Sensitivity analyses from the INPULSIS™ trials of nintedanib

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. The primary endpoint was the annual rate of decline in forced vital capacity (FVC). Key secondary endpoints were time to first acute exacerbation over 52 weeks and change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score over 52 wee…