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Purpose: A high cardiovascular risk has been described in patients with rheumatoid arthritis (RA); the effects of different biological agents have also been described in these patients. The aim of the present study is to examine the effects of tumor necrosis factor inhibitors (TNFi) in the lipoprotein profile of RA patients using a broad laboratory assessment including a large number of non-routine tests. Patients and Methods: RA patients treated with and without TNFi (70 patients in each group) were cross-sectionally compared regarding a broad spectrum of lipoprotein parameters including serum levels of total and HDL, LDL and VLDL cholesterol triglycerides, lipoprotein A (LpA), apolipoprotein A1 (Apo A), B100 (Apo B) and paroxonase. For each lipoprotein subfraction (HDL, LDL and VLDL), we assess specific concentrations of cholesterol, triglycerides, phospholipids and proteins and total mass of each one. Additionally, HDL Apo A, LDL and VLDL Apo B concentrations and number of particles of LDL and VLDL were also determined. Exploratory univariate and multivariate analyses of the different variables were performed. Results: Seventy patients in each subset were enrolled. Patients on treatment with TNFi showed a trend to be younger and to have a longer disease duration. Regarding the lipoprotein analyses, borderline significant higher levels of serum Apo A were detected and an independent association with lower HDL mass, LDL triglyceride, VLDL cholesterol, VLDL Apo B, VLDL mass, number of VLDL cholesterol molecules and number of particles of VLDL was clearly observed. Conclusion: TNFi treatment was associated with beneficial atherogenic effects at the lipoprotein level especially centered in the VLDL-related parameters consistent with a reduction of the atherogenic risk. Funding: This study was carried out with the support of Instituto de Salud Carlos III (ISCIII) (grant number PI0810119).

Objective To evaluate the budget impact and the direct costs of the introduction of subcutaneous belimumab (SC) into the Spanish National Health Service (NHS) for patients with systemic lupus erythematosus (SLE) in Spain. Methods This study was conducted from the Spanish NHS perspective with a time horizon of 3 years. The budget impact analysis compared the cost difference between two scenarios: current market (standard therapy (ST) and intravenous belimumab (IV)) and other market in which patients switched from belimumab IV to belimumab SC until reaching 17% of the total market share. The eligible population was calculated to receive treatment with belimumab, applying the EPISER (study of the prevalence of rheumatic diseases in adult population in Spain) prevalence (91 per 100,000 inhabitants), Autoimmune Systemic Diseases Study Group (GEAS) incidence (2 per 100,000 inhabitants), and the risk of annual mortality to the Spanish adult population. Patients with severe active lupus nephritis and with severe active CNS lupus were excluded. Patients' characteristics, flare rates and severity, and healthcare resource consumption were evaluated based on data from the literature and interviews with an expert panel. A sensitivity analysis was performed. Results Currently, there is an estimated 34,697 adult patients with SLE in Spain and 3849 patients who are eligible to be treated with belimumab. The introduction of belimumab SC into the Spanish NHS could generate savings in direct healthcare costs of 6 million euros over the 3 years. Conclusion The introduction of belimumab SC shows direct savings for the Spanish NHS. These savings could contribute to sustainability and decision-making.

Systemic lupus erythematosus is a complex and heterogeneous autoimmune disease with a relatively low incidence. Clinical research in this disease at individual centers is complicated by the difficulty of accruing enough patient numbers. In this context, the development of cohorts and multi-institutional registries during the last decades has allowed an increase in knowledge regarding the clinical course and management of this disease. This article aims to describe the main study designs linked to lupus registries and to give an overview of the main international registries and cohorts, as well as their principal achievements in the context of this complex entity.

Ethnic variation in the frequency and outcome of systemic lupus erythematosus (SLE) has been recognized for decades. The reasons underlying these discrepancies are not completely understood but it is most likely that both genetic and nongenetic factors are responsible for them. Sorting out the extent to which these factors, particularly those of a nongenetic nature, exert their influence in SLE is not easy given inherent methodological difficulties in studying them. To establish this review properly, we would like to make it clear from the outset that ethnicity is a broad construct that implies not only biological but also nonbiological features including cultural and sociodemographic, among others. We will then describe the epidemiological differences of SLE among Caucasian and non-Caucasian populations followed by a succinct review of the genetic predisposition to SLE with special emphasis in ethnic heterogeneity. Differences in disease activity, lupus nephritis, damage and mortality as a function of ethnic group will then be described. Finally, we will present a comprehensive model of the influence of ethnicity on SLE.

Ilona Steigerwald,1 Matthias Müller,1 Jolanta Kujawa,2 Jean-Charles Balblanc,3 Jaime Calvo-Alén,41Medical Affairs Europe & Australia, Grünenthal GmbH, Aachen, Germany; 2Medical University of Lodz, Medical Rehabilitation Clinic, Lodz, Poland; 3Department of Rheumatology, General Hospital of Belfort, Belfort, France; 4Hospital Universitario Sierrallana and IFIMAV Research Institute, Universidad de Cantabria, Cantabria, SpainAbstract: This open-label, phase 3b study (ClinicalTrials.gov Identifier: NCT00983073) evaluated the effectiveness, and tolerability of tapentadol for severe, chronic osteoarthritis knee pain that was inadequately managed with World Health Organization (WHO) Step I or II analgesics or co-analgesics, or that was not treated with regular analgesics. Prior to starting study treatment, patients discontinued any WHO Step II analgesics, while Step I analgesics and/or co-analgesics were continued at the same dose. Patients received tapentadol prolonged release (50–250 mg bid) during a 5-week titration period and a 7-week maintenance period. Doses of tapentadol immediate release 50 mg (≤twice/day; ≥4 hours apart) were permitted throughout the study (total daily dose of tapentadol prolonged and immediate release, ≤250 mg bid). The primary endpoint was the change in pain intensity on an 11-point numerical rating scale-3 (NRS-3; recalled average pain intensity [11-point NRS] during the last 3 days) from baseline to Week 6, using the last observation carried forward (LOCF) to impute missing pain intensity scores. The mean (standard deviation) change from baseline to Week 6 (LOCF) in pain intensity was -3.4 (2.10; P < 0.0001) for all patients evaluated for effectiveness (n = 195). Significant decreases in pain intensity were also observed at Weeks 6, 8, and 12 (all P < 0.0001) using observed-case analysis. Corresponding significant improvements from baseline to Weeks 6 and 12 were observed in the Western Ontario and McMaster Universities osteoarthritis index, the EuroQol-5 Dimension health status questionnaire, the Short Form-36 health survey, and the Hospital Anxiety and Depression Scale (all P ≤ 0.0103). Treatment-emergent adverse events were in line with those observed in previous studies of tapentadol prolonged release. Overall, the results of this study indicate that tapentadol treatment results in significant improvements in pain intensity, health-related quality of life, and function in patients with inadequately managed, severe, chronic osteoarthritis knee pain.Keywords: tapentadol, osteoarthritis, chronic pain, opioid