Efficacy of Nintedanib in Idiopathic Pulmonary Fibrosis across Prespecified Subgroups in INPULSIS
Efficacy of Nintedanib in Idiopathic Pulmonary Fibrosis across Prespecified Subgroups in INPULSIS
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DOI：
10.1164/rccm.201503-0562oc
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发表时间：
2016-01-15
影响因子：
24.7
通讯作者：
Azuma, Arata
中科院分区：
文献类型：
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作者：
Costabel, Ulrich;Inoue, Yoshikazu;Azuma, Arata
基本原理：在两项重复、安慰剂对照、52周、III期INPULSIS试验中，尼达尼布150 mg每日两次显著降低了特发性肺纤维化（IPF）受试者的FVC年下降率（主要终点）。目前尚不清楚这种效应是否在所有接受nintedanib治疗的受试者中一致。目的：研究人口统计学和临床变量与nintedanib在IPF受试者中的效应的潜在相关性。方法：预先规定了INPULSIS试验汇总数据的亚组分析。按性别、年龄（≥ 65岁）、人种分析亚组（白色，亚洲人），基线FVC预测百分比（70%），基线圣乔治呼吸问卷（SGRQ）总分（40），吸烟状态（从未，既往/当前），全身皮质类固醇使用（是/否）和支气管扩张剂使用（是/否）。测量和主要结果：共1，061例受试者接受治疗（尼达尼布n = 638，安慰剂n = 423）。尼达尼布对主要终点或关键次要终点（SGRQ总分较基线的变化或至首次急性加重时间）的影响在任何亚组中均无统计学显著性差异。在基线FVC受试者中，关键次要终点的治疗效应似乎更明显
Rationale: In the two replicate, placebo-controlled, 52-week, phase III INPULSIS trials, nintedanib 150 mg twice daily significantly reduced the annual rate of decline in FVC, the primary endpoint, in subjects with idiopathic pulmonary fibrosis (IPF). It is unknown if this effect was uniform across all subjects treated with nintedanib.Objectives: To investigate the potential association of demographic and clinical variables with the effect of nintedanib in subjects with IPF.Methods: Subgroup analyses of pooled data from the INPULSIS trials were prespecified. Subgroups were analyzed by sex, age (= 65 yr), race (white, Asian), baseline FVC percentage predicted (70%), baseline St. George's Respiratory Questionnaire (SGRQ) total score (40), smoking status (never, ex/current), systemic corticosteroid use (yes/no), and bronchodilator use (yes/no).Measurements and Main Results: A total of 1,061 subjects were treated (nintedanib n = 638, placebo n = 423). There was no statistically significant difference in the effect of nintedanib for the primary endpoint or the key secondary endpoints of change from baseline in SGRQ total score or time to first acute exacerbation in any subgroup. Treatment effects for the key secondary endpoints seemed more pronounced in subjects with baseline FVC