P279 Reduction In Disease Progression With Nintedanib In The Inpulsis Trials

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.