Effects of nintedanib on circulating biomarkers of idiopathic pulmonary fibrosis
BackgroundBiomarkers that change in response to nintedanib in subjects with idiopathic pulmonary fibrosis (IPF) would be valuable. We investigated the effects of nintedanib on circulating biomarkers in subjects with IPF in the INMARK trial.MethodsSubjects with IPF were randomised 1:2 to receive nintedanib 150 mg bid or placebo for 12 weeks, after which all patients received open-label nintedanib for 40 weeks. Fold changes in adjusted mean levels of circulating biomarkers were analysed using a linear mixed model for repeated measures.Results346 subjects were treated (116 randomised to nintedanib, 230 to placebo). SP-D and CA-125, markers of epithelial injury, decreased in subjects treated with nintedanib versus placebo. Fold changes from baseline in SP-D at week 12 corresponded to a 4% decrease and 3% increase in the nintedanib and placebo groups, respectively (ratio 0.94 [95% CI: 0.89, 0.99]; p=0.024). Fold changes in CA-125 at week 12 corresponded to a 22% decrease and 4% increase in
