Effect of nintedanib on decline in forced vital capacity (FVC) over time in the INPULSIS trials in patients with idiopathic pulmonary fibrosis (IPF)
23 February 2017 (online)
The INPULSIS® trials assessed the efficacy and safety of nintedanib in patients with IPF. Compared with placebo, nintedanib significantly reduced the annual rate of decline in FVC, reflecting a slowing of disease progression.
In a post-hoc analysis, we assessed the effect of nintedanib versus placebo on adjusted change from baseline in FVC (mL) at each time point when FVC data was collected in the individual INPULSIS® trials and in pooled data from both trials. Spirometric tests were conducted at baseline and at 2, 4, 6, 12, 24, 36, and 52 weeks. Adjusted absolute mean difference versus placebo at each time point was based on a mixed effects model for repeated measures.
In INPULSIS®-1, the difference in adjusted mean change from baseline in FVC was statistically significant in favor of nintedanib compared with placebo from week 12 (52.1 mL [95% CI: 15.2, 89.1]; p = 0.0057), through week 24 (63.5 mL [95% CI: 26.3, 100.6]; p = 0.0008), week 36 (110.7 mL [95% CI: 73.3, 148.2]; p < 0.0001) and week 52 (109.9 mL [95% CI: 71.3, 148.6]; p < 0.0001). In INPULSIS®-2, nintedanib significantly reduced adjusted mean change from baseline in FVC compared with placebo from week 12 (54.9 mL [95% CI: 17.5, 92.2]; p = 0.0040), through week 24 (44.0 mL [95% CI: 6.4, 81.6]; p = 0.0220), week 36 (80.1 mL [95% CI: 42.2, 118.1]; p < 0.0001), and week 52 (109.8 mL [95% CI: 70.9, 148.6]; p < 0.0001). In pooled data, nintedanib significantly reduced adjusted mean change from baseline in FVC compared with placebo at weeks 12, 24, 36 and 52. Consistent findings were observed for changes from baseline in FVC % predicted over time in the individual trials and pooled data.
In the INPULSIS® trials in patients with IPF, a significant effect of nintedanib on reducing lung function decline was observed as early as week 12 and continued up to week 52.
Presented at ATS 2016.