New data for Vargatef in Pulmonary Fibrosis-Boehringer

A pre-specified, pooled subgroup sensitivity analysis from the two identically designed Phase III INPULSIS trials, evaluated the impact of Vargatef (nintedanib), from Boehringer, on reducing the decline in lung function, as measured by annual rate of decline in forced vital capacity (FVC), in patients with Idiopathic Pulmonary Fibrosis (IPF) based on the severity of lung function impairment at baseline. The efficacy and safety of nintedanib in the treatment of IPF has not been established. In this analysis, nintedanib produced a similar reduction in lung function decline across two pre-specified groups after 52 weeks of treatment: Baseline FVC less than 70% predicted: -111.3mL (nintedanib) vs. -220.3mL (placebo). Additionally: Baseline FVC more than 70% predicted: -119.7mL (nintedanib) vs. -233.2mL (placebo).

In the pre-specified, pooled subgroup analysis, 95.5% of patients who received nintedanib and 89.6% of those who received placebo experienced an adverse event. In total, these events were severe in 27.3% in the nintedanib arm and 23.4% in the placebo arm. Adverse events led to treatment discontinuation in 19.3% and 13.0% of patients receiving nintedanib and placebo, respectively. Data were presented at the European Respiratory Society International Congress (ERS).