SummaryBackgroundThe aim of this study was to assess and compare patients’ access to biologic anti-RA drugs in selected Central and Eastern European (CEE) countries and to analyze the determinants of differences between countries.Material/MethodsThis is a multi-country survey study, based on a combination of desk research and direct contact with national RA stakeholders. Data was collected using a pre-defined questionnaire. Affordability was measured using an affordability index, calculated comparing the index of health care expenditures to the price index, using Poland as an index of 1.ResultsThe percentage of patients on biologic treatment in 2009 was highest in Hungary (5% RA patients on biologic treatment), followed by Slovenia (4.5%), Slovakia (3.5%), Czech Republic (2.92%), Romania (2.2%), Estonia (1.8%), and Croatia, Serbia, Poland (below 1.5%). Infliximab, etanercept, adalimumab and rituximab were included in the reimbursement system in all countries, but abatacept and tocilizumab were included only in Slovakia. In Slovenia, public payer covered 75% of the price, and 25% is covered by supplementary health insurance; in Bulgaria public payer covered 50% of etanercept and adalimumab costs, and 75% of rituximab cost. In other countries, biologic drugs are reimbursed at 100%. Affordability index for biologic drugs was the lowest in Slovenia (0.4). In each country national guidelines define which patients are eligible for biologic treatment. Disease Activity Score (DAS28) of over 5.1 and failure of 2 or more disease-modifying anti-RA drugs, including methotrexate, are commonly used criteria.ConclusionsThe most important factors limiting access to biologic anti-RA treatment in the CEE region are macroeconomic conditions and restrictive treatment guidelines.

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Introduction. The risk of cardiovascular disease is increased in rheumatoid arthritis (RA). A meta-analysis showed increased intima media thickness (IMT) in RA. It has been shown that disease modifying antirheumatic drugs (DMARDs) may influence the progression of atherosclerosis. However, it was suggested that biologics may be more efficient than other DMARDs (including methotrexate—MTX) in protecting against atherosclerosis. Objectives. The aim of this study was to assess the influence of different RA characteristics and treatment regimens on IMT and atherosclerotic plaques. Patients and Methods. 317 RA patients and 111 controls were included in the study. IMT was measured in carotid (CIMT) and femoral (FIMT) arteries. Arteries were screened for the presence of plaques. Results. CIMT, FIMT, and prevalence of plaques were lower in patients treated with methotrexate (MTX) ≥ 20 mg/wk, cyclosporine (CsA), or biologics than in patients treated with lower doses of MTX and other disease modifying antirheumatic drugs. No differences in IMT between patients treated with MTX ≥ 20 mg/wk, biologics, or CsA were found. Conclusions. We found a beneficial effect of MTX ≥ 20 mg/wk, biologics, and CsA on atherosclerosis. We do not confirm a stronger influence of biologics on IMT compared with therapeutic doses of MTX.

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Background Several studies have demonstrated low 25(OH)D3 serum levels, which could influence pathogenesis and clinical outcomes of immune-mediated diseases such as rheumatoid arthritis (RA) (1,2). Objectives In order to investigate the necessity to implement specific vitamin D patient related outcomes we performed a pilot European multicentre study, involving individuals from different countries/latitudes, to explore 25(OH)D3 serum levels and their possible correlation with disease activity and related outcomes in RA patients during winter season. Methods We enrolled 270 RA patients (not treated with vitamin D supplementation) and 180 healthy subjects as controls (CNT), from Rheumatology centers in 10 European countries. RA patients mean disease duration was 10±9 years and mean age 56±10 years. Patients informed consent was obtained before collecting blood samples. Complete medical history, health assessment questionnaire (HAQ), rheumatoid arthritis impact disease score (RAID), disease activity scale (DAS28) were recorded. 25(OH)D3 serum levels were evaluated centrally using chemiluminescence immunoassay with an automatic analyser (LIAISON, DiaSorin), and classified as normal (>30 ng/ml), insufficient (between 20 and 30 ng/ml) or deficient (<20 ng/ml) (3). Results 25(OH)D3 serum levels were significantly lower in RA patients compared to controls (median 16 vs 20 ng/ml) (p<0.0001). In particular, we registered 25(OH)D3 deficiency (<20 ng/ml) in 25% and insufficiency in 70% of RA patients. Male and female RA patients showed similar 25(OH)D3 values (median 19 vs 17 ng/ml) (p=n.s.). We found statistically significant difference in 25(OH)D3 levels between some European countries such as significantly higher 25(OH)D3 serum levels in Spanish RA patients (Canaries Islands) compared to patients from Latvia, Lithuania, Romania, Croatia, Russia and Italy (p<0.01). In agreement with previous observations (4), we found in RA patients statistically significant negative correlations between 25(OH)D3 values and HAQ (r=-0.29, p=0.03), RAID (r=-0.32, p=0.02), and DAS28 scores (r=-0.41, p=0.003), respectively. Conclusions The results of this multicentre study confirms, at least in winter time, the presence of significantly lower 25(OH)D3 serum levels in RA patients than in healthy control subjects, which seem correlated with disease activity at all latitudes in Europe. The significant negative correlations observed between 25(OH)D3 serum levels and DAS28, HAQ and RAID scores justify the need to develop specific questionnaires for patient reported outcomes (PRO) vitamin D-related, and to validate them in a large European multicentre study. References 1. Cutolo et al. Autoimmun Rev 2011;11:84-87. Aranow C. J Investig Med. 2011; 59: 881–886. 3. Holick MF. N Engl J Med 2007;357:266-81. 4. Cutolo M. Ann Rheum Dis 2013;72:473-5. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.4145

Objective. The aim of this study is to investigate the morbidity rate due to Rheumatoid Arthritis (RA) in the Polish population during 2008-2012, calculated per 1,000 inhabitants, and taking into account the differences between provincess, area of residence (urban or rural) and gender. Materials and method. From the NFZ IT systems, PESEL number information was obtained for all 17 types of services contracted in 2008-2012, for patients whose main diagnosis in the report was the ICD-10 disease code: M05.X-seropositive rheumatoid arthritis, or M06.X-other rheumatoid arthritis. The number of patients, gender and age were calculated based on the PESEL number provided in the statistical reports of the patient with the analysed ICD-10 diagnosis. Urban and rural cases were compared using commune zip codes. The basis for classifying the patient as a member of an urban or rural population was the Zip Code of the declared place of residence. Urban and rural areas are classified based on administrative criteria provided by the Central Statistical Office: the National Official Register of Territorial Division of the Country (TERYT). Results. During the studied period the number of RA patients increased from 173,844-230,892. In urban areas, the most patients were recorded in the Śląskie Province, the least in Lubuskie Province. Patients from rural areas were approx. 1/3 rd of the total population of patients in Poland. In rural areas, the most patients were recorded in the Mazowieckie Province, the least in Lubuskie Province. The morbidity rate in cities was 5.08 in 2008 and increased to 8.14 in 2012 in rural areas, respectively, it was 3.74 and increased to 3.98. Regardless of the place of residence the women fell ill 3.5 times more frequently. The lowest morbidity rate, both in rural and urban areas, was recorded in the Lubuskie Province, the largest in Świętokrzyskie Province. The the most probable explanation of the highest morbidity rate in the latter province is a worse access to a rheumatologist: in this province there is the lowest number of inhabitants per one employed rheumatologist. Conclusion. In Poland, the number of RA sufferers is increasing, which is probably a result of increasing life expectancy. In Poland, also exists a differences in morbidity between urban and rural inhabitants. Differences may also derive from undiagnosed cases of the disease.

ObjectiveThe objective of the study was to analyse the prevalence of psoriatic arthritis (PsA) in Poland and to assess the costs generated by treatment of PsA patients in the system of public healthcare.Material and methodsThe analysis was based on the database of the public payer, the National Health Fund (NFZ). PsA was defined by the diagnostic ICD-10 codes M07 (Enteropathic arthropathies) and L40.5 (Psoriatic arthropathies). The estimate of the costs was based on the reports submitted to the NFZ by health service providers. The prevalence rates were calculated using the NFZ data and the population estimates from the Central Statistical Office of Poland (GUS).ResultsIn 2015, the prevalence of PsA (ICD-10: L40.5 and M07) in Poland was 3.2 per 10 000 population (3.7 in women and 2.6 in men). In 2015, nearly 7.3 thousand patients with the diagnosis of M07 and 6.3 thousand patients with the diagnosis of L40.5 received healthcare benefits. Women accounted for 60.6% of those patients. Nearly three fourths of PsA patients were aged 40 to 69 years with the median age of 54 years (56 years in women and 50 years in men). Between 2008 and 2015 the NFZ expenditure on the treatment of PsA increased from 6.6 million Polish zloty (PLN) (1.9 million EUR) to PLN 50.8 million (12.1 million EUR). In the same period, the number of PsA patients increased from 3.4 thousand to 11.9 thousand. In 2015, the mean cost of treatment per PsA patient was PLN 3.8 thousand.ConclusionsThe PsA prevalence rates estimated by the authors from the NFZ database are clearly lower than those derived from studies in other European countries, which may suggest that the actual number of PsA patients in Poland may be underestimated. Still the number of patients treated for PsA increased nearly 3.5-fold during 2008–2015, when the cost of PsA treatment rose more than 7 times.