Coca Andreea, Anolik Jennifer H
University of Rochester School of Medicine Box 695, 601 Elmwood Avenue, Rochester, NY 14642 USA.
F1000 Med Rep. 2009 May 8;1:28. doi: 10.3410/M1-28.
Recently, two large randomized controlled trials of distinct biologic therapies in systemic lupus erythematosus, B-cell depletion with rituximab and co-stimulatory blockade with CTLA4Ig (abatacept), failed to meet primary endpoints. Given the great need for new treatments in lupus, these results were met with disappointment and have left the rheumatology and immunology community searching for an explanation. Are these experimental agents ineffective in lupus or are there trial design issues or other considerations? In this commentary, we discuss our perspective on these results within the context of current understanding of the pathophysiology of lupus and the mechanism of action of biologic therapies.
最近，两项针对系统性红斑狼疮的不同生物疗法的大型随机对照试验——利妥昔单抗进行B细胞清除以及CTLA4Ig（阿巴西普）进行共刺激阻断——均未达到主要终点。鉴于狼疮对新治疗方法的迫切需求，这些结果令人失望，也让风湿病学和免疫学领域的研究人员寻找原因。这些实验药物在狼疮治疗中无效，还是存在试验设计问题或其他因素？在这篇评论中，我们将在当前对狼疮病理生理学和生物疗法作用机制的理解背景下，讨论我们对这些结果的看法。
