論文No1753
Stability or improvement in forced vital capacity with nintedanib in patients with idiopathic pulmonary fibrosis
Kevin R. Flaherty, Martin Kolb, Carlo Vancheri, Wenbo Tang, Craig S. Conoscenti, Luca Richeldi
European Respiratory Journal 52 (2) 1702593; DOI: 10.1183/13993003.02593-2017 Published 2 August 2018
＜背景＞
第III相INPULSIS試験で、ニンテダニブは特発性肺線維症(IPF)患者において
プラセボと比較して努力性肺活量(FVC)の年間減衰を改善した。
＜方法＞
我々はINPULSIS試験のFVC変化の分布についてpost hoc解析を行い、
INPULSIS試験でFVCが改善したか減少しなかったサブグループにおいて
オープンラベルの拡張試験であるINPULSIS-ONでFVC変化について検討した。
＜結果＞
FVCの年間変化率に基づき、638名のニンテダニブ治療群のうち158名(24.8%)、
およびプラセボ治療423名中38名(9.0%)がINPULSIS試験でFVCが改善した／減少しなかった。
FVCが改善／減少しなかった群で、52週時点のFVC改善中央値(四分位範囲)は
ニンテダニブ群で76.5(31-152) mLであり、プラセボ群で57.5(31-103) mLであった。
INPULSIS-ON試験でベースラインから48週のFVC変化はINPULSIS試験と同様であった。
＜感想＞
INPULSIS試験でFVCが減少しなかった割合は、ニンテダニブ群で24.8%、プラセボ群で9.0%だったようです。
In the Phase III INPULSIS® trials, nintedanib reduced the annual rate of decline in forced vital capacity (FVC) versus placebo in patients with idiopathic pulmonary fibrosis (IPF).
We conducted post hoc analyses of the distribution of changes in FVC in the INPULSIS® trials and FVC changes in the open-label extension trial INPULSIS®-ON in subgroups of patients based on whether patients had shown an improvement or no decline in FVC in INPULSIS®. Analyses were descriptive.
Based on the annual rate of change in FVC, 158 of 638 patients (24.8%) treated with nintedanib and 38 of 423 patients (9.0%) treated with placebo had an improvement/no decline in FVC in the INPULSIS® trials. In patients whose FVC improved/did not decline, median (interquartile range) improvements in FVC at week 52 were 76.5 (31–152) mL and 57.5 (31–103) mL in the nintedanib and placebo groups, respectively. Changes in FVC from baseline to week 48 of INPULSIS®-ON were similar in patients whose FVC improved or declined in the preceding INPULSIS® trial.
In the INPULSIS® trials, treatment with nintedanib resulted in a greater proportion of patients with IPF showing an improvement/no decline in FVC compared to taking placebo. Mechanisms underlying improvement in FVC in patients with IPF are unknown.