Efficacy and safety of nintedanib in advanced idiopathic pulmonary fibrosis

Hee Young Yoon, Sojung Park, Dong Soon Kim, Jin Woo Song

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57 Scopus citations


Background: Phase 3 trials have shown that nintedanib reduces the decline in forced vital capacity (FVC) in patients with mild-to-moderate idiopathic pulmonary fibrosis (IPF) with acceptable safety profiles; however, its effects on advanced IPF are unclear. We investigated the efficacy and safety of nintedanib in patients with advanced IPF. Methods: Prospective data were obtained from 108 IPF patients administered at least one dose of nintedanib. Of these patients, 47.2% had advanced IPF (FVC < 50% predicted, or diffusing capacity < 30% predicted). Results: The median treatment duration was 42.2 weeks. Nintedanib significantly reduced the decline rate in both FVC (- 0.55% [before] vs. -0.32% [after] predicted/month, p = 0.020) and total lung capacity (TLC) (- 0.35% vs. -0.06% predicted/month, p < 0.001) in all patients. A significant improvement in FVC decline rate after treatment was also observed in the advanced group (- 0.77% vs. -0.22% predicted/month, p = 0.003), but not in the non-advanced group (- 0.41% vs. -0.33% predicted/month, p = 0.564). Adverse events occurred in 97.2% of the cohort, including diarrhoea (50.0%) and anorexia (45.4%). Following adjustment for treatment duration, no inter-group difference in odds ratio was observed for the occurrence of adverse events. However, the advanced group showed a higher frequency of treatment interruption (68.0% vs. 40.0%), mainly as a result of disease progression (47.1% vs. 36.4%). Conclusions: The efficacy and safety profiles of nintedanib in the advanced group were comparable to those in the non-advanced group except for a higher frequency of discontinuation, which may be due to the advanced status itself.

Original languageEnglish
Article number203
JournalRespiratory Research
Issue number1
StatePublished - 19 Oct 2018

Bibliographical note

Funding Information:
This study was supported by a grant of the Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Science and ICT (NRF-2016R1A2B4016318). The funding sources were not involved in the study design, analysis or interpretation of data, or the decision to submit the manuscript for publication.

Publisher Copyright:
© 2018 The Author(s).


  • Adverse effects
  • Idiopathic pulmonary fibrosis
  • Nintedanib
  • Respiratory function tests
  • Treatment outcome


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