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Lancet Rheumato:系统性红斑狼疮临床治疗终点的确定

2019-09-09 MedSci MedSci原创

研究认为,LLDAS的实现与降低SLE耀斑和损害显著相关,LLDAS可作为SLE临床研究的终点

靶向治疗策略通过简单的临床或实验室终点可评估单器官疾病的治疗效果,但复杂多器官疾病(如系统性红斑狼疮,SLE)目前缺乏有效的终点评估手段。近日研究人员开展前瞻性研究,旨在明确验证SLE治疗目标终点。

在这项前瞻性队列研究中,招募了来自8个国家的13个中心的年龄在18岁或18岁以上的SLE患者,并进行前瞻性跟踪。研究期间至少两次访问患者,间隔不超过6个月,每次访问时评估狼疮低活动状态(LLDAS)的实现情况。研究的主要结果是不可逆器官损伤的累加,定义为系统性狼疮国际合作/美国风湿病学会损害指数至少增加1个百分点。研究人员使用时间相关的危险回归模型和广义线性模型来评估LLDAS与不可逆的终末器官损伤或耀斑(关键次要结果)之间的关系。

1707名患者,平均随访2年,共计随访12689次。在任何时间点获得LLDAS均与损伤发生(0.59)及随后的耀斑(0.65)有关。LLDAS的累积时间与改善预后相关: LLDAS中观察时间少于平均时间的患者相比,LLDAS时间在平均值以上患者损伤累积风险(0.54)和耀斑的风险(0.41)降低。同样,持续性LLDAS的持续时间延长与损害累积风险逐渐降低有关。在研究开始时,无论先前存在的损伤或疾病活动如何,均观察到LLDAS与损伤累积减少的关联。

研究认为,LLDAS的实现与降低SLE耀斑和损害显著相关,LLDAS可作为SLE临床研究的终点。

原始出处:


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    2019-09-25 howi
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    2019-09-11 zhouqu_8
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    2019-09-09 天地飞扬

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