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Imaging evaluation in rheumatoid arthritis (RA) has evolved significantly in last decades. Even if the modern imaging technics like ultrasound and magnetic resonance imaging have unequivocal place in the assessment of early disease (especially for synovial inflammation, bone oedema, erosions), radiographic evaluation of hands and feet is still the most widely used imaging technic for quantification of joint damage in RA. In the current review we aim to address some practical issues related to the radiographic evaluation in RA from daily practice perspective, followed by a broader approach from the clinical trials point of view.

SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) is responsible for the current pandemic, causing so far over 100.000 cases and more than 4500 deaths in Romania. Clinical manifestations are variable, ranging from mild forms (fever, dry cough, dyspnea, tachypnea, asthenia, myalgia) to severe bilateral pneumonia (COVID-19). Generally, patients with inflammatory/autoimmune rheumatic diseases have an increased risk of infections compared to the general population, especially if under treatment with immunosuppressive therapies. In the absence of infection or exposure to SARS-CoV-2, the use of specific drugs (non-steroidal anti-inflammatory drugs – NSAIDs; glucocorticoids - GC; conventional synthetic - csDMARDs, targeted synthetic – tsDMARDs and biologic disease-modifying anti-rheumatic drugs - bDMARDs, denosumab) should be unaffected. In patients with exposure to SARS-Co V-2, but without symptoms of COVID-19, NSAIDs, hydroxychloroquine, sulfasalazine and, in specific cases, IL-6 inhibitors may be continued, methotrexate, leflunomide, non-anti-IL-6 bDMARDs, tsDMARDs and immunosuppressants should be temporarily discontinued until a negative result for SARS-CoV-2 or for up to 2 weeks asymptomatic state for specific post-epidemiological COVID-19 symptoms. In patients with confirmed or suspected COVID-19 infection, non-anti-IL-6 bDMARDs, tsDMARDs, methotrexate, leflunomide, sulfasalazine and immunosuppressants must be temporarily discontinued. In such particular cases, IL-6 inhibitors and hydroxychloroquine may be continued, depending on the clinical context. In forms with severe respiratory manifestations, NSAIDs must be stopped. In all cases, non-essential medical consultations and maneuvers should be reduced where appropriate, with optimal use of telemedicine. Social distancing, facial masks and constant hand hygiene is advised for all patients, according to national and international recommendations.

Objective. In this study, we aim to evaluate the frequency of enthesitis in psoriatic arthritis (PsA), using musculoskeletal ultrasonography (MSUS) and to determine to what extent it is correlated to clinical spontanous or provoked pain, disease activity and biologic inflammatory markers. Methods. 320 entheses, belonging to 20 PsA patients, were evaluated clinically and MSUS. For each patient, the medical history form included questions regarding spontaneous pain, targeted to 16 entheseal sites. Then, a thorough enthesis clinical exam was performed, evaluatig pain upon pressure (digital pressure on the enthesis overlying skin). Two Esaote My Lab machines were used, with 6-12/8-18 MHz linear probes. All evaluations were performed by the same clinician/ultrasonographer. Results. The Achilles, followed by the quadriceps tendons were the most affected by MSUS-detected enthesitis, both in gray scale (GS) (100%, 75% respectively) and power Doppler (PD) (40%, 35% respectively), while the proximal patellar tendon (35% GS, 25% PD), the plantar fascia (40% GS, 25% PD) and the flexor tendons (45% GS, 25% PD) were the least affected. Ultrasound abnormalities were found in up to 68.4% of the asymptomatic entheses, with high variation between the entheseal sites. The number of ultrasound-detected enthesitis for each patient was significantly correlated with the patient’s global assessment for DAPSA and also with the CRP levels, in this lot of patients with high disease activity. Conclusions. In PsA, the entheses involvement is a central feature, underscored in this study by the high percentages of both GS and PD abnormalities, even in the least affected entheseal sites. There is a low correlation between clinical symptoms and imaging signs of enthesitis in PsA, which proves the need for an imagistic enthesitis score in the diagnostic process, in order to establish the full extent of the disease and a more personalised therapeutic plan.

The number of rheumatoid arthritis (RA) patients with visits introduced in the Romanian Registry of Rheumatic Diseases (RRBR) has been steadily increasing within the last 3 years. Included patients display the classical phenotype of established RA, with a relatively high prevalence of extra-articular manifestations, cardiovascular comorbidity and a high burden regarding early retirement due to RA. Data regarding treatment showed a very low prevalence of monotherapy with biologic and targeted synthetic disease-modifying drugs (b/tsDMARD) and a low prevalence of glucocorticoid-therapy. Approximately a fifth of the patients started b/tsDMARD-therapy early during disease course (under 2 years from diagnosis). The most frequent prescribed bDMARD was etanercept, followed by adalimumab and rituximab. Treatment decisions trends in 2019 showed that some molecules present a negative balance, such as abatacept and rituximab, while others present a positive balance such as bDMARD biosimilars and tsDMARDs. Overall, b/tsDMARD achieved treatment target (DAS28-defined remission and LDA) within the first 6 months of treatment in 81.4% of treated patients. Also, RRBR data indicate a slow but significant increase in tapered regimens. Thus, the RRBR has proved to be a very valuable tool in capturing data regarding RA management in a real-life national setting of rheumatology healthcare.

Given the limited resources of the health system, rheumatologists are interested in reducing the costs of modern treatments for rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, given that the therapeutic targets are obtained and maintained. Data from the Romanian Registry of Rheumatic Diseases (RRBR, in Romanian) from 2016 to 2019 showed for all three diseases that: continuations on the same regimen with tapering experienced a marked increase; the yearly drug cost per patient steadily decreased towards 2019; adalimumab and etanercept originators present the most number of administrations per year and consequently the highest afferent costs in the entire observation period; new drugs (biologic biosimilars and targeted synthetic drugs) are gaining specific portions of the market; switches decrease costs of treatment since the hypothetical models in which switches would not have been performed and patients would have continued their previous treatment throughout the respective year showed 11% increases of costs. RRBR data have shown that reaching and maintaining therapeutic targets (including by switching strategies), reducing risks of adverse events by reducing exposure (tapering) and increasing the use of biosimilar biologics lead to significant cost reductions.

Background. The novel therapies in inflammatory rheumatic diseases have changed dramatically the evolution of these conditions, improving patient outcomes, as well as the quality of life. Nevertheless, the efficacy data continuously needs safety reports, on short and long term. Aim. The present study reports adverse events (AEs) captured by the Romanian Registry of Rheumatic Diseases (RRBR, in Romanian), during 2019. Methods. This observational study included all AEs reported in RRBR in 2019, the severity class, outcome and previous exposure to the therapeutic agent. Results. For the active cohort of 9,255 patients that had at least one visit during 2019, there have been 934 reported AEs: 568 cases for rheumatoid arthritis (RA) patients, 291 cases for ankylosing spondylitis (AS) patients and 75 cases for psoriatic arthritis (PsA) patients. The most prevalent AEs were infections, especially in RA patients. Of all AEs, 102 (11%) were serious AEs, with an equal impact of 11% in RA and AS groups. A number of 25 deaths were reported during the last year. Conclusion. AEs seem to be under-reported in the RRBR database, is accordance with literature data for registries which not do have a standardized method for AE reporting. This is an unmet need for safety data that also requires improving the knowledge about AE reporting requirements.

Objective The study aims to compare the efficacy and safety of biosimilar etanercept (SB4) to original etanercept (ETN) in a real-life national cohort of rheumatoid arthritis (RA). Methods Data from RA patients were retrieved electronically from the Romanian Registry of Rheumatic Diseases (RRBR), which contains all patients receiving biologics in the country. Results The study included 242 patients with efficacy and safety data after 6 months of treatment: 123 (50.8%) with ETN, 119 (49.2%) with SB4. There were no significant differences after 6 months regarding composite scores of RA activity between patients on ETN and SB4 (e.g. DAS28 remission: 18.7% in ETN group and 17.6% in SB4 group, p = 0.823; Boolean remission: 11.4% in ETN group and 11.8% in SB4 group, p = 0.926). There were 11 adverse events (AE) in the ETN subgroup (including 3 severe AE: lower respiratory tract infection, enterocolitis and anaphylaxis) and 12 AE in SB4 subgroup (including 4 severe AE: lower respiratory tract infection, vasculitis, anaphylaxis and rash). Conclusion Biosimilar and original etanercept showed similar efficacy and safety after the first 6 months of treatment in RA patients from a national registry, which brings further evidence for biosimilarity in unselected patients in real-world setting.

Objective. The study aimed to observe the frequency of ultrasound-defined tenosynovitis in ankle tendon and to evaluate the relationship of ankle tenosynovitis with clinical examination and rheumatoid arthritis (RA) activity measures. Methods. RA patients were recruited in 2018 in the random order of presentation from the out-patient clinic. On the same day of inclusion, all patients underwent clinical examination, laboratory tests (inflammatory markers), ankle ultrasound and patient-reported outcomes. Results. the study included 183 patients with established RA, mostly women (86.3%), with mean age of 57.3 years. The most frequent tenosynovitis was observed in the tibialis posterior tendon (TP; 40.4%), followed by the peroneus longus (23.0%) and peroneus brevis (18.0%) tendons. Compared to patients without TP tenosynovitis, patients with TP tenosynovitis had significantly higher titres of rheumatoid factors (RF; median of 123 IU/mL compared to 64 IU/mL; p = 0.023). Clinically tender (55.2%) and swollen (30.6%) ankles were 4.2 and respectively 11.6 times more likely to reveal tenosynovitis on ultrasound. The presence of ankle tenosynovitis was associated with higher disease activity measures. DAS28 increased proportionally and significantly with the number of ankles with tenosynovitis, the grade of ankle tenosynovitis and power Doppler activity. The absence of ankle tenosynovitis independently and significantly decreased DAS28 with 1.2 points (p < 0.001). Conclusions. the most frequent ankle tenosynovitis observed in RA patients involves the TP tendon, which is associated with higher titres of RF. Swollen ankles are more specific and better predictors of ultrasound-defined ankle tenosynovitis, which has a directly proportional relationship with disease activity in RA. Disease activity scores should include clinical evaluation of ankles and ultrasound information.

The objective of the present study was to evaluate whether an innovative quantitative ultrasound (QUS) technique, Radiofrequency Echographic Multi Spectromety, which combines B-mode ultrasound and radiofrequency signals, is reliable in typical Romanian patients compared to previous results obtained using dual-energy X-ray absorptiometry (DXA). The study prospectively included previously unscreened post-menopausal females with rheumatoid arthritis (RA) and age-matched healthy controls. Bone mineral density (BMD) measurements were performed with an EchoS machine (Echolight®), which combines B-mode ultrasound and radiofrequency signals. The study included 106 RA patients, with a median disease duration of 3.2 (0.5-22) years and 119 controls. RA patients had a significantly lower body weight, body mass index (BMI) and basal metabolic rate (BMR) than the controls, while the prevalence of obesity and body fat differed insignificantly. RA patients had a significantly lower spine and hip BMD, higher fracture risk and higher prevalence of osteoporosis. Compared to RA patients without osteoporosis, those with osteoporosis were significantly older and had a longer menopause duration, but they had a significantly lower BMI, body fat, BMR and prevalence of obesity. Among the controls and RA patients, the median spine and hip BMD became significantly higher as the BMI increased from underweight to obesity. In conclusion, osteoporosis is prevalent among RA patients, as a part of a complex transformation of body mass composition, involving BMI and fat mass. The novel QUS scanning technique was able to replicate the results of the established DXA measurement of BMD and is potentially suitable for screening wide populations for osteoporosis.

Objective. We aimed to evaluate the prevalence and differences of clinical and ultrasound involvement of ankles in rheumatoid arthritis (RA) patients in remission. Methods. RA patients were recruited in 2018 in the random order of presentation from the out-patient clinic. In the day of enrolment, all patients underwent clinical examination (by a senior rheumatologist, blind to other evaluations), inflammatory markers (e.g. C-reactive protein – CRP) and ankle ultrasound (performed and interpreted by a single rheumatologist with more than 7 years of experience). Results. The sample included 59 patients in DAS28CRP remission, 27 in SDAI remission and 20 in Boolean remission. Among these 3 categories of remission, overall clinical ankle involvement presented similar prevalence (revolving around 30%). On average, 77% of patients presented overall ultrasound ankle involvement among the 3 categories of remission, with similar frequencies of ankle joint synovial hypertrophy (SH; 33%), power Doppler (PD) positive joint SH (15%), ankle joint effusion (60%), ankle tenosynovitis (27%) and PD positive ankle tenosynovitis (15%). In the subgroup of RA patients in DAS28CRP remission, compared to patients without clinical or ultrasound ankle involvement, those with at least one involved ankle had a significantly higher median CRP (0.34 mg/dl versus 0.19 mg/dl, p = 0.042). Conclusion. Among RA patients in remission, regardless of its definition, clinical and ultrasound involvement of ankles is frequent. Clinical and ultrasound screening of ankles in RA patients in remission seems an appropriate strategy.

Objective. The study aimed to investigate the relationship between ankle involvement and disease activity in rheumatoid arthritis (RA), from clinical and ultrasound perspectives. Methods. RA patients were recruited in 2018 in the random order of presentation from the out-patient clinic. On the same day of inclusion, all patients underwent clinical examination, laboratory tests (inflammatory markers), ankle ultrasound and patient-reported outcomes. Results. The study included 183 patients with established RA, mostly women (86.3%), with mean age of 57.3 years. Clinical examination revealed 101 (55.2%) patients with at least one tender ankle and 56 (30.6%) patients with at least one swollen ankle. Regression analysis revealed that both clinically tender and swollen ankles were 2.8 and respectively 3.4 times more likely to reveal ultrasound ankle joint synovial hypertrophy (SH). The presence of ankle SH was associated with higher disease activity: for example, compared to patients without ankle SH, patients with ultrasound-detected SH in any ankle joint had significantly higher median DAS28CRP (4.60 compared to 2.73, p Conclusion. Clinical ankle involvement and ultrasound-detected ankle SH have a directly proportional relationship with disease activity in RA.

Introduction. There is accumulating evidence that high normal serum uric acid (SUA) levels of 6-7 mg/dL are associated with cardiovascular morbidity and metabolic syndrome (MetS), hence the need to redefine its upper limit of normal (ULN). We aimed to derive ULN based on statistics and evidence in a representative sample of the population and to observe its relation to MetS components. Methods. All SUA measurements form a university rheumatology hospital were extracted between January 5th 2010 and March 21st 2018. SUA levels were measured by a single biochemist a unique type of commercially available kit. Follow-up measurements, patients with diagnoses influencing SUA levels and outlying measurements were excluded. ULNs were studied using least square analysis. Results. Of the 22503 SUA measurements in the database, only 3318 came from normal individuals: 33.3% men (n=1105), 66.7% women (n = 2213). Least square analysis revealed the following SUA reference intervals (RI): 3.43-6.19 mg/dL for the combined sample; 4.44-7.01 mg/dL for men, 3.28-5.56 mg/dL for women. The values corresponding to the 66th percentile of each group presented lower ULNs: 5.36 mg/dL for all, 6.10 mg/dL for men, 4.90 mg/dL for women. The prevalence of hyperuricemia increased from 13.8% (manufacturer’s gender-specific ULN) to 19.9% (derived ULN). Mean SUA levels significantly increased with the number of MetS components. Conclusion. We recommend that hyperuricemia should be defined using a statistical approach of ULN selection corresponding to the genderand population-specific 66th percentile of data range.

Spondyloarthritis (SpA) is a group of associated chronic systemic inflammatory immune-mediated rheumatic diseases affecting axial and peripheral joints and entheses. The aim of the present study was to identify what parameters are useful to determine in order to better understand the correlation between the disease activity/severity and the microbiological results/immune status against intestinal and/or urogenital pathogens. Microorganisms known to trigger SpA, including Klebsiella spp., Yersinia spp., Salmonella spp., Campylobacter spp. and Chlamydia spp., were analyzed in various specimens (stool, urine, synovial fluid and serum) collected from 27 randomly selected SpA patients and 26 healthy controls using a combined direct and indirect approach relying on conventional culture technique and nucleic acid-based assays together with serological testing by ELISA. Although Escherichia coli derived from phylogroup A prevailed in the gut microflora of the patients and controls, differences were observed regarding the representatives of the other phylogroups with a higher prevalence of E.coli members of phylogenetic group B1 in the stool specimens of patients. Antibodies against the targeted species were detected in SpA patients and controls, and the serological profiles of the former were more diverse and complex. In conclusion, the detection of anti-bacterial antibodies combined with other specific laboratory investigations should be more extensively used to monitor SpA patients in association with their symptoms and in order to determine and administer more effective therapeutics.

The objectives of the study were to evaluate bone metabolism in primary prostate cancer (PCa) patients prior to any treatment and to compare estrogens and anti-androgens in terms of bone metabolism. The study prospectively included consecutive patients with primary PCa who were proposed for radical prostatectomy and androgen deprivation therapy (ADT; either estrogens-group E, or anti-androgens -group A) and age-matched controls. Bone markers (osteoprotegerin -OPG; osteocalcin; deoxypyridinoline) were measured before treatment and after 6 months. Bone mineral density (BMD) was measured by dual X-ray absorptiometry before treatment and after 12 months (osteoporosis was defined as a spine or hip T score � -2.5). Continuous variables are reported as mean � standard deviation. The study included 30 controls (aged 70 � 6 years), 15 patients treated with estrogens (aged 71 � 6 years) and 15 patients with anti-androgens (aged 72 � 5 years). At baseline, 0% of controls, 33.3% of group E (p = 0.002 versus controls) and 53.3% of group A (p = 0.0001 versus controls) had osteoporosis. In group E, compared to baseline, OPG (4.67 � 1.38 versus 5.27 � 1.89; p = 0.043) and DPD (6.85 � 3.24 versus 8.63 � 2.42; p = 0.008) increased, while spine (0.99 � 0.32 versus 0.94 � 0.31; p = 0.019) BMD decreased. In group A, compared to baseline, OPG (6.37 � 3.04 versus 5.02 � 1.12; p = 0.041), spine (1.03 � 0.15 versus 0.89 � 0.15; p = 0.0003) and hip (0.82 � 0.18 versus 0.75 � 0.17; p = 0.003) BMD decreased. Osteoporosis is prevalent among hormone-na�ve PCa patients. Estrogens are associated with an increase of serum OPG, while anti-androgens with a decrease of serum OPG. Irrespective of ADT type, BMD still decreases in primary PCa patients.

Objective. The aim of the study was to identify a clinical pattern of spondyloarthritis (SpA)-associated uveitis in order to facilitate proper rheumatologic referral by ophthalmologists. Methods. Demographic data were recorded and acute phase reactants were measured using standard methods between May and August 2017, for all adult patients (age > 18 years) presenting with acute uveitis (standardization of uveitis nomenclature). Afterwards, they were referred to a rheumatology clinic to be screened for the 2009 Assessment of SpondyloArthritis International Society (ASAS) classification criteria of SpA. SpA and non-SpA patients were then compared using appropriate statistical tests (significant if p < 0.05). All the patients offered a written informed consent and the study was approved by the local ethics committee. Results. The sample included 67 subjects, of whom 32 (47.8%) were classified with SpA, of whom 21 were known with this diagnosis (median disease duration of 13.6 years), while 11 (34.4% of the SpA subgroup) fulfilled the ASAS classification criteria for SpA without a prior diagnosis. Compared to non-SpA patients, SpA patients were more frequently male urban dwellers, they were significantly younger, they had a higher prevalence of HLA-B27 and recurrent uveitis, and they had higher median of C-reactive protein and lower median of white blood counts. Conclusions. Uveitis is an important revelatory manifestation of SpA. Young men presenting in an ophthalmology department with acute anterior uveitis and inflammatory back pain should be referred to a rheumatology unit. Abbreviations: AAU = Acute Anterior Uveitis, AS = Ankylosing Spondylitis, ASAS = Assessment Of Spondyloarthritis International Society, CRP = C-Reactive Protein, ESR = Erythrocyte Sedimentation Rate, HLA = Human Leukocyte Antigen, IBP = Inflammatory Back Pain, IBD = Inflammatory Bowel Disease, IL = Interleukin, MRI = Magnetic Resonance Imaging, Nsaids = Non-Steroidal Anti-Inflammatory Drugs, SD = Standard Deviation, Spa = Spondyloarthritis, Tnfα = Tumour Necrosis Factor Alpha, WBC = White Blood Count.

Objective. The study aimed at observing drug survival and determining potential predictors of anti-TNFα switch among ankylosing spondylitis (AS) patients. Methods. The study retrospectively recorded clinical data of patients fulfilling modified New York criteria in a single university clinic. The data were analyzed using appropriate statistical test, which were considered significant if p < 0.05. Results. A total of 120 patients met the inclusion criteria. Switchers had a median BASFI score of 2.7, a median ASDASCRP of 1.59 and a 41.7% prevalence of uveitis, compared to non-switchers which had a median BASFI score of 2.0, a median ASDASCRP of 1.20 and a uveitis prevalence of 22.9% respectively (p = 0.009; p = 0.025; p = 0.043). After a median of 7.0 years of observation, 96 patients (80.0%) were still being treated with their first anti-TNFα agent, with a Kaplan-Meier survival time estimate of 11.5 (10.1-12.9) years. The Kaplan-Meier study of the time of treatment until switch of the first biologic agent according to ASDASCRP categories revealed 9.3 (8.8-9.8) years for inactive disease, 10.6 (8.8-12.5) years for moderately active disease and 7.1 (5.7-8.5) years for highly active disease. The switch hazard ratio for CRP was 1.019 (1.007-1.031; p = 0.002), for BASDAI 1.226 (1.017-1.477; p = 0.032), for BASFI 1.264 (1.057-1.513; p = 0.010) and for ASDASCRP 1.592 (1.173-2.159; p = 0.003). Conclusion. Romanian AS patients on anti-TNFα agents exhibit high retention rate and drug survival of anti-TNFα agents. Switchers have significantly higher baseline disease activity indices which, along baseline acute phase reactants, can significantly predict switching of the first anti-TNFα agent. Patients with AS treated with anti-TNFα agents had a higher prevalence of uveitis than those who did not therapeutic switch.

Objective. This exploratory study aimes at comparing Romanian gout patients with or without colchicine treatment in order to determine if colchicine is associated with a lower cardiovascular morbidity. Methods. The study was cross-sectionally designed to include all the patients randomly admitted to the hospital between January and July 2015 and discharged with a diagnosis of idiopathic gout according to their attending physicians. The clinical observation sheets served as retrospective sources of information regarding study variables (demographics, addictive behavior, gout phenotype and treatment, cardiovascular morbidity). Data analysis included non-parametric tests and binary logistic regressions (significant if p < 0.05). Results. The sample included 96 subjects, predominantly men (77.1%), with a mean age of 62.7 years. 60 (62.5%) subjects received colchicine. Compared to patients who didn‘t receive colchicine, they had a significantly lower prevalence of ischemic heart disease, chronic heart failure and atherosclerosis (p < 0.05). Colchicine was a significant protective factor for atherosclerosis (OR = 0.243; 95% CI: 0.076-0.784). Conclusions. Primary and secondary cardiovascular prevention may benefit from low doses of colchicine. Further prospective blind randomized clinical trials are needed to test these hypotheses.

Aim: To evaluate the frequency of tibiotalar and subtalar joints together with extensor, flexor and peroneal tendons inflammatory lesions in rheumatoid arthritis (RA) patients by using ultrasound (US) and magnetic resonance imaging (MRI).Material and methods. Fifty RA patients and 25 healthy subjects were prospectively included. All patients and controlsunderwent clinical examination (to screen for swollen and/or tender ankles) and ankle US and MRI (to screen for synovialhypertrophy – SH, tenosynovitis and power Doppler – PD signals). The imaging tests were compared using overall agreement, positive agreement, Cohen’s κ, sensitivity, specificity and positive likelihood ratio.Results. The subtalar joint had the highest frequency of US-detected SH (30%), as well as positive PD signals (10%). Regarding US joint effusion, the tibiotalar joint recorded the highest frequency (44%). The most frequent US tenosynovitis was detected in the tibialis posterior tendon (40%). Compared to MRI, US evaluation of tibiotalar joints had very good agreement and large effect on detection probability for both SH and effusion (kappa 0.84, positive likelihood ratio 21.1). Compared to MRI, the sensitivity and specificity for US joint involvement ranged between 72.0-88.5% and 82.4-95.8%, and for tenosynovitis were 33.3-78.6% and 85.2-100%, respectively. Compared to asymptomatic RA patients (n=25), those with at least one symptomatic ankle (n=25) had significantly higher frequencies of both SH and effusion in all the evaluated structures.Conclusion: US has high sensitivity and specificity in detecting RA inflammatory lesions in the ankle and rearfoot, in very good agreement with MRI. The high frequency of ankle inflammatory lesions in RA should result in increased interest in the imaging evaluation of these structures.

Rheumatoid arthritis (RA) is associated with increased costs generated by resource utilization and loss of work productivity. We have studied 206 RA patients and analyzed indirect costs of RA in Romania (estimated using the human capital approach) in comparison with reported data for other countries. Data were collected using self-reported questionnaires. The average age at inclusion was 55 years, with mean disease duration of 9.4 years; 55 patients had permanent work disability due to RA; 6.35 days of sick leave per patient were reported for the entire year of follow-up; the cost of permanent work disability was 1256€ per patient. From a societal perspective, the average indirect costs for a patient with RA were 1506€, significantly lower than the ones reported by other countries, especially due to the low monetary value of paid work.

Objectives. The study aims at comparing classical and biological treatment of ankylosing spondylitis (AS) in terms of efficacy and to determine which treatment type is a significant predictor of low disease activity in a real life clinical situation. Methods. The study was cross-sectionally designed to include all the patients randomly admitted between January and July 2015 to the “Sfanta Maria” Clinical Hospital Department of Rheumatology and discharged with a diagnosis of AS according to their attending physicians. The retrospectively collected variables (demographics, disease phenotype and activity, treatment, laboratory measures) were analyzed using appropriate statistical tests (Mann Whitney, χ2, linear and logistic regression). Results. The study sample included 105 cases of established AS with a mean age of 43.2 years: 64 patients (60.9%) were on tumor necrosis factor inhibitors (TNFi: adalimumab, etanercept or infliximab), 55 (52.4%) took non-steroidal anti-inflammatory drugs (NSAIDs) and 30 (28.6%) had sulfasalazine. TNFi were associated with lower disease activity compared to NSAIDs and sulfasalazine and they were significant predictors for low BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), either as mono-therapy or combined with NSAIDs and/or sulfasalazine. Conclusion. TNFi are more efficacious than NSAIDs and sulfasalazine for the treatment of AS. A combination of TNFi with NSAIDs (and sulfasalazine for peripheral arthritis) would be the ideal therapeutic association.

Introduction: Rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA) are poor prognostic factors in rheumatoid arthritis (RA). The therapeutic implication of antinuclear antibody (ANA) positivity in RA is still debated. The study aims to evaluate ANA positivity as a prognostic factor for the therapeutic response to biologics in RA. Methods: observational study; data were gathered from the Romanian Registry of Rheumatic Diseases which comprises all biological-treated RA patients in Romania. We included only RA patients who were tested for ANA before initiating biologics. Results: A number of 740 RA patients were included (72.4% treated with TNF-α blockers, 27.6% with rituximab). Compared to ANA-negative patients, ANA-positive patients (26.9%) had: a higher disease activity score (DAS28) prior to biologics, at the time of treatment switch and after the observation period; lower drug persistence (p < 0.001 for all tests). Multiple linear regressions showed that ANA positivity is a significant predictor of the current value of DAS28, independently of the presence of RF and/or ACPA (p < 0.05). Conclusion: ANA positivity in RA patients before starting biologics may be a poor prognosis factor for efficacy and drug persistence. Further studies are needed to confirm these observations.

Introduction. The study aimed to evaluate the influence of socioeconomic factors on rheumatoid arthritis (RA) patients’ access to biologics in Romania. Method. Cross-sectional data were collected in January 2014 from the Romanian Registry of Rheumatic Diseases (RRRD) comprising all RA patients on biologics from 42 Romanian counties. “Territorial” access to biologics was defined by patients receiving biologics in their home county. A county was “equitable” if Results. The RRRD included 4507 RA patients aged 56.7±12.1 years, with a disease duration of 12.1±8.3 years. Urban dwellers (67.8%) had a significantly higher prevalence of territorial biologic access than rural dwellers (83.1% compared to 74.1%; p<0.001). Gross domestic product (GDP) in 1000 €/capita/county (odds ratio (OR) = 1.224) and number of physicians/1000 inhabitants/county (OR = 2.198) predict territorial access to biologics and also predict the number of territorially treated RA patients. Inequitable counties exhibited significantly lower socioeconomic indicators than equitable counties. Conclusion. In Romania, RA patients’ access to biologics varies significantly between counties. Urban dwellers and patients living in counties/regions with high living standards are more likely to receive biologics locally than those living in more deprived areas.

Aim. The study aims to assess the potential influences of rheumatoid arthritis (RA) and its specific disease measures on lean body composition phenotypes of female patients. Methods. The study was cross-sectionally designed to include Caucasian postmenopausal female RA patients and age-matched postmenopausal female controls. All the subjects gave written informed consent and the study was approved by the local ethics committee. Each subject underwent in the same day a clinical examination, laboratory tests, whole body dual X-ray absorptiometry (DXA) composition and physical activity estimation using a self-administered questionnaire. Correlations, differences and predictive power were analyzed with appropriate statistical tests. Results. The study included 107 RA patients and 104 controls. Compared to the normal subjects, who recorded higher levels of physical activity, the RA patients had significantly lower appendicular lean tissue absolute and relative indices and higher prevalence of sarcopenia. The whole body and appendicular lean tissue indices showed significant negative correlations with measures of disease severity (duration, inflammation, quality of life and radiographic progression), independent of age, levels of physical activity, body mass index and smoking. Conclusions. The measures of disease activity and severity independently predict lean tissue phenotypes in RA patients, behaving as risk factors for sarcopenia and rheumatoid cachexia. The diagnosis of RA in itself is a significant predictive factor of sarcopenia.

Rationale. Data from controlled trials showed that adalimumab, a humanized anti-TNF monoclonal antibody, is effective and safe in the treatment of ankylosing spondylitis (AS). Objectives. The present study aimed to observe the effi cacy and safety of adalimumab in AS in a real life clinical setting. Methods. The study observed cross-sectionaly and retrospectively the efficacy and safety of adalimumab in all the patients admitted to the Rheumatology Department of “Sfânta Maria” Clinical Hospital between January 2008 and June 2013 who were classified as having AS according to the modified New York criteria. The diagnosis and follow-up of uveitic cases were done in the Ophthalmology Department of the Emergency University Hospital. Results. Within the study time-frame, 79 AS patients met the inclusion criteria: 71 (89.9%) had adalimumab for at least 24 months; 8 (10.1%) switched from adalimumab to another biological, as follows: 3 (3.8%) because of serious adverse events, 3 (3.8%) were primary non-responders and 2 (2.5%) were secondary non-responders. The clinical response was fast: after 3 months of treatment, 59 (83.1%) patients had BASDAI < 4 and 55 (77.5%) patients had BASFI < 4. Regarding safety, the serious adverse effects recorded were: infectious arthritis, pulmonary tuberculosis, pulmonary sarcoidosis. There were no cases of cancer or demyelinating disease during the study frame. Conclusions. Therapy with adalimumab in AS produces a prompt and lasting effect. The efficacy (remission) and safety (adverse events) of adalimumab can be monitored in the real-life clinical setting using BASDAI, BASFI, and routine clinical evaluations. Clinicians may need to expect a slightly higher rate of serious adverse events and rate of treatment discontinuation than those reported by controlled trials.

Aim. Rheumatoid arthritis (RA) may influence not only abdominal fat, but also whole body adiposity, since it is associated with chronic inflammation and disability. The study aims to evaluate the whole body adiposity of RA patients and to assess potential influences of disease specific measures. Methods. The study was designed to include Caucasian postmenopausal female RA patients and age-matched postmenopausal female controls. Each subject underwent on the same day clinical examination, laboratory tests, whole body dual X-ray absorptiometry (DXA) composition and physical activity estimation using a self-administered questionnaire. Results. A total of 107 RA women and 104 matched controls were included. Compared to controls, the RA group had less physical activity and a higher prevalence of normal weight obesity. Overfat RA women had a significantly higher toll of inflammation, disease activity, glucocorticoid treatment and sedentary behavior. RA women with inflammation, glucocorticoid treatment and higher disease activity class had higher whole body and trunk adipose tissue indices and higher prevalence of overfat status. Glucocorticoid treatment, inflammation, disease duration and severity correlated with whole body adipose tissue and significantly predicted high adiposity content and overfat phenotypes. Conclusions. RA disease duration and severity are associated with higher whole body and regional adiposity. Low-dose glucocorticoid treatment seems to contribute to adiposity gain and redistribution. Clinicians may need to assess body composition and physical activity in RA patients in order to fully manage cardiovascular outcomes and quality of life.

Introduction. Atherosclerosis and osteoporosis share an age-independent bidirectional correlation. Rheumatoid arthritis (RA) represents a risk factor for both conditions.Objectives. The study aims to evaluate the connection between the estimated cardiovascular risk (CVR) and the loss of bone tissue in RA patients.Methods. The study has a prospective cross-sectional design and it includes female in-patients with RA or without autoimmune diseases; bone tissue was measured using whole body dual X-ray absorptiometry (wbDXA); CVR was estimated using SCORE charts and PROCAM applications.Results. There were 75 RA women and 66 normal women of similar age. The wbDXA bone indices correlate significantly, negatively, and age-independently with the estimated CVR. The whole body bone percent (wbBP) was a significant predictor of estimated CVR, explaining 26% of SCORE variation along with low density lipoprotein (P < 0.001) and 49.7% of PROCAM variation along with glycemia and menopause duration (P < 0.001). Although obese patients had less bone relative to body composition (wbBP), in terms of quantity their bone content was significantly higher than that of nonobese patients.Conclusions. Female patients with RA and female patients with cardiovascular morbidity have a lower whole body bone percent. Obese female individuals have higher whole body bone mass than nonobese patients.

Background The efficacy of anti TNFblockers in active ankylosing spondylitis (AS) is widely accepted. In Europe, high costs related to biological treatment lead to significant differences regarding the patient9s accessibility to treatment depending on the level of economic development of different countries. In Romania, according to the national reimbursement protocol, a patient is eligible for treatment with TNF blockers if the disease is active despite using at least two non-steroidal anti-inflammatory drugs and sulfasalazine (for peripheral arthritis). Objectives The aim of the study is to assess the accessibility of patients with AS to biological therapy in Romania, depending on their area of residence and socio- economical indicators for each region. Methods A cross-sectional study was performed in 41 counties and Bucharest. Data were collected from the Romanian Registry of Rheumatic Diseases and the socio- economic indicators from the yearbook of the National Institute for Statistics. Results Data were gathered for 2013 AS patients treated with biologics. The mean age was 45.46 yrs (±12.07), 78% were male, 71% live in urban residences and the mean disease duration was 11.53 yrs. 74% (n=1498) of patients had access to biologics in their county of residence, while 26% (n=524) of patients had to travel for treatment to another county. Compared to the group treated inside their county of residence, those treated outside, originated from areas with a lower gross domestic product per capita (5701.77 € compared to 8722.44 €; p 2 test); so the latter have to travel in order to being cared by a rheumatologist. The patients9 age had a great influence on the accessibility to biologics: the patients treated outside of their county of residence were younger than those treated inside (44.1 yrs compared to 45.9 yrs; p=0.003, t test). On a national scale, the majority of AS patients treated outside their county of residence (86%; 449); were treated in Bucharest (the capital city); so the majority of patients treated with biologics in Bucharest are originating from other counties (60%; n=449/751). Conclusions In Romania, although there is a national protocol for biological therapy in AS, applied in the same way in every region of the country, the accessibility to biologic therapy varies a lot, mostly due to differences in the socio- economic status of each area of residence. Disclosure of Interest None declared

Background and Objectives Osteoporosis and cardiovascular morbidity are strongly associated with age and menopause. The study aimed to evaluate the association of cardiovascular risk (CVR), estimated using SCORE charts, with BMD measured using lumbar dual X-ray absorptiometry (DXA). Materials and Methods We included female in-patients, who underwent a lumbar DXA measurement between January-June 2013, which revealed a T-score ≤ -2.5. The correlations of normally distributed data were assessed using Pearson coefficients and t tests respectively. For non-normally distributed data we used Spearman coefficients and Mann Whitney tests respectively. Differences between qualitative data were evaluated using χ 2 or Fisher tests where appropriate (SPSS v. 17). Statistical significance was stated if p Results A total of 101 female patients fulfilled the inclusion criteria. All lumbar spine DXA measurements correlated significantly and negatively with the SCORE estimate (for example Z-score: r = - 0.468; p 0.2). Instead, regardless of age, these bone variables correlated significantly and positively with height (for example LBM: r = 0.350; p 2 = 0.287). The ROC area for lumbar bone mass and fragility fractures at the time of the DXA measurement was 0.795 (95% CI: 0.668 – 0.923; p Conclusions Osteoporosis and cardiovascular morbidity are independent variables which evolve separately in the context of ageing. A prospective study using whole body bone indices and better cardiovascular (surrogate) end-points would strengthen this conclusion. Romanian urban female patients exhibit better lumbar DXA bone indices compared to rural women.

Background Atherosclerosis and osteoporosis share an age-independent bidirectional correlation.[1] Rheumatoid arthritis (RA) represents a risk factor for both conditions. So far, only hip and lumbar spine indices were used in clinical studies.[2] Objectives The study aims to evaluate the connection between the estimated cardiovascular risk (CVR) and the loss of whole body bone tissue in RA patients. Methods Prospective cross-sectional design; female in-patients with RA or without autoimmune diseases; bone tissue was measured using whole body dual X-ray absorptiometry (wbDXA); CVR was estimated using SCORE charts and PROCAM applications. Results There were 75 RA women and 66 normal women of similar age. The wbDXA bone indices correlate significantly, negatively and age-independently with the estimated CVR. The whole body bone percent (wbBP) was a significant predictor of estimated CVR, explaining 26% of SCORE variation along with low density lipoprotein (p Conclusions Female patients with RA and female patients with cardiovascular morbidity have a lower whole body bone percent. Obese female individuals have higher whole body bone mass than non-obese patients. The study suggests a common pathogenic process involving whole body bone tissue and atherosclerosis. References Farhat GN, Cauley JA. The link between osteoporosis and cardiovascular disease. Clin Cases Miner Bone Metab 2008; 5(1): 19-34. Shibuya K, Hagino H, Morio Y et al., Cross-sectional and longitudinal study of osteoporosis in patients with rheumatoid arthritis. Clin Rheumatol 2002; 21(2): 150-8. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.3671