Effect of FEV1/FVC ratio on reduction in FVC decline with nintedanib in the INPULSIS™ trials

Background: The two replicate randomized, placebo-controlled, 52-week Phase III INPULSIS™ trials assessed the efficacy and safety of nintedanib 150 mg twice daily in patients with IPF. Patients with an FEV1/FVC ratio of < 0.7 were excluded. Compared with placebo, nintedanib slowed disease progression by significantly reducing the annual rate of decline in forced vital capacity (FVC), the primary endpoint, in both trials. Methods: A post-hoc subgroup analysis of the effect of nintedanib on the primary endpoint in patients with a baseline FEV1/FVC ratio of > 0.8 versus ≤0.8 was conducted using pooled data from bot…