Search

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.

Background. Registries data are important contributors to complement information provided by randomized controlled trial reports in terms of effectiveness and safety evaluation for anti-rheumatic drugs used in clinical practice. Objectives. We aimed to estimate the 12 month secukinumab retention rate and effectiveness in patients with axial spondyloarthritis. Data from the Romanian Registry of Rheumatic Diseaases (RRBR, in Romanian) were collected for all patients who received at least one course of secukinumab. The retention rate was calculated using Kaplan-Meier method with log-rank test. Effectiveness was assessed at 6-month and at 12-month for inactive disease and for low disease activity states (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI < 2 and BASDAI < 4) and Ankylosing Spondylitis Disease Activity Score (ASDAS < 1.3 and ASDAS < 2.1). Results. The study included 616 patients with axial spondyloarthritis who received secukinumab. 226 patients were naïve to biologic treatments; 220 patients had one prior bDMARD; 170 patients used two or more bDMARDs. The overall 6-months and 12-months secukinumab retention rates were 68%/49% with significant differences in favour of biologic naïve patients: bDMARD-naïve: 78%/58%, 1 prior bDMARD: 63%/45%, ≥ 2 prior bDMARDs: 61%/41%. The 6-month and 12-month results for effectiveness: overall BASDAI < 2: 54%/66%; overall BASDAI < 4: 91%/97%; overall ASDAS < 1.3: 14%/19%; overall ASDAS < 2.1: 53%/73%. The number of previous bDMARDs had an impact on effectiveness, with more responders being observed in the biologic naïve group. Conclusions. Our results show that the best retention rate for secukinumab treatment, as well as efficacy, is attained for the bio-naive treatment group. The main reason for discontinuation of secukinumab treatment is secondary loss of efficacy

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. The study aimed to observe the variability of rheumatoid arthritis (RA) disease activity scores according to the type of patient global assessment (PtGA) and to compare these subjective assessments with objective measurements. Methods. Prospective study in which RA patients four types of assessments in the same day of their inclusion in the study: completing a questionnaire (including PtGA on a 100 mm visual analogue scale – VAS, and a 0-10 Likert scale), clinical interview and joint examination performed by each attending rheumatologist and peripheral venous blood sampling for acute phase reactants. Results. The study included 110 RA patients (57.5 years average age, 9.4 years median disease duration, 90.0% women, 58.2% in remission or low disease activity). There was low concordance and agreement between PtGA and physician global assessment (PhGA): the two evaluations were significantly but poorly correlated, and in 71.8% of cases VAS and Likert PtGA were higher than PhGA with at least 2 points in average. Patients with no tender or swollen joints (27.3%) reported a median VAS-PtGA of 27 cm and a median Likert-PtGA of 4.2 points. Likert-PtGA were higher than VAS-PtGA in the general sample and for patients with normal objective measures (patients in remission according to DAS28-3v-CRP reported a median VAS-PtGA of 5 points, compared to VAS-PtGA of only 2.2 cm). The strongest correlations of PtGA on both VAS and Likert scales were recorded for mHAQ (r = 0.521 and 0.589, p < 0.001), DAS28-3v-CRP (r = 0.419 and 0.422, p < 0.001) and the presence of prolonged morning stiffness (r = 0.361 and 0.485, p < 0.001). Conclusion. Romanian patients with RA seem to favour and understand the Likert scale better than the VAS when reporting PtGA.

The Romanian Register of Rheumatic Diseases (RRBR, in Romanian) is an electronic database which includes data regarding all patients with immune-mediated rheumatic diseases who receive biologic therapies. These real-life data include: demographics, clinical disease forms, comorbidities, treatment regimens with biologic disease-modifying anti-rheumatic drugs (bDMARDs), and efficacy and safety data related to these treatments. The purpose of this study was to analyse the data of patients with psoriatic arthritis (PsA) introduced in the RRBR in RRBR was relatively constant compared to previous years. Patients with PsA had numerous comorbidities, with cardiovascular being the most commonly encountered. Most patients continue to receive combination therapy with a conventional synthetic DMARD (csDMARD), methotrexate being the most commonly used, but the percentage was lower than 2018. The concomitant use of systemic glucocorticoids has been recorded at a very low percentage. There is a tendency to initiate biologic treatment earlier, with over one third of patients receiving biologic therapy within the first 2 years after diagnosis. The most prescribed bDMARDs are still TNF blockers, with etanercept (original + biosimilar) being the most common, followed by adalimumab (original + biosimilar). The only biologic agent with another mechanism of action that was reimbursed in Romania in 2019 was secukinumab, this drug being used in almost one third of initiation and being the main option in the case of switches. The efficacy data show that the vast majority of patients have a low disease activity or are in remission. Although the percentage of patients who had a tapering regimen was reduced, this strategy proved to be a valid option for the majority of those to which it was applied. RRBR is an extremely useful tool for evaluating real-life data related to patients with PsA and the therapeutic strategies used in Romania, allowing their integration and interpretation in the context of similar registers in other countries.

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.

The Romanian Registry of Rheumatic Diseases (RRBR, in Romanian) is an electronic application that includesdata of all patients with inflammatory rheumatic diseases treated with biologics in Romania. First patients with axial spondyloarthritis (axSpA) were included in 2015 and the registry collected multiple variables like demographics,axSpA therapies, disease activity, adverse events, in order to provide data for patients in our country. The number of axSpA patients introduced in RRBR has been steadily increasing within the last 3 years. Thepatients included in the registry are with the two types of ax SpA (non-radiographic and radiographic spondyloarthritis) with a relatively high prevalence of extra-scheletal manifestations and a lot of comorbidities. Dataregarding treatment showed a prevalence of monotherapy with biologic disease-modifying anti rheumatic drugs (bDMARDs), TNF-alpha inhibitors being used by 91% of the patients. 41% of the patients started bDMARD-therapy early during disease course (under 2 years from diagnosis). The most frequent prescribed bDMARDs wasadalimumab, followed by etanercept. Treatment decisions trends in 2019 showed that some molecules present a positive balance such as bDMARD biosimilars and secukinumab. Overall, bDMARDs achieved treatment target(ASDAS defined remission and LDA) within the first 6 months of treatment in 87.6% of treated patients. Also,RRBR data indicate a slow but significant increase in tapered regimens. Thus, the RRBR has proved to be avery valuable tool in capturing data regarding axial spondyloarthrits management in a real-life national setting ofrheumatology healthcare.

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.

Background: Even though certolizumab pegol (CZP) has been licensed for the treatment of rheumatoid arthritis (RA) a long time ago, observational data in real-life settings are still lacking. Moreover, recent data on the lack of transplacental passage (1) make CZP particularly appealing for the treatment of RA women with a desire of pregnancy. Objectives: To evaluate in a real-life international cohort the frequency of use, the clinical response, and the retention rate of CZP in RA women of childbearing age. Methods: Data were retrospectively extracted from the Italian LORHEN and the Romanian Registry of Rheumatic Diseases (RRBR) registries, which include all RA patients treated with CZP between December 2010 and October 2018. The analysis was limited to women who received CZP as first-line biologic agent. The study population was stratified according to childbearing age (18-49 versus >49 years). The 6-, 12- and 24-month clinical response was evaluated as the proportion of patients achieving Disease Activity Score 28 (DAS28) remission and compared between the subgroups by a chi-squared test. The 5-year retention rate was calculated by the Kaplan-Meier method and compared between the subgroups by log-rank test. Results: The whole cohort included 630 RA patients treated with CZP. According to the inclusion criteria, the study population consisted of 308 female RA patients (mean [± standard deviation, SD] age 54.2±12.1 years; mean disease duration 8.7±8.4 years; baseline DAS28 5.25±1.72, positive anti-citrullinated peptide antibody 161/254 [63.4%], positive rheumatoid factor 213/297 [71.7%]). Apart from mean age (39.6±6.6 vs 60.8±7.2, respectively; p Conclusion: In our real-life data, CZP showed a high remission rate with a good safety profile and high persistence on treatment over 5 years. These findings were even more favorable during the childbearing age, supporting the use of CZP in RA women with a desire for pregnancy. Reference: [1] Mariette X, Forger F, Abraham B, et al. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018;77:228-33. Disclosure of Interests: Ennio Giulio Favalli: None declared, Andrea Becciolini: None declared, Roberto Caporali Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Roche, Genzyme, Lilly, MSD, Pfizer, UCB, Piercarlo Sarzi Puttini: None declared, Roberto Gorla: None declared, R Ionescu: None declared, S Rednic: None declared, A Balanescu: None declared, E Rezus: None declared, C Mogosan: None declared, Catalin Codreanu: None declared

Background: Rheumatoid arthritis (RA) is associated with increased mortality, with longitudinal studies averaging a standardised mortality ratio of 1.5 (95%CI 1.2 to 1.8) for RA patients compared to the general population [1]. In contrast, information on mortality in ankylosing spondylitis (AS) is scarce, whereas there are conflicting reports of the mortality risk among patients with psoriatic arthritis (PsA), but it is accepted that patients with PsA do not have a significantly elevated risk of mortality [2]. Objectives: To estimate the Mortality Rate in RA, SA and PsA for patients (pts) treated with biologics in Romania. Methods: Data were gathered from the Romanian Registry of Rheumatic Diseases (RRBR), which comprises all patients treated with biologics in Romania for RA, AS and PsA. We have studied demographic data, disease duration, exposure to biologics in person-years (PY), and all-cause mortality until 01.01.2018. Results: The cohort included 9577 pts (35596.83 PY) as following: 5224 RA pts (18676.75PY), 3469 AS pts (12680.63PY) and 884 PsA pts (4212.45PY). The mean age of the cohort was 54.86 yrs (62.87 yrs for RA, 45.54 yrs for AS, 56.18 yrs for PsA); 3196 pts (33.37%) were men: 79 (1.5%) RA pts, 2681 (77.28%) AS pts and 436 (49.3%) PsA pts. Mean disease duration for the cohort was 16.46 yrs for RA, 11.46 yrs for AS and 10.99 yrs for PsA. The number of all-cause deaths was 89 (74 deaths in RA, 11 in AS and 4 in PsA group). The mortality rate for the entire cohort was 0.25/100PY, and the rate varied across the diseases: 0.39/100PY in RA pts, 0.08/100PY in AS pts and 0.09/100PY in PsA. Infections were the major mortality cause in RA (0.09/100PY) and AS (0.04/100PY). Cardiovascular fatal events occurred in 0.06/100PY in RA population, significantly higher than 0.007/100PY in AS pts. Rate of solid neoplasm death in RA cohort was 0.04/100PY, compared to 0.007/100PY in AS; non-Hodgkin lymphoma was recorded only in RA pts (0.005/100PY). All deaths reported in PsA cohort (4 deaths) were of unknown cause. Conclusion: This is the first report on mortality rate in biological treated patients in Romania. These data support data from the literature, showing that RA patients have a higher mortality risk compared to AS and PsA. References [1] Dadoun S, Zeboulon Ktorza N, et al. Mortality in rheumatoid arthritis over the last fifty years: systematic review and meta-analysis. Joint Bone Spine. 2013:80(1):29-33 [2] Ogdie A, Haynes K, Troxel AB, et al. Risk of mortality in patients with psoriatic arthritis, rheumatoid arthritis and psoriasis: a longitudinal cohort study. Ann Rheum Dis. 2012;73(1):149-53. Disclosure of Interests: None declared

Background:JAK inhibitors are the newest therapeutic class available in Romania for the treatment of rheumatoid arthritis (RA). Both available JAK inhibitors (baricitinib and tofacitinib) are fully reimbursed.Objectives:Efficacy and safety data for JAK inhibitors, derived from the Romanian Registry of Rheumatic Diseases (RRBR).Methods:cohort retrospective study, the data being gathered from RRBR, which includes all the patients treated with biologics and targeted synthetic DMARDs in the country. Inclusion criteria: at least one treatment course of JAK inhibitors, until end of 2019. The collected data: demographic and disease characteristics, efficacy parameters (DAS28) and safety data (exposure to JAK inhibitors in person-years (PY) and reported adverse events (AE).Results:the RA cohort treated with JAK inhibitors included 416 patients (7.6% of all RA patients registered in RRBR) exposed to baricitinib (306 pts) or tofacitinib (110 pts) for 66255 PY. The mean age was 57.91 years, 365 (88%) women, 41 (10%) smokers, mean RA duration 11.32 years, 316 (76%) RF positive, 254 (61%) ACPA positive, 356 (85.5%) patients associate a synthetic DMARD, 76 (18%) use steroids (66% 0.05). Steroid use, the presence of RF or disease duration have no influence on the efficacy DAS28. On contrary, the ACPA positivity subgroup has a significantly lower DAS28 score, compared to ACPA negativity (3.18 vs 3.82, pConclusion:JAK inhibitors represent a safe and efficacious treatment option for patients with active RA.Disclosure of Interests:Catalin Codreanu Consultant of: Speaker and consulting fees from AbbVie, Accord Healthcare, Alfasigma, Egis, Eli Lilly, Ewopharma, Genesis, Mylan, Novartis, Pfizer, Roche, Sandoz, UCB, Speakers bureau: Speaker and consulting fees from AbbVie, Accord Healthcare, Alfasigma, Egis, Eli Lilly, Ewopharma, Genesis, Mylan, Novartis, Pfizer, Roche, Sandoz, UCB, Corina Mogosan Consultant of: Speaker and consulting fees from AbbVie, Novartis, Pfizer, Roche, Sandoz, Speakers bureau: Speaker and consulting fees from AbbVie, Novartis, Pfizer, Roche, Sandoz, Denisa Predeteanu Consultant of: Speaker fee for: Pfizer, Abbvie, Roche, MSD, Speakers bureau: Speaker fee for: Pfizer, Abbvie, Roche, MSD, Simona Rednic: None declared, Magda Parvu Consultant of: Speaker fee and consultant: Pfizer, Novartis, Roche, Abbvie, UCB, Eli-Lilly, Speakers bureau: Speaker fee and consultant: Pfizer, Novartis, Roche, Abbvie, UCB, Eli-Lilly, Elena Rezus: None declared, 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

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.

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 Data on the efficacy and safety of biological therapies for Rheumatoid Arthritis (RA) that come from Patient Registries present the results of clinical practice all over the world. In terms of efficacy, treatment persistence in RA is largely related to reaching the therapeutic target, i.e. remission or low disease activity. Objectives To measure drug persistence with tumor necrosis factor alpha (TNF) antagonists and anti CD20 monoclonal antibody, among RA patients in Romania, as well as identify/determine additional factors that could influence it. Methods Population-based cohort study carried out with RA patients in Romania. Data was gathered from the Romanian Registry of Rheumatic Diseases. The study cohort included RA patients who initiated the first course of a TNF antagonist or anti CD20 monoclonal antibody, anytime between 2004 and 2015. Persistence was measured as the time period during which the drug had been administered to a patient. Drug discontinuation was defined as drug treatment being interrupted due to adverse events, primary or secondary non-responder, or switching to another molecule. The influence of any other factors on persistence used T test and persistence was estimated using survival analysis. Results The study cohort included 4,395 RA patients, mean age 59.55 yrs, 85.3% women, mean RA duration 14.37 yrs, treated with etanercept (29.7%), adalimumab (23.5%), infliximab (original 7.1%, biosimilars 0.7%), rituximab (38.9%); 23.1% used steroids (19.8% with Conclusions Longer persistence was observed with infliximab, followed by rituximab, etanercept, and adalimumab in RA patients in Romania, for more than 10 years of biologics use. Reaching the state of remission or LDA, as well as low steroids regimens and long-standing disease seem to positively correlate with drug persistence. Disclosure of Interest None declared

Background Rheumatoid Arthritis (RA) treatment targets remission or low disease activity. Patient Registries offer real-world data about effectiveness on long term. Comparing different tools for assessing effectiveness (disease activity, functional status and utility) could provide a more comprehensive approach on the term “achieve and maintain” the therapeutic goal, as a measure of efficacy. Objectives To evaluate interrelations of disease activity – functional status – utility in a group of RA patients, treated with tumor necrosis factor alpha (TNF) antagonists and anti CD20 molecule, as well as any factor that could influence it. Methods Cross-sectional study carried out over a cohort of RA patients in Romania. Data was gathered from the Romanian Registry of Rheumatic Diseases and included only RA patients treated with biologics, for who were available all three variables under study: EQ5D (for utility), HAQ score (for functional status), and DAS28 and SDAI (for disease activity). The interrelations of the efficacy parameters were analyzed using correlation tests, T test, ANOVA. Results The study cohort included 777 RA patients, mean age 58.72 (±12.37) yrs, 84.4% women, mean RA duration 14.08 (±8.33) yrs, 77.1% retired, treated with etanercept (30.6%), adalimumab (22.7%), infliximab (original 6.3%, biosimilars 0.7%), rituximab (26.3%) with a mean treatment duration 174.90 (±143.40) weeks; 27.3% used steroids (20.2% with 5.1 = 0.16 (±.38); for HAQ-DAS28: 5.1 = 1.76 (±0.56). Steroids use belongs to more active disease; doses >7.5 mg/day represent a cutoff for patients with severe disease activity [HDA]. Disease duration had not any influence on EQ5D, HAQ or DAS28, as well as all other factors (age, sex, residency, education, work status). Conclusions Disease activity influences the patient well-being and functionality. Considering the dynamics of disease activity over time and the fluctuating values of utility and HAQ score within DAS28 categories, analyzing treatment efficacy from a combined perspective may be helpful in evaluating the time trends on achieving and maintaining the therapeutic goals. Disclosure of Interest None declared

Background: rheumatoid arthritis (RA) is associated with loss of overall functionality of the locomotion system and it is connected with substantial economic losses. Objective: to describe the clinical characteristics and healthcare resource utilization characteristics and to analyze the correlations in a cross–sectional sample of 206 patients in Romania. Method: RA cases have been enrolled from southern and western part of the country, covering a surface of 23 counties. Results: particularly in the literature data, Romanian RA patients become work disabled at 5.65 ± 5.99 years old after the diagnosis. At cohort level, retirement in the first year after RA diagnosis is of 22.9%. From those, 13% were treated with biologic DMARDs; those on non–biologic DMARDs were 28.6%. In oral therapy group the most prescribed drug is lefunomide (61.2%). RA has an important impact on pain, function and utility, influenced by social factors. Patients' follow up is often based on hospitalization. Conclusion: currently, when the clinician may choose for one certain therapy or another, the social influence is still overwhelming at all the evaluation levels in RA patients, as well as at economic impact.

Background Therapeutic target in rheumatoid arthritis (RA) aims at achieving remission or low disease activity (1). Among the known poor prognostic factors are anti–citrullinated protein antibody (ACPA) and rheumatoid factor (RF). Clinical significance and therapeutic implications of the positivity of antinuclear antibodies (ANA) in serum of RA patients is still under debate. Objectives The implications of ANA positivity, as a prognostic factor, in the therapeutic response to biologic therapy in RA, as measured by DAS28 score. Methods Cross sectional, observational study; all data were gathered from the electronic database of Romanian Registry of Rheumatic Diseases (RRBR) which comprises all RA patients following biological treatment in the country. There were included only RA patients who were evaluated for the presence of ANA, before initiating biologic therapy. Results 740 RA patients were included in the study, mean age 56.50 years (±12.59), 84.5% women, mean disease duration 12.54 years (±7.67), 66.4% from urban areas, 74.7% retired. At baseline (prior to biologic start), 26.9% patients were positive for ANA, 89.8% for RF and 37% for anti-CCP antibodies and the mean DAS28 was 5.09±2.35. 72.4% patients were treated with TNF-alpha blockers, while 27.6% with anti-CD20 drugs. During evolution, 22% of subjects required switch of therapy. Biologics persistency (the duration of therapy under one drug) was on average 31.70 (±29.95) months (for those without switch) and the latest DAS 28 score was 2.90±1.41. There were statistically significant differences between DAS28 values at all assessments, depending on the presence of ANA. At biological start, DAS28 score in ANA positive group was 5.70±2.06, while in ANA negative group was 4.86±2.41 (p Conclusions ANA positivity in patients with RA, before initiating the biological therapy, may be a poor prognostic factor for the therapeutic efficacy, as well as for the drug persistence. More studies are needed to confirm these observations. References Smolen JS, Landewe R, Breedveld FC, Buch M, Burmester G, Dougados M et al,EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update Ann Rheum Dis. Mar 2014; 73(3): 492–509. Disclosure of Interest None declared

Background Romania fully reimburses through the National Insurance Health House (NIHH) six biological products for patients with active rheumatoid arthritis (RA), non-responders to at least 2 conventional remissive drugs: infliximab (IFX) original and biosimilars: inflectra (IFN), remsima (REM), etanercept (ETA), adalimumab (ADA), rituximab (RTX). All RA patients treated with biologics are registered in the national electronic database of the Romanian Registry of Rheumatic Diseases (RRBR) - application developed in 2013. Currently, 39.000 cases of RA are treated in Romania, according to NIHH data. Objectives Characteristics of RA population treated with biological agents in Romania, efficacy and safety data from RRBR, after 2 years of initiation. Methods Observational cross sectional study, which included all RA patients treated with biologics. Results 4470 RA patients were included, mean age 57.11 years (±12.02), 85.5% women, mean RA duration 13.51 years (±7.97), 64.8% living in urban areas, 77.4% retired (50% of them permanently work disabled due to RA), 33% with elementary education; mean body mass index (BMI) 26.09 (±4.60). Current treatment: 7.27% IFX, 0.08% IFN, 0.23% REM, 20,74% ADA, 27.21% ETA, 39.91% RTX. Methotrexate is used in 56.3% cases, leflunomide in 41.2%, sulphasalasine in 12.6% and hydroxychloroquine in 9.4%. 23% patients use steroids (20.8% Conclusions In Romania, the use of biologics in RA is on a positive trend (11.5% of all RA treated cases). 1/3 of patients have low education and 38.7% are permanently work disabled. Overall treatment efficacy of biological class in terms of T2T strategy (remission) reaches 52.4% (DAS28) and 41.4% (SDAI). Compared with other patients Registries from Europe or USA (1) in Romania there is a higher proportion of women treated and the percentage of steroids use is lower; DAS28 value is significantly lower (near-remission) compared to literature data (1), probably due to the strict evaluations imposed by the NIHH, while the adverse events seem less common (perhaps a lack of registration of all clinical situations). The impact of active disease on quality of life (EQ-5D) is major. References Curtis JR, Jain A, AsklingJ et al. A Comparison of Patient Characteristics and Outcomes in Selected European and U.S. Rheumatoid Arthritis Registries, Semin Arthritis Rheum. Aug 2010; 40(1): 2–14.e1., doi: 10.1016/j.semarthrit.2010.03.003, PMCID: PMC2958101, NIHMSID: NIHMS234142 Disclosure of Interest None declared

Background Clinical trials have proven the efficacy of biological therapy for rheumatoid arthritis (RA) worldwide. However, high costs have set boundaries to their use, especially in developing countries. Whereas in Europe, there are countries without any biological reimbursed, other countries have a more liberal prescription, regardless of the RA duration and previous therapy. To be eligible for biologics, in Romania, patients with active RA must be non-responders to at least two synthetic DMARDs; up to date four biological products are reimbursed: infliximab, etanercept, adalimumab, rituximab. Objectives The aim of the study is to evaluate patients9 accessibility to biological therapy on a national scale (41 counties and Bucharest, i.e. the capital) and its correlation with socio-economical indicators for each region. Methods Cross-sectional study carried out in 41 counties and Bucharest. Data was gathered from the Romanian Registry of Rheumatic Diseases, while the socio-economic indicators were extracted from the yearbook of the National Institute for Statistics (EUROSTAT). Results The sample comprised data of 4507 RA patients (4267 being treated with biologics and 240 being eligible for biologic therapy). The mean age was 56.69 yrs (±12.07), 85.24% women, 67.80% live in urban residences, with a mean RA duration of 12 yrs. 80.20% (n=3614) of patients had access to biologics in their county of residence, whereas 19.80% (n=893) of patients were treated elsewhere. The group treated outside of their county of residence come from areas with high deficit of physicians (1.67 physicians/1000 inhabitants, compared to 3.24 physicians/1000 inhabitants, for the group treated locally), and with decreased welfare (GDP/inhabitant: €6634.83, compared to €4891.02, p Conclusions In Romania, the accessibility of RA patients to biological therapy greatly varies according to the socio-economic situation of their county of residence. Living in an area with a low socio-economic status significantly decreases the patients9 chances of getting treated with biologics compared to other national counties, even when therapeutic protocols are equal and equitable. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.4640