Ann Rheum Dis:IFN-K治疗系统性红斑狼疮的疗效和安全性

2020-01-05 xiangting MedSci原创

IFN-K诱导抗IFN-α2b抗体的中和,明显减少IFN基因标记,并且安全性可接受。

这项研究旨在评估一项为期36周(W)的IIb期随机、双盲、安慰剂(PBO)对照试验中活动性系统性红斑狼疮(SLE)成年患者在标准治疗外,接受干扰素-αKinoidIFN-K免疫治疗疫苗的疗效和安全性。

将疾病活动性中至重度且干扰素(IFN)基因标记阳性的SLE患者(185)随机分配接受IFN-KPBO肌肉注射(第0728天以及W12W24)。W36的主要共同终点是IFN基因标记的中和,以及强制皮质类固醇(CS)减量改良的基于BILAG狼疮综合评估指数(BICLA)。

IFN-K91%的患者中诱导了抗IFN-α2b血清抗体的中和,并减少了IFN基因标记(p<0.0001)。W36IFN-K41%)与PBO34%)组间的改良BICLA反应无统计学差异。IFN-K组系统性红斑狼疮应答者指数-4的趋势占优,其中包括W36时的类固醇减量,当分析仅限于出现抗IFN-α2b抗体中和患者时差异变得有显著性(p<0.05)。W36时两组达到狼疮低疾病活动状态(LLDAS)的比率有差异,其中IFN-K组占优(53vs 30%,p=0.0022)。从W28开始观察到IFN-K组明显的CS节约效应,与PBO相比,W36IFN-K组的每日泼尼松剂量减少24%(p=0.0097)。IFN-K的安全性可接受。

IFN-K诱导抗IFN-α2b抗体的中和,明显减少IFN基因标记,并且安全性可接受。尽管未达到临床主要终点,但IFN-K组达到了相关次要终点,其中包括达到LLDAS和类固醇减量。

原始出处:

Frederic A Houssiau. IFN-α kinoid in systemic lupus erythematosus: results from a phase IIb, randomised, placebo-controlled study. Ann Rheum Dis. December 2019.

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    2020-01-07 zhouqu_8
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    2020-01-07 bugit
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    2020-01-05 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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Clinica Chimica Acta:系统性红斑狼疮的潜在生物标志物?

系统性红斑狼疮(SLE)是一种自身免疫性、多系统疾病。目前的诊断仍主要基于美国风湿病学会制定的复杂标准。此外,特异性生物标志物的缺乏也对诊断提出了挑战。