Effect of baseline FVC on lung function decline with nintedanib in patients with IPF

Abstract

Background: The efficacy and safety of nintedanib 150 mg twice daily (bid) in patients with idiopathic pulmonary fibrosis (IPF) were assessed in the two replicate, 52-week, Phase III INPULSIS ® trials. Patients with forced vital capacity (FVC) ≥50% predicted were eligible to participate. Compared with placebo, nintedanib significantly reduced the annual rate of decline in FVC, the primary endpoint, in both trials. Aim: To assess the impact of baseline lung function impairment on the effect of nintedanib using an FVC threshold relevant for treatment reimbursement in several countries. Methods: Post-hoc analyses of patients with baseline FVC >80% vs ≤80% predicted were conducted using pooled data from both trials. Results: 485 patients (nintedanib 295; placebo 190) had FVC >80% predicted and 576 patients (nintedanib 343; placebo 233) had FVC ≤80% predicted. For patients with baseline FVC >80% predicted, mean age was 67.8 years, 75.5% were male and mean carbon monoxide diffusion capacity (DL CO ) was 51.3% predicted. For patients with baseline FVC ≤80% predicted, mean age was 65.9 years, 82.5% were male and mean DL CO was 43.8% predicted. There was no significant treatment-by-subgroup interaction for the primary endpoint (p=0.4959). In patients with baseline FVC >80% predicted, the nintedanib vs placebo difference in the adjusted annual rate of decline in FVC was 128.4 mL/year (95%CI: 78.0, 178.8); in patients with baseline FVC ≤80% predicted, it was 94.8 mL/year (95%CI: 48.3, 141.4). Conclusion: In a subgroup analysis of pooled data from the INPULSIS ® trials, nintedanib 150 mg bid reduced the decline in lung function by a similar magnitude in patients with IPF with baseline FVC >80% and ≤80% predicted.