New antirheumatic drugs: any real added value? A critical overview of regulatory criteria for their marketing approval

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• 作者：Vittorio Bertele-/a> ; Alessandro Assisi ; Valeria Di Muzio ; Danila Renzo and Silvio Garattini
• 关键词：ACR ; Adalimumab ; Anakinra ; Etanercept ; Infliximab ; Leflunomide ; Methotrexate ; Radiographic progression ; Rheumatoid arthritis ; Signs and symptoms
• 刊名：European Journal of Clinical Pharmacology
• 出版年：2007
• 出版时间：September, 2007
• 年：2007
• 卷：63
• 期：9
• 页码：879-889
• 全文大小：194 KB
• 刊物类别：Biomedical and Life Sciences
• 刊物主题：Biomedicine
  Pharmacology and Toxicology
  
• 出版者：Springer Berlin / Heidelberg
• ISSN：1432-1041

文摘

Objective Rheumatoid arthritis (RA) is a systemic autoimmune disorder causing chronic polyarticular synovial inflammation and progressive joint damage. New anti-rheumatic drugs, such as leflunomide, infliximab, etanercept, adalimumab and anakinra, have recently become available. The aim of this paper is to summarize and critically evaluate the type of studies and clinical endpoints accepted by the European Medicines Agency (EMEA) to approve these new drugs.