論文

国際誌
2021年10月

Efficacy and safety of nintedanib in Japanese patients with progressive fibrosing interstitial lung diseases: Subgroup analysis of the randomised, double-blind, placebo-controlled, phase 3 INBUILD trial.

Respiratory medicine
  • Yoshikazu Inoue
  • Takafumi Suda
  • Hideya Kitamura
  • Masaki Okamoto
  • Arata Azuma
  • Naohiko Inase
  • Masataka Kuwana
  • Shigeki Makino
  • Yasuhiko Nishioka
  • Takashi Ogura
  • Ayako Takizawa
  • Hiroyuki Ugai
  • Susanne Stowasser
  • Rozsa Schlenker-Herceg
  • Tsutomu Takeuchi
  • 全て表示

187
開始ページ
106574
終了ページ
106574
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1016/j.rmed.2021.106574

BACKGROUND: The efficacy of nintedanib in progressive fibrosing interstitial lung diseases (ILDs) was demonstrated in the randomised, double-blind, placebo-controlled INBUILD trial. This subgroup analysis evaluated the efficacy and safety of nintedanib in the Japanese population. METHODS: Patients with progressive fibrosing ILDs (evaluated by physicians within 24 months of screening) were randomised (1:1) to twice-daily 150-mg nintedanib or placebo; treatment continued until the last patient completed 52 weeks. The primary endpoint was the annual rate of decline in forced vital capacity (FVC) over 52 weeks. Time-to-first acute ILD exacerbation or death and time-to-death up until the last patient had completed the week 52 visit were evaluated. This subgroup analysis included 108 Japanese patients. RESULTS: The adjusted annual rates of FVC decline (mL/year) over 52 weeks for Japanese patients were -148.31 (nintedanib) and -240.36 (placebo), adjusted difference: 92.05 (95% CI: -10.69-194.80) and for non-Japanese patients were -67.41 (nintedanib) and -177.65 (placebo), adjusted difference: 110.24 (95% CI: 64.97-155.52). No heterogeneity in treatment effect between Japanese and non-Japanese subgroups was observed (treatment-by-subgroup interaction, p = 0.75). The risks of "acute exacerbation or death" (hazard ratio, 0.30 [95% CI: 0.10-0.91]) and mortality (hazard ratio, 0.54 [95% CI: 0.14-2.11]) in Japanese patients were numerically lower for nintedanib than placebo. There were no new or unexpected safety findings. CONCLUSIONS: In Japanese patients, nintedanib slowed ILD progression, evidenced by a reduction in the annual rate of decline in FVC vs placebo. The efficacy and safety of nintedanib in Japanese patients were consistent with the overall INBUILD population. CLINICALTRIALS.GOV: NCT02999178 (21-Dec-2016).

リンク情報
DOI
https://doi.org/10.1016/j.rmed.2021.106574
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/34564020
ID情報
  • DOI : 10.1016/j.rmed.2021.106574
  • PubMed ID : 34564020

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