A&R:尼达尼布可以减缓系统性硬化症相关间质性肺病(ILD)患者的肺功能下降速度

2022-06-20 彼岸河边草 MedSci原创

在INBUILD试验中,尼达尼布减缓了进展性纤维化自身免疫性疾病相关间质性肺病患者的用力肺活量百分比(FVC)下降速度,大多数患者可以控制不良事件。

目的尼达尼布是一种酪氨酸激酶的细胞内抑制剂,已被美国食品和药物管理局批准用于减缓系统性硬化症相关间质性肺病(ILD)患者的肺功能下降。本文研究目的在于分析尼达尼布在具有进行性表型的纤维化性自身免疫病ILD患者中的疗效和安全性。

方法INBUILD试验招募了非特发性肺纤维化的纤维化ILD患者,在高分辨率计算机断层扫描中弥漫性纤维化肺病程度> 10%,用力肺活量百分比预测(FVC%)45%,并且肺一氧化碳百分比预测≥30%<80%患者在筛选前的24个月内满足了方案定义的ILD进展标准,尽管患者治疗方案在临床实践中是恰当的。受试者被随机分配接受尼达尼布或安慰剂。研究人员评估了自身免疫性疾病相关ILD亚组52周内FVCml/年)和不良事件(AE)的下降率。

结果170名自身免疫性疾病相关ILD患者中,尼达尼布组52周内FVC下降率为-75.9 ml/年,安慰剂组为 -178.6 ml/年(差异102.7 ml/[95%置信区间23.2, 182.2] ; 标称 P=0.012)。根据ILD诊断,在各亚组中未检测到尼达尼布与安慰剂的效果存在异质性(P=0.91)。最常见的不良事件是腹泻,尼达尼布组和安慰剂组分别有63.4%27.3%的受试者报告。在尼达尼布组和安慰剂组中,不良事件分别导致17.1%10.2%的受试者永久停用试验药物。

结论INBUILD试验中,尼达尼布减缓了进展性纤维化自身免疫性疾病相关ILD患者的FVC下降速度,大多数患者可以控制不良事件。

出处:Matteson, E.L., Kelly, C., Distler, J.H.W., et al (2022), Nintedanib in Patients With Autoimmune Disease–Related Progressive Fibrosing Interstitial Lung Diseases: Subgroup Analysis of the INBUILD Trial. Arthritis Rheumatol, 74: 1039-1047. https://doi.org/10.1002/art.42075

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    2023-01-03 amy0559
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