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 <25% of RA patients received biologics outside it. 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.

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BackgroundRomania 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.ObjectivesCharacteristics of RA population treated with biological agents in Romania, efficacy and safety data from RRBR, after 2 years of initiation.MethodsObservational cross sectional study, which included all RA patients treated with biologics.Results4470 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% <10mg prednisone daily). The current mean DAS28 is 2.86 (±1.32) and SDAI 6.88 (±7.98); 52.4% cases are in remission (according to DAS28), but only 41.4% according to SDAI; 21.5% cases are in LDA (according to DAS28) and 41.8% (SDAI). Mean EuroQoL 5D (EQ-5D) is 0.73 (±0.26). There is a strong negative association between EQ-5D and DAS28 (r = - 0.7, p<0.01). DAS28 levels correlate positively with BMI (r =0.2, p<0.05). On safety issues, 105 severe adverse events have been reported (2.34%), 21 infections, other than tuberculosis (TB), 21 cases of TB, 15 solid malignancies, 1 case of Hodgkin lymphoma, 11 major cardiovascular events; 13 cases were fatal.ConclusionsIn 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.ReferencesCurtis 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, PMCI...

Background and Objectives: Real-world evidence should reflect the evidence obtained from controlled trials; therefore, the study aimed to compare biosimilar adalimumab (bADA) to original adalimumab (oADA) in terms of efficacy and safety in a real-life national cohort of rheumatoid arthritis (RA) patients. Materials and Methods: The following study is a prospective observational study in which we analyzed patients treated with reimbursed biologics from the Romanian Registry of Rheumatic Diseases (RRBR). RA cases must fulfill the 2010 classification criteria, as well as specific inclusion and exclusion criteria. The RRBR database was queried for all RA patients starting oADA or bADA (FKB327, GP2017, MSB11022, SB5 available) from 2 May 2019 (the first bADA initiation) until 26 March 2022 (study search date). Results: The study included 441 patients who started oADA (48.3%) or bADA (51.7%) in the same time period. At baseline, patients starting bADA had a significantly higher mean age and lower prevalence of women. After the first six months of treatment, there were no significant differences between the oADA and bADA regarding rates of Boolean (15.0% vs. 12.3%, p = 0.401), DAS28-CRP (32.4% vs. 34.2%, p = 0.686) and SDAI (16.4% vs. 14.0%, p = 0.483) remission rates. There were 107 cases of adverse events (AE): 81.3% on oADA and 18.7% on bADA. Notably, 51.4% of AE were infections. Regarding severity, 49.5% of AEs were mild, 34.6% were moderate, and 15.9% were severe. Conclusion: Biosimilar adalimumab showed similar efficacy and safety to original adalimumab after the first six months of treatment in RA patients from a national registry.

BackgroundThe 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 patient's 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).ObjectivesThe 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.MethodsA 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.ResultsData 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<0.001; t test) and with high deficit of physicians (1.28 physicians/ 1000 inhabitants, comparated to 2.63 physicians/ 1000 inhabitants; p<0.001; t test). The urban habitat was associated with a higher accessibility to biologics (75.9%) inside their county of residence compared to patients living in rural areas (69.2%) (p=0.002, χ2 test); so the latter have to travel in order to being cared by a rheumatologist. The patients' 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).ConclusionsIn 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 InterestNone declared

BackgroundThe ankles may be affected by rheumatoid arthritis (RA). In daily evaluation of RA patients, the ankles are often neglected by clinical examinations, while composite activity scores do not include themObjectivesThe aim of the study is to assess the inflammatory lesions in RA ankles, regarding frequency and possible correlation with activity diseaseMethodsThe study included 76 RA patients fulfilling the 2010 ACR/EULAR classification criteria. In every patient we recorded clinical ankle involvement (ankle swelling and/or tenderness on physical examination); both ankles were evaluated by gray scale (GS) and Power Doppler (PD) ultrasound examination, graded from 0–3. In each joint we assessed: tibio-talar joint (TT); tibialis anterior (TA) tendon; extensor hallux (EH) and extensor digitorum (ED) tendons; talo-navicular joint (TN); tibialis posterior (TP) tendon; flexor digitorum (FD) and flexor hallux (FH) tendons; peroneus brevis (PB) and longus (PL) tendons; Achilles tendon (AT); subtalar joints (SJ; posterior, lateral, medial recesses); plantar fascia (PL). We recorded the following abnormalities: synovitis, tenosynovitis, bursitis, entesopathy and rupture. Activity scores (DAS28, DAS44, SDAI), inflammatory markers (ESR, CRP), serology (FR, ACPA) and HAQ were also assessedResultsThe mean age was 57.2±14.2 years; 88% were women; mean disease duration was 12.2±9.2 years; 56.6% had symptomatic ankles; 81.6% had ultrasound ankle abnormalities. The most frequent ultrasound pathology encountered was ST synovitis (56.6%), followed by TT synovitis (48.7%), TN synovitis (38.2%), TP tenosynovitis (30.3%), PL tenosynovitis (15.8%). Ultrasound abnormalities were recorded in 93% of the symptomatic ankle patients and in 66.7% of the asymptomatic ankle patients (p=0.008). Overall, 43% had positive PD signals, but the prevalence of positive PD signals was significantly higher in symptomatic ankle patients than in asymptomatic ankle patients (60.5% compared to 21.2%, p=0.011). Statistically significant correlations were found between ultrasound inflammatory pathology (synovitis and tenosynovitis), activity disease markers and quality of life (Table 1).Table 1.Correlations of GS ultrasound measures with disease activity and HAQESRCRPDAS28CRP DAS28ESR DAS44SDAIHAQ TT0.1040,360**0,395***0,283*0,317**0,352**0.150TN0.1590,426***0,442***0,330**0,366**0,391***0.007PL0.272*0.366**0.368**0.347**0.362**0.340**0,292*PB0.0740.1390.2000.2150.231*0.2230,243*TP0.408***0.466***0.543***0.548***0.558***0.542***0,268*FD0.1660.1450.254*0.260*0.285*0.259*0,256*Note: the reported values represent the rho coefficients of bivariate Spearman correlations: *p<0,05; **p<0,01; ***p<0,001.ConclusionsMusculoskeletal ultrasound detected a high prevalence of inflammatory abnormalities in rheumatoid arthritis ankles, in both symptomatic and asymptomatic patients, while power Doppler signal was present mostly in symptomatic patients. The ultrasound pathology was highly correlated with activity disease markers and quality of lifeReferences M Backhaus, G-R...

Introduction: Rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA)

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.