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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 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 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