Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume.
BACKGROUND
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.


BACKGROUND
NCT01335464 and NCT01335477.
McMaster University, Hamilton, Ontario, Canada.
Martin
M
Kolb
National Institute for Health Research Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, University of Southampton, Southampton, UK.
Luca
L
Richeldi
Medizinische Klinik und Poliklinik V, University of Munich and Asklepios Klinik München-Gauting, Member of the German Center for Lung Research, Munich, Germany.
Jürgen
J
Behr
NIHR Biomedical Research Unit Royal Brompton Hospital, London, UK.|Fibrosis Research Group, National Heart and Lung Institute, Imperial College, London, UK.
Toby M
http://orcid.org/0000-0001-7192-9149
TM
Maher
Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA.
Wenbo
W
Tang
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
Susanne
S
Stowasser
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
Christoph
C
Hallmann
Imperial College, London, UK.
Roland M
RM
du Bois
D000368:Aged; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000188:drug therapy* / Q000503:physiopathology*; D007211:Indoles / Q000627:therapeutic use*; D008176:Lung Volume Measurements; D008297:Male; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D004791:Enzyme Inhibitors; D007211:Indoles; C530716:nintedanib
Idiopathic pulmonary fibrosis
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