First Data on Efficacy and Safety of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis and Forced Vital Capacity of ≤50 % of Predicted Value.
First Data on Efficacy and Safety of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis and Forced Vital Capacity of ≤50 % of Predicted Value.
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作者：
Wuyts WA;Kolb M;Stowasser S;Stansen W;Huggins JT;Raghu G
在第三阶段的INPULSIS®试验中，与安慰剂相比，在特发性肺纤维化(IPF)患者中，使用inetedanib进行52周的治疗可以减少用力肺活量(FVC)的下降。完成INPULSIS®试验的患者可以在开放标签延长试验(INPULSIS®-ON)中接受九替丹尼。预计FVC为50%的患者被排除在INPULSIS®之外，但可以参加INPULSIS®-ON。在INPULSIS®-ON开始时预测基础用力肺活量为≤50%和50%的患者中，从基线到48周INPULSIS®-ON的FVC绝对平均变化分别为−62.3和−87.9mL.(n=0.24和n=0.558)。与INPULSIS®相比，INPULSIS®-ON中没有发现新的安全信号。根据基线FVC%预测，两个亚组INPULSIS®-ON的FVC下降与INPULSIS®相似，这表明在晚期疾病患者中，9tedanib对疾病进展的影响可能与非晚期疾病患者相似。
In the Phase III INPULSIS® trials, 52 weeks’ treatment with nintedanib reduced decline in forced vital capacity (FVC) versus placebo in patients with idiopathic pulmonary fibrosis (IPF). Patients who completed the INPULSIS® trials could receive nintedanib in an open-label extension trial (INPULSIS®-ON). Patients with FVC <50 % predicted were excluded from INPULSIS®, but could participate in INPULSIS®-ON. In patients with baseline FVC ≤50 % and >50 % predicted at the start of INPULSIS®-ON, the absolute mean change in FVC from baseline to week 48 of INPULSIS®-ON was −62.3 and −87.9 mL, respectively (n = 24 and n = 558, respectively). No new safety signals were identified in INPULSIS®-ON compared with INPULSIS®. The decline in FVC in INPULSIS®-ON in both subgroups by baseline FVC % predicted was similar to that in INPULSIS®, suggesting that nintedanib may have a similar effect on disease progression in patients with advanced disease as in less advanced disease.
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