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.

Abstract

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).

• Authors: 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
• Journal: Respiratory medicine (Respir Med) Vol. 187 Pg. 106574 (10 2021) ISSN: 1532-3064 [Electronic] England
• PMID: 34564020 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Chemical References

• Indoles
• nintedanib

Topics

• Asian People
• Disease Progression
• Double-Blind Method
• Humans
• Idiopathic Pulmonary Fibrosis (drug therapy, mortality, physiopathology)
• Indoles (administration & dosage, therapeutic use)
• Lung Diseases, Interstitial (drug therapy, mortality, physiopathology)
• Safety
• Time Factors
• Treatment Outcome
• Vital Capacity