Consistent effect of nintedanib on reducing FVC decline across interstitial lung diseases (ILDs)

Abstract

Background: The effect of nintedanib on the rate of FVC decline has been investigated in clinical trials across a spectrum of fibrosing ILDs. Aim: To assess the consistency of the effect of nintedanib vs placebo on the rate of FVC decline across phase III clinical trials in subjects with various fibrosing ILDs. Methods: The effects of nintedanib were investigated in placebo-controlled trials in subjects with idiopathic pulmonary fibrosis (IPF) (INPULSIS-1 and -2), systemic sclerosis-associated ILD (SENSCIS) and progressing fibrosing ILDs other than IPF (INBUILD). In each trial, the primary endpoint was the annual rate of decline in FVC (mL/year) assessed over 52 weeks. We performed a meta-analysis based on the relative treatment effects of nintedanib vs placebo on the annual rate of decline in FVC (mL/year) to account for the different natural histories of these diseases, to estimate the combined relative effect and to test for heterogeneity across trials. Results: Nintedanib slowed the annual rate of decline in FVC vs placebo in the combined analysis by 51.0% (95% CI 39.1, 63.0). The results were consistent across the spectrum of trials in different ILDs (Figure). Conclusion: Nintedanib had a consistent effect on reducing the annual rate of decline in FVC across clinical trials conducted in subjects with a range of fibrosing ILDs.