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Interstitial lung disease
Original article
Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume
  1. Martin Kolb1,
  2. Luca Richeldi2,
  3. Jürgen Behr3,
  4. Toby M Maher4,5,
  5. Wenbo Tang6,
  6. Susanne Stowasser7,
  7. Christoph Hallmann7,
  8. Roland M du Bois8
  1. 1McMaster University, Hamilton, Ontario, Canada
  2. 2National Institute for Health Research Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, University of Southampton, Southampton, UK
  3. 3Medizinische Klinik und Poliklinik V, University of Munich and Asklepios Klinik München-Gauting, Member of the German Center for Lung Research, Munich, Germany
  4. 4NIHR Biomedical Research Unit Royal Brompton Hospital, London, UK
  5. 5Fibrosis Research Group, National Heart and Lung Institute, Imperial College, London, UK
  6. 6Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA
  7. 7Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany
  8. 8Imperial College, London, UK
  1. Correspondence to Dr Martin Kolb, Department of Medicine and Pathology/Molecular Medicine, McMaster University, 50 Charlton Ave. E., Hamilton, ON L8N 4A6 Canada; kolbm{at}mcmaster.ca

Abstract

Rationale There is no consensus as to when treatment for idiopathic pulmonary fibrosis (IPF) should be initiated. Some physicians prefer not to treat patients with preserved lung volume.

Objective To investigate whether patients with IPF and preserved lung volume receive the same benefit from nintedanib as patients with more impaired lung volume.

Methods Post hoc subgroup analyses of pooled data from the two replicate phase III INPULSIS trials by baseline FVC % predicted (≤90%, >90%).

Results At baseline, 274 patients had FVC >90% predicted and 787 patients had FVC ≤90% predicted. In patients treated with placebo, the adjusted annual rate of decline in FVC was consistent between patients with FVC >90% predicted and FVC ≤90% predicted (−224.6 mL/year and −223.6 mL/year, respectively). There was no statistically significant difference between these subgroups in the effect of nintedanib on annual rate of decline in FVC, change from baseline in St George's Respiratory Questionnaire total score or time to first acute exacerbation. In patients with baseline FVC >90% predicted and ≤90% predicted, respectively, the adjusted annual rate of decline in FVC with nintedanib was −91.5 mL/year (difference vs placebo: 133.1 mL/year (95% CI 68.0 to 198.2)) and −121.5 mL/year (difference vs placebo: 102.1 mL/year (95% CI 61.9 to 142.3)). Adverse events associated with nintedanib were similar in both subgroups.

Conclusions Patients with IPF and preserved lung volume (FVC >90% predicted) have the same rate of FVC decline and receive the same benefit from nintedanib as patients with more impaired lung volume.

Trial registration number NCT01335464 and NCT01335477.

  • Idiopathic pulmonary fibrosis

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/thoraxjnl-2016-208710

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