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在进行性肺纤维化患者中开展的INBUILD试验的关键经验教训。

Key learnings from the INBUILD trial in patients with progressive pulmonary fibrosis.

作者信息

Mira-Avendano Isabel, Kaye Mitchell

机构信息

Department of Pulmonary, Critical Care and Sleep Medicine, UTHealth, Houston, TX 77030, USA.

Minnesota Lung Center, Minneapolis, MN, USA.

出版信息

Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241266343. doi: 10.1177/17534666241266343.

Abstract

In a patient with interstitial lung disease (ILD) of known or unknown etiology other than idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis (PPF) is defined by worsening lung fibrosis on high-resolution computed tomography (HRCT), decline in lung function, and/or deterioration in symptoms. The INBUILD trial involved 663 patients with PPF who were randomized to receive nintedanib or placebo. The median exposure to trial medication was approximately 19 months. The INBUILD trial provided valuable learnings about the course of PPF and the efficacy and safety of nintedanib. The relative effect of nintedanib on reducing the rate of forced vital capacity decline was consistent across subgroups based on ILD diagnosis, HRCT pattern, and disease severity at baseline, and between patients who were and were not taking glucocorticoids or disease-modifying anti-rheumatic drugs and/or glucocorticoids at baseline. The adverse events most frequently associated with nintedanib were gastrointestinal, particularly diarrhea, but nintedanib was discontinued in only a minority of cases. The results of the INBUILD trial highlight the importance of prompt detection and treatment of PPF and the utility of nintedanib as a treatment option.

摘要

对于病因已知或未知(非特发性肺纤维化 [IPF])的间质性肺疾病 (ILD) 患者,进行性肺纤维化 (PPF) 的定义为高分辨率计算机断层扫描 (HRCT) 显示肺纤维化加重、肺功能下降和/或症状恶化。INBUILD 试验纳入了 663 例 PPF 患者,这些患者被随机分配接受尼达尼布或安慰剂治疗。试验药物的中位暴露时间约为 19 个月。INBUILD 试验提供了关于 PPF 病程以及尼达尼布疗效和安全性的宝贵经验。基于 ILD 诊断、HRCT 模式和基线疾病严重程度的亚组,以及基线时服用和未服用糖皮质激素或改善病情抗风湿药物和/或糖皮质激素的患者之间,尼达尼布降低用力肺活量下降率的相对效果是一致的。与尼达尼布最常相关的不良事件是胃肠道事件,尤其是腹泻,但只有少数病例停用了尼达尼布。INBUILD 试验结果突出了 PPF 早期检测和治疗的重要性以及尼达尼布作为一种治疗选择的效用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/56b5/11311158/e8313a081dcd/10.1177_17534666241266343-fig1.jpg

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