Inoue, Yoshikazu National Hospital Organization Kinki-Chuo Chest Medical Center
Suda, Takafumi Hamamatsu University School of Medicine
Kitamura, Hideya Kanagawa Cardiovascular and Respiratory Center
Okamoto, Masaki Kurume University
Azuma, Arata Nippon Medical School
Inase, Naohiko Hiratsuka Kyosai Hospital
Kuwana, Masataka Nippon Medical School
Makino, Shigeki Osaka Medical and Pharmaceutical University
Nishioka, Yasuhiko Tokushima University Tokushima University Educator and Researcher Directory KAKEN Search Researchers
Ogura, Takashi Kanagawa Cardiovascular and Respiratory Center
Takizawa, Ayako Nippon Boehringer Ingelheim
Ugai, Hiroyuki Nippon Boehringer Ingelheim
Stowasser, Susanne Boehringer Ingelheim International
Schlenker-Herceg, Rozsa Boehringer Ingelheim Pharmaceuticals
Takeuchi, Tsutomu Keio University
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.
This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
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