PT  - JOURNAL ARTICLE
AU  - Kevin R Flaherty
AU  - Martin Kolb
AU  - Carlo Vancheri
AU  - Wenbo Tang
AU  - Craig S Conoscenti
AU  - Luca Richeldi
TI  - Stability or improvement in forced vital capacity with nintedanib in patients with IPF
AID  - 10.1183/13993003.02593-2017
DP  - 2018 Jan 01
TA  - European Respiratory Journal
PG  - 1702593
4099  - http://erj.ersjournals.com/content/early/2018/05/31/13993003.02593-2017.short
4100  - http://erj.ersjournals.com/content/early/2018/05/31/13993003.02593-2017.full
AB  - In the Phase III INPULSIS® trials, nintedanib reduced the annual rate of decline in forced vital capacity (FVC) versus placebo in patients with IPF.We conducted post-hoc analyses of the distribution of changes in FVC in the INPULSIS® trials and FVC changes in the open-label extension trial INPULSIS®-ON in subgroups of patients based on whether patients had shown an improvement/no decline in FVC in INPULSIS®. Analyses were descriptive.Based on annual rate of change in FVC, 158 of 638 patients (24.8%) treated with nintedanib and 38 of 423 patients (9.0%) treated with placebo had an improvement or no decline in FVC in the INPULSIS® trials. In patients whose FVC improved or did not decline, median (interquartile range) improvements in FVC at week 52 were 76.5 (31–152) mL and 57.5 (31–103) mL in the nintedanib and placebo groups, respectively. Changes in FVC from baseline to week 48 of INPULSIS®-ON were similar in patients whose FVC improved or declined in the preceding INPULSIS® trial.In the INPULSIS® trials, a greater proportion of patients with IPF treated with nintedanib than placebo had an improvement or no decline in FVC. Mechanisms underlying improvement in FVC in patients with IPF are unknown.FootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of interest: Dr. Flaherty reports grants and personal fees from Boehringer Ingelheim, grants and personal fees from Roche/Genentech, personal fees from Veracyte, personal fees from Biogen, grants from Afferent, personal fees from Aeolus, personal fees from Pharmakea, personal fees from Fibrogen, personal fees from Sanofi-Genzyme, outside the submitted work.Conflict of interest: Dr. Kolb reports grants from Canadian Pulmonary Fibrosis Foundation, other from Roche, other from Sanofi, other from Boehringer Ingelheim, grants from Canadian Institute for Health Research, grants and other from Pulmonary Fibrosis Foundation, personal fees from Boehringer Ingelheim, grants and personal fees from Roche Canada, personal fees from GlaxoSmithKline, personal fees from AstraZeneca, personal fees from Vertex, personal fees from Genoa, personal fees from Gilead, grants and personal fees from Janssen, personal fees from Prometic, personal fees from Alkermes, outside the submitted work.Conflict of interest: Dr. Vancheri reports grants and personal fees from Roche, grants and personal fees from Boehringer Ingelheim, outside the submitted work.Conflict of interest: Dr. Tang is an employee of Boehringer Ingelheim Pharmaceuticals, Inc (BIPI).Conflict of interest: Dr. Conoscenti is an employee of Boehringer Ingelheim Pharmaceuticals, Inc (BIPI).Conflict of interest: Dr. Richeldi reports grants and personal fees from InterMune, personal fees from Medimmune, personal fees from Biogen-Idec, personal fees from Sanofi-Aventis, personal fees from Roche, personal fees from Takeda, personal fees from ImmuneWorks, personal fees from Shionogi, personal fees from Boehringer Ingelheim, personal fees from Pliant Therapeutics, outside the submitted work.