RT Journal Article
SR Electronic
T1 Reduction in disease progression with nintedanib in the INPULSIS™ trials
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 1906
VO 44
IS Suppl 58
A1 Vincent Cottin
A1 Hiroyuki Taniguchi
A1 Harold R. Collard
A1 Luca Richeldi
A1 Susanne Stowasser
A1 Inga Tschoepe
A1 Rozsa Schlenker-Herceg
A1 Ganesh Raghu
YR 2014
UL http://erj.ersjournals.com/content/44/Suppl_58/1906.abstract
AB Background: Nintedanib, an intracellular inhibitor of tyrosine kinases, is in development for the treatment of idiopathic pulmonary fibrosis (IPF). The INPULSIS™ trials were two replicate 52-week, randomized, double-blind, placebo-controlled Phase III trials that investigated the efficacy and safety of nintedanib 150 mg twice daily in 1066 patients with IPF. Declines in forced vital capacity (FVC) % predicted of >5% and >10% in patients with IPF have been proposed as indicators of disease progression and have been associated with reduced survival.Aim: To determine the effect of nintedanib on changes in FVC % predicted in the INPULSIS™ trials.Methods: The proportions of patients with absolute and relative declines in FVC % predicted of >5% and >10% at week 52 in each INPULSIS™ trial were determined in a post-hoc analysis.Results: In each trial, a significantly greater proportion of patients in the placebo group had an absolute decline in FVC % predicted of >5% compared with the nintedanib group. In INPULSIS™-1, a significantly greater proportion of patients in the placebo group had an absolute decline in FVC % predicted of >10% compared with the nintedanib group; the difference between groups in INPULSIS™-2 was numerically in favour of nintedanib but did not reach statistical significance. In each trial, significantly greater proportions of patients in the placebo group had relative declines in FVC % predicted of >5% and >10% compared with the nintedanib group.Conclusion: In the INPULSIS™ trials, nintedanib reduced the proportion of patients with IPF who experienced disease progression as measured by categorical FVC decline.