University of Toronto, Institute of Medical Science, Lupus Clinic, Toronto Western Hospital, Centre for Prognosis Studies in the Rheumatic Diseases, Toronto, Ontario, Canada.
Expert Opin Biol Ther. 2013 May;13(5):723-37. doi: 10.1517/14712598.2013.764411. Epub 2013 Jan 23.
In the last decade, the development of a number of potential drugs for lupus that target the pathogenesis of the disease at different levels has been witnessed. Despite a number of negative trials during this period, belimumab was recently approved for the treatment of adult seropositive lupus patients with mild-to-moderate disease activity.
This review summarizes the results of the most recent drug trials in lupus and highlights the aspects that require further refinement and modification in order to facilitate positive results in new drug trials for lupus.
The success of a clinical trial depends on the efficacy of the study drug and its appropriate dosing. Several other factors play a major role in the success of trials, including the patient inclusion criteria, the choice of evidence-based study outcomes and endpoints and other aspects of study design that are described in this review.
在过去的十年中，已经见证了许多针对疾病发病机制不同层面的潜在狼疮治疗药物的发展。尽管在此期间有许多阴性试验，但贝利尤单抗最近已被批准用于治疗成人血清阳性、疾病活动度为轻度至中度的狼疮患者。
本文综述了狼疮最新药物试验的结果，并强调了为促进狼疮新药试验取得积极结果而需要进一步完善和修改的方面。
临床试验的成功取决于研究药物的疗效及其适当的剂量。其他几个因素在试验的成功中起着重要作用，包括患者纳入标准、基于证据的研究结果和终点的选择以及本文中描述的研究设计的其他方面。
