Effect of baseline FVC on decline in lung function with nintedanib: results from the INPULSIS™ trials

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 randomized, double-blind, placebo-controlled, 52-week Phase III trials that assessed the efficacy and safety of nintedanib 150 mg twice daily in patients with IPF. The primary endpoint was the annual rate of decline in forced vital capacity (FVC), which was significantly reduced in the nintedanib group compared with placebo in both trials. Aim: To assess the impact of baseline FVC on the effect of nintedanib on rate of decline…