Seminars in arthritis and rheumatism
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Semin. Arthritis Rheum. · Aug 2016
ReviewThe impact of underlying disease on fracture risk and bone mineral density in children with rheumatic disorders: A review of current literature.
Childhood rheumatic diseases are associated with negative impacts on the skeleton, related to both the underlying illness and complications of therapy. The effects of medications like corticosteroids are well recognized, leading to reductions in bone mineral density and bone strength and concomitant increases in bone fragility and fracture risk. The impact of factors directly attributable to the underlying disease is not as well recognized. ⋯ These data are strongest for juvenile arthritis, while conclusions are more limited for other rheumatic illnesses, like juvenile systemic lupus erythematosus or juvenile dermatomyositis, due to small numbers of patients studied. Finally, we make recommendations for areas in need of further research. These include the need for long-term longitudinal studies and for data to be collected in patients who have not been treated with corticosteroids.
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Semin. Arthritis Rheum. · Aug 2016
The association of distal femur and proximal tibia shape with sex: The Osteoarthritis Initiative.
Risk of knee osteoarthritis (OA) is much higher in women than in men. Previous studies have shown that bone shape is a risk factor for knee OA. However, few studies have examined whether knee bone shape differs between men and women. The purpose of the present study was to determine whether there are differences between men and women in knee bone shape. ⋯ The shapes of the distal femur and proximal tibia that form the knee joint differ by sex. Additional analyses are warranted to assess whether the difference in risk of OA between the sexes arises from bone shape differences.
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Semin. Arthritis Rheum. · Jun 2016
Direct and indirect costs for systemic lupus erythematosus in Sweden. A nationwide health economic study based on five defined cohorts.
The main objectives of this study were to calculate total costs of illness and cost-driving disease features among patients with systemic lupus erythematosus (SLE) in Sweden. ⋯ Based on this study and an estimate of slightly more than 6000 SLE patients in Sweden, the total annual cost for SLE in the country is estimated at $188 million (=129.5 million €). Both direct (30%) and indirect costs (70%) are substantial. Medication accounts for less than 10% of the total cost. The tax paid national systems for health care and social security in Sweden ensure equal access to health care, sick leave reimbursements, and disability pensions nationwide. Our extrapolated annual costs for SLE in Sweden are therefore the best supported estimations thus far, and they clearly underline the importance of improved management, especially to reduce the indirect costs.
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To provide an overview of the underlying scientific principles and standards for developing a biosimilar product. ⋯ The rigorous and highly regulated processes required to develop a biosimilar have been designed as such to establish a high degree of biosimilarity with a reference product in terms of the structural, functional, biological, and clinical attributes.
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To discuss current terminology and the regulatory standards and processes involved in the development of biosimilars. ⋯ The addition of biosimilars to the market has the potential to improve access to biologic therapies. Many regulatory agencies have enacted stringent pathways, which must be followed for a biosimilar to be labeled and approved as such; following the pathways will help protect and maintain the integrity, quality, and safety of the biosimilar product.