Boehringer Ingelheim announced results from a pre-specified, pooled subgroup sensitivity analysis from the Phase 3 INPULSIS-1 and INPULSIS-2 trials that evaluated the use of nintedanib in patients with idiopathic pulmonary fibrosis (IPF) based on the severity of lung function impairment at baseline.
INPULSIS-1 and INPULSIS-2 are double-blind, randomized, and placebo-controlled trials evaluating the effect of oral nintedanib on annual rate of decline in forced vital capacity (FVC), in people with IPF over 52 weeks. The trials had an identical design, dosing, inclusion criteria, and endpoints. The primary endpoint was the annual rate of decline in FVC (expressed in mL over 52 weeks).
In this analysis, nintedanib produced a similar reduction in lung function decline across two pre-specified groups after 52 weeks of treatment:
- Baseline FVC >70% predicted: -111.3mL (nintedanib) vs. -220.3mL (placebo)
- Baseline FVC <70% predicted: -119.7mL (nintedanib) vs. -233.2mL (placebo)
Nintedanib is an investigational small molecule tyrosine kinase inhibitor (TKI) that targets the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), and platelet-derived growth factor receptor (PDGFR).
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