P279 Reduction In Disease Progression With Nintedanib In The Inpulsis™ Trials. (10th November 2014)

• Record Type: Journal Article
• Authors: Cottin, V; Taniguchi, H; Collard, HR; Richeldi, L; Stowasser, S; Tschoepe, I; Schlenker-Herceg, R; Raghu, G
• Is Part Of: Thorax. Volume 69(2014)Supplement 2
• Page Start: A196
• Page End: A196
• Publication Date: 2014-11-10
• Subjects: Chest -- Diseases -- Periodicals; Thorax; Chest -- Diseases; Periodicals; Periodicals; 617.54
• DOI: 10.1136/thoraxjnl-2014-206260.397
• Languages: English
• ISSNs: 0040-6376

Abstract

Abstract : 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, randomised, 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.