Search

Our investigation sought to understand what the family physicians think about the oxidative stress (OS) and its role in various medical pathologies. Using a structured interview the concept was evaluated on six domains: general interest in OS, general knowledge about OS, acceptability of OS concept as a valid explanation of the daily seen pathologies, the perceived role of OS in rheumatic diseases (and also in non-rheumatic), therapeutic options covering this concept. We found a suboptimal knowledge and utilization of OS in practice but an increasing interest in.

Background: No fully validated index is available for assessing overall disease activity in systemic sclerosis (SSc). Objectives: To estimate the effect of disease activity as measured by different disease activity indices on the risk of subsequent organ damage. Methods: The European Systemic sclerosis study group activity index (EScSG AI), the European Scleroderma Trials and Research Group Activity Index (r-EUSTAR AI), 12 point activity index proposed by Minier (12point AI) were calculated for 91 patients; the CRISS (The Composite Response Index for Systemic Sclerosis) for patients included after 2016. Data were analysed by parametric and non-parametric tests and logistic regression. Results: EscSG AI, r-EUSTAR AI and 12point AI correlated with lung involvement. EScSG AI and r-EUSTAR AI correlated with diffuse skin involvement. EscSG AI correlated with digital ulcers and diffuse cutaneous involvement and r-EUSTAR AI with a renal crisis. Bivariate analysis showed an inverse correlation between the three disease activity scores and forced vital capacity (FVC) (p Conclusion: Our study could not establish a gold standard to assess disease activity in SSc; especially EscSG AI and r-EUSTAR AI could quantify and predict major organ involvement in daily practice. CRISS can be useful as an outcome measure for patients with short disease duration included in clinical studies.

Background: This study aims to investigate willingness to pay for a potential vaccine against SARS-CoV-2 / COVID-19 among adult persons in Romania. The study was conducted during the peak period of the pandemic curve in Europe and Romania, too.Methods: An online survey was developed and delivered to Romanian general population by using two of the largest social networking web services (Facebook and LinkedIn). The questionnaire included demographic data, description of the responder’s financial situation and their willingness to pay for a hypothetical anti COVID-19 vaccine. The study was based on the Van Westendorp Price Sensitivity Meter method.Results: A total of 203 adult subjects participated in the survey; 42.4% male and 55,2% members of a family with at least one child. Mean participants’ age was 44.12 ± 8.9 (mean ± SD). The acceptable price range for a vaccine against SARS-CoV-2 / COVID-19 was situated between 20 and 200 EUR. Subgroup analyses revealed similar price range in all groups with the notable exception of those with excellent financial situation who selected a 50 to 400 EUR interval. These results match the existing optional various vaccination schemes offered in the private health care sector: 43.2 ± 32.1 EUR. Conclusions: Despite substantial social impact of SARS-CoV-2, potential patients would pay for a perfect vaccination scheme against COVID-19 a price in the same range with the prices of existing vaccination schemes. Our findings could impact the way a vaccination policy will be developed in this context both in terms of general acceptance of vaccine and personal and social costs.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of autoantibodies, which deposit within tissues and fix complement leading to systemic inflammation (1). Is a heterogeneous disease with a continuum of disease activity. Some patients can have predominant skin and joint involvement, whereas others can present with organ-threatening diseases such as nephritis, cardiac involvement or even neurologic manifestations. Relatives of patients with SLE appear to be at higher risk of SLE and other autoimmune diseases, but estimates of individual familial risks are largely unavailable or unreliable (2,3).

B cell hyper-reactivity implied in the pathogenesis of Sjö gren’s syndrome (SS) justifies the therapy that involves B cell depletion. Ultrasound of salivary glands demonstrated alterations during disease progression. Objective. To evaluate changes in salivary gland parenchyma with ultrasound after rituximab treatment in patients’ with secondary SS (sSS). Methods. 7 patients evaluated at baseline (under treatment with rituximab) and after 6 months, underwent ultrasonography of major salivary gland (submandibular and parotid). Clinical data as dryness, pain and diseases activity evaluated with ESSDAI were registered. Salivary gland ultrasound (SGUS) was performed to asses echogenity (using a semiquantitative score from 0-4, with improvement defined as an at least 1 point decrease), size of gland and glandular borders. Results. Of 7 patients, 14% had clinically detectable bilateral parotid tumefaction at baseline. 6 patients (85.71%) showed ultrasonographic alterations at baseline. Parotid parenchyma echostructure improved in 42.85% of patients versus 14.28% in control group (p=0.05). At the submandibular glands, both submandibular glands showed changes in 28.57% of patients, while control group showed no changes. 42.85% patients showed parotid tumefaction which changed in 66.6% of patients at 6 months. Conclusion. Ultrasonography showed improvement in salivary gland echostructure in secondary Sjogren Syndrome with rituximab.

Autoimmune rheumatic disorders have a multifactorial determinism, caused by various environmental factors acting on the individual’s genetic susceptibility, destabilizing the systems which regulate the immune response. Epidemiological and genetic investigations are very important to demonstrate the contribution of genetic factors to the development of these autoimmune diseases. The contribution of genetic factors in causing autoimmune diseases has been demonstrated by familial aggregation. Moreover, it was also quantified by determining heritability, expressing the proportion of genetic factors in the etiology. It is now clear that common genes underlie multiple autoimmune disorders.

Background Currently there is no fully validated index for assessing overall disease activity in patients with systemic sclerosis (SSc). Objectives To estimate the effect of disease activity as measured by 4 disease activity indices on the risk of subsequent organ damage in a EUSTAR center cohort. Methods Longitudinal observational study; European Systemic sclerosis study group disease activity index (EScSG DAI), revised EUSTAR disease activity index (r-EUSTAR DAI), 12 point activity index proposed by Minier (12point DAI) were calculated for all patients; the CRISS (The Combined Response Index for Systemic Sclerosis) only for patients included after 2016. Student t-test/Mann-Whitney test, chi-square test were used to evaluate differences across subgroups; Pearson’s bivariate correlation/Spearman’s rank correlation coefficient to evaluate the association between variables. The predictive value of various variables for major organ involvement was assessed by Roc curves and univariate regression. Results 91 patients were selected,77 females (84,61%), 51,65(13,20) years old at diagnosis, 49,45% diffuse subset. Disease activity scores were all higher in male patients and in patients with diffuse cutaneous involvement, digital ulcers(DU), lung fibrosis, scleroderma renal crisis (SRC), arrythmias, muscle atrophy, gastric involvement, antitopoisomerase-1 positive, EscSG DAI correlated with forced vital capacity (FVC)(r=0.73,p R- EUSTAR DAI correlated with FVC(r=0.6,p 12 point DAI correlated with FVC(r=0.57,p EscSG predicted well lung fibrosis (AUC=0.79,p 12point DAI was a good predictor for lung fibrosis(AUC=0.74,p In the regression analysis, lung fibrosis(beta=0.5,95%CI=1,21-2,58,p The CRISS cohort included 35 patients, 32 females(91,42%), 48.48(14.24) years old, 62.85% diffuse subset, medium disease duration 11.88(7.9) months. 8 patients were excluded due to new onset or worsening of lung fibrosis or SRC. None of the patients had a CRISS score with a probability of improvement>0.6. Conclusion We could not conclude that there is a gold standard to measure disease activity; for daily practice especially EscSG and r-EUSTAR DAI quantify and predict major organ involvement. CRISS can be useful as an outcome measure for patients with short disease duration and closely monitored in clinical studies. References [1] K. Melsens, et al. Disease activity indices in systemic sclerosis: a systematic literature review Clin Exp Rheumatol2016; 34 (Suppl. 100):S186-S192. Disclosure of Interests Laura Groseanu: None declared, Sorana Petrescu: None declared, Andra Balanescu Speakers bureau: multiple, Daniela Opris-Belinski Grant/research support from: GLORIA, Speakers bureau: multiple, Violeta Bojinca Speakers bureau: multiple, Florian Berghea: None declared, Ioana Saulescu: None declared, Sanziana Daia-Iliescu: None declared, Diana Mazilu Speakers bureau: Pfizer, UCB, Andreea Borangiu: None declared, Cosmin Constantinescu: None declared, Maria Magdalena Negru: None declared, Mihai Abobului: None declared, Violeta Vlad: None declared, Ruxandra Ionescu: None declared

Background: The usefulness of capillaroscopy in the follow-up of scleroderma (SSc) patients and the possible prognostic role for the appearance of visceral involvement is suggested by many authors but still under debate. Objectives: The aim of this study was to assess the role of monitoring capillaroscopic abnormalities (qualitative and semiquantitative) in relation with parameters of interstitial lung involvement and pulmonary arterial hypertension(PAH). Methods: Longitudinal prospective study, 118 SSc patients, follow-up 2000-2017 based on MEDS evaluation sheets. Student t-test/Mann-Whitney test, chi-square test were used to evaluate differences across subgroups. Pearson’s bivariate correlation/Spearman’s rank correlation coefficient were used to evaluate the association between variables. Nailfold videocapillaroscopy (NVC) was performed by a trained physician: qualitative (scleroderma pattern) and semiquantitative scoring (microangiopathy evolution score-MES) were evaluated. Results: 118 patients were included, 103 females (87,29%), 50,58(12,71) years old at diagnosis, 53.39% diffuse subset, mean disease duration 2,81(4.3) years, mean follow-up duration 4.42(3.16)years. At baseline 43.22% of the patients had lung fibrosis,18.64% had PAH, 9,32% had both. At first capillaroscopic evaluation: 12.7% had early, 46.61% active and 37.29% late pattern, medium MES was 4,76(1.43). Baseline active and late capillaroscopic pattern were correlated with lung fibrosis (χ2=9.62, p=0.047) and PAH (χ2=15,36, p=0.004). A strong correlation was identified between initial MES and FVC (r=-.47, p=0.002), FEV(r=-.45, p=0.003), DLCO (r=-.51, p At the 2nd evaluation 5.93% of the patients had early, 0.85% active and 54,24% late scleroderma pattern, mean MES was 5.88(1.74). 19.49% had one step progression of capillaroscopic pattern, 1.69% had 2 steps progression. Lung involvement worsening was defined as decrease of FVC >15%, DLCO>10%, new diagnosis of alveolitis on high resolution computerized tomography or new diagnosis of PAH. Active and late capillaroscopic pattern were correlated with diagnosis of lung fibrosis (χ2=14, p=0.007) and pulmonary hypertension at follow-up examinations (χ2=14,2, p=0.007). Progression of capillaroscopic pattern at follow-up evaluations was not correlated with significant worsening of lung volumes, DLCO, sPAP. Instead, progression of MES (>1) was asociated with worsening of FVC (r=0.32,p Conclusion: Active and late capillaroscopic pattern are associated with increased frequency of interstitial lung disease and pulmonary hypertension in SSc patients. Semiquantitative scoring (microangiopathy evolution score), rather then qualitative capillaroscopic assessment can have a predictive role for new involvement or worsening of previous lung involvement (especially interstitial lung disease) in scleroderma patients, confirming the putative role of capillaroscopy as biomarker in SSc. References [1] Sulli a How to Score the Qualitative Capillaroscopic Patterns in Systemic Sclerosis annals of the Rheumatic Diseases 2013;72:A11 Disclosure of interests: Laura Groseanu: None declared, Patricia Paraschiva: None declared, andra Balanescu Speakers bureau: multiple, Violeta Bojinca Speakers bureau: multiple, Daniela Opris-Belinski Grant/research support from: GLORIA, Speakers bureau: multiple, Florian Berghea: None declared, Diana Mazilu Speakers bureau: Pfizer, UCB, Sanziana Daia-Iliescu: None declared, Ioana Saulescu: None declared, andreea Borangiu: None declared, CLAUDIA COBILINSCHI: None declared, Maria Magdalena Negru: None declared, cosmin-laurentiu constantinescu: None declared, Violeta Vlad: None declared, Mihai abobului: None declared, Ruxandra Ionescu: None declared

Background:The term elderly onset of rheumatoid arthritis (EORA) refers to patients with rheumatoid arthritis (RA) onset after the age of 60. Data published in the literature suggest a special clinical pattern and different prognostic factors in this class of patients.Objectives:To analyze prospectively a cohort of patients diagnosed with EORA, their disease particularities, comorbidities and treatment.Methods:This cohort included consecutive EORA patients, diagnosed and treated in “Sfanta Maria” Clinical Hospital, Bucharest, Romania. The study was conducted for 2 years. Demographic, clinical and laboratory data was obtained. Disease activity was assessed using Disease Activity Score of 28 joints with erythrocyte sedimentation rate (DAS28-ESR). The patients were monitored using disease activity, treatment schedule modifications and possible adverse reactions.Results:The cohort included 110 patients (88 females, 22 males). Their mean age at the beginning of disease manifestations was 70.14 years and the mean age at the diagnosis was 70.85 years. There was no statistical difference regarding the patient’s residential area (urban/rural) and the period between the appearance of clinical signs and the moment of diagnosis confirmation. A great proportion of patients (77 patients, 70%) had seropositive RA, ACPA being found in 84% of the patients with seropositive RA. The mean DAS28-ESR at the diagnosis was 4.44(±1.54). A proportion of 40% of the patients had moderate disease activity, 35 patients (32.73%) - high disease activity, 11 patients (10%) - low disease activity and unexpectedly there were 19 patients (17.27%) in remission at the moment of RA diagnosis. Joint distribution was analyzed: 61.82% patients had large joint involvement, 91.82% - small joint involvement and 53.64 % had mixed joint pattern involvement. A negative significant correlation was found between the small joint involvement pattern and the body mass index (BMI) (p=0.028, R=-0.21). The mean BMI at the diagnosis was 25.81±5.358. Ninety five patients (86,36%) had at least one cardiovascular comorbidity. Hypertension was found in 70% of the patients. Only 4.55% of the patients had rheumatoid nodules and a similar proportion (4.55) had Sjogren syndrome associated. Pulmonary fibrosis was found in only 2 patients. At the moment of diagnosis 50% of patients had anemia, 36.36% had osteoporosis, 25.46% of the patients - hepatic disease, 11.82% - chronic kidney failure and 6.36% were found with a neoplasia. The main conventional synthetic disease modifying drug (csDMARD) that was recommended was methotrexate (81.8%). The second most used csDMARD was hydroxichroloquine (42 patients, 38,18%). The proportion of patients with monotherapy (50%) was similar to that with csDMARD combination (49.09%). During the follow up period only 8 patients (7.27%) had biologic therapy (4 patients - an anti TNF drug). Non steroid anti-inflammatory drugs were used in 46.63%. Cortisone therapy was used for more than 3 months in 80% of the patients. In patients with biologic therapy chronic glucocorticoids were stopped. At least one infection was documented in 20.91% of patients: 2 patients out of 6 patients (33.33%) with biologic DMARD, 14.81% of the patients with csDMARD combination and 21.81% of the patients with csDMARD monotherapy. csDMARD therapy was well tolerated with only 23.63% adverse reactions.Conclusion:Compared to the data published in the literature, in our cohort the rate female:male was higher (4:1). A distinct feature was the high proportion of patients with seropositive RA. The joint pattern seems to be influenced by BMI: small joint pattern is less found in patients with higher BMI. As expected, the patients with EORA had multiple cardiovascular comorbidities. Arterial hypertension was the most frequent. Caution is needed in choosing treatment regarding comorbidities and the risk of infection in these patients.References:[1]Villa-Blanco JI, Calvo-Alén J. Elderly onset rheumatoid arthritis: differential diagnosis and choice of first-line and subsequent therapy. Drugs Aging. 2009;26(9):739-50.Disclosure of Interests:None declared

Background:Two pivotal studies, RAPIDS-1 and RAPIDS-2 revealed that bosentan reduces the development of new digital ulcers (DUs) in patients with systemic sclerosis (SSc). However data regarding the long-term use of this dual endothelin antagonist receptor in the treatment of DUs is scarce.Objectives:The aim of the present study was to evaluate long term efficacy and safety profile of bosentan in patients with DUs related to SSc.Methods:A prospective observational case-control study, conducted between 2014 and 2020 enrolled 65 SSc patients with ≥1 active DUs at baseline, who received bosentan therapy. Demographic and clinical features, including DUs incidence and patients subjective perception of DU pain and/or Raynaud’s Phenomenon, were collected. Nailfold videocapillaroscopy was performed in all patients.Results:The study included 51 females and 14 males, with a mean age of 52.6 years, 30 with diffuse subset, most of them with late scleroderma pattern (46/65). Number of DUs at baseline was 4.55 (±2.8), median duration of treatment was 25.95 (±19.4) months. Microangiopathy evolution score (MES) was 5.1 (2.19), visual analog scale (VAS) for DU was 77.9, VAS for Raynaud was 73.4.Patients receiving bosentan had clinically significant reduction in the mean number of DU (pThere was a clear trend towards an improvement in MES score, between baseline and the next follow-up assessments (p=0.003). The difference was statistically significant when compared to control group, but only for the first 18 months of treatment (p14 patients (28.75%) discontinued bosentan therapy for administrative reasons. The median time among patients who interrupted the treatment was 6.9 months. An accelerated development of new DU was described 6 months after (p=0.02). Following recommencement of bosentan, the mean number of DU has rapidly decreased (p=0.008). There was no significant difference between patients who temporarily discontinued bosentan for 6 or 12 months.Bosentan was stopped due to lack of efficacy in 2 cases and due to side effects in 7 cases: 4 elevated liver enzymes, 1 severe trombocytopenia, 1 dyspneea agravation and low blood pressure.Conclusion:The present data suggest that treatment with endothelin receptor antagonist bosentan was associated with a significant reduction in the mean number of DU in patients with SSc. The beneficial effect of bosentan persisted throughout the study but was most evident in the first 6 months of treatment. Statistical analysis showed a significant improvement of the microangiopathy evolution score from baseline to end of therapy. 14 patients had a high relapse rate due to potential rebound effect, 6 months after bosentan withdrawal.The drug was reintroduced succesfully for 10 (70%) patients with a significant decrease in the number of DU.References:[1]UK Scleroderma Study Group: digital vasculopathy in systemic sclerosis, Rheumatology, Volume 54, Issue 11, November 2015, Pages 2015[2]Groseanu L, Berghea F, Bojinca V, et al AB0779 Long term follow-up of a systemic sclerosis group treated with bosentan, Annals of the Rheumatic Diseases 2018;77:1523-1524.Disclosure of Interests:None declared

Background:Systemic sclerosis is associated with increased risk of cardiovascular disease (CVD) (1) and studies using MRI suggest that microvascular disease has an important role (2). Capillaroscopy is a non invasive and safe technique that assesses peripheral microvascular damage (3).Objectives:The objective of this study was to evaluate the predictive value of the capillaroscopy in relation to major adverse cardiovascular events (MACE).Methods:Retrospective study with three timepoints (at baseline, at 5 and 10 years) including patients with scleroderma from EUSTAR center 096. Data were collected from the registry and observation papers. We performed capillaroscopy to all patients at the time of inclusion in the EUSTAR registry (2004) and at baseline (2009). Also, CV risk scores were calculated at baseline and were reassessed at 5 and at 10 years using the SCORE calculator. Risk score was considered low if was between 0 and 2, moderate 3-9 and high >10. The relation between capillaroscopy and MACE was tested in using bivariate regression.Results:Of 22 patients, mean (standard deviation (SD)) age was 43.1 (11.5), all patients were females, mean (SD) disease duration was 5.4 (4.5). During the 10 years of follow up, 5 (22.7) patients had been lost of follow up and 8 (36.4) patients had died. Only 9 (40.9) patients completed the 10 year follow up.At the time of inclusion in the EUSTAR, one patient showed early scleroderma pattern at capilaroscopy, 15 had active pattern and 6 patients had late pattern. Capillaroscopic scoring showed 2 (9.1) patients with disarranged (50%) aspect, 4 (18.2) patients with local paucity, 10 (45.5) patients with enlarged loop bordering local paucity and 1 patient (4.5) with complete paucity.Capilaroscopy at baseline showed active pattern in 4 patients and late pattern in 18 patients. Thus, 13 (59.1) of patients had a progression of the disease at capilaroscopy before follow up.At baseline, 14 (63.6) patients had traditional CV risk factors. Cardiovascular risk scores found 21 (95.5) patients with a low risk score and 1 (4.5) patient with a moderate risk score. At 5 years 11 (0.5) patients had a low risk score and 1 (4.5) patient had moderate risk score and at 10 years, 5 (22.7) and 2 (9) patients had low and moderate risk scores, respectively. We found 6.2 MACE/100 patient-year and 5.5 deaths/100 patient-year.Capillaroscopy (p=0.684), disease progression on capillaroscopy (p=0.781), capillaroscopic scoring (p=0.92) and CV risk score (p=0.98) were not predictive factors of MACE.Conclusion:Patients with systemic sclerosis are at high risk of MACE and traditional CV risk scores underestimate this risk. Changes/progression on capilaroscopy is not predictive for MACE. However, this hypothesis needs to be tested on a bigger cohort.References:[1]Xintao Cen, SIning Feng, Shanshan Wei, Lu Wan, Ledong Sun, Systemic sclerosis and risk of cardiovascular disease: A PRISMA – compliant systemic review and meta-analysis of cohort studies, Medicine (Baltimore), 2020, 99(47)[2]N Galea, E Rosato, A Gigante, C Borrazzo, A Fiorelli et al, Early myocardial damage and microvascular dysfunction in asymptomativ patients with systemic sclerosis: A cardiovascular magnetic resonance study with cold pressor test, PLoS One 2020, 15 (12)[3]F Ingegnoli, R Gualtierotti, A systematic overview on the use and relevance of capillaroscopy in systemic sclerosis, Expert Rev CLin Ummunol, 2013, 9(11):1091-7Disclosure of Interests:None declared

Background:Certainly, the year 2020 changed the healthcare system due to SARS-CoV2 pandemic that affected globally, more than 100 million people, causing more than 2 million of deaths worldwide. The evidence of how this infection impact patients with rheumatic and musculoskeletal diseases treated with disease modifying anti-rheumatic drugs is still an unmet need.Objectives:The main focus of this study is to evaluate the influence of DMARDs therapy on the evolution of COVID-19 disease in patients with RMDs. The second objective is to study and find correlations between the severity of infection in patients with rheumatic diseases.Methods:A retrospective observational study was conducted between June 2020 and January 2021, enrolling 81 patients with rheumatic diseases that went through SARS-CoV2 infection. The data was collected using patients’ clinical documents and through telemedicine, in accordance with EULAR COVID-19 Rheumatological Database.Results:Among the 81 patients, 53 (65,43%) were females and 28 (34,56%) were males. The mean age was 47,9 years old (49,49 years old for females and 45,25 years old for males). The majority lives in urban areas – 62 patients (76,54%).The temporal trends of COVID-19 observed in this cohort was in consonance with the evolution of the pandemic in Romania: one third of cases were recorded between June and October 2020 and two-thirds between November 2020 and January 2021, when the number of COVID-19 cases tripled in the general population.Surprisingly, more than 27% of patients in this study were asymptomatic at the time of COVID-19 diagnosis. They were tested according to the protocol before admission to the hospital. 9,8% of patients also asymptomatic, were tested positive as a screening before leaving the country. The majority (45,6%) were symptomatic or contact with someone infected with SARS-CoV2-and tested positive with RT-PCR.We divided the cohort in 3 groups: patients with mild infection that required no hospitalization (22 patients counting for 27,16%), moderate infection – hospitalization but not in the Intensive Care Unit (52 patients – 64,19%) and severe infection – admission to the ICU/deaths (7 patients in the ICU, 4 deaths – 4,9%).Mild and moderate COVID 19 disease was identified in patients with axial spondyloarthtis (56,7%), with remission or with low disease activity, with a few or no comorbidities, with a mean age of 47,56 years old and also in patients in treatment with MTX (14,86%) or TNF alfa inhibitors (35,13%). 51% of patients stopped the therapy during COVID19 diseases.Factors correlated with severe infection and death were age (the mean age was 62,14), high and moderate disease activity RA, overlap syndromes (RA with SLE or Sjogren Syndrome) and important cardiovascular comorbidities. Two of the deceased patients were in treatment with MTX and RTX (the last infusion was more than 6 months).Conclusion:The data in our study suggests that the use of cs DMARDs (MTX) and TNF alfa inhibitors is associated with better outcomes for patients with RMDs and COVID-19. These results are in accordance with the data found in literature [1,2,3]. The limitation of this study is the little number of patients and the fact that the real number of COVID-19 cases might be higher in reality due to asymptomatic or pauci-symptomatic patients.References:[1]Filière des Maladies Autoimmunes et Autoinflammatoires Rares (FAI2R); Hôpital Huriez, CHU Lille, Univ. Lille, Lille, France, Severity of COVID-19 and survival in patients with rheumatic and inflammatory diseases: data from the French RMD COVID-19 cohort of 694 patients, Annals of the Rheumatic Diseases Published Online First: 02 December 2020[2]Sanchez-Piedra C et al., On behalf of the BIOBADASER study group, et al, Clinical features and outcomes of COVID-19 in patients with rheumatic diseases treated with biological and synthetic targeted therapies,Annals of the Rheumatic Diseases 2020;79:988-990.[3]Hyrich, K.L et al. Rheumatic disease and COVID-19: epidemiology and outcomes. Nat Rev Rheumatol 17, 71–72 (2021)Disclosure of Interests:None declared

Background:The low overall prevalence of systemic sclerosis (SSc) and the low proportion of male patients have resulted in a scarcity of studies assessing sex differences in SSc patients, and contradictory results have often been observed.Objectives:The aim of the study was to assess differences in disease manifestations in a cohort of SSc patients according to gender.Methods:We performed a retrospective observational study using data extract from the EULAR scleroderma trials and research (EUSTAR) cohort 096.We looked at sex influence on disease characteristics at baseline and then focused on patients with at least 2 years of follow-up to estimate the effects of sex on disease progression and survival.Results:173 patients with SSc were available for the baseline analyses. Males were older (52,96 vs 45,88, p=0.009), were more likely to smoke (73% vs 7%, pIn the longitudinal analysis after a mean follow-up of 3,5(±0,65) years, male sex was associated with a higher risk of scleroderma renal crisis (OR:9.45 (1.49 to 59.69); p=0.004), digital contractures (OR:8,2 (3,1 to 21,9); pConclusion:Although more common in women, SSc appears as strikingly more severe in men. Our results demonstrate a higher risk of severe organ involvement and poor prognosis in men. These results raise the point of including sex in the management and the decision-making process.Disclosure of Interests:None declared

Background:The low overall prevalence of systemic sclerosis (SSc) and the low proportion of male patients have resulted in a scarcity of studies assessing sex differences in SSc patients, and contradictory results.Objectives:To evaluated sex influence on disease characteristics at baseline and then to estimate the effects of sex on disease progression and survival.Methods:We performed a retrospective observational study using data extract from the EULAR scleroderma trials and research (EUSTAR) cohort 096. 173 patients were analysed (26 males).The severity of organ system involvement was defined as described previously (1).Results:Males were significantly older at symptom onset (p=0.007) and at first center visit (p=0.009). There were no differences regarding disease duration at first visit or the interval between the onset of Raynaud syndrome and other non-Raynaud manifestations (p=0.06). Male patients were significantly more likely to have ever smoked (pIn multivariate analysis, male sex was independently associated with a higher risk of diffuse cutaneous subtype (OR: 1.56, (1.35 to 1.84); pConclusion:In essence, the disease prophyle in females is that of younger age of onset, longer disease duration at first center visit, less severe peripheral vascular involvement, the most frequent cause of death being PAH. In contrast, males are older at onset, present earlier in their disease, have dcSSc, more severe peripheral vascular disease, higher mRSS, more frequent and severe ILD, more frequent heart involvement, higher risk of PAH and SRC, the most common cause of death being ILD. These results raise the point of including sex in the management and the decision-making process.References:[1]Peoples C, Medsger TA Jr, Lucas M et al Gender differences in systemic sclerosis: relationship to clinical features, serologic status and outcomes.J Scleroderma Relat Disord. 2016;1(2):177–240Disclosure of Interests:Laura Groseanu Speakers bureau: novartis, eli-lilly, ucb, pfizer,sandoz, Andra Balanescu Consultant of: pfizer, Speakers bureau: Abbvie, Eli-Lilly, Novartis, Pfizer, Roche, Sandoz, UCB, Violeta Bojinca Speakers bureau: Eli-Lilly, Novartis, Pfizer, Daniela Opris-Belinski Speakers bureau: Abbvie, Eli-Lilly, Novartis, Pfizer, Roche, Ioana Saulescu Speakers bureau: Eli-Lilly, Pfizer, Diana Mazilu: None declared, Sanziana Daia-Iliescu Speakers bureau: sandoz, Andreea Borangiu: None declared, Florian Berghea Paid instructor for: abbvie, Speakers bureau: gideon richter, egis, novartis,ucb, cosmin-laurentiu constantinescu: None declared, CLAUDIA COBILINSCHI Speakers bureau: novartis, Maria Magdalena Negru: None declared, mihai abobului Speakers bureau: gideon richter, Ruxandra Ionescu Consultant of: Consulting fees from Abbvie, Eli-Lilly, Novartis, Pfizer, Roche, Sandoz, Speakers bureau: Consulting and speaker fees from Abbvie, Eli-Lilly, Novartis, Pfizer, Roche, Sandoz

Background Prospective studies with Bosentan have shown short term efficacy, while it is not clear whether long-term treatment may be effective or whether ulcers may recur once treatment is discontinued. Objectives Our objective was to evaluate the long term efficacy and tolerability of bosentan in patients with systemic sclerosis (SSc) who develop digital ulcers (DU). Methods In the present prospective, observational, non-controlled study, we followed 26 SSc patients treated with Bosentan from Sept 2014 to Dec 2017 Number of DU, semiquantitative capillaroscopic scoring, VAS (visual analoque scale) for Raynaud, VAS for DU and HAQ were evaluated every 6 month. Results are presented as mean(sd). The difference between efficacy measures at follow-up visits was tested with the Wilcoxon’s signed-rank test. Results The group included 26 patients, 16 females, 11 diffuse subsets, age was 48.08 (9.8) years, disease duration was 84.35 (76.04) months, number of DU was 4.27 (3.71), most of them had a late scleroderma pattern pattern (16/26). Microangiopathy evolution score was 5.19 (2.04), VAS for DU was 75.52 (16.17), VAS for Raynaud was 67,43 (14.16), HAQ was 1.62 (0.55). 5 patients received Bosentan less then 6 month, so they were excluded from the statistical analysis. 6 month evaluation revelead significant decrease in the number of DU (p Regarding Bosentan safety: 6 patients died during the follow up (3 cases of severe pulmonary arterial hypertension, 1 scleroderma renal crisis, 1 heart failure, 1 post vascular surgery). Bosentan was stopped due to lack of efficacy in 2 case and due to side effects in 3 cases: 2 elevated liver enzymes, 1 severe trombocytopenia and 1 dyspneea agravation. 12 patients had a follow up after a 6 months Bosentan stop. We did not notice any significant increase in the number of DU, the VAS for DU or Raynaud, the capillaroscopic semiquantitative scoring or the HAQ. Conclusions We noted a significant decrease in the number of DU, patients perception of Raynaud and of DU after 6 months of treatment and the effect was maintained in the 3 years follow-up, even 6 months after Bosentan was stopped. In this long-term follow-up no new unidentified adverse reactions were found, except for the unexpected severe thrombocytopenia. The present study is limited due to the small sample size, to the observational nature and should be viewed as descriptive. Questions rise about drug costs (6 months or long term treatment), but it also has to be emphasised that most of these lesions were chronic and nonresponsive to previous treatments. References [1] Matucci-Cerinic M, et al.Bosentan treatment of digital ulcers related to systemic sclerosis: results from the RAPIDS-2 randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2011;70(1):32–8 2] P. Garcia de la Pena-Lefebvre, et al. Long-term experience of bosentan for treating ulcers and healed ulcers in systemic sclerosis patients. Rheumatology (Oxford). 2008;47(4):464–6. Disclosure of Interest None declared

Background While macrovascular disease and higher cardiovascular (CV) risk are well documented in other systemic rheumatic diseases, the risk for major cardiovascular events for patients with systemic sclerosis (SSc) is yet to be established. Objectives The aim of the study was to determine the ability of different cardiovascular risk indices to predict major cardiovascular events (MACE) in systemic sclerosis. Methods The study included 144 patients followed in EUSTAR centre 096, but only patients with a follow-up for more then 10 years were selected for statistical analyses. Cardiovascular risk was estimated using QRiskII, systemic coronary risk evaluation (SCORE) and ACC/AHA risk indices. MACE were defined as: myocardial infarctions, strokes, peripheral vascular disease and cardiovascular related death. Data were compared by non-parametric tests. Results 32 patients, 31 females, 12 diffuse SSc subsets were included. The control group included 30 age and sex matched patients without autoimmune diseases. Mean age of the group was 52 years±SD 9.7, mean disease duration was 8 years±SD 9. The prevalence of traditional risk factors was: 13% smokers, significant family history 38%, obesity 16%, dyslipidemia 32%, older age 13%, hypertension 16%. There were no significant differences from the control group. Major cardiovascular events were: 13% myocardial infarction, 9% peripheral vascular disease, 9% CV related deaths. Concerning CV risk indices of the 32 SSc patients, 4 (13%) were classified as having high CV risk according to QRiskII/SCORE/ ACC risk.. In SSc patients, we could not identify any correlation between the above mentioned risk indices and MACE, including death of cardiovascular causes, except for a slight correlation between the SCORE and cardiovascular related death (p=0.04). Conclusions In our study, the main prediction indices were not correlated with the 10 year risk for CV events in SSc patients suggesting that we need better risk prediction tools. Both traditional risk factors and endothelial dysfunction have been proposed to participate at the onset and progression of vascular disease in SSc. Special attention should be paid to correct the traditional risk factors in combination with specific treatment for SSc. References [1] Psarras A, Soulaidopoulos S, Garyfallos A, Kitas G, Dimitroulas T A critical view on cardiovascular risk in systemic sclerosis. Rheumatol Int2017;37(1):85–95. [2] Groseanu L, Bojinca V, Gudu T, Saulescu I, Predeteanu D, Balanescu A, et al. Low vitamin D status in systemic sclerosis and the impact on disease phenotype Eur J Rheumatol2016;3(2):50–55. Disclosure of Interest None declared

Aims: Doppler ultrasonography assessment is mandatory nowadays for the complete description of rheumatic disease activity. Initially it was performed in semi quantitative way but recently the (fully) quantitative assessment is gaining more interest. In quantitative assessment, the ratio between total colorized and total pixels (CTR) is computed for the whole image or just for the region of interest (ROI). The frame with the highest amount of Doppler signal (also called worst case scenario image – WCSI) is usually the only one analyzed. The technique requires a very precise identification of WCSI from a certain number of consecutive frames, captured from the same position of the US probe, (and in most cases this is done manually). Our study examined the ability of both experienced and in-training sonographers to identify WCSI using a computerized analytical system as the gold standard.Materials and methods: The study analyzed 480 frame selections done in two distinct exercises. The WCSI and other 3 images with a 5%, 10% and respectively 20% lower level of CTR compared with WCSI were packed in one selection. All frames emerging from the same video clip were randomly presented to six experienced and six in training sonographers; the request was to select the frame with the highest CTR (WCSI) from each package (twenty packages in total). A similar exercise was performed with CTRs decreasing in steps of 2%.Results: In the first exercise the WCSI was correctly identified in 79.1% cases and in 67% of cases in the 2nd exercise. The interobserver agreement between experienced and in-trainer evaluators for the 1st exercise was 0.78 and 0.4 in the 2nd exercise.Conclusion: Using computerized analysis as the gold standard, we demonstrated a large heterogeneity across sonographers regarding their ability to identify the best Doppler image even from a small group of frames.

Background Proper diagnosis of scleroderma is often long and difficult, since it is such a rare disease, and one which few doctors or patients are familiar with. Objectives To establish the interval between the symptoms9 onset of systemic sclerosis (SSc) and what type of investigations are performed until the patients reach the final diagnosis of a rheumatologist Methods This is a cross-sectional study that included randomly selected patients with a a diagnosis of SSc which were evaluated based on a questionnaire about symptoms at onset, specific consults and investigations. Descriptive statistics were used. Results The study group included 47 patients, of which only 5 were males and 17 from rural areas.The medium age was 53 (14.4) years. First symptom of onset was Raynaud phenomena 91.3% of the cases, followed by skin changes (56.5%), puffy fingers (52,2%), gastrointestinal and musculoarticular symptoms (23.9% each). The medium duration between the first symptom and a medical consult was 6 (63.5) months. The first medical consult was done by a internal medicine specialist -38.3%, by a rheumatologist-29.8%, a gastroenterologist-12.8%, a dermatologist-8.5%, a nephrologist and a pneumologist-4.2% and neurologist 2.1% The first suspected diagnosis was SSc in 14 cases, Raynaud syndrome in 8, connective tissue disease in 5, rheumatoid arthritis in 4, cancer, autoimmune hepatitis, idiopathic pulmonary fibrosis each in 2 cases and none in 10 cases. The medium number of consults until final diagnosis was 3.4 (1.7). The medium duration from the first symptom until the correct diagnosis was 39.2 (74) months. The first investigations recommended were blood tests in almost all of the patients (95.7%), but only a third of them included specific scleroderma autoantibodies. Capillaroscopy was performed as an initial diagnostic test in only 6 patients (12.8%). The mean interval from disease onset until the patient was referred to the first capillaroscopy was 13.5 (28.8) months, to specific autoantibodies was 40.17 (61.3) month, to echocardiography was 36.38 (54) months, to lung function tests and lung CT – 41.76 (65.8) months. There were no significant statistical differences between patients coming from rural environment and those coming from urban environment. The only significant statistical difference between diffuse and limited subset was the time the patient was referred to echocardiography (19.8 (47.6) months for the diffuse subset, 66.8 (94.6) months for the limited subset, p=0.04). The only statistical difference between males and females was related to the interval that capillaroscopy was performed (14 (20.5)months in females, 4.8 (5) months in males, p=0.02). Conclusions Scleroderma is a less well-known disease. This lack of awareness contributes to delayed diagnosis and delayed onset of therapy. Often such diagnostic uncertainty and frustration takes a huge toll on the psychological well-being of these patients, who describe their journey to diagnosis as being one of the most difficult part of their illness. One of our missions as rheumatologist is to increase recognition of this disorder. References https://www.sclero.org/scleroderma/diagnosis/difficult. Disclosure of Interest None declared

Background Psoriatic arthritis (PsA) is associated with important comorbidities: cardiovascular, gastro-intestinal, infectious, malignant, and psychiatric [1, 2]. However, they are less studied in PsA compared to other chronic inflammatory arthritis. Objectives The objective of this study was to calculate the prevalence of comorbidities and risk factors in a cohort of PsA patients. Methods This was an observational cross-sectional study, including consecutive, unselected adult patients, with a diagnosis of PsA according to their rheumatologist. Data collected: demographical, clinical (affected joints, current psoriasis, axial involvement, enthesitis, dactylitis), biological (acute phase reactants), and treatment related (nonsteroidal anti-inflammatory drugs, synthetic remissive drugs and biologics). Data on comorbidities and risk factors were collected according to the European League Against Rheumatism (EULAR) recommendations on reporting comorbidities in chronic inflammatory rheumatic diseases in daily practice [3]. Results In all, 129 PsA patients were included: 77 (59.7%) women, mean age ± standard deviation 53.5±11.8 years, disease duration 7±7.4 years; 53 (41.1%) had axial involvement, 33 (25.6%) dactylitis, 18 (14%) enthesitis, and 24 (18.6%) current moderate/severe psoriasis. Most of them had low or moderate disease activity and almost a quarter of them (32; 24.8%) were taking a biologic. The most prevalent comorbidities were: dyslipidaemia 103 patients (79.8%), hypertension 67 (51.9%), obesity 44 (34.1%), diabetes 21 (16.3%) and ischemic heart disease 15 (11.6%). Almost a third of patients (42, 32.6%) suffered a cardiovascular event after their PsA diagnosis, of which heart attack 2 patients, stroke 4, cardiac failure 4 and peripheral arterial disease one patient. Cardiovascular events correlated with smoking (r=0.893, p Regarding infectious comorbidities: 11 patients (8.5%) had a history of tuberculosis after being diagnosed with PsA, 7 (5.4%) chronic viral hepatitis, of which 4 with B virus and 3 with C virus, and 5 patients (3.9%) developed severe infections. Five patients (3.9%) were diagnosed with neoplasia, but no correlation was identified with any of the clinical, biological or treatment related included variables. Only 11 patients (8.5%) were diagnosed with depression, but the prevalence is probably underestimated, since not all patients were screened to this end. Conclusions PsA is associated with a high prevalence of comorbidities, especially cardiovascular diseases. This should be taken into consideration in the therapeutic and the global management of PsA patients. References Husni ME, Mease PJ. Managing comorbid disease in patients with psoriatic arthritis. Curr Rheumatol Rep 2010;12(4):281–7. Ogdie A, Yu Y, Haynes K, et al. Risk of major cardiovascular events in patients with psoriatic arthritis, psoriasis and rheumatoid arthritis: apopulation-based cohort study. Ann Rheum Dis 2015;74(2):326–32. Baillet A, Gossec L, Carmona L, et al. Points to consider for reporting, screening for and preventing selected comorbidities in chronic inflammatory rheumatic diseases in daily practice: a EULAR initiative. Ann Rheum Dis 2016;75(6):965–73. Disclosure of Interest None declared

Background The Quality of life (QoL) in patients with SLE is deeply affected by multiple factors including psychological and physical factors, the functional status and the general perception over health. Objectives Evaluation of Quality of life and the perceptions over the disease in patients with SLE.functional status and the general perception over health. Methods This is a 10 month prospective, cross-sectional study performed on 52 patients hospitalized diagnosed with SLE according to SLICC 2012 criteria. There were evaluated demographic data, organs manifestations, disease activity scores (SLEDAI, SLICC) and treatment. To evaluate the QoL several questionnaires were performed: Health Assessment Questionnaire (HAQ), EuroQol five dimensions questionnaire (EQ5d), Illness Perception Questionnaire and SF-36. Results All patients were women with the mean age 49 years with a mean durations of illness 136 month (14). The mean SLEDAI – 5,52 (5,37) and SLICC – 2,25 (1,71). The mean HAQ value was 0,83 (0,81). The HAQ score doesn9t correlate with SLICC (p=0,461) and with SLEDAI (p=0,172), but it was correlated with the neuropsychiatric manifestations. So the psychiatric affectation influences performing the usually daily activities (p=0,005). When assessing Illness Perception Questionnaire, patients considered their life seriously affected by pain, mean value 6,3 (2,6), 72% consider the illness will be present for the rest of their lives, 90% appreciate that treatment is improving the QoL mean 9,3 (1,3), 68% consider to have many severe symptoms, more than 80% patients consider themselves preoccupied for their illness, more than 70% are emotionally affected by their illness and 48% consider stress being the main determinant factor of their illness. Questionnaire EQ-5d: 10% must stay in bed due to the disease, 8,33% can not wash or dress themselves, 12,5% are unable to perform usual daily activities, 62% experience pain or a moderate uncomfortable state and 65% are worried and or depressed. Cardio-vascular manifestations are correlated with diminished mobility (p=0,002) leading to deficiency in self care (p=0,002)also correlated with renal (p=0,034) and psychiatric (p=0,022) manifestations. Psychiatric manifestations also affect usual daily activities (p=0,05). Age is correlated with pain and uncomfortable state (p=0,004) but the responses to this item of EQ5D are not correlated with organ affectation, biological modification or disease activity scores. The presence of cutaneous manifestations is correlated with anxiety and depression (p=0,02). Based on SF36 when calculating the mean value on each category was observed all the 8 categories affected - smallest values at physical role (37,32) and general health (34,21), less influenced part being the social function (51,32).None of this items of SF 36 is correlated with SLICC or SLEDAI. Conclusions SLEDAI as well as SLICC or specific organ involvement give no indications over the patients QoL, which must be assessed by performing HAQ and SF 36. References Lupus. 2016 Mar 16. pii: 0961203316638934. [Epub ahead of print]Gender differences in systemic lupus erythematosus concerning anxiety, depression and quality of life.Macedo EA1, Appenzeller S2, Costallat LT2. Disclosure of Interest None declared

To identify the particularities of the clinical phenotype of endothelial dysfunction in a lot of Romanian patients from a reference center and compare it to data reported by international registries.51 patients were included in a cross-sectional study. The patients were evaluated for the pattern of disease, main visceral involvement, serum markers of disease.41.2% patients had history of digital ulcers, 27.45% had pulmonary arterial hypertension; cardiovascular involvement also included: diastolic dysfunction in 31.1% of the patients, global systolic dysfunction in 9.8%, rhythm and conduction disturbances in 19.6%, peripheral vascular disease in 19.6%. Scleroderma renal crisis was identified in 2 patients.Vascular complications are a major cause of morbidity and mortality in systemic sclerosis. Earlier therapeutic intervention demands improved screening and diagnosis in all cases.

to identify the particularities of the clinical phenotype of endothelial dysfunction in a lot of Romanian patients from a reference center and compare it to data reported by international registries.51 patients were included in a cross sectional study. The patients were evaluated for the pattern of disease, main visceral involvement, serum markers of disease.41.2% patients had history of digital ulcers, 27.45% had pulmonary arterial hypertension; cardiovascular involvement also included: diastolic dysfunction in 31.1% of the patients, global systolic dysfunction in 9.8%, rhythm and conduction disturbances in 19.6%, peripheral vascular disease in 19.6%. Scleroderma renal crisis was identified in 2 patients.Vascular complications are a major cause of morbidity and mortality in systemic sclerosis. Earlier therapeutic intervention demands improved screening and diagnosis in all cases.

Background Digital ulcers are frequent in patients with systemic sclerosis and have a high morbidity. No previous studies have evaluated the efficacy of immunosuppression on digital ulcers risk. Current treatment guidelines do not include the use of immunosuppressants as routine treatment for digital ulcers. Objectives To asses the efficacy of imunosuppresive therapy on the digital ulcer prevention in patients with systemic sclerosis Methods Prospective study on EUSTAR cohort 096 during september 2005-september 2015. Patients with systemic sclerosis (SSc) without previous digital ulcers at their first presentation in the clinic were selected. Immunosupression was started based on current recommandations according to specific organ involvement. Patients were evaluated every 6 month according to MEDS evaluation sheets and a special evaluation form for digital ulcer (number, type of ulcer, date of onset). Results 116 systemic sclerosis (SSc) patients were evaluated, but only those without previous ulcers at their first presentation in the clinic were selected – 60 patients; 12 of them were lost to follow-up. There were 40 females, 8 males, 23 diffuse and 25 limited SSc. 26 out of the 48 patients received immunosupressants. The mean (±SD) interval of follow up was 72.67 (±60.75) months. No significant statistical difference was identified between patients with immunosuppression and those without regarding the age, the disease duration, the visceral involvement and the follow-up period. 69.23% received Methotrexate, 3,84% received Mycophenolate and 26.92% received monthly pulses of Cyclophosphamide. The use of immunosupresants was related to diffuse subset (R=0.631,p=0.001), antiSCL70 positivity (R=0.624, p=0.001) and lung involvement (R=0.331, p=0.034). There was no difference of the immunosuppressants efficacy regarding the new digital ulcers onset. The incidence of digital ulcers was 15.38% in patients receiving immunosuppression and 68.18% in patients without immunosuppression (p=0.001). The mean (±SD) number of ulcers in the follow-up period was 0.85 (±1.4) in immunosuppresed patients and 6.18 (±4.79) in the other group, p=0.001. The onset of new digital ulcers was also correlated with advanced age (R=0.392, p=0.032) and longer follow-up interval (R=0.036, p=0.049). The mean (±SD) interval from first visit of the patient until the appearence of the first digital ulcer was 7.3 (±5.43) month in patients with immunosuppression and 30 (±11.78) months in patients without immunosuppression. Conclusions Immunosupression might decrease the risk and the number of digital ulcers of patients with SSc, but they do not seem to extend the interval until their first appearance. More prospective, multicentric studies on larger cohorts with longer follow-up interval are needed in order to aasses the efficacy of immunosuppression on digital ulcers onset, number, rate and time to healing. Disclosure of Interest None declared

Background Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used by rheumatic patients for both acute and chronic conditions. A certain increase in blood pressure of 3–5 mmHg seems to be a NSAID class effect. Although the effect appears from the beginning of the treatment, due to his“modest” amplitude, it was largely ignored both by patients and physicians. However, new epidemiological data suggest that such a small increase in BP could produces in USA about 21.000 deaths per year (higher than in case of gastrointestinal deaths produced by the unprotected usage of nonselective NSAID). For the time being we do know that topical and systemic NSAID have similar therapeutic effect on superficial exposed joints (e.g. knee, wrists, elbows etc). Objectives The aim of the study was to evaluate whether or not the use of topical NSAIDs in rheumatic patients affects blood pressure or pulse rate values. Methods This was a prospective study which included patients diagnosed with various rheumatic diseases using a continuous Automated BP Monitoring (ABPM): both BP and pulse rate have been continuously recorded for 48 hours at baseline (24 hours without topical NSAID use) and day1 (24 hours with topical NSAID use). Same NSAID (namely Aceclofenac) in same dose was used in all cases. Subjects that changed their concomitant medication have been excluded from the analyses. Daytime (0700–2200), nighttime (2201–0659) and all-day (24h) systolic and diastolic BP along with pulse rate values have been analyzed. Difference between Baseline and Day1 have been tested by using ANOVA and Fisher exact test; a p Results 15 subjects have been evaluated between October 2015 to January 2016. The meanSystolic BP varied between 101.75 and 147.9 in Baseline respectively between 103.9 and 132.25 during D1. The mean diastolic BP varied between 55.5 – 88.1 in Baseline and respectively between 56.4–82.5 during D1. Pulse varied between 60.2 and 95.9 in Baseline and respectively 59.3 and 90.2 during Day1. No difference between baseline and Day1 have been identified for Systolic or DiastolicBP, cardiac pulse; same results have been obtained for all-day, nighttime and daytime subanalysis. Conclusions Although this study has certain limitations our data suggest no significant change in BP or cardiac pulse associated to topic use of NSAID (in our case Aceclofenac). Larger studies should be made to confirm the conclusion of this pilot study. References Snowden S, Nelson R- The effects of nonsteroidal anti-inflammatory drugs on blood pressure in hypertensive patients. Cardio Rev2011 Jul-Aug;19(4):184–91. Howard Lee,MD; KeeSikKim,MD,- Ambulatory Blood Pressure Response to Once-Daily Fimasartan: An 8-Week, Multicenter, Randomized, Double- Blind, Active-Comparator, Parallel-Group Study in Korean Patients With Mild To Moderate Essential Hypertension Clinical Therapeutics/Volume 35, Number 9, 2013. Disclosure of Interest None declared

Background There is an increased appreciation of the burden of cognitive impairment in people with autoimmune diseases (1). Recent studies have demonstrated that patients with systemic sclerosis (SSc) have a specific pattern of cognitive impairment: the dysexecutive syndrome (2). Objectives We evaluated the prevalence of cognitive impairment in SSc and assessed the association with the disease features and impact on daily living Methods Consecutive SSc from EUSTAR center 096 were examined. Montreal Cognitive Assessment (MoCA) was used to assess cognitive dysfunction and scores ≤26 were considered abnormal (3). SSc patients were assessed according tu MEDS evaluation sheets to determine organ involvement, autoantibody profile, disease activity (Valentine Activity Index) and disease severity (Medsger Severity Index). sHAQ (Scleroderma Health Assessment Questionnaire) has also been completed. Data were compared by difference tests according to the types of variables: t-test, Mann-Whitney or chi-square. To evaluate correlations between variables Pearson or Spearman correlations were used. Results A total of 70 SSc patients [36 (51.42%) limited SSc (lSSc) and 34 (48.57%) with diffuse SSc (dSSc), 60 female; mean age 54.5 (±11.62) years; mean disease duration 66 (±429.6) months] were included in the study. 47.14% of the patients had active disease, the mean Rodnan score was 7 (±4.17), the mean Medsger score was 5.5 (±2.89), 24.28% of the patients had lung involvement and 20% had pulmonary arterial hypertension. The mean HAQ was 1 (±0.59). Cognitive impairment was identified in 65.71% SSc patients; the mean MOCA score was 26 (±2.83). Cognitive impairment of SSc patients was related to older age (r=-0.378, p=0.001), rural provenience (r=-0.351,p=0.003), severity of the disease evaluated by the Medsger score (r=–0.262,p=0.029) and poor quality of life evaluated by sHAQ (r=-0.323,p=0.003).Correlations were also identified with musculoarticular involvement (r=-0.330,p=0.006), advanced capillaroscopy patttern (r=-0.331, p=0.006). The diiffuse SSc patients were more likely to have cognitive dysfunction (likehood ratio 0.012) as were those with SCL70 positive (0.0.18). No relationship was identified between cognitive impairment and lung, heart or renal involvement, the presence of digital ulcers, the use of corticosteoids or immunosuppression. Conclusions An increased prevalence of cognitive impairment was observed in SSc and associated with age, rural provenience, more severe disease, muscle involvement and poor quality of life. Further studies are needed to be compared with healthy controls and to assess the role of microvascular damage or that of other confounders. References T.N.Amaral et al. Prevalence and significance of cognitive impairment in systemic sclerosis Ann Rheum Dis 2015;74:605 Ylmaz N. et al Dysexecutive syndrome: a specific pattern of cognitive impairment in systemic sclerosis Cogn Behav Neurol. 2012 Jun;25(2):57–62. www.mocatest.org/normative-data/ Disclosure of Interest None declared

Background Assessment of synovitis in Rheumatoid Arthritis (RA) is a major issue for a proper treatment administration; it has been proven that ultrasound (US) examination could be of valuable help and it is currently being investigated as a possible outcome measure for the disease. It is, though, of greatest importance to accurately establish the place of US scores among the already validated outcome measures, according to Outcome Measures for Rheumatoid Arthritis in Clinical Trials (OMERACT) filter. The present study is designed to compare the results of gray-scale ultrasound (GSUS) and Power Doppler ultrasound (PDUS) additive scores, separately calculated for volar and dorsal aspects of the hand, with physical examination, patient's evaluation of disease pain and global activity on Visual Analogic Scale (VAS) and traditional scores for disease activity assessment (DAS28, CDAI, SDAI, HAQ). The final aim is to prove the advantages of volar US evaluation in RA patients. Methods 42 RA patients have been clinically evaluated for pain and swelling of their hand joints, completed VAS and HAQ questionnaires and underwent both volar and dorsal sonography of the hands during the same day. The US examiner was blinded to clinical assessments and lab results. For each patient 20 joints were assessed by sonography (radiocarpal, intercarpal, metacarpophalangeal (MCP) 2-5, proximal interphalangeal (PIP) 2-5). Carpal joints were only evaluated from dorsal view, while MCPs and PIPs were evaluated both from dorsal and volar aspect resulting a total of 36 distinct evaluations for each patient. GSUS synovial hypertrophy was assessed both by quantitative measurement and semiquantitative scale (0-3 grades); Doppler signal (PDUS) was recorded on a semiquantitative scale (0-3 grades). The semiquantitative grades for both GSUS and PDUS evaluation of each joint were added and the sum was defined as the Echographic Score (ES) of each patient. Separately, we added the semiquantitative grades for volar and dorsal side, resulting in Volar ES (VES) and Dorsal ES (DES) of each patient. Results We found ESs correlated with other activity scores: DAS28, CDAI, SDAI, HAQ. Correlations with clinical indices as CDAI and SDAI were stronger for VES than for DES. US discovered more synovitis than clinical examination. Conclusion VES is a suitable reflection of RA activity and volar US examination should accompany the dorsal one both in clinical practice and in clinical trials.

Background Systemic sclerosis (SSc) has a case-based mortality that is one of the highest among the rheumatic diseases. Objectives To identity predictors of mortality in patients with systemic sclerosis from their first evaluation in a reference center Methods 90 SSc patients were followed between JAN 2010 – JAN 2015. A complete baseline evaluation of all patients was done according to MEDS evaluation sheets (demographics, disease history, main organ involvement). A complete follow-up was done every year. Univariate and multivariate predictors of survival were assessed using proportional hazards regression modelling Results Amongst the cohort of 90 patients the mean age at diagnosis was 55,65 (SD 12,45) years, medium disease duration was 11,7 (SD 6,9) years. Medium disease activity score was 3,43 (SD 2,14) years. In the deceased group (10 patients), the mean age of death was 43,7 years (SD 8,9 years). The 5- year survival rate at was 88,88%. The most common cause of SSc-related mortality was pulmonary complications (60%). 70% of deaths were attributed directly to SSc. Of the SSc-related deaths, 28,57% were attributed to pulmonary fibrosis, 57,14% to pulmonary arterial hypertension (PAH) and 14,28% to cardiac causes (arrhythmias). Among the non-SSc-related causes, infections (33%) and malignancies (33%) were followed by indidental causes (33%). Sex- and age-adjusted univariate analysis identified the diffuse subset, a modified Rodnan score (mRSS)>14, pulmonary fibrosis, pulmonary hypertension, scleroderma renal crisis and a Medsger score>10 to be associated with increased mortality in all patients. Sex- and age-adjusted multivariate model identified a mRSS >14 OR 1,562 [1.00; 2.42] and pulmonary hypertension OR 1.336 [1.03; 1.73] as predictors of death. Conclusions Disease-related causes, in particular pulmonary hypertension and pulmonary fibrosis accounted for the majority of deaths in SSc. Mortality rate in the center seems to be a little bit higher than the EUSTAR cohort, especially in patients with pulmonary hypertension possibly related to difficult acces to specific vasodilator treatment. Higher Rodnan skin scores at baseline evaluation still remains an important mortality predictor. References Nikpour M, Baron M. Mortality in systemic sclerosis: lessons learned from population-based and observational cohort studies. Curr Opin Rheumatol. 2014;26(2):131-7 Tyndall AJ, Bannert B, Vonk M, Airo P, Cozzi F, Carreira PE et al. Causes and risk factors for death in systemic sclerosis: a study from the EULAR Scleroderma Trials and Research (EUSTAR) database.Ann Rheum Dis. 2010 Oct;69(10):1809-1 Disclosure of Interest None declared

Background Systemic sclerosis (SSc) has a female predominance, however, little is understood about the effect of sex on SSc manifestations and survival. Objectives The objectives of our study were to evaluate differences in disease manifestations, and survival rates between males and females with SSc. Methods A retrospective cohort study of EUSTAR center 096 was conducted to evaluate sex-based differences in disease manifestations and survival. A complete baseline evaluation of all patients was done according to MEDS evaluation sheets. A complete follow-up was done every year. All calculations were performed with SPSS Statistics 20.0. Student t-test or Mann-Whitney test and chi-square test were used to evaluate differences for variables. Pearson9s bivariate correlation or Spearman9s rank correlation coefficient were used to evaluate the association between evaluated variables. The values of r>0.5 and p Results 90 SSc patients (82 females and 8 males) were followed between JAN 2010 – JAN 2015, with a female:male ratio of 10,25:1. Male patients with systemic sclerosis are younger (48.63±13.46 years compared to 55.63±11.51 years in females), have a shorter disease duration (76±78.13 months compared to 124.11±86.6 months in females), higher Rodnan skin scores (12.38±7.46 compared to 8.85±5.14 in females) with more frequent diffuse skin involvement (62,5% compared to 52,38% in females), develop more frequent digital ulcers (50% compared to 40,29% in females), pulmonary fibrosis (62,5% compared to 35,82% in females), pulmonary arterial hypertension (37,5% compared to 17,91% in females) and have higher Medsger severity score (8.75±3.28 compared to 6.87±3.06); yet none of the above reached statistical significance. Still, activity score seems to be higher in male patients (5,62±3,00 compared to 3,53±1,87, p=0,007). Mortality rates at 5 years was 50% for men compared to 8,95% for women, close to statistical significance (p=0,061). Male sex was associated with increased risk of scleroderma renal crisis (p=0.001). Conclusions The differential effect of disease between sexes is small, yet males have increased risk of scleroderma renal crisis compared to females with SSc. References Hussein H, Lee P, Chau C, Johnson SR. The effect of male sex on survival in systemic sclerosis.J Rheumatol. 2014;41(11):2193-200 Disclosure of Interest None declared

Background Eye gaze tracking (EGT) is a method used to measure eye position and eye movement, defined as visual attention. Much existing research has used the connection between visual attention and EGT in a broad spectrum of fields such as psychology or cognitive linguistics. The application of EGT in terms of evaluating the knowledge and expertise of individuals has been widely ignored, although a strong frame of study has indicated that this method may be weighed as unbiased indicator of the focus of visual attention. Objectives To evaluate the ability of EGT in assessing quantitatively and qualitatively how rheumatologists analyze musculoskeletal ultrasound images (MSUS). Methods 11 young rheumatologists in training were evaluated in December 2014. Two experts in this field were also asked to participate. 12 ultrasound images of different rheumatologic pathologies were used (displayed on 21inch HD monitor), and 6 other different images were used in order to calibrate the machine. The images were analyzed using The Eye Tribe (Hardware) and Eyeproof (Software). The data was analyzed using SPSS and Microsoft Excel. For every ultrasound image 1 to 5 regions of interest were set by a team of MSUS experts. Items assessed were: Total time of evaluation (TTE), time spent to reach the first region of interest (TSRF), time spent upon the region of interest (TSUR), ratio of time spent in the region of interest (ROI) and time spent outside the region of interest, number of elements identified in the region of interest versus the rest of the image. Results Total time of evaluation - mean (SD) - for experts was 5,4 (1,3) seconds versus 8,9 (2,7) seconds for unexperienced rheumatologists. Time spent to reach the first region of interest for experts was 0,6 (0,8) msec and 3,2 (2,1) msec for non-experts. The unexperienced sonographers focused on a higher number of elements outside the region of interest than experts: 8,6 (3,8) vs. 2 (0,5). There was no significant difference between the two groups of evaluators regarding the time spent upon the region of interest. Conclusions Experienced sonographers spend less time than unexperienced ones when assessing an ultrasound image (mainly because they focus quicker on the ROIs). Once focused on a particular ROI both groups tend to act similarly. EGT can be a useful tool in assessing the way ultrasound images are visually analyzed and can be used to improve MSUS training and optimize the visual analyze pattern of the sonographer. References Robert H. Tai, John F. Loehr, Friederick J. Bringham An exploroation of the use of eye-gaze tracking to study problem-solving on standarized science assessments. International Journal of Research&Method in Education, volume 29, Issue 2, 2006. Carlos H. Morimoto, Marcio R.M. Mimica Eye gaze tracking techniques for interactive applications. Computer Vision and Image understanding Vol 98, issue 1, April 2005 Olmeda, R. A. (2002) Using eye movements to differentiate students with and without ADHD in a simple reading task. Unpublished manuscript, Charlottesville, VA, The University of Virginia Acknowledgements RCRD team. Disclosure of Interest None declared

Background Cardiac involvement in systemic sclerosis is associated with poor prognosis and can be difficult to manage. Recent epidemiologic and experimental evidence has suggested that low vitamin D levels may play a role in cardiovascular conditions, including coronary artery disease, congestive heart failure, stroke and hypertension. Low vitamin D may lead to vascular smooth muscle cell proliferation, endothelial cell dysfunction, vascular and myocardial cell calcification, and increased inflammation. Objective To evaluate the influence of vitamin D status in cardiovascular involvement in systemic sclerosis. Methods 51 scleroderma patients were included in the study. Cardiac involvement was assessed by tissue Doppler imaging. 25(OH)D level was measured in the sera by an ELISA kit [DIASource ® 25-Hydroxyvitamin D Total ELISA assay (Nivelles, Belgium)]. 25(OH)D levels were considered normal for values ≥30 ng/ml, insufficient for values between 20–30 ng/ml and deficient for values under 20 ng/ml. Results Patients with impaired vitamin D had higher sPAP than those with normal D levels (34.2 ± 14.33 vs. 25.25 ± 3.77, p = 0.008) and a trend for negative correlation between 25(OH)D and sPAP was identified (p = 0.053, r = -0.29). Patients with normal vitamin D levels did not have systolic or diastolic disfunction, rhythm or condunction disturbancies. Those patients with vitamin D deficiency had the highest frequencies of the above mentioned. Patients with vitamin D supplementation developed less rhythm and condunction disturbances than those without supplementation (p = 0.034). Negative correlations were identified between 25(OH)D levels and diastolic disfunction cu (p = 0.033, r = -0.318). An opposite variation was identified between 25(OH)D levels and right cardiac output, Anova test confirmed the differences between vitamin D subgroups (p = 0.001), but there was no correlation between parameters. 25(OH) level had a negative correlation with VTI_LVOT (velocity time integral left/right ventricular output) (p = 0.005, r = 0.663); an oppsosite variation was identified between vitamin D levels and left cardiac output and VTI_LVOT with significant differences between vitamin D subgroups confirmed by Anova test (p = 0.004, p = 0.001). There was also an opposite variation between 25OH)D levels and Et (early diastolic peak lateral mitral annular velocity) and At (late diastolic peak lateral mitral annular velocity), and in the same direction with Et/At ratio. Anova test validated differencies between subgroups: for Et (p = 0.039) and Et/At (p = 0.006). Conclusions Vitamin D deficiency is associated with more severe cardiovascular involvement in systemic sclerosis. Our results suggest that patients with scleroderma might benefit from vitamin D supllementation, considering the fact that heart involvement in systemic sclerosis has no specific treatment.

Background and objectives Paget disease (PD), also known as osteitis deformans, is characterised by single or multiple bone site alteration, including accelerated osteoclast-mediated resorption followed by increased low quality bone production. This process results in a disorganised, unsteady structure that may lead to bone deformity. This condition affects elderly adult population, with a slightly higher predominance in males and it is thought to have important genetic determinants. The association of comorbid conditions places a burden on the patients and imposes regular monitoring. The present study aims to evaluate associated medical conditions in patients suffering from PD. Methods We retrospectively identified 39 patients who were diagnosed with PD, based on clinical presentation, plain x-rays, scintigraphy or when necessary biopsy or bone turnover markers’ detection. For the study group we noted the presence of cardiovascular disorders – hypertension, ischaemic heart disease or rhythm abnormalities such as atrial fibrillation. Median body mass index (BMI) was calculated. Neurologic conditions namely hearing loss, Parkinson’s disease or cerebral stroke history were taken into account, as well as type 2 diabetes and prostate adenoma. Tobacco use was also assessed for the study group. Development of neoplasia was reviewed. Information was gathered from patients’ clinical charts over a period of one year. Results Out of the 39 patients included in the study lot, 64.1% were males and 35.9% of female gender (1.7:1 ratio) with a mean age of 65.67 years, who were mainly diagnosed on the basis of clinical and radiographic assessment (97.4%). 7.6% had positive family history of PD. The polyostotic form of PD encountered in 26 patients (66%) is prevalent over the monostotic pattern (13, 33.3%). The most common affected sites were the hip in 71.0% of patients, skull (44.7%), femoral bone (26.3%) and the lumbar spine (21.05%). 61.5% of patients were hypertensive while 28.2% associated ischaemic heart disease. 27.6% were priorly diagnosed with atrial fibrillation. Mean BMI value was calculated at 27.7 kg/m². 12.8% of patients were hypoacusic, 5.1% suffered from a cerebral stroke and the same percentage were diagnosed with Parkinson’s disease. 52% of males had prostate adenoma, 15.3% suffered from type 2 diabetes. 20.5% patients confirmed smoking status. Three patients developed neoplasia, namely squamous cell carcinoma, carcinoma of the breast and rectum with no correlation to disease duration. Conclusions Taking into consideration the difficulties that PD brings with it, associated comorbidities tend to diminish further the health and quality of life in these patients. Therefore a complete medical check-up is recommended on each follow up visit in order to improve their status.

Background Biologic therapy is extensively used in various rheumatic disease adding a plus of efficacy to classical DMARDS. Standardized regimes are based on continuous use of biologics but for various reasons (e.g. health insurance issues, patients9 concerns related to safety of long term use or a surgical emergency) a drug holiday might come into discussion. While rheumatologists9 reasons to support or not this holiday are widely presented in the literature little is known about the patients9 beliefs and attitudes in this matter. Objectives To evaluate the rheumatic patients9 beliefs and attitudes regarding a potential drug holiday during biologic treatment. Methods A structured questionnaire was developed to capture demographic data, personal experience and acceptance of biologic therapy, level of knowledge about possible drug holiday, personal beliefs and attitudes regarding such regime. Rheumatic patients receiving biologic treatment have been invited to answer the questionnaire. SPSS 19.0 have been used to perform statistical analysis. Data are presented in mean (sd) format; a p Results A number of 69 subjects accepted to participate in this study. Demographic data revealed: age 51.6 (13.6) years, sex ratio (F:M) – 1.3:1, 69.6% suffering from Rheumatoid arthritis and 30.4% from spondilarthritis, duration of biologic therapy: 34.67 (27.5) months. 44.9% of the subjects already considered of the possibility of a drug holiday (no difference between gender, living area or education based groups). 75.0% believe that such a holiday will produce a “totally negative” and a “mainly negative” impact on the control of disease. Those who believe this holiday will have a greater impact are the same who predict a predominant negative impact – Pearson correlation index: o,42. A small minority (14.7%) declared them as being favorable to such a holiday, however these answers went mainly from those who believe this holiday will have a small impact on the control of disease and are ready to try this in the near future. 82.7% of the subjects expect their doctor to open such a subject. Those who are not favorable to such a holiday are ready to pay extra for the treatment (20.6%) or to receive a less expensive drug (75.0%). Conclusions There is a great need for research regarding the potential effects of drug holiday during the biologic therapy and to respond to various concerns patients do have. A large proportion of patients have negative feelings concerning this possibility. Those patients (not so many) that feel they control the disease are the same who are ready to try this change – this raise the question whether or not the patients follow their treatment because they are more scared than informed of their disease. A very large proportion of patients are ready to accept a less expensive drug in exchange not to start a drug holiday – while biologic biosimilars already offer this opportunity it might be interesting to explore the consequences of such a decision. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.3322

Background Bisphosphonates are widely prescribed and highly effective at limiting the bone loss in senile osteoporosis in both men and women. Although they are generally well tolerated, potential adverse effects may limit bisphosphonate use for longer periods. In addition these drugs accumulate in bone and continue to produce a therapeutic effect – that9s why the idea of a drug holiday in this case received an increasing attention during last years. While rheumatologists9 reasons to support this holiday are widely presented little is known about the patients9 beliefs and attitudes in this matter. Objectives To evaluate the patients9 beliefs and attitudes regarding a potential drug holiday during bisphosphonates treatment. Methods A structured questionnaire was developed to capture demographic data, personal experience and acceptance of bisphosphonates, level of knowledge about possible drug holiday, personal beliefs and attitudes regarding such regime. Osteoporotic patients following a bisphosphonate treatment have been invited to answer the questionnaire. SPSS 19.0 have been used to perform statistical analysis. Data are presented in mean (sd) format; a p Results A number of 61 subjects accepted to participate in this study. Demographic data revealed: age 64.1 (9.7) years, sex ratio (F:M) – 6:1, history of fractures in 32.8 cases, duration of bisphosphonate therapy: 3.67 (2.6) years. One third of the subjects were aware of the possibility of a drug holiday (no difference between gender, living area or education based groups). 78.7% believe that such a holiday will produce a “totally negative” and a “mainly negative” impact on the control of disease. Those who believe this holiday will have a greater impact are the same who predict a predominant negative impact – Pearson correlation index: 0,53. Around half of the subjects (52.5%) declared them as being favorable to such a holiday, however these answers went mainly form those who believe this holiday will have a small impact on the control of disease and are ready to try this in the near future. 86.9% of the subjects expect their doctor to open such a subject. Those who are not favorable to such a holiday are ready to pay extra for the treatment (41%) or to receive a less expensive drug (42.5%). Conclusions There is a great need for patient education regarding the potential effects of drug holiday during the treatment of osteoporosis and to respond to various concerns patients do have. A large proportion of patients have negative feelings concerning this possibility. Those patients (not so many) that feel they control the disease are the same who are ready to try this change – this raise the question whether or not the patients follow their treatment because they are more scared than informed of osteoporosis. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.3020

Background Biological drugs represents today a major therapeutic line in many rheumatic diseases. Introduced in current practice about ten years ago these molecules have been considered much more difficult to manage than classical DMARDs. In addition, a whole new kind of potentially associated adverse reactions increased both patients9 and doctors9 anxiety. From clinical point of view the decision to initiate such a therapy is very well standardized; so is the decision to switch from one biologic to a different one. However recent studies performed in USA and replicated in EU by our group have shown that rheumatic patients decide to start and follow such a treatment for quite different reasons. Little is known about the way our patient decide what drug he/she prefers in case of switch (same class? different class? a biosimilar?) and what are the values that determine such selection. Objectives To evaluate the perceived importance from the switchers9 point of view of 24 aspects of a new biological therapy. Methods 24 aspects of biological therapy already tested in USA patients have been tested in a pilot study performed in one single European tertiary rheumatology unit. 30 consecutive patients previously exposed to a switch of their biologic therapy received a structured questionnaire developed to capture on a four points Likert scale the patients9 perceived importance of each aspect. SPSS 19.0 have been used for statistical analysis. Results 22 women and 8 men mainly living in urban areas (73.3%) and most of them with at least 12 years of formal education (73.3%) have been included in the study. Mean age was 56.8 (sd: 12.7) years and mean duration on biological therapy was 49 (20.2) months. In 22 cases (73.3%) patients received a new treatment because of the lack of efficacy of the previous one, in two cases it was an allergic reaction and in 6 cases (20%) an administrative reason determined this change. The aspects our patients considered as being most important when select a 2nd biologic are: the efficacy of new drug compared with the previous one, treatment schedule, the impact of new treatment on previous comorbidities, the global efficacy of new drug. On the opposite side are: the route of administration, the potential role of a health worker in drug administration, the possible financial aid (co-reimbursement) schemes. We also evaluated how deep every of these 24 aspects have been discussed with the rheumatologists at the moment of switch and found significant differences between what patients consider important and the attention paid by the rheumatologist to that particular aspect. Conclusions This pilot study revealed a large difference between various aspects of biological therapy as is it perceived by the final users. In order to standardize the informed consent process across the EU it will be mandatory to understand how our patients rank these aspects not just at the moment they come in contact with this therapyfor the first time but aslo in the moment they have to change the biological molecule. References Bolge, Susan C., Goren, Amir PhD; Brown, Duncan; Meyer, Roxanne; Ginsberg, Seth - Initiation of biologic therapy - the patient perspective - ACR Meeting 2013 Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.5114

Background Non-biological DMARDs are important treatment in rheumatic patients that receive biological therapy. In the absence of the first ones the final outcome may be jeopardized despite a full adherence to the rest of regimes. In real practice a patient receive a biological therapy in addition to an existing non-biological DMARD regime, a regime that was not sufficient to control the disease. However the patient is not always informed enough to understand the important role of a treatment that was not so good in the past – non-biological DMARDs. That explains why some patients reduce their classical DMARDS usage; is important to know better their profile in order to focus the efforts in their education. Objectives To characterize the profile of the rheumatic patient with impaired adherence to non-biological DMARDs during mixed (biological and nonbiological) treatment regimes. Methods In a focus group exercise we defined several characteristics (of the rheumatic patient) that could impact the adherence to non-biological DMARDs. We selected education, income, total number of distinct drugs used daily, perceived effect of previous regime, perceived effect of new regime to be analyzed in addition to regular patient’s characteristics (sex, age and living area). A structured questionnaire have been developed and delivered to 50 rheumatic patients consecutive admitted. Statistic analyses have been done with SPSS 16.0 Results We split the lot of responders in highly adherent (HA) group – no or just a few doses of nonbiologic DMARD not used and poor adherent (PA) group – many to all doses of drug not used. The sex ratio was different in HA group (female: male ratio was 6:1 in HA and 10:1 in PA, p 0.05). Other sub-group analyses have been done, too including patient’s opinion regarding the potency of biological ad non-biological DMARDs. Conclusions The patient adherent to non-biological part of their mixed treatment regime has a different profile that the one who is non adherent. In addition there is a difference between those who are non-adherent to any kind of medication and those who ignore just the non-biological part of their regime. The understanding of these differences might be helpful in evaluation of the results of clinical trials. Disclosure of Interest None Declared

Background Epidemiological evidence indicates a significant association between vitamin D deficiency and an increased incidence of several autoimmune diseases. Low vitamin D levels have also been reported in patients with systemic sclerosis (SSc), but the number of studies is limited with conflicting data. Objectives To investigate 25-OH vitamin D concentrations in a group of systemic sclerosis (SSc) patients and establish connections between a deficient vitamin D status and SSc disease activity and severity or on the clinical consequences that such deficiency might cause. Methods 44 scleroderma patients were evaluated during June 2010 - June 2012 in InternalMedicine and Rheumatology Department of Sf. Maria Hospital, Bucharest, Romania. All patients gave informed consent for all procedures, which were carried out with the local ethics committee’s approval. We performed a complete evaluation of all patients following: MEDS evaluation sheets; disease activity was evaluated with the Disease Activity Score (DAS) according to the European Scleroderma Study Group guidelines, HAQ (Health assessment questionnaires) have been also completed. Vitamin D was measured with the RIA Diasorin kit or expressed as“RIA Diasorin equivalent”. According to current recommendations, vitamin D concentrations Results 95,45% of all patients were women, 56,81% had diffuse skin involvement, mean age 35,9 years, medium disease duration 12,5 years+/- 3,4. mean Rodnan 9,5+/-2,4, mean activity score=3,13+/- 0,8, mean Medsger 6,66+/- 1,1. 36,36% had interstitial lung disease, 18,7% had pulmonary hypertension. Only 3 patients had optimal levels of 25(OH)2 D; most of the patients had an insufficient (65,9%) or deficient (27,27%)level, mean vitamin D serum concentration was/18,6+/-3,5ng/ml. A negative correlation between patients’ age and vitamin D concentration was observed. A significant correlations were found between low vitamin D levels and age, Rodnan score, European disease activity score, Medsger score, pulmonary fibrosis and low DLCO., distal joint contracture, muscular weakness/myalgia. Conclusions Most of the patients of the group had suboptimal low levels of vitamnin D. Some clinical correlations were indentified. We are aware of the limitations of the study that are : small group, lack of control group and the fact that measurements of vitamin D were not done in the same period of the year. Given the most recent findings, we consider further research would be clinically important to elucidate the causes of hypovitaminosis D in SSc, its relevance to disease progression, its influence on immune functions, and the potential effects of supplementation References Rios-Fernandez R et al Bone mass and vitamin D in patients with systemic sclerosis from two Spanish regions. Clin Exp Rheumatol. 2012 Nov-Dec;30(6):905-11. Vacca A, Cormier C, Mathieu A, Kahan A, Allanore Y. Vitamin D levels and potentialimpact in systemic sclerosis. Clin Exp Rheumatol. 2011 Nov-Dec;29(6):1024 Arnson Y, Serum 25-OH vitamin D concentrations are linked with various clinical aspects in patients with systemic sclerosis: a retrospective cohort study and review of the literature. Autoimmun Rev. 2011 Jun;10(8):490-4. doi: 10.1016/j.autrev.2011.02.002. Disclosure of Interest None Declared

Background Diagnostic errors in medical practice are neither rare nor minor. Diagnoses that are delayed, wrong or missed entirely result in 40,000 to 80,000 U.S. hospital deaths annually [1]. In USA, about 40% of medical liability lawsuits involve diagnostic errors. Rheumatic diseases need an early diagnostic in order to avoid permanent damages. Unfortunately this is not always possible and many cases receive wrong diagnostics. Objectives Our objective was to create an inventory of the most important causes of diagnostic errors in rheumatology Methods Six highly experienced rheumatologists (with more than 15 years of practice) have been involved in a focus group exercise with the aim of developing a draft inventory of the most commune causes of diagnostic errors. 27 such causes equally divided in three groups have been identified. 98 Rheumatologists have been invited to participate in a two stage internet based Delphi exercise to rank these items according their susceptibility to generate diagnostic errors. In the first stage all participants have been instructed to evaluate the potential effect of each item on a 10 point Likert-type scale (with 0 for “this item is definitely not involved in diagnostic errors” and 10 for “this is a major cause of diagnostic errors”). In the 2nd stage we involved just the responders from the 1 stage; the participants were also asked whether mean value obtained for each item is appropriate or should be smaller or higher. Results The draft inventory of possible causes of diagnostic errors included 27 causes divided in: causes related to doctors, related to patients and to medical system. 49 responders (50%) of the invited rheumatologists participated in the first stage and 42 in the final. Their clinical experience was between 1 and 45 years with a mean of 22 years and a SD of 8.6. 81.6% of responders were from an academic city, 71.4% were employed by public hospitals and 53% were active in private practice (full or part-time). 15 items passed the two stages: four related to doctors, four related to patients and seven related to health system. The highest ranked was computed for: Relevant investigations are missing (7.6), Incorrect clinical examination (7.5), Incorrect evaluation of differential diagnostics (7.4), Clinicians are overloaded with non-clinical activities (teaching, research, management) (7.3), Clinicians are overloaded with clinical activities (7.2). As a general rule, patient related items received lower ranks. Significant difference between inpatient and outpatient doctors exists. Conclusions The responsibility for diagnostic errors should be shared between doctors, patients and medical system. Not a single cause can’t be removed or fixed – but first is important to be identified. Our study offers an instrument to audit the potential of developing of such errors in one setting, to identify active causes and to propose potential solutions. References Kevin B. O’Reilly Diagnostic errors: Why they happen? American Medical News. www.ama-assn.com. Posted Dec. 6, 2010. Croskerry P. The importance of cognitive errors in diagnosis and strategies to minimize them. Acad Med. 2003;78(8):775–80 Disclosure of Interest C. Rosca: None Declared, F. Berghea Grant/Research support from: Pfizer, Consultant for: Amgen, Abbott, RG, C. Constantinescu: None Declared, M. Abobului: None Declared, V. Vlad: None Declared, I. Saulescu: None Declared, L. Groseanu: None Declared, M. Negru: None Declared, D. Opris: None Declared, V. Bojinca: None Declared, M. Bojinca: None Declared, A. Balanescu: None Declared, D. Predeteanu: None Declared, R. Ionescu: None Declared

Background Adherence is defined as the extent to which the patient continues the agreed-upon mode of treatment under limited supervision when faced with conflicting demands. Adding a biological agent to a classical DMARD in a mixed regime represents a major milestone for rheumatic patients: in addition to the perceived risks of nonbiologicals, such patients accept new future risks associated with biological therapy. Usually doctors pay a supplementary attention to listen and answer to patient concerns’ about biological DMARD that create an inequality of information and disfavor nonbiological DMARDs. As a consequence such patients that use mixed therapy may change their minds regarding what is best to treat their disease. In addition the perceived effect of new therapy, social support, level of education, and age also contribute to adherence. Furthermore, drug tolerability appears to affect adherence too. Some data regarding adherence might be extracted from the registers but patient’s perceptions are not captured in these: this study intended to improve the knowledge around this issue and add information about reasons of nonadherence to mixed regimes. Objectives To identify patients’ related causes of non-adherence to a mixed regime usually not captured in largest registers. Methods In a focus group exercise we identified 21 factors for noncompliance to mixed regime in rheumatic patients. In a literature search we reviewed the data regarding the information available in biological registers around each of these factors. We selected the following factors that might influence adherence to a mixed treatment and are not covered (enough) in registers: patient’s opinion regarding the total number of drugs that have to use, patient’s thoughts regarding the efficacy of added biological-DMARD, patient’s fear of biological and non-biological DMARDs, patient’s hope in curative effect of biological and non-biological DMARDs. A structured questionnaire have been developed and delivered to 50 rheumatic patients consecutive admitted. Statistic analyses have been done with SPSS 16.0 Results We coded the responders in two categories: good compliance (all or almost all drug doses used) and poor compliance (many to almost all doses lost). 26.3% patients of the good compliance group consider the number of drugs they take as being too large and 58.3% from poor compliance group have the same idea (p 0.05 are happy with added biological DMARDs). Patient’s fear of biological and non-biological DMARDs was similar regarding biological DMARDs (less than 10% are seriously worried about risks of biological therapy) and slightly higher for classical DMARDs in good compliance group. Patient’s hope in curative effect of biological is higher in good compliance group (index of hope = 92 vs. 53 in poor compliance group). Additional analyses have been done regarding cortisone and patient characteristics. Conclusions Patient’s compliance to a mixed regime might be influenced by patient’s personal thoughts; these factors might be added in the core of biological registers in order to understand better patient’s behavior. Disclosure of Interest None Declared