Seminars in arthritis and rheumatism
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Discuss issues regarding clinical trial design for the development of biosimilars in the European Union and the United States, with special focus on monoclonal antibodies used in the treatment of inflammatory diseases. ⋯ Clinical trials aim to resolve uncertainties that may remain following nonclinical development regarding the similarity of the proposed biosimilar with the reference product. Pharmacokinetic and pharmacodynamic studies form the backbone of early clinical development and serve to inform phase 3 clinical development. Factors to be considered in clinical development include study population, design, end points, sample size, duration, and analytical methods.
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This article provides insight into the guidelines issued by the European Medicines Agency (EMA) and the draft guidances issued by the US Food and Drug Administration (FDA) regarding potential safety considerations associated with the development and use of biosimilars. ⋯ Safety considerations in the development of biosimilars are an important focus of regulatory guidelines, although topics such as interchangeability, automatic substitution, and nomenclature are still being debated.
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Semin. Arthritis Rheum. · Apr 2015
Review Meta AnalysisThe association between lumbar spine radiographic features and low back pain: a systematic review and meta-analysis.
Low back pain (LBP) is a prevalent musculoskeletal condition and represents a substantial socioeconomic burden. Plain film radiography is a commonly used imaging technique. Radiographic features (RFs) such as disc space narrowing, osteophytes, spondylosis, endplate sclerosis, spondylolisthesis, and facet joint osteoarthritis have all been debated as potential pain generators in the lumbar spine. The aim of this study is to (1) determine the association between LBP and lumbar spine RFs in both community- and occupation-based groups and (2) to determine if there are differences in these associations between these two groups. ⋯ A significant association was found between disc space narrowing in both community- and occupational-based populations without significant differences between the associations. A significant strong association was found between spondylolisthesis and LBP among the occupational group but was weakly associated in the community-based group, which supports that spondylolisthesis may contribute a specific cause for LBP.
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Semin. Arthritis Rheum. · Apr 2015
Review Meta AnalysisCoronary artery disease in giant cell arteritis: a systematic review and meta-analysis.
To investigate the association between giant cell arteritis (GCA) and risk of coronary artery disease (CAD). ⋯ In contrast to other chronic systemic inflammatory disorders, our meta-analysis did not show any statistically significant increased risk of CAD among patients with GCA.
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Semin. Arthritis Rheum. · Feb 2015
Low-dose pulse cyclophosphamide in interstitial lung disease associated with systemic sclerosis (SSc-ILD): efficacy of maintenance immunosuppression in responders and non-responders.
To investigate the long-term disease course of patients with recently deteriorated systemic sclerosis (SSC)-interstitial lung disease (ILD) undergoing continuous immunosuppressive treatment with cyclophosphamide (CYC) as induction therapy. ⋯ Our study supports the use of low-dose pulse CYC as induction therapy of recently deteriorated SSc-ILD. Moreover, it suggests that AZA should be administered to CYC-responsive patients but does not show any definite effect of MMF in unresponsive patients.