Seminars in arthritis and rheumatism
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Semin. Arthritis Rheum. · Oct 2016
Review Meta AnalysisClinical benefit of intra-articular saline as a comparator in clinical trials of knee osteoarthritis treatments: A systematic review and meta-analysis of randomized trials.
Hyaluronic acid and corticosteroids are common intra-articular (IA) therapies widely used for the management of mild to moderate knee osteoarthritis (OA). Many trials evaluating the efficacy of IA administered therapies commonly use IA saline injections as a placebo comparator arm. Using a systematic review and meta-analysis, our objective was to assess the clinical benefit associated with use of IA saline in trials of IA therapies in the treatment of patients with painful knee OA. ⋯ Pain relief observed with IA saline should prompt health care providers to consider the additional effectiveness of current IA treatments that use saline comparators in clinical studies, and challenges of identifying IA saline injection as a "placebo."
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Semin. Arthritis Rheum. · Oct 2016
Review Meta AnalysisClinical benefit of intra-articular saline as a comparator in clinical trials of knee osteoarthritis treatments: A systematic review and meta-analysis of randomized trials.
Hyaluronic acid and corticosteroids are common intra-articular (IA) therapies widely used for the management of mild to moderate knee osteoarthritis (OA). Many trials evaluating the efficacy of IA administered therapies commonly use IA saline injections as a placebo comparator arm. Using a systematic review and meta-analysis, our objective was to assess the clinical benefit associated with use of IA saline in trials of IA therapies in the treatment of patients with painful knee OA. ⋯ Pain relief observed with IA saline should prompt health care providers to consider the additional effectiveness of current IA treatments that use saline comparators in clinical studies, and challenges of identifying IA saline injection as a "placebo."
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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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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.
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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.