Early Myocardial Changes in Patients with Rheumatoid Arthritis without Known Cardiovascular Diseases-A Comprehensive Cardiac Magnetic Resonance Study.

Clinically silent cardiac disease is frequently observed in rheumatoid arthritis (RA), and cardiovascular complications are the leading cause of mortality in RA. We sought to evaluate the myocardium of young RA patients without known cardiac disease using cardiac magnetic resonance (CMR), including T1/T2 mapping sequences. Eighteen RA patients (median age 41 years, 83% females) mainly with low disease activity or in remission and without any known cardiovascular disease were prospectively included to undergo CMR. A control group consisted of 10 sex- and age-matched patients without RA or any known structural cardiovascular disease. Heart chambers size and left/right ventricular systolic function were similar in patients with RA and controls. Signs of myocardial oedema were present in up to 39% of RA patients, including T2 time above cut-off value in 7 patients (39%) in comparison to none of the controls (p = 0.003) and T2 signal intensity ratio above the cut-off value in 6 patients (33%) and in none of the controls (p = 0.06). Extracellular volume was similar in both groups signifying a lack of diffuse fibrosis in studied group of RA patients. There were also no signs of late gadolinium enhancement (LGE) in either group except for one patient with RA who was found to have prior silent myocardial infarction. No correlation was found between markers of disease severity and markers of oedema observed on CMR in patients with RA. Nevertheless, patients with increased T2 time (≥50 ms) were more likely to have X-ray erosions (p = 0.02) and a longer duration between symptom onset and diagnosis (p = 0.02). Finally, there were no significant arrhythmias on 24-h ECG Holter monitoring in RA patients. CMR features of myocardial oedema without signs of myocardial fibrosis were found in 39% of young RA patients without known heart disease or cardiac symptoms. Presence of myocardial oedema was associated with X-ray erosions and a longer duration between symptom onset and diagnosis. The clinical significance of the observed early myocardial changes accompanying RA requires additional studies.

A dose-dependent beneficial effect of methotrexate on the risk of interstitial lung disease in rheumatoid arthritis patients.

OBJECTIVES: The aim of the study was to assess the influence of different factors, including treatment, on the risk of ILD in the course of RA. METHODS: A total of 109 RA patients were included in the analysis. High-resolution computed tomography (HRCT) of chest was obtained in each patient. Patients were classified as having ILD (ILD group) or not (N-ILD group). The ILD was graded using the semi-quantitative Warrick scale of fibrosis. Warrick extent score (WES) and Warrick severity score (WSS) were calculated separately for each patient, then combined to obtain a global score (WGS). RESULTS: In univariate analysis the presence of ILD was associated positively with age (P = 5x10-6) and negatively with MTX treatment (P = 0.0013), mean MTX dose per year of treatment (P = 0.003) and number of DMARDs used (P = 0.046). On multivariate analysis only age and treatment with MTX were independently associated with the presence of ILD. WGS was significantly lower in patients treated with MTX in a dose of ≥15 mg/week (MTX≥15 group) as compared to patients treated with lower doses of MTX (0

Trends in psoriatic arthritis epidemiology in Poland.

Psoriatic arthritis (PsA) is a heterogeneous inflammatory arthritis, usually seronegative and associated with psoriasis (Ps). The prevalence and incidence of psoriatic arthritis show strong ethnic and geographic variations. The aim of the study was to assess the epidemiological trends in psoriatic arthritis in Poland. The National Health Fund (NHF) database for the period 2008-2018 was analyzed. PsA was defined as ICD-10 codes L40.5, M07, M07.0, M07.1, M07.2 and M07.3, while psoriasis as ICD-10 codes L40 and L40.X (L40.0 to L40.9). A steady increase in the number of PsA patients (from 16,790 to 32,644) and in PsA recorded prevalence (from 38.47 per 100,000 in 2008 to 73.11 per 100,000 in 2018) was observed between 2008 and 2018. The PsA/Ps ratio increased to a similar extent (from 8.3 to 17.5%). The percentage of PsA patients receiving rehabilitation services remained constant throughout the observation period (mean: 17.35%; range 16.7-18.9%). The study showed a steady and continuous increase in PsA recorded prevalence. A simultaneous increase in the PsA/Ps ratio suggests that the main reason for the observed trend is greater disease detection .

Prevalence of axial spondyloarthritis in Poland.

The prevalence of axial spondyloarthritis (axSpA) in the published data varies significantly. Two types of axSpA can be distinguished depending upon the presence of abnormalities consistent with sacroiliitis on plain radiography: ankylosing spondylitis (AS) and nonradiographic axial SpA (nr-axSpA). The aim of this study is to perform a retrospective analysis of axSpA prevalence in Poland in the years 2008-2017. The National Health Fund (NHF) database for the period 2008-2017 was analysed. Data of all patients with the ICD-10 codes M46 (M46.1, M46.8, M46.9) or M45 (further named other inflammatory spondylopathies-OIS and AS, respectively) as the main or co-existing diagnosis were extracted and analysed. The AS prevalence was stable during the period under examination amounting to approximately 0.083%, while the OIS prevalence increased from 0.036 to 0.059%. For both men and women, the AS prevalence increased with age, reaching a maximum around the age of 70; however, in men, a marked increase in prevalence was observed earlier as compared to women (20-24 vs. 40-44 years, respectively). The OIS prevalence also increased with age; however, the maximum was reached earlier as in case of AS. Moreover, a sharp increase in OIS prevalence occurred earlier than in AS (15-19 years) with no difference between sexes. In Poland, approximately 0.1% of the population suffers from AS-the prevalence remained stable over the last decade. The prevalence of OIS increased markedly over the studied period which presumably reflects an increasing prevalence of nr-axSpA as the effect of the introduction of ASAS classification criteria for axSpA.

Quality of life and clinical outcomes in Polish patients with high activity rheumatoid arthritis treated with leflunomide (Arava®) in Therapeutic Program: A retrospective analysis of data from the PLUS study.

BACKGROUND: Rheumatoid arthritis (RA) is a chronic autoimmune disease. Therapy is based on disease-modifying agents. Methotrexate (MTX) is used in first-line therapy and, in the case of failure, its alternatives include leflunomide, which was recommended in Poland within the National Health Fund Therapeutic Program. OBJECTIVES: The purpose of the study was to evaluate the parameters of quality of life of Polish patients with high RA activity during treatment with leflunomide. Additional aims were to evaluate the effectiveness and safety of treatment. MATERIAL AND METHODS: We performed a retrospective analysis of the data from the PLUS study. The PLUS study comprised 887 adult patients from 30 centers. During the study patients received leflunomide in a maintenance dose of 20 mg or 10 mg once daily. Before the study, 100 mg of leflunomide had been administered daily for 3 days, followed by a maintenance dose of 20 mg/day or 10 mg/day for at least a month before enrollment. The PLUS study observation time was up to 12 months with 1 control visit every 3 months. The patients' quality of life was assessed with Health Assessment Questionnaire Disability Index (HAQ-DI). Erythrocyte sedimentation rate (ESR), Disease Activity Score (DAS28) and CRP (C-reactive protein) concentration were used to assess the disease activity. RESULTS: Six hundred seventy-nine patients completed the study. The HAQ-DI decreased after 3 months of observation (mean value 1.46 vs baseline 1.63; p = 0.001) and remained stable. The percentage of patients with HAQ-DI less than 1 and greater than 2 increased from 12.2% to 17.8% and decreased from 33.2% to 20.3%, respectively (p < 0.0001); DAS28 progressively decreased on subsequent visits. C-reactive protein and ESR decreased after 3 months and remained stable. Adverse events were observed in 4.4% of patients. CONCLUSIONS: Treatment with standard leflunomide doses is safe and allows for significant clinical improvement.

Common atherosclerosis genetic risk factors and subclinical atherosclerosis in rheumatoid arthritis: the relevance of disease duration.

Rheumatoid arthritis (RA) is a common systemic autoimmune disease characterized by increased cardiovascular morbidity. Several previous studies assessed associations between common atherosclerotic genetic risk factors and subclinical atherosclerosis (SA) in RA patients, yet most of them gave negative results. We undertook a cross-sectional study to evaluate the association between previously reported SNPs and subclinical atherosclerosis in a cohort of Polish RA patients. 29 SNPs associated with atherosclerosis in general population were genotyped in 289 RA patients: 116 patients with SA (increased carotid intima-media thickness and/or presence of carotid plaque) and 173 patients without SA. To assess the cumulative effect of SNPs we calculated 3 weighted genetic risk scores: GRSIMT, GRSCP and GRSCAD, comprising intima-media thickness-associated SNPs, carotid plaque-associated SNPs and coronary artery disease-associated SNPs, respectively. None of the SNPs showed a significant association with SA. However, we found an association between SA and GRSIMT. Interestingly, this association was limited to patients with short disease duration (P = 0.00004 vs. P > 0.5, for comparison of GRSIMT among patients within the 1st quartile of disease duration vs. others, respectively). Patients within the 1st quartile of disease duration were more frequently disease modifying anti-rheumatic drugs (DMARDs)-naïve and less frequently treated with biologics. Our study suggests that in patients with early RA subclinical atherosclerosis may be driven by similar genetic factors as in general population, while in long-lasting disease, the role common genetic risk factors may decrease. Possibly, this effect may be due to the influence of DMARDs.

Satisfaction and discontent of Polish patients with biological therapy of rheumatic diseases: results of a multi-center questionnaire study.

OBJECTIVES: Biologics are medications widely applied in the management of inflammatory rheumatic diseases. The drugs were found to be effective but their application is associated with some disadvantages. Medication with biologics is relatively expensive, and in Poland, it is carried out in specialized centers. The study was designed to evaluate various aspects of satisfaction and dissatisfaction of Polish patients treated with biologics. MATERIAL AND METHODS: An anonymous questionnaire was distributed in 23 Polish rheumatological centers involved in the treatment; 1212 returned questionnaires were used for analysis. Responses were received from 606 patients with rheumatoid arthritis, 427 with ankylosing spondylitis, 117 psoriatic arthritis, and 62 adult patients with juvenile idiopathic arthritis (in whom administration of the drugs had been introduced before they were 18 years old). The investigated group constituted about one-fifth of all rheumatic patients on biologics in Poland. RESULTS: A beneficial or very beneficial influence of the medication on the state of physical health was found mostly in patients with rheumatoid arthritis (51.3 and 30.5%) and ankylosing spondylitis (51.0 and 36.8%). Family life was improved by the treatment especially in patients with ankylosing spondylitis (40.7 and 35.6% beneficial and very beneficial, respectively), sleep quality and sexual life mostly in those with ankylosing spondylitis (beneficial/very beneficial influence 41.5/38.4, and 38.7/23.9, respectively). There was a rather small influence of biological treatment on the financial situation of the patients. In general, satisfaction with the treatment was evaluated as positive or very positive in 88% of all investigated patients.In a significant part of the patients, transportation to the medical center was considered as a disadvantage of the treatment. About one-third of the patients considered laboratory and imaging tests to be done before initiation of the medication as a difficulty, and for about 40% waiting time for qualification for the medication was a significant disadvantage. The route of drug administration was without importance for 4/5 of the patients. CONCLUSIONS: Summing up, the results were similar in the patients suffering from various diseases although those with psoriatic arthritis felt the highest satisfaction (possibly due to the positive aesthetic effect), and those with ankylosing spondylitis had significant improvement in sexual life (probably due to younger age). Relatively low satisfaction was found in patients with juvenile idiopathic arthritis. There was a small influence of medication on financial status of the patients. Application of biologics has few disadvantages and most of them are associated with the organization of health services (waiting time for the tests, transportation to the medical centers).

The impact of vitamin D supplementation on vitamin D level, urinary calcium excretion and bone density in patients with hypercalciuria and vitamin D deficiency - preliminary report.

AIM: To study the impact of vitamin D supplementation on vitamin D concentration in plasma, calcium urinary excretion and bone density in patients with urolithiasis in the course of idiopathic hypercalciuria and with a low vitamin D level. MATERIALS AND METHOD: Prospective analysis concerning 28 patients (16 boys, 12 girls) aged 6-14 years (average 10.4) in terms of urinary calcium excretion (mg/kg/day and Ca/Creatinine ratio in morning urine sample), 25OHD blood level after 3, 6, 9 and 12 months of individually recommended doses of vitamin D supplementation (400 IU or 800 IU). The doses were determined on the basis of 25 (OH) D deficiency. The children were on a normocalcemic diet. The bone mineral density of the patients was assessed before and after 12 months of vitamin D use at the aforementioned doses. RESULTS: There was no statistically significant correlation between 25 (OH) D plasma concentration and urinary calcium excretion measured on Ca /Creatinine ratio in daily urine collection and Ca/Creatinine ratio in the morning urine sample. No statistically significant change in calcium excretion was noted (measured by calciuria in daily urine collection and the calcium to creatinine ratio in the morning urine sample). A statistically significant increase in vitamin D plasma concentration was observed. Improvement in bone mineral density was not statistically significant. CONCLUSIONS: Supplementation of vitamin D in the children with idiopathic hypercalciuria and urolithiasis who were examined seems to be safe. The decision to start treatment and the selection of the vitamin D dose should be considered individually. Patients with urolithiasis should be carefully monitored for calcium/phosphate metabolism parameters and the activity of the disease. Supplementation of low doses vitamin D in the children examined did not improve bone mineral density.

Sequentiality of treatment in the rheumatoid arthritis drug programme in the years 2009-2014.

Approximately 1% of the population suffers from rheumatoid arthritis (RA) worldwide (0.45% in Poland). The therapy consists of the use of disease-modifying antirheumatic drugs (DMARDs). Biologics are used in the form of the drug programme. Analysis of the NHF database demonstrated the sequence of conversion between drugs and time spent in a single treatment. In 2009, the patients would start the following treatments: adalimumab 5.8%; etanercept 14.4%; infliximab 23.1%; leflunomide 53.6%; rituximab 3%. After the first year 16% of patients changed therapy or abstained, and in the second year this situation affected 65% of patients. The following percentages maintained the same treatment in the last 6 years: infliximab 4%; adalimumab 15%; etanercept 21%; leflunomide on prescription was continued by 70%. Patients remain too long on the same therapy when it is inefficient. Achieving remission or low disease activity (DAS28 < 2.6) should take place within 6 months of starting therapy.

Validity of the rheumatoid arthritis impact of disease (RAID) score and definition of cut-off points for disease activity states in a population-based European cohort of patients with rheumatoid arthritis.

OBJECTIVES: To assess the validity of the rheumatoid arthritis impact of disease (RAID) for measuring disease activity of rheumatoid arthritis (RA) and to determine cut-off values for defining the disease activity states. METHODS: A total of 622 RA patients from an European database have been included. Cross-validation was based on assessment of convergent and discriminant validity. Optimal cut-offs were determined against external criteria by calculating the respective 25th and 75th percentiles mean values of RAID. External criteria included definitions for remission (REM), low disease activity (LDA), moderate disease activity (MDA) and high disease activity (HDA), cut-offs of the 28-joint disease activity score-C-reactive protein (DAS28-CRP) score. RESULTS: The RAID showed a moderate degree of correlation with respect to DAS28-CRP (rho=0.417; P<0.0001). The receiver operating characteristic (ROC) curves to discriminate the ability of RAID to distinguish patients with active and non-active disease was very good with an area under the curve (AUC) of 0.847 (95% confidence interval [CI]: 0.816 to 0.878; P<0.0001). Based on the distributions of RAID in the different disease activity groups, we propose the following cut-off values for REM: RAID ≤3; for LDA: RAID >3 and ≤4; for MDA: RAID >4 and ≤6; for HDA: RAID >6. Mean RAID differed significantly between patients classified as REM, LDA, MDA or HDA (P=0.001). CONCLUSIONS: The cut-offs revealed good measurement characteristics in cross-validation analysis, had great discriminatory performance in distinguishing patients with different levels of disease activity and are suited for widespread use in everyday practice application and research.

European multicentre pilot survey to assess vitamin D status in rheumatoid arthritis patients and early development of a new Patient Reported Outcome questionnaire (D-PRO).

OBJECTIVE: To collect data on vitamin D (25(OH)D) serum levels in a large number of rheumatoid arthritis (RA) patients from different European countries, to investigate their relation with disease activity, disability, quality of life, and possibly to construct a new Patient Reported Outcome (PRO) questionnaire in order to self-estimate if they are at risk for vitamin D insufficiency/deficiency-related clinical implications (D-PRO). METHODS: This was a European League Against Rheumatism (EULAR) supported cross-sectional study (project No CLI064) which involved 625 RA patients (mean age 55±11years, mean disease duration 11±9years), 276 age and sex matched healthy subjects, and rheumatologists working in academic institutions or hospital centres, as well as PARE organizations (patient representatives) from 13 European countries. Serum samples for 25(OH)D level measurement were collected during winter time and analyzed in a central laboratory using chemiluminescence immunoassay (DiaSorin). Patient past medical history was recorded. RA patients were provided with three questionnaires: the Rheumatoid Arthritis Impact Diseases score (RAID), the Health Assessment Questionnaire (HAQ), and the new D-PRO questionnaire at the time of 25(OH)D serum sampling. D-PRO questionnaire consisted of three domains, Symptom Risk Score (SRS), Habitus Risk Score (HRS) and Global Risk Score (SRS+HRS=GRS), constructed with items possibly related to vitamin D deficiency. D-PRO was correlated with both clinical and PRO scores. DAS28-CRP was also evaluated. Statistical analysis was performed by non parametric tests. RESULTS: Mean serum concentration of 25(OH)D in RA patients (17.62±9.76ng/ml) was found significantly lower if compared to the levels obtained in matched controls (18.95±9.45ng/ml) (p=0.01), with statistically significant differences among several European countries. Negative correlations were found between 25(OH)D serum levels and DAS28-CRP (p<0.001), RAID (p=0.05) and HAQ (p=0.04) scores in the RA patients group. Negative correlations were also found in the cohort of enrolled RA patients between 25(OH)D serum concentrations and SRS (p=0.04), HRS (p=0.02) and GRS (p=0.02) domains of the D-PRO questionnaire. CONCLUSIONS: This first multicentre European survey add new evidences that vitamin D insufficiency/deficiency is frequent in RA patients with statistically significant differences among several countries. Vitamin D serum concentrations seem to correlate negatively and significantly with the D-PRO Global Risk Score, clinimetric indexes for quality of life, disease activity and disability in present cohort of RA European patients.

Safety and Efficacy of SBI-087, a Subcutaneous Agent for B Cell Depletion, in Patients with Active Rheumatoid Arthritis: Results from a Phase II Randomized, Double-blind, Placebo-controlled Study.

OBJECTIVE: To evaluate subcutaneous SBI-087 to treat rheumatoid arthritis (RA). METHODS: A total of 210 adult patients with active RA were randomized to receive either 200 mg SBI-087 or placebo (Pbo), according to one of these patterns: SBI/Pbo/Pbo (SBI on Day 1), SBI/SBI/Pbo (SBI days 1 and 15), SBI/Pbo/SBI (SBI days 1 and 84), SBI/SBI/SBI (SBI days 1, 15, and 84), or Pbo/Pbo/Pbo (Pbo all 3 days). All patients were seropositive and taking background methotrexate. The primary endpoint was proportion of patients achieving 20% improvement from baseline at Week 16 by American College of Rheumatology criteria (ACR20). Other outcomes included 28-joint Disease Activity Score (DAS28)-C-reactive protein (CRP), physician's and patient's global assessments of disease activity (PGA and PtGA, respectively) and Health Assessment Questionnaire-Disability Index (HAQ-DI). Peripheral CD19+ B cells were measured by high-sensitivity flow cytometer. Statistical significance was set at 2-sided α 0.10 level. RESULTS: The SBI/SBI/SBI group demonstrated significant improvement in ACR20 and DAS28-CRP from Week 8 onward, sustained improvement in CRP levels from Week 12 onward, and significant improvements in PGA and PtGA in weeks 16 through 24, and in HAQ-DI at Week 24. The SBI/Pbo/Pbo and SBI/SBI/Pbo groups did not meet the primary endpoint but demonstrated improvements in several secondary endpoints. All treatment groups exhibited depletion of peripheral CD19+ B cells throughout the study. Overall, 61.5% of patients receiving SBI-087 and 55.0% of patients receiving Pbo reported adverse events. CONCLUSION: SBI-087 effectively depleted peripheral CD20 B cells and was well tolerated. Improvements were consistently observed in the SBI/SBI/SBI group for the majority of efficacy and quality-of-life outcomes.

Epidemiology of Rheumatoid Arthritis (RA) in rural and urban areas of Poland - 2008-2012.

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 Slaskie 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 Swietokrzyskie 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.

Prevalence of psoriatic arthritis and costs generated by treatment of psoriatic arthritis patients in the public health system - the case of Poland.

OBJECTIVE: The 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 METHODS: The 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). RESULTS: In 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. CONCLUSIONS: The 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.

Treat-to-target therapy does not prevent excessive progression of carotid intima media thickness during the first year of therapy in early rheumatoid arthritis.

INTRODUCTION: The aim of the study was to investigate the presence of subclinical atherosclerosis and predictors of change in carotid intima-media measures in early rheumatoid arthritis patients (eRA) as compared to chronic RA patients and patients without arthritis. MATERIAL AND METHODS: Fifty-five consecutive eRA patients were assessed at the time of diagnosis and after 1 year of therapy. Fifty-five sex- and age-matched chronic RA patients and 29 patients without inflammatory disease were used as controls. Carotid artery intima-media thickness (CIMT) and carotid plaques were measured at baseline and after follow-up. In eRA patients ultrasound assessment of hand joints was performed before and after treatment. Carotid artery intima-media thickness was assessed again after 2 years in 44 eRA patients. RESULTS: Carotid artery intima-media thickness progression after 1 year of therapy was higher in eRA patients compared to both control groups (p = 0.017) and correlated with symptoms duration (p = 0.017) and DMARD monotherapy (p = 0.015). Ultrasound progression of hand joint erosions was associated with longer symptoms duration (p = 0.006). After 2 years of observation CIMT progression was similar in all examined groups. CONCLUSIONS: We observed rapid CIMT progression during the first year of RA therapy. Longer symptoms duration and less aggressive therapy were associated with CIMT increase.

Prevalence of Atherosclerosis in diabetic and non-diabetic patients with rheumatoid arthritis.

OBJECTIVES: (1) To compare the prevalence of preclinical atherosclerosis in diabetic vs. non-diabetic rheumatoid arthritis (RA) patients; (2) to determine the influence of classical and RA-related factors on atherosclerosis; (3) to assess the usefulness of combined carotid and femoral ultrasonography in detecting atherosclerosis. METHODS: The study comprised 42 non-diabetic RA patients, 42 diabetic RA patients and 42 controls. Intima media thickness (IMT) was measured in the common carotid and superficial femoral arteries. These vessels were screened for atherosclerotic plaque. RESULTS: Plaque was more prevalent in diabetic RA patients than in non-diabetic RA patients or controls. Carotid IMT and femoral IMT were higher in diabetic RA patients compared to controls. So was femoral IMT in diabetic compared to non-diabetic RA patients. The prevalence of increased IMT and plaque was comparable in carotid ultrasonography and combined carotid and femoral ultrasonography in all groups. CONCLUSIONS: Subclinical atherosclerosis was found to be higher in diabetic RA patients than in non-diabetic RA patients. The combination of carotid and femoral artery ultrasonography did not improve the detection of atherosclerosis in RA.

Juvenile idiopathic arthritis morbidity rate in rural and urban areas of Poland 2008-2012.

OBJECTIVE: The aim of this study was to investigate the juvenile idiopathic arthritis (JIA) morbidity rate in the Polish population, calculated per 1,000 inhabitants of a given province, taking into account the differences between urban and rural areas, gender and area of residence (province) 2008-2012. METHOD: From the NFZ IT systems information was obtained on the treatment of patients who had M08 and M09 juvenile arthritis, diseases classified elsewhere by the ICD-10 diagnosis code in the settlement report of the hospital. The number of patients, their gender and age at individual diagnoses 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 basic for classifying the patient as a member of a urban or rural population was the zip code of the declared place of residence. RESULTS: In Poland, the number of patients suffering from juvenile idiopathic arthritis has been increasing since 2008 - from 9.2 thousand in 2008 to 11.4 thousand in 2012. The majority were girls (approx. 62%). Most patients were living in urban areas; in 2008, 5.9 thousand: urban areas - 64% of women and 36% of men; 3.2 thousand: rural areas - 62% of women, 38% of men); in 2012, 7.2 thousand - urban areas); 4.2 thousand - rural areas. The morbidity indicators ranged from 0.195 - 0.357 per 1,000 inhabitants, depending on the year, gender and place of residence (province and commune).

Methotrexate, Cyclosporine A, and Biologics Protect against Atherosclerosis in Rheumatoid Arthritis.

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.

Changes in the morbidity and costs of systemic lupus erythematosus in Poland in the years 2008-2012.

OBJECTIVES: The goal of the article is to present the changes in morbidity and costs of systemic lupus erythematosus (SLE) in Poland in the 2008-2012 period, depending on the province of residence of the patients based on data reported to the public payer - the National Health Fund. MATERIAL AND METHODS: Based on the ICD-10 code and the patient's personal identity number, the number of patients and medical costs (cost of hospitalization, pharmaceutical, medical procedures, dialysis and specialist consultations) were calculated by province (voivodeship) and urban or rural residence. RESULTS: Annually on average in the assessed period in Poland approximately 20 000 patients were diagnosed with SLE. The studied group was dominated by women (they were 5.2 times more numerous). The morbidity rate was 52.183 patients per 100 thousand inhabitants. Most patients were in the age range of 48-56 years. Average annual expenses for this group of patients over the examined period were USD 16,327 million. Two times more was expended on patients inhabiting cities, approximately 4 times more on women. Calculated per patient, the average cost of therapy was USD 810.63. CONCLUSIONS: The population of SLE patients in Poland is highly stable. The results of analysis indicate 1.64 times more frequent occurrence in urban areas, which may be connected with availability of doctors. The SLE treatment costs in Poland are much lower than in other countries, which is related mainly to the fact that therapy with biological drugs is not financed.

Rheumatoid arthritis treatment with TNF inhibitors and alternative procedures in case of its failure - results of the Polish survey in the context of EULAR recommendations.

INTRODUCTION: According to the European League Against Rheumatism (EULAR), rheumatoid arthritis (RA) treatment aims to achieve remission or low disease activity (LDA) within 6 months. In Poland, despite the existence of the National Health Fund Drug Program (NHF-DP), data on the effects of treatment with biological agents in patients with RA are not publicly available. Also we cannot compare registers from other countries with the Polish results because the rules of the therapeutic program in Poland impose restrictions that do not exist in other countries. For this reason, the data will not be comparable, but the results of the currently used regimen for biological treatment in Poland should be analyzed and compared with the recommendations of the European EULAR as a contribution to further discussion. OBJECTIVES: To determine the tumor necrosis factor α (TNF-α) inhibitor treatment patterns in RA patients in Poland, to evaluate the frequency and causes of treatment failure as well as post-failure recommendations, and to compare Polish clinical practice enforced by the therapeutic program with the EULAR recommendations. MATERIAL AND METHODS: The data on 895 RA patients were retrospectively collected from routine medical records. A questionnaire was completed only once for each patient. RESULTS: After 3 months of treatment with a TNF-α inhibitor, the therapeutic target was achieved in 72% of patients: 4% in remission, 8% LDA, and 60% with moderate disease activity (MDA); after 9 months, 46% had reached the target: 16% in remission, 30% with LDA. An average of 49% of patients presented with MDA or high disease activity (HDA), thus requiring treatment modification. Treatment failure was confirmed in 14% of patients and a modified therapy administered: rituximab (72%) or adalimumab (20%). The most common cause of failure was inefficacy of treatment (70%). CONCLUSIONS: In the Polish therapeutic program, despite the persistence of MDA or HDA, the treatment with TNF inhibitors rarely qualifies as ineffective and therefore is seldom modified by switching to another biologic drug. As long as the initiation of treatment and its modifications are enforced by the NHF-DP and not the recommendations of EULAR, treatment may be less effective and paradoxically cost-intensive. Therefore, it seems obvious that it is necessary to change and adapt the NHF-DP requirements to European standards.