Dobashi Masaki, Tanaka Hisashi, Taima Kageaki, Itoga Masamichi, Ishioka Yoshiko, Shiratori Toshihiro, Okumura Fumihiko, Tabe Chiori, Tanaka Yoshihito, Morimoto Takeshi, Hasegawa Yukihiro, Yasugahira Hideo, Okudera Koichi, Takanashi Shingo, Tasaka Sadatomo
Department of Respiratory Medicine, Hirosaki University Graduate School of Medicine, Aomori, Japan.
Department of Respiratory Medicine, Hirosaki National Hospital, Aomori, Japan.
SAGE Open Med. 2021 Jun 6;9:20503121211023357. doi: 10.1177/20503121211023357. eCollection 2021.
The INPULSIS trials revealed that nintedanib reduced the decline in lung function in patients with idiopathic pulmonary fibrosis. We aimed to evaluate the efficacy and safety of nintedanib in Japanese idiopathic pulmonary fibrosis patients in real-world settings.
Medical records of idiopathic pulmonary fibrosis patients, who received treatment with nintedanib in five institutions between July 2015 and June 2017, were reviewed. Patients with % forced vital capacity ⩾50% and % predicted diffusing capacity of the lung carbon monoxide ⩾30% were classified as the moderate group and those with more impaired lung functions as the severe group.
Among 158 patients analyzed, 132 (84.6%) were classified as the moderate group and 26 (15.4%) as the severe group. In the moderate group, changes in forced vital capacity in 12 months were significantly different between before and after nintedanib administration (-253 ± 163 vs -125 ± 235 mL; = 0.0027). In contrast, changes in forced vital capacity in 12 months were not significantly changed by nintedanib treatment in the severe group (-353 ± 250 vs -112 ± 341 mL; = 0.2374). Incidence of acute exacerbation was higher in the severe group than in the moderate group (30.8% vs 18.9%). The overall survival of the moderate and the severe groups was 17.2 and 10.1 months.
In real-world practice, nintedanib showed comparable efficacy to those observed in previous trials. In the severe group, the efficacy of nintedanib might be limited.
INPULSIS试验显示，尼达尼布可减缓特发性肺纤维化患者的肺功能下降。我们旨在评估尼达尼布在日本特发性肺纤维化患者实际临床环境中的疗效和安全性。
回顾了2015年7月至2017年6月期间在五家机构接受尼达尼布治疗的特发性肺纤维化患者的病历。将用力肺活量百分比≥50%且肺一氧化碳弥散量预测值百分比≥30%的患者分类为中度组，肺功能受损更严重的患者分类为重度组。
在分析的158例患者中，132例（84.6%）被分类为中度组，26例（15.4%）为重度组。在中度组中，尼达尼布给药前后12个月的用力肺活量变化有显著差异（-253±163 vs -125±235 ml；P = 0.0027）。相比之下，重度组中尼达尼布治疗后12个月的用力肺活量变化无显著改变（-353±250 vs -112±341 ml；P = 0.2374）。重度组急性加重的发生率高于中度组（30.8% vs 18.9%）。中度组和重度组的总生存期分别为17.2个月和10.1个月。
在实际临床实践中，尼达尼布显示出与先前试验中观察到的疗效相当。在重度组中，尼达尼布的疗效可能有限。
