Arthritis Rheumatol:lenabasum治疗成人系统性硬化症2期试验的安全性和疗效

2020-05-09 xiangting MedSci原创

lenabasum改善了疗效结局和潜在的疾病病理,并具有良好的安全性。

这项研究旨在评估lenabasum治疗弥漫性皮肤型系统性硬化症(dcSSc)的安全性和疗效。

在美国9个SSc诊所进行了一项双盲、随机、安慰剂对照2期试验。接受稳定的标准治疗并且病程≤6年的dcSSc成年患者接受lenabasum(N=27)或安慰剂治疗(N=15)。lenabasum剂量为5mg每天1次(QD)、20mg QD或20mg每天2次(BID),持续4周,然后20mg BID,持续8周。在第4、8、12和16周进行安全性和疗效评估。

lenabasum组有63%的患者出现不良事件,安慰剂组为60%,没有与lenabasum相关的严重不良事件。与安慰剂相比,lenabasum治疗与美国风湿病学会综合反应指数的弥漫性皮肤型系统性硬化症(CRISS)评分以及其他评估整体疾病、皮肤受累和患者报告功能的疗效结局改善更大相关。研究期间lenabasum组的CRISS评分增加,在第16周时达到0.33,而安慰剂组为0.00(p=0.07,两面混合模型重复测量)。与安慰剂组相比,lenabasum组通过皮肤活检的组织学评估,发现炎症和纤维化途径中的基因表达减少,炎症和纤维化得到改善(p均≤0.05)。

尽管试验时间短且患者数量少,但在这项dcSSc的2期研究中,lenabasum改善了疗效结局和潜在的疾病病理,并具有良好的安全性。

原始出

Robert Spiera. Safety and efficacy of lenabasum in a phase 2 randomized, placebo‐controlled trial in adults with systemic sclerosis. Arthritis Rheumatol. 26 April 2020.

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    2020-05-11 zhaojie88
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    2020-05-09 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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