Wiesik-Szewczyk E, Olesinska M
Institute of Rheumatology, Department of Connective Tissue Diseases, Warsaw, Poland.
Biologics. 2012;6:347-54. doi: 10.2147/BTT.S25407. Epub 2012 Sep 26.
Systemic lupus erythematosus (SLE) is a complex autoimmune disease of unknown etiology, and the limited available therapeutic options for this disease, are frustrating to both clinicians and patients. However, recent advances in the understanding of disease mechanisms have given rise to numerous studies on specific approaches to SLE treatment. Rituximab, the first chimeric, mouse-human monoclonal antibody which is directed against CD20, seems to be a new therapeutic option. The purpose of this review is to explain the current clinical evidence on the therapeutic use of rituximab in adult SLE patients. Two randomized clinical trials with rituximab (the EXPLORER and LUNAR studies) failed to prove efficacy of this drug on SLE. Ongoing data analysis continues to explain the reasons behind why this treatment fails to work. However data from open source and observational studies contrast with clinical trials results. The global analysis of this data supports the off-label use of rituximab in subsets of SLE that are refractory to standard treatment.
系统性红斑狼疮(SLE)是一种病因不明的复杂自身免疫性疾病,针对该疾病有限的现有治疗选择,令临床医生和患者都倍感沮丧。然而,对疾病机制认识的最新进展引发了众多关于SLE治疗特定方法的研究。利妥昔单抗,第一种针对CD20的嵌合型鼠-人单克隆抗体,似乎是一种新的治疗选择。这篇综述的目的是解释利妥昔单抗在成年SLE患者治疗应用方面的当前临床证据。两项使用利妥昔单抗的随机临床试验(EXPLORER和LUNAR研究)未能证明该药物对SLE有效。正在进行的数据分析持续解释这种治疗无效背后的原因。然而,来自开源和观察性研究的数据与临床试验结果形成对比。对这些数据的全面分析支持在对标准治疗难治的SLE亚组中利妥昔单抗的非标签使用。