Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume

• Published in: Thorax Vol. 72; no. 4; pp. 340 - 346
• Main Authors: Kolb, Martin, Richeldi, Luca, Behr, Jürgen, Maher, Toby M, Tang, Wenbo, Stowasser, Susanne, Hallmann, Christoph, du Bois, Roland M
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.04.2017; BMJ Publishing Group
• Series: Original article
• Subjects: Aged; Drug dosages; Enzyme Inhibitors - therapeutic use; Female; Humans; Idiopathic Pulmonary Fibrosis - drug therapy; Idiopathic Pulmonary Fibrosis - physiopathology; Indoles - therapeutic use; Interstitial Lung Disease; Lung Volume Measurements; Male; Missing data; Mortality; Pulmonary fibrosis; Surveys and Questionnaires; Treatment Outcome; Idiopathic pulmonary fibrosis
• ISSN: 0040-6376; 1468-3296
• DOI: 10.1136/thoraxjnl-2016-208710

RationaleThere 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.ObjectiveTo investigate whether patients with IPF and preserved lung volume receive the same benefit from nintedanib as patients with more impaired lung volume.MethodsPost hoc subgroup analyses of pooled data from the two replicate phase III INPULSIS trials by baseline FVC % predicted (≤90%, >90%).ResultsAt 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.ConclusionsPatients 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 numberNCT01335464 and NCT01335477.