The risk of PMI was similar in ATA-lcSSc and ANA-lcSSc but lower than in ACA-lcSSc; no difference in PH and mortality risk was observed among lcSSc subsets. The risk of any organ involvement, PMI and PH was lower and the mortality tended to be lower in ATA-lcSSc vs ATA-dcSSc. Conclusion ATA-lcSSc patients have a high risk of ILD, albeit with a lower risk of progression compared with ATA-dcSSc, supporting careful screening for ILD in this subgroup.

Objectives The early trajectory of skin fibrosis provides insights into the disease course of systemic sclerosis (SSc) including mortality; however, little is known about late skin fibrosis. The aims of our study were to ascertain the prevalence and characteristics of late skin fibrosis in SSc. Methods We developed and tested three conceptual scenarios of late (>5 years after first non-RP feature) skin fibrosis including new worsening of skin disease, and failure to improve after worsening within 5-year window. We defined skin worsening as change in modified Rodnan skin score (mRSS) ≥5 units or ≥25%. Using strict inclusion criteria including complete mRSS, we identified 1,043 (out of 19 115) patients within the EUSTAR database for our analysis. We further restricted analysis within 887 (out of 1043) patients who had lcSSc or dcSSc at baseline. Results One-fifth of patients among the whole cohort (n = 208/1043, 19.9%) experienced mRSS worsening, including in patients with lcSSc or dcSSc at baseline (n = 193/887, 21.8%). This was largely due to new skin worsening after the 5-year window or failure to improve with worsening within the 5-year window. Patients with lower baseline mRSS and lcSSc were more likely to develop late skin fibrosis. Anti-Scl-70 was associated with progression from baseline lcSSc to dcSSc, and anticentromere was protective. Conclusions Late skin fibrosis is not uncommon in SSc. We have identified different patterns relevant to clinical practice and trial design. Late skin fibrosis is a neglected manifestation of SSc and warrants further investigation including to determine clinical outcomes and optimal therapeutic strategy.

Objective Digital pitting scars (DPS) are frequent, but little studied in SSc to date. Methods An analysis of SSc patients enrolled in the EUSTAR database. Primary objectives were to (i) examine DPS prevalence; (ii) examine whether DPS are associated with digital ulcers (DUs) and active digital ischaemia (DUs or gangrene); and (iii) describe other associations with DPS including internal organ complications. Secondary objectives were whether DPS are associated with (i) functional impairment; (ii) structural microvascular disease; and (iii) mortality. Descriptive statistics and parametric/non-parametric tests were used. Binary logistic regression was used to examine the association between DPS and DUs, active digital ischaemia and mortality. Results A total of 9671 patients were included with reported DPS at any time point (n = 4924) or ‘never’ DPS (n = 4747). The majority (86.9%) were female and mean age was 55.7 years. DPS were associated with longer disease and Raynaud’s duration (both P ≤ 0.001). DPS were associated with interstitial lung disease, pulmonary hypertension, conduction blocks, telangiectases, calcinosis (all P ≤ 0.001) and joint synovitis (P = 0.021). Patients were more likely to have more severe capillaroscopic abnormality and greater hand functional impairment. Multivariable logistic regression analyses showed that DPS were associated (odds ratio) with DUs: 22.03 (19.51–24.87), active digital ischaemia: 6.30 (5.34–7.42) and death: 1.86 (1.48–2.36). Conclusion DPS are associated with a severe disease course including death. The impact of DPS on hand function and ischaemia is significant. The presence of DPS should alert the clinician to a poor prognosis and need to optimize the therapeutic strategy.

espanolIntroduccion El Educational Needs Assessment Tool-version espanola (SpENAT) es un cuestionario autorreportado que evalua las necesidades educacionales (NEd) con el fin de dar informacion adaptada y centrada en el paciente con artritis reumatoide (AR). Comprende 39 preguntas agrupadas en 7 dominios: Manejo del dolor, Movimiento, Sentimientos, Proceso de artritis, Tratamientos, Medidas de autoayuda y Sistemas de apoyo. Objetivos Evaluar las NEd en pacientes con AR mediante el SpENAT y determinar cuales son las principales fuentes de informacion a las que consultan. Material y metodos Estudio multicentrico, observacional, analitico, de corte transversal. Se incluyeron pacientes consecutivos ≥ 18 anos con diagnostico de AR (ACR 87 y/o ACR-EULAR 2010). Se consignaron datos demograficos, nivel educativo, caracteristicas de la enfermedad y medidas clinimetricas. Todos los pacientes completaron el SpENAT y fueron interrogados acerca de las fuentes a las que acuden para obtener informacion de su enfermedad. Analisis estadistico Se describieron las caracteristicas poblacionales. Se determinaron las NEd como porcentajes del puntaje maximo posible de cada dominio. Se compararon las necesidades por dominio segun sexo, anos de educacion, tiempo de evolucion, uso de biologico y capacidad funcional mediante test de Anova y las comparaciones de a pares con prueba t de Student y correccion de Bonferroni. Se determino correlacion entre los dominios con test de Spearman. Se comparo la edad segun la fuente de informacion con la prueba t de Student. Resultados Se incluyeron 496 pacientes de 20 centros de todo el pais. Se observaron mayores NEd en los dominios Movimiento, Sentimientos y Proceso de artritis. Los pacientes de mayor nivel educacional (> 7 anos) refirieron mayores NEd en los dominios Proceso de artritis y Medidas de autoayuda. Un mayor deterioro funcional (HAQ ≥ 0,87) se asocio con unas mayores NEd en todos los dominios. Los pacientes con alta actividad mostraron mayores NEd que los pacientes en remision en los dominios Manejo del dolor, Movimiento, Sentimientos, Tratamientos y Sistemas de apoyo, y que los pacientes con baja actividad en los dominios Medidas de autoayuda y Sistemas de apoyo. Todos los dominios del SpENAT mostraron correlaciones positivas entre si (p Conclusion Los pacientes con AR manifestaron un gran interes por conocer mas sobre su enfermedad. Un elevado deterioro funcional se asocia con mayores NEd. Los pacientes con alta actividad de la enfermedad presentan mayores NEd en casi todos los dominios. El medico reumatologo es la principal fuente de informacion del paciente con AR. EnglishBackground The SpENAT, a Spanish version of the Educational Needs Assessment Tool, is a self-completed questionnaire that assesses educational needs (ENs) with the purpose of providing tailored and patient-centered information. It consists of 39 questions grouped into the 7 following domains: Pain management, Movement, Feelings, Arthritic process, Treatments, Self-help measures and Support system. Objectives The objective of the study was to describe the ENs of rheumatoid arthritis (RA) patients using the SpENAT and to determine the main sources of information consulted by these patients. Material and methods Multicenter, observational, cross-sectional study. We included consecutive patients ≥ 18 years with diagnosis of RA (ACR 87/ACR-EULAR 2010). Sociodemographic data, disease characteristics and clinimetric properties were recorded. All patients completed the SpENAT and were asked about the sources employed to obtain information about their disease. Statistical analysis Population characteristics were described. ENs were determined as percentages of the highest possible score for each domain. Needs for each domain according to sex, years of education, disease duration, use of biologicals and functional capacity were analyzed by means of ANOVA, and bivariate comparisons were made with Student's t-test and the Bonferroni correction. Correlation between domains was determined with the Spearman correlation coefficient. We compared patients’ age by source of information with Student's t-test. Results We included 496 patients from 20 centers across the country. More ENs were observed in the domains of Movement, Feelings and the Arthritic process. Patients with higher educational level (> 7 years) reported more ENs in the Arthritic process and Self-help measure domains. A higher functional impairment (HAQ-A ≥ 0.87) was associated with more ENs in every domain. Patients with high activity showed more ENs than those in remission in the domains of Pain management, Movement, Feelings, Treatments and Support system, as well as those with low activity in Self-help measures and Support system domains. All SpENAT domains showed positive correlations among each other (P Conclusion RA patients were very interested about knowing more about their disease. High functional impairment was associated with more ENs. Patients with high disease activity had higher EN levels in almost every domain. The rheumatologist was the main source of information for the patient with RA.

The SpENAT, a Spanish version of the Educational Needs Assessment Tool, is a self-completed questionnaire that assesses educational needs (ENs) with the purpose of providing tailored and patient-centered information. It consists of 39 questions grouped into the 7 following domains: Pain management, Movement, Feelings, Arthritic process, Treatments, Self-help measures and Support system.The objective of the study was to describe the ENs of rheumatoid arthritis (RA) patients using the SpENAT and to determine the main sources of information consulted by these patients.Multicenter, observational, cross-sectional study. We included consecutive patients≥18 years with diagnosis of RA (ACR 87/ACR-EULAR 2010). Sociodemographic data, disease characteristics and clinimetric properties were recorded. All patients completed the SpENAT and were asked about the sources employed to obtain information about their disease.Population characteristics were described. ENs were determined as percentages of the highest possible score for each domain. Needs for each domain according to sex, years of education, disease duration, use of biologicals and functional capacity were analyzed by means of ANOVA, and bivariate comparisons were made with Student's t-test and the Bonferroni correction. Correlation between domains was determined with the Spearman correlation coefficient. We compared patients' age by source of information with Student's t-test.We included 496 patients from 20 centers across the country. More ENs were observed in the domains of Movement, Feelings and the Arthritic process. Patients with higher educational level (7 years) reported more ENs in the Arthritic process and Self-help measure domains. A higher functional impairment (HAQ-A≥0.87) was associated with more ENs in every domain. Patients with high activity showed more ENs than those in remission in the domains of Pain management, Movement, Feelings, Treatments and Support system, as well as those with low activity in Self-help measures and Support system domains. All SpENAT domains showed positive correlations among each other (P.0001), the most important being Pain management/Movement and Treatments/Arthritic process (r≥0.7). The source of information most frequently consulted was the rheumatologist (93.95%); those who made use of Internet were on average younger (P=.0004).RA patients were very interested about knowing more about their disease. High functional impairment was associated with more ENs. Patients with high disease activity had higher EN levels in almost every domain. The rheumatologist was the main source of information for the patient with RA.

To validate the Quality of Life-Rheumatoid Arthritis Scale II (QOL-RA II) in an Argentinean cohort of patients with rheumatoid arthritis (RA). Patients ≥ 18 years old, with a diagnosis of RA according to ACR-EULAR 2010 criteria, were included in a cross-sectional study. Sociodemographic data, comorbidities, RA characteristics, disease activity, and current treatment were registered. Questionnaires were administered, including EQ-5D-3 L, QOL-RA II, HAQ-A, and PHQ-9. The QOL-RA II was re-administered in 20 patients to evaluate reproducibility. Four hundred and thirty patients were included. Median QOL-RA was 6.6 (IQR 5.3–8). Mean time to complete it was 1.7 ± 0.57 min and to calculate it was 12 ± 1.7 s. It showed very good reliability (Cronbach’s alpha 0.97), reproducibility (ICC, 0.96), and good correlation between the different items and the total questionnaire, without evidence of redundancy. Besides, QOL-RA II presented good correlation with EQ-5D-3L (Rho, 0.6) and moderate with DAS28 (Rho, 0.38), and CDAI (Rho, 0.46). Worse quality of life was observed in patients not doing physical activity, unemployed, and current smokers. Patients with higher disease activity had a significant poorer quality of life. Adjusting by age, sex and disease duration, unemployment, higher disease activity, disability, and the presence of depression were independently associated to worse quality of life. QOL-RA II demonstrated good construct validity, reproducibility, and reliability. It was easy to complete and calculate and does not require a license for its use, thus making it the optimal tool for assessing the quality of life in Spanish-speaking patients with RA.

Objectives To estimate the prevalence of long-term exposure to glucocorticoids (GCs) and to identify factors associated with, and variations in prescribing practices over time and across recruiting countries. Methods We included patients with SSc having a visit recorded in the EUSTAR database from January 2013 onward. We analysed the prevalence and the main features of GCs users, their exposure to GCs over time, and their GCs dosages. Multivariable linear regression was used to analyse the factors identified as associated with GCs intake duration. Time trends, and variations in GCs utilization across recruiting countries were explored. Missing data were imputed using multiple imputation with chained equations. Results The 9819 patients included were mostly females (85%), the majority had lcSSc (73%), and the median age was 58 years. At baseline, 34% of patients (n = 2769/8109) (48% dcSSc vs 29% lcSSc) were on GCs, and the median dose was 7.5 mg/day. GCs users were more frequently males and anti-Scl70 positive, and more commonly had dcSSc and more severe disease. On average, GCs users spent 25% of their follow-up time (median 33.2 months) on GCs, with no significant between-subsets difference. Notably, 33% (n = 971/2959) and 22% (n = 647/2959) of patients followed up for >1 year had received GCs for >6 and >12 months, respectively. Multivariable analysis showed that patient and disease characteristics poorly explained the variability in GCs exposure (adjusted-R2 = 0.06, P Conclusions GCs are widely and long-term prescribed in SSc, with significant between-countries and within-country differences. A gradual decrease in their utilization has been observed.

Background: The current subclassification of systemic sclerosis into cutaneous subtypes does not fully capture the heterogeneity of the disease. We aimed to compare the performances of stratification into LeRoy's cutaneous subtypes versus stratification by autoantibody status in systemic sclerosis. Methods: For this cohort study, we assessed people with systemic sclerosis in the multicentre international European Scleroderma Trials and Research (EUSTAR) database. Individuals positive for systemic-sclerosis autoantibodies of two specificities were excluded, and remaining individuals were classified by cutaneous subtype, according to their systemic sclerosis-specific autoantibodies, or both. We assessed the performance of each model to predict overall survival, progression-free survival, disease progression, and different organ involvement. The three models were compared by use of the area under the curve (AUC) of the receiver operating characteristic and the net reclassification improvement (NRI). Missing data were imputed. Findings: We assessed the database on July 26, 2019. Of 16 939 patients assessed for eligibility, 10 711 patients were included: 1647 (15·4%) of 10 709 were male, 9062 (84·6%) were female, mean age was 54·4 (SD 13·8) years, and mean disease duration was 7·9 (SD 8·2) years. Information regarding cutaneous subtype was available for 10 176 participants and antibody data were available for 9643 participants. In the prognostic analysis, there was no difference in AUC for overall survival (0·82, 95% CI 0·81–0·84 for cutaneous only vs 0·84, 0·82–0·85 for antibody only vs 0·84, 0·83–0·86 for combined) or for progression-free survival (0·70, 0·69–0·71 vs 0·71, 0·70–0·72 vs 0·71, 0·70–0·72). However, at 4 years the NRI showed substantial improvement for the antibody-only model compared with the cutaneous-only model in prediction of overall survival (0·57, 0·46–0·71 for antibody only vs 0·29, 0·19–0·39 for cutaneous only) and disease progression (0·36, 0·29–0·46 vs 0·21, 0·14–0·28). The antibody-only model did better than the cutaneous-only model in predicting renal crisis (AUC 0·72, 0·70–0·74 for antibody only vs 0·66, 0·64–0·69 for cutaneous only) and lung fibrosis leading to restrictive lung function (AUC 0·76, 0·75–0·77 vs 0·71, 0·70–0·72). The combined model improved the prediction of digital ulcers and elevated systolic pulmonary artery pressure, but did poorly for cardiac involvement. Interpretation: The autoantibody-only model outperforms cutaneous-only subsetting for risk stratifying people with systemic sclerosis in the EUSTAR cohort. Physicians should be aware of these findings at the time of decision making for patient management. Funding: World Scleroderma Foundation.

The aim of this study was to ascertain the frequency of use, search intent (SI), level of accessibility, and degree of reliability of sources of information (SOIs) in rheumatology.A survey among adult outpatients with rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, and spondyloarthritis was conducted. They were asked if they had procured information from 12 selected SOIs during the past year. Search intent was defined as the source they would like to consult. Accessibility and reliability were assessed through 0-to-10 scales (minimum and maximum, respectively).Four hundred two patients were surveyed. They had consulted a median of 3 SOIs (interquartile range, 2-6) but described a higher SI: median of 5 SOIs (interquartile range 3-8); p = 0.001.The most consulted SOIs were the physician (83%), other patients (45%), and Facebook (36%). The main differences between SI and the searches actually performed were observed in community lectures by health care professionals (49%), scientific societies (48%), and associations of patients (27%); p0.001. These 3 sources showed low level of accessibility. Facebook, press, radio, and YouTube were the least reliable sources.Patients consulted a median of 3 SOIs but reported a significantly higher SI. Although patients demand more information, the request is leveled at SOIs with difficult accessibility but high reliability.

Patients with systemic sclerosis (SSc) undergo chest radiographs and high-resolution computed tomography (HRCT) of the thorax both for interstitial lung disease (ILD) detection and for disease progression monitoring.The aim of this study was to assess whether lung ultrasound (LUS) is a useful screening tool for ILD in patients with SSc in comparison with HRCT.This was a longitudinal cohort study carried out from December 2015 to April 2016. An LUS was performed to examine B-lines in 67 consecutive patients who met the 2013 American College of Rheumatology/European League Against Rheumatism classification criteria for SSc and had a previous HRCT. B-lines were quantified and classified according to the score modified from Picano. Severity and extent of lung involvement on the HRCT were determined by means of the Warrick score.Twenty-nine patients had both abnormal HRCT (Warrick score7) and abnormal LUS, 2 had a mild score (6-15 B-lines), and 27 had either moderate or severe scores (≥16 B-lines). Of the 38 patients with negative HRCT, 25 presented some degree of lung involvement on the LUS. Thus, LUS has a sensitivity of 100% and a specificity of 34%. Receiver operating characteristic curve analysis showed the analytic relation between the number of B-lines and the presence of ILD on the HRCT (area under the curve, 0.80; 95% confidence interval, 0.69-0.90).Lung ultrasound may be a method to detect abnormal lung findings in a noninvasive manner in patients with SSc. Because of its high sensitivity, a low score almost rules out the need for an HRCT.

We have recently validated the Quality of Life-Rheumatoid Arthritis Scale (QOL-RA). We have found some limitations, that is why, with the author’s permission, we have changed two questions and developed a new Spanish version, QOL-RA II. Objective: to validate the QOL-RA II in an Argentinean cohort of patients with Rheumatoid Arthritis (RA). Material and methods: cross-sectional study. Patients ≥18 years old, with a diagnosis of RA according to ACR-EULAR 2010 criteria were included. Sociodemographic data, comorbidities, RA characteristics, disease activity current treatment were registered. Questionnaires were administered: EQ-5D-3L, QOL-RA, HAQ-A and PHQ-9. The QOL-RA II was re-administered in 20 patients to evaluate reproducibility. Statistical analysis: Student´s T, ANOVA and Chi2 tests. Spearman correlation. Cronbach´s alpha. Reproducibility using ICC. Multinomial logistic regression with completed factorial model. Multiple linear regression.

Background/Objective: Psoriatic arthritis (PsA) is preceded by psoriasis in approximately 80% of cases. Dermatologists are pivotal for early detection. It is important to have simple tools that allow the detection of PsA in patients with skin psoriasis. The aim of our study was to evaluate the performance of an adapted version of the GEPARD Questionnaire in Spanish in Argentinian patients with psoriasis. Methods: This is a cross-sectional study. A new Spanish (Argentinian) (GEPARDa) translated version of the original questionnaire (German) was developed and then tested as a diagnostic tool in patients with psoriasis, PsA, osteoarthritis associated to psoriasis, and osteoarthritis, all evaluated by rheumatologists who used the CASPAR criteria. Results: Eighty-three patients were included (55 [66.3%] women with a mean age of 50.7 years [SD 6.3]). Forty-four patients had PsA (29 [34.9%] patients had previous diagnosis of PsA, and 15 [18%] were newly diagnosed after referral by their dermatologists), and 39 patients were without PsA (18 [21.6%] patients had psoriasis without articular involvement, 6 [7.22%] had psoriasis associated with osteoarthritis, and 15 [18%] had osteoarthritis). An area under the curve of 0.9554 (SD 0.01; 95% CI 0.91–0.99) was calculated considering the CASPAR criteria as the gold standard. With a cutoff of ≥6 the questionnaire showed a sensitivity of 88.64%, a specificity of 89.74%, a positive likelihood ratio of 8.6, and a negative likelihood ratio of 0.12. Conclusions: The GEPARDa version has proven to be a diagnostic tool with excellent performance so that it can be considered a valid tool for the detection of PsA in Argentinian patients.

To validate the Quality of Life-Rheumatoid Arthritis Scale II (QOL-RA II) in an Argentinean cohort of patients with rheumatoid arthritis (RA). Patients ≥ 18 years old, with a diagnosis of RA according to ACR-EULAR 2010 criteria, were included in a cross-sectional study. Sociodemographic data, comorbidities, RA characteristics, disease activity, and current treatment were registered. Questionnaires were administered, including EQ-5D-3 L, QOL-RA II, HAQ-A, and PHQ-9. The QOL-RA II was re-administered in 20 patients to evaluate reproducibility. Four hundred and thirty patients were included. Median QOL-RA was 6.6 (IQR 5.3-8). Mean time to complete it was 1.7 ± 0.57 min and to calculate it was 12 ± 1.7 s. It showed very good reliability (Cronbach's alpha 0.97), reproducibility (ICC, 0.96), and good correlation between the different items and the total questionnaire, without evidence of redundancy. Besides, QOL-RA II presented good correlation with EQ-5D-3L (Rho, 0.6) and moderate with DAS28 (Rho, 0.38), and CDAI (Rho, 0.46). Worse quality of life was observed in patients not doing physical activity, unemployed, and current smokers. Patients with higher disease activity had a significant poorer quality of life. Adjusting by age, sex and disease duration, unemployment, higher disease activity, disability, and the presence of depression were independently associated to worse quality of life. QOL-RA II demonstrated good construct validity, reproducibility, and reliability. It was easy to complete and calculate and does not require a license for its use, thus making it the optimal tool for assessing the quality of life in Spanish-speaking patients with RA. Key Points • The evaluation of quality of life is very important in patients with Rheumatoid Arthritis. • Most of the questionnaires used to assess the quality of life require a license to use. • QOL-RA II is a valid and simple questionnaire to evaluate the quality of life of patients with RA and does not require a license for its use.

Gastrointestinal (GI) involvement is almost universal in patients with systemic sclerosis (SSc) and is associated with significant disease-related morbidity and mortality.1 The entire GI tract can be involved and other disease features (eg, low mood, terminal organ failure and functional hand impairment) can result in significant nutritional impairment. Severe GI involvement has been reported to occur in ~10% of patients with SSc and often occurs early in the course of the disease.2 However, identification of patients at high risk of clinically significant weight loss is extremely challenging, including from the high prevalence of GI symptoms in patients with SSc. Therefore, there is a need to understand high-risk patients including potentially modifiable risk factors, with a view to early intervention strategies. Against this background, the aim of this study was to examine potential clinical risk factors of significant weight loss in patients with SSc. We performed an analysis of patients with SSc enrolled in the multinational, longitudinal European League Against Rheumatism (EULAR) Scleroderma Trials and Research (EUSTAR) database. In our study, we defined significant weight loss as 4.5 kg and/or least 5% of their body weight at 5 months onwards.3 Patients with a recorded second visit after 3 months and before 12 months were included in the analysis. We adopted a pragmatic approach (relevant to clinical practice) in …

The objective of the study was to analyse resources for rheumatology training, and speciality certification and recertification requirements in Argentina. Information was gathered regarding vacancies, entry requirements, duration and validity of the specialist degree in every residency and postgraduate course in adult rheumatology. The following aspects were analysed: monitoring authority, certification and recertification requirements, and mandatory recertification. Six out of 36 universities offer rheumatology postgraduate courses. Out of 65 vacancies, 36 (55%) are implemented by a National Public University in the Autonomous City of Buenos Aires (CABA), and 46 (70%) are in CABA. There are 32 vacancies for rheumatology residencies in 7 out of 24 districts, 16 of them (50%) in CABA. There are 2- to 3-year postgraduate courses; entry requirements range from 1-year experience in internal medicine to either complete residency or specialist degree in internal medicine. Training formats vary from full-time university residency to either university-based courses with part-time dedication in a rheumatology service without residency or non-university courses with part-time dedication. Not every specialist degree is automatically homologated in every jurisdiction. Provincial governments and colleges of physicians are the certification and recertification authorities; medical school was included in one district. Recertification is mandatory in only 8 districts; 40-50% of the process is achieved by merely practising as a rheumatologist. Most of the training resources are concentrated in CABA. Although there are various options, not all of them are automatically homologated. Recertification is not mandatory nationwide, and a significant part of the process involves practising as a rheumatologist.

Background:There are limited data worldwide on the behavior of SARSCOV2 in patients with Spondyloarthritis (SpA).Objectives:To describe the incidence and severity of COVID-19 disease in patients with SpA in Argentina.Methods:Patients with axial spondyloarthritis (AxSpA) radiological (EA) and non-radiological (AxSpA-nr) and peripheral spondyloarthritis (according to ASAS criteria) and psoriatic arthritis (PsA) (according to CASPAR criteria) were included. Sociodemographic data, comorbidities, disease activity and treatments were collected at baseline. The patients were followed up by phone or in person monthly. Data were collected from 1/4/2020 to 9/20/2020. Descriptive statistics were performed with mean and standard deviation (SD) and median and quartile 25-75 according to distribution, and the cumulative incidence (AI) of the disease was calculated.Results:320 patients were included, of which 55% were male, with a mean age of 50 SD 13, 21.6% had a diagnosis of AS, 6.9% SpAax-nr, 6.9% SpAp, and 64.7% PsA, BASDAI 3.65 (3), BASFI 3 (1.5-9), PASI 0.3 (0-7), BSA 0.2 (0-6). Fourteen patients with a diagnosis of COVID-19 (4.4%) were reported, of which 10 diagnoses were by positive PCR and 4 by positive symptoms and close contact. 93% (13) of the cases were patients from the Province of Buenos and CABA and 1 patient from Santiago del Estero. The total IA for the country was 0.04. Of the 14 patients with COVID-19, 7 (50%) were men, 4 had a diagnosis of AS, 1 of SpAax-nr, 9 (64.3%) PsA. 100% live in urban areas, 2 (14%) have hypertension, 1 (7%) DBT, 1 (7%) COPD, 2 (14%) depression or anxiety, 11(97%) had received influenza vaccine 2020, 13 (93%), Antineumoccic 23, 14 (100%) Antineumoccic 13. Regarding the treatments: 4 (28.6%) were in treatment with anti TNF (3 with Adalimumab, 1 with certolizumab pegol), 4 (28.6%) with Anti IL17 (3 with Secukinumab, 1 with Ixekizumab), 8 (57%) with methotrexate and 2 (14%) with Leflunomide. Place of follow-up of the disease: 10 (71.4%) at home, 3 (21.4%) in the common room and 1 (7) in the intensive care unit. Treatments received for COVID-19: 1 (7%) antiretroviral, 1 (7%) antibiotic and 1 (7%) steroids. None of the patients died from COVID-19.Conclusion:An incidence of 4.4% of COVID-19 was found in this population with SpA and most of the patiend had mild symptoms and no deaths were reported.Disclosure of Interests:Victoria Martire: None declared, Carla Airoldi: None declared, María Soledad Gálvez Elkin: None declared, MAXIMILIANO MACHADO ESCOBAR: None declared, Noel Callahuara: None declared, Vanesa Duarte Employee of: Novartis, José Alcivar Navarrete: None declared, Emilio Buschiazzo: None declared, Etel Saturansky: None declared, María Julieta Gamba: None declared, Paula Girard Bosch: None declared, David Zelaya: None declared, Rodrigo Garcia Salinas: None declared, María Alejandra Medina: None declared, Micaela Cosatti Employee of: Jannsen, SANTIAGO SCARAFIA: None declared, Maria Laura Acosta Felquer: None declared, Vanesa Cosentino: None declared, Fernando Sommerfleck: None declared, Ramiro Luis: None declared, Gisela Paola Pendon: None declared, Rodrigo Águila Maldonado: None declared, Silvina Nasi: None declared, Romina Nieto: None declared, Leila Abbas: None declared, Diego Vila: None declared, Eduardo Kerzberg: None declared, Mariana Benegas: None declared

Systemic lupus erythematosus (SLE) is a rheumatic disease, which during its evolution may present neurocognitive dysfunction with fronto-subcortical compromise. However, there is no enough published evidence regarding the relationship between cognitive dysfunction and SLE activity and SLE induced damage. The objective of the study was to analyze this association. We designed an observational cross-sectional study including 84 patients with SLE. We used the SLEDAI index to evaluate activity and the SLICC index to evaluate cumulative damage. We used neuropsychological tests to assess the presence of cognitive symptoms, global cognitive function, verbal and visual memory, visual-construction, semantic verbal fluency, processing speed and working memory. Scores more than 1.5 standard deviations below adjusted normal values were considered as cognitive dysfunction. We observed a statistically significant association between the higher value of SLEDAI and working memory impairment and a higher value of SLICC and viso-construction and semantic verbal fluency impairment. The association observed in SLE patients between disease activity or damage and some cognitive domains may be involving different pathophysiological brain mechanisms of different areas with different degrees of severity and vulnerability.

Background:The questionnaire “Assessment of Spondyloarthritis international Society Health Index” (ASAS HI) was developed to measure functionality and health status in patients with spondyloarthritis (SpA)1.Objectives:To describe the state of health measured by ASAS HI in Argentinian patients with SpA and to evaluate factors associated with poor health.Methods:Analytical, cross sectional, multicenter study. Patients with SpA according to ASAS criteria were consecutively included from 15 Argentinian centers. Statistical analysis: frequencies and percentages (%), mean and standard deviation (SD) or median and interquartile range (IQR). Bivariate analysis and logistic regression were performed to evaluate the factors associated with poor health status (ASAS HI > or equal to 12). Correlation with other parameters was evaluated by Spearman correlation.Results:We included 274 patients with a mean age 49 (SD 14) years, median disease duration 60 month (IQR 24-135), 155 (56.6%) of patients are male, 47% (n:129) axial SpA and 52.9 (n:145) peripheral SpA. One hundred and nine patients (43.4%) presented good health status, 117 (42.7%) had moderate state of health and 38 (13.9%) had poor health. In the bivariate analyses patients with ASAS health index greater than or equal to 12 (poor status), were older [54 (11) vs 48 (14), p: 0.01], had higher disease duration [11(IQR 57-192) vs 60 (IQR 24-120), p: 0.02], more hypertension [20 (52.6%) vs 67 (28.4%), p:0.004], more diabetes mellitus [10 (26.3%) vs 22(9.3%), p: 0.006], depression [6 (15.8%) vs 10 (4.2%), p:0.013], anxiety [8 (21%) vs (22 (9.3%),p:0.046], less years of education [9.8 (SD 3.5) vs 13 (SD 10), p:0.001], higher ASQol [12.6 (SD 4.6) vs 5.7 (SD4), p < 0.001], BASFI [7(SD2) vs 4(SD6), p: 0.001], DAS28 [4.71 (SD3.2) vs 2.8 (SD1),p: Conclusion:Poor health status is associated with disease activity, poor quality of life and functional activity. ASAS HI has a good correlation with other parameters to evaluate SpA, reinforcing the construct validity of this new tool.References:[1]Kiltz U,et al.Ann Rheum Dis2018;0:1–7.Disclosure of Interests:None declared

Background Neonatal lupus (NL) is a disease in children of mothers who have specific anti-Ro/La IgG autoantibodies by passive transplacental transfer. LN is characterized by skin and cardiac involvement, as well as cytopenias, hepatic or neurological manifestations. NL can be diagnosed intra-uterus or in neonatal period, being self-limiting in several months or be irreversible. Congenital heart block (CHB) in a structurally normal heart, is perhaps the most serious manifestation with an estimated mortality rate of around 19%. Objetives: to estimate the frequency of NL in children of mothers with anti-Ro/La in reference centers in the management of pregnancy and autoimmune diseases in Argentina, and to describe maternal and children features. Methods A descriptive multicenter study was conducted in reference centers in the management of autoimmune diseases and pregnancy in Argentina. Inclusion criteria were the presence of positive maternal serology anti-Ro/La and at least one pregnancy. Demographic and maternal-fetal clinical data were obtained from the clinical histories and each center completed a data collection form created for this study. We defined a NL case (born or not) who presented, pre and/or postpartum, characteristic skin lesions, cytopenias, cardiac involvement (CHB, endocardial fibroelastosis and dilated cardiomyopathy), hepatic or neurological manifestations. Ethnicity was classified using GLADEL groups. NL frequency was calculated dividing the number NL cases by the number of mothers with positive anti-Ro/La serology. Results 18 reference centers in the management of autoimmune diseases and pregnancy participated in this study in 7 different geographic areas of Argentina (6 of Buenos Aires, 6 of Cordoba, 1 of Jujuy, 1 of Mendoza, 1 of Santa Fe, 1 of Santiago del Estero and 2 of Tucuman). 193 mothers with positive anti-Ro/La serology were included with 364 pregnancies. 19 cases NL cases were reported (10 diagnosed during pregnancy and 9 in post-partum. The frequency of NL was estimated at 9.8% [95% CI 6.3–14.9] (CHB=6.2% [IC95% 3.5–10.7]). Table 1 describes the maternal and fetal characteristics of NL cases. The most frequent manifestations were skin (n=7) and cardiac involvement (n=12). In 1 case, there was a history of NL in a previous pregnancy. Of the patients with CHB, 5 required a pacemaker. Conclusions In conclusion, the frequency of NL in our multicentric cohort is greater than other international cohorts. Differences could be related to genetic/environmental factors as well as methodological limitations and selection bias. Funding Source(s): None

To analyse the administration of systemic glucocorticoids (SGC) to patients with Psoriatic arthritis (PsA). Online, anonymous, multiple-choice, closed-ended survey on SGC use in PsA, dose, duration of therapy, and the reason for administration. One hundred and twenty rheumatologists from Argentina (ARG) and 75 from other countries in Latin-America (LAT) completed the survey. Only 6% of the respondents indicated that they did not prescribe SGC, and 65% claimed that they administered them to less than 10% of their patients. Among those physicians who used SGC, 71% prescribed between 5 and 10 mg/day of prednisone, and only 5% over 10 mg/day. Seventy-three percent of the respondents administered SGC for less than 3 months, and 93% associated them with DMARDs, Biological Therapy (BT), or DMARDs plus BT. Clinical indications for SGC were (more than one option was possible): peripheral arthritis (79%), dactylitis (23%), enthesitis (20%), cutaneous involvement (11%), and axial involvement (8%). Thirty-four percent of ARG physicians versus 21% of LAT used SGC in over 10% of their patients (p 0.07) while 76.5% of ARG versus 59% of LAT administered doses higher than 5 mg/day of prednisone (p 0.01). SGC were indicated by most of the rheumatologists surveyed, but only to a reduced number of patients with PsA, at low doses, for short periods of time, associated with DMARDs/BT, and with the aim of treating peripheral joint manifestations. Argentinian physicians tended to prescribe SGC to more patients and at slightly higher doses.

Low back pain (LBP) is the most common cause of pain in adults and the second health condition that prompts patients to seek ambulatory medical care visits. To analyse the impact of LBP on hospitalisations in healthcare facilities within the official subsector in Argentina between 2006 and 2010. Discharges in which the original diagnosis had been either adult LBP or lumbosciatica were assessed. The data comprised age, gender, province of residence, average length of stay (LOS) in the hospital, intra-hospital death, and the Provincial Human Development Index (PHDI). 17,859 discharges had an original diagnosis of LBP and 10,948 of lumbosciatica, which jointly accounted for 18.7 % of all the discharges documented for Diseases of Osteomuscular System and Connective Tissue (DOMS). Hospital discharges of female patients represented 53.7 %. The average age upon admission was 47.7 years in men versus 47.9 in women. The average LOS was slightly higher in men (4.2 vs. 3.8 days, p 0.01). In provinces with a PHDI below the national average, a surgical procedure was performed in 3.1 % of the discharges versus 4.1 % in the provinces with a PHDI above the national average (p < 0.001). LBP was the most frequent cause of hospitalisation due to DOMS. It occurred with a slightly higher frequency in women and prompted short hospitalisations. A surgical procedure was carried out during hospitalisation in very few cases, but the percentage of surgeries during hospitalisation was higher in provinces with a PHDI above the national average.

Background:Work disability is an important outcome in the treatment of Spondyloarthritis (SpA) since this disease affects people in the most productive stage of life.Objectives:The aim of this study is to investigate the working status and the factors associated with work productivity loss (WPL) in patients with axial (axSpA) and peripheral SpA (pSpA).Methods:Patients with SpA according to ASAS criteria were included consecutively in this multicentric cross-sectional study. Evaluation of activity through a visual analogue scale (0-100), enthesitis (LEI), functional capacity (HAQ and BASFI), disease activity (DAS28 and BASDAI), health status (ASAS Health Index) and quality of life (ASQoL) were calculated. The Ankylosing Spondylitis Disease Activity Score (ASDAS) was recorded. The Work Productivity and Activity Impairment Spondyloarthritis (WPAI SpA) questionnaire was used to assess work productivity.Spearman’s correlation coefficient (ρ) was used to assess the correlation with the percentage of WPL.Results:274 patients with SpA were recruited, 129 (47.1%) with axSpA and 145 (52.9%) with pSpA. 56.6% were women and 33.2% stopped working due to the underlying disease.Among axSpA patients, 70% were radiographic and 30% non radiographic, mean age 45.5 (SD14) yrs, median disease duration 72 (IQR 36-144) months and diagnosis delay 20 (IQR 11-70) months. 45.7% were employed, median hours worked in the last week was 40 (IQR 25-45), median scores for absenteeism was 0% (IQR 0-2), presenteeism 30% (IQR 5-40), WPL 30% (IQR 10-52.5) and activity impairment 30% (IQR 10-50). A positive correlation was found between WPL and the following variables: HAQ (ρ:0.40, pAmong pSpA patients, mean age was 52.3 (SD13) yrs, median disease duration 60 (IQR 14-120) months and diagnosis delay 12 (IQR 3-24) months. 46.9% were employed, median hrs worked in the last week was 30 (IQR 14-40), absenteeism 0% (IQR 0-7), presenteeism 30% (IQR 2.5-58), WPL 30% (IQR 5-52) and activity impairment 20% (IQR 0-40). A positive correlation was found between WPL and: HAQ (ρ:0.49, pConclusion:Our study showed that WPL in this national cohort was 30% in both groups of patients and is associated with disease activity, enthesitis, health status, quality of life and functional ability.Disclosure of Interests:None declared

Background:Few studies in Latin America have analysed the time lag since patients experience the first joint symptoms until they consult a physician, and a diagnosis is made, and most of them have dealt with patients sustaining Rheumatoid Arthritis (RA)1-2.Objectives:To study both patient and disease factors that have some bearing on the time lag until a physician is first consulted and a diagnosis is made.Methods:Multiple-choice survey to patients of 18 years of age or older who metSystemic Lupus Erythematosus (SLE) Classification Criteria (2012). The following aspects were measured:time lag from symptom onset to first medical consultation (Time 1), time lag since first medical consultation until a diagnosis is made (Time 2), and time lag until the first consultation with a rheumatologist.Patients were interviewed at the time or within 6 months of diagnosis, and asked about the physician they first consulted and the one who made the diagnosis. They were also requested to describe one disease onset out of 4 trajectories: acute, acute with temporary remissions, chronic with partial improvements, or sustained chronic. Patients were required to recount their response to the first symptoms, the limitations brought about by the disease (employing the Steinbrocker scale), and whether help-seeking was first aimed at consulting a physician or they decided to wait. A group of patients with Rheumatoid Arthritis (RA) answered the same survey. Every patient signed an informed consent form, and the study was approved by the Hospital Bioethics Committee.Results:Twenty-eight patients with SLE and 29 patients with RA filled in the survey. SLE patients were younger as expected (32 years vs 49 years; p Table 1.SLERAPn2829Education (median)SecondarySecondary0.07Had a job11 (39%)15 (52%)0.5Had health insurance8 (29%)15 (52%)0.1Had computer/mobile phone with an Internet connection25(89%)18(62)%0.04Steinbrocker (median with range 25-75%)3(2-3)3(3-4)0.06Immediately sought medical help15 (54%)16 (56%)0.9Did not know what to do when the first symptoms appeared7 (25%)13(45%)0.2Diagnosis made by a rheumatologist20 (71%)23 (80%)0.7Time 1 in patients with SLE was significantly lower with a median of 7 days, range(25-75%)1-30 days vs 30 days in RA, range 14-180 (p 0.01), and the former also showed a trend to lower median Time 2: 81 days, range 25-209 vs 185 days in RA, range 60-275 (p 0.1). Besides, they showed a significantly shorter time lag until the first visit to a rheumatologist with a median of 120 days, range 35-225 vs 330 days, range 120-450 in patients with RA (p 0.005).Conclusion:SLE patients consult a physician and visit a rheumatologist sooner than RA patients do, and they also show a trend to obtain a faster diagnosis. Education, health insurance, employment, the disease impact on their daily life and initial response to the symptoms do not appear to account for their swiftness in seeking medical help.References:[1]Mussano E, Missakian S, Onetti CM (2007) Estudio demográficosocial de pacientes con artritis reumatoidea en la provincia de Córdoba (Argentina). Rev Argent Reumatol 4:13–22.[2]Rodríguez-Polanco E, Al Snih S, Kuo YF et al (2011) Lag time between onset of symptoms and diagnosis in Venezuelan patients with rheumatoid arthritis. Rheumatol Int 31:657–665. doi:10.1007/s00296-009-1358-9.Disclosure of Interests:None declared

To compare the prevalence of cardiovascular disease (CVD) and major CVD risk factors among rheumatoid arthritis (RA) patients enrolled in a large US and multinational registry. We compared CVD and CVD risk factor prevalence from 11 countries enrolled in the CORRONA US and CORRONA International registries; patients from the 10 ex-US participating countries were grouped by region (Eastern Europe, Latin America, and India). Unadjusted summary data were presented for demographics and disease characteristics; comparisons for prevalence of CVD risk factors and CVD were age/gender standardized to the age/gender distribution of the US enrolled patients. Overall, 25,987 patients were included in this analysis. Compared to patients from the ex-US regions, US participants had longer disease duration and lower disease activity, yet were more likely to receive a biologic agent. Additionally, CORRONA US participants had the highest body mass index (BMI). Enrolled patients in India had the lowest BMI, were more rarely smokers, and had a low prevalence of hyperlipidemia, hypertension, and prior CVD compared to the US and other ex-US regions. Participants from Eastern Europe had a higher prevalence of hypertension and hyperlipidemia and highest prevalence of all manifestations of CVD. Differences in the prevalence of both CVD and major CVD risk factors were observed across the four regions investigated. Observed differences may be influenced by variations in both non-modifiable/modifiable characteristics of patient populations, and may contribute to heterogeneity on the observed safety of investigational and approved therapies in studies involving RA patients from different origins.

Background Biobadasar is a registry that monitors adverse events in patients who use biological treatments in rheumatologic diseases conducted by the Argentine Society of Rheumatology. As in others international registries the community acquired pneumonia (CAP) has been detected as one of the most frequent infectological adverse events. Although all immunosuppressed patients should be vaccinated against streptococcus pneumoniae, there is a proportion of patients who are not. Objectives Evaluate the prevalence of pneumococcal vaccination in patients with CAP within the Biobadasar database. Assess factors associated with Severe CAP in these patients. Methods A cross-sectional, multicentric study was made in BIOBADASAR database from 2010 to2016. In patients who reported CAP data of demographics, comorbidities and state of pneumococcal immunization was collected. Microbiological data, treatment and outcome of the event were considered. The severity of CAP was assessed according to the opinion of the attending physician, hospitalization, risk of life and/or death. Values are expressed as mean ± standard deviation, median (ranges) and frequencies (percentages), as appropriate. We performed bivariate and multivariate logistic regression analysis to identify variables associated with the event. Results Of the 4029 patients enrolled in the registry, the cumulative incidence of CAP was 4.2% (n 170), 72.4% (n 123) were women. The mean age was 57 (SD +/- 14.5). Biological treatment was found in 81.8% (n 139). Patient s that have received the pneumococcal vaccine were 40.6% (n=69). Severe CAP was detected in 7.1%. Streptococco Pneumoniae was the main pathogen isolated in 13% of the cases. Overall mortality was 4.1%. In the univariate analysis for severe CAP we found statistical significance for Smoking OR 3.88, CI95 1.063–14.22, p= 0.029 and chronic kidney disease (CKD) OR 31, CI95 2.6–376, p= 0.007. When performing a multiple logistic regression model, only renal failure OR 7.39 CI95 0.003–0.38 p= 0.007 was a predictor of severe CAP. Not significative association with immunosuppressive treatment (p: 0.09), age (p: 0.464), or vaccination (p: 0.937) Conclusions The annual incidence of CAP in Argentina varies between 0.5 -1.1% while in our cohort it was four times higher. The prevalence of pneumococcal vaccination was less than 50%, showing that, although the literature and guidelines establish the need for vaccination, this is not so in the real world. In the multivariate analysis, only CKD was related to severe CAP. Although in the univariate analysis the CKD and the smoking habit represented factors associated with severity. We must emphasize the medical education in following the international vaccination guidelines. Disclosure of Interest None declared

Background in order to ensure the pharmacological action of thermolabile drugs, it is mandatory to keep the cold chain unbroken from manufacturing to administration since lack of observance of these rules may compromise their efficacy. (1,2) Objectives to ascertain key aspects of transportation and storage of Biological Therapy (BT) on the part of the patients. Methods survey among outpatients who either were treated in the centre or attended the centre for the administration of a BT. Inclusion criteria encompassed patients of over 18 years of age, who were receiving a BT (at least one dose over the last 12 months) whose patient information leaflet indicated, “... must be refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze.” The survey comprised 31 questions about transportation and storage of the BT from the moment of collection from the pharmacy to its administration. This study was approved by the Bioethics Committee. Every patient signed an informed consent form. Results Eighty-three patients were interviewed (76% female and 24% males), their average age was 53 years old, 60% had Rheumatoid Arthritis, 24% Psoriatic Arthritis, and 16% sustained other conditions. Sixty-four percent were undergoing BT for the first time. Forty-eight percent were enrolled in a patient assistance programme. Had patients been fully informed of the importance of proper transportation and storage of the drug?No, 20% acknowledged that the first time they dealt with a BT, they had not been made aware of the relevance of its correct preservation. Are patients administered the BT immediately after collecting it from the pharmacy?No, 77% collected the drug at least 7 days before administration and though they received the BT in a cooler with ice packs (except in 5 cases) 71% was uninformed of how long it could be kept in this condition. Is the BT duly stored in the patient9s refrigerator?No, 28% misplaced the drug (65% in the freezer), and 90% did not know the temperature range at which it should be kept in the fridge. Only 1 patient used a thermometer to control the appliance temperature. Is there another crucial point as to BT storage at home?Yes, 53% of the 83 patients had experienced frequent power cuts in summer; out of these, 59% on a weekly basis. Forty percent of the 83 patients had power cuts of over 12 hours, 28% of over 24 hours, and 22% of over 48 hours. Out of the 83 patients, 37% took the BT to another house to avoid wasting it, and 4 had to dispose of it due to a protracted power cut. Five patients were away from home for over 48 hours during which the BT was in the fridge and they had not assigned another person to take care of the drug during their absence. Is the BT removed from the fridge only for its immediate administration?No, 46% of the respondents travelled to a centre, half of them for over an hour, carrying the BT. Conclusions before administering a BT, it is imperative to brief patients on suitable transportation and storage methods. Thus, treatment failure should prompt a thorough assessment of transportation and storage conditions. References Allegra JR, Brennan J, Lanier V, Lavery R, Markenzie B. Storage temperatures of out-of-hospital medications. Acad Emerg Med. 1999;6:1098–103. Marco JL, Cuellar MJ, Perez-Castellό I, Castellό A, Muelas J, Pelegri J. La cadena del frio de los medicamentos termolabiles en el domicilio del paciente. Pharm Care Esp. 2008;10:40–3. Disclosure of Interest None declared

To assess breastfeeding in patients with systemic lupus erythematosus (SLE), a cross-sectional study of patients with SLE compared to a non-SLE sample was performed. Patients who had pregnancies subsequent to their diagnosis of SLE and who were followed up in the hospital were interviewed. The group of non-SLE mothers consisted of patients who had no known rheumatic disease at the time of their pregnancy, and who were approached at the hospital paediatrics service waiting room. Thirty-six pregnancies in 31 patients with SLE and the same number of non-SLE mothers were studied. The number of SLE patients who did not initiate breastfeeding was higher than that of non-SLE mothers (19.4 vs 5.6%, respectively; p 0.07). The average duration of breastfeeding in SLE patients was 6 months (SD 6 months) versus 12 months (SD 8 months) in non-SLE mothers (log rank p: 0.003). Fifty-three percent of the non-SLE mothers indicated no particular reason for weaning, and considered that they had nursed their children a suitable amount of time. Conversely, SLE patients often set weaning in motion on the grounds that they had been placed on medication (41%). However, when the treatment was analysed, in 6 out of 12 cases, it consisted of low doses of either corticosteroids or hydroxychloroquine. Patients with SLE showed reduced rates of initiating breastfeeding. They also showed reduced duration of breastfeeding, and the reason for cessation was frequently cited to be therapies which were actually of low risk. Breastfeeding duration could be optimised by improving the level of information provided to patients.

Objective To assess intercentre variability in the ACR core set measures, DAS28 based on three variables (DAS28v3) and Routine Assessment of Patient Index Data 3 in a multinational study. Methods Seven thousand and twenty-three patients were recruited (84 centres; 30 countries) using a standard protocol in the Quantitative Standard Monitoring of Patients with RA study. Analysis of variance (ANOVA) and mixed-effect analysis of covariance models were used to model the relationship between study centre and different patient-reported and physician-reported RA activity measures. These models were built to adjust for the remaining ACR core set measure (for each ACR core set measure or each composite index), socio-demographics and medical characteristics. ANOVA and analysis of covariance models yielded similar results, and ANOVA tables were used to present variance attributable to recruiting centre. Results The proportion of variances attributable to recruiting centre was lower for patient reported outcomes (PROs: pain, HAQ, patient global) compared with objective measures (joint counts, ESR, physician global) in all models. In the full model, variance in PROs attributable to recruiting centre ranged from 1.53% for patient global to 3.71% for HAQ compared with objective measures that ranged from 5.92% for physician global to 9.25% for ESR; and was lower for Routine Assessment of Patient Index Data 3 (2.6%) compared with DAS28v3 (11.75%). Conclusion Intercentre variability in PROs is lower than objective measures of RA activity demonstrating that PROs may be more comparable across centres, and the need for standardization of objective measures.

Objective: Qualitative capillaroscopy patterns in juvenile- and adult-onset systemic sclerosis (SSc) were studied in adulthood using data from the EULAR Scleroderma Trials and Research (EUSTAR) database. Methods: Data collected between June 2004 and April 2013 were examined with focus on capillaroscopy. In this retrospective exploratory study, series of patients with juvenile-onset SSc were matched with series of adult-onset SSc having the same gender and autoantibody profile. Results: 30 of 123 patients with juvenile-onset and 2108 of 7133 with adult-onset SSc had data on capillaroscopy. Juvenile-onset SSc showed scleroderma pattern more frequently than adult-onset SSc (93.3% and 88%). The OR was 2.44 and 95% Cl 0.57-10.41. An active scleroderma pattern was present in 58% of juvenile- and 61% of adult-onset SSc. The OR was 0.91 and 95% Cl 0.28-2.93. The late scleroderma pattern was present in 61% of juvenile- and 55.5% of adult-onset SSc. The OR was 1.06 and 95% Cl 0.34-3.56. Conclusion: This is the first exploratory study on the comparison of capillaroscopy between juvenile- and adult-onset SSc in adulthood. Juvenile-onset SSc had an increase prevalence of sderoderma pattern, but a similar distribution of the three patterns was suggested. Further studies are needed to define this issue. (C) 2015 Elsevier Inc. All rights reserved.

Background Breastfeeding is the optimal source of nourishment for newborns and infants during their first year of life.Both short and long benefits accrue to mothers who breastfeed (1,2). The clinical condition of patients with systemic lupus erythematosus (SLE) may have an impact on breastfeeding onset and duration. Objectives Assess breastfeeding in patients with SLE. Methods Retrospective case-control study. Patients who had got pregnant after being diagnosed with SLE (4 or more SLICC ACR/EULAR criteria) and whose pregnancies had been followed up in the hospital were interviewed. The control group consisted of patients approached in the waiting-room of the paediatrics service. The data collected included epidemiological information, main features of their pregnancies and newborns, breastfeeding duration, and reasons for weaning. This study was approved by the Bioethics Committee of the Ramos Mejia Hospital, and both patients and controls signed the informed consent form. Results Thirty-six pregnancies in 31 patients with SLE and the same number of controls were studied. The following features were similar in both groups: current age, age at the time of delivery, level of education, average number of children, number of patients that breastfed for the first time, and preterm birth rates. Patients with SLE had planned their pregnancies ahead less frequently than controls (16.7% vs 44.4%, p 0.02), they had experienced a greater number of complications during the pregnancies (33.6% vs 5.6%; p 0.007), and their newborns showed a higher trend to minor complications (25% vs 11.1%; p 0.2). Twenty-five percent of the patients with SLE presented some kind of complication during puerperium, mainly related to disease activity, versus none in the controls (p 0.001). Also, a higher number of patients with SLE did not even initiate breastfeeding (19.4% vs 5.6% in the controls; p 0.07). Breastfeeding average duration in patients with SLE was 6 months (SD 6 months) versus 12 months (SD 8 months) in the controls (Log Rank p: 0.003). Fifty-two percent of the controls mentioned that there had been no reason for weaning and considered that they had nursed their children a suitable amount of time. Conversely, patients with SLE frequently set weaning in motion on the grounds that they had been placed on medication (42%). However, when the medication was analysed, in 6 of 11 cases (55%), it consisted of low doses of corticoids or Hydroxychloroquine. Conclusions In this retrospective case-control study it was observed that patients with SLE show a lower trend to initiate breastfeeding, and they sustain it for less time than controls (6 months vs 12 months respectively). Although the most common reason for weaning is the administration of medication, breastfeeding duration could be optimised by improving the level of information provided to patients. References American Academy of Pediatrics. Section on breastfeeding: policy statement: breastfeeding and the use of human milk. Pediatrics 2012; 129: e827–41. World Health Organization. Breastfeeding health topic. Available at http://www.who.int/topics/breastfeeding/es[accessed on 15 January 2016]. Acknowledgement Prof. Ana Insausti. Disclosure of Interest None declared