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Biomarkers of extracellular matrix turnover in patients with idiopathic pulmonary fibrosis given nintedanib (INMARK study): A randomised, placebo-controlled study

The Lancet Respiratory Medicine Sep 10, 2019

Maher TM, Stowasser S, Nishioka Y, et al. - Researchers undertook this randomised, double-blind, placebo-controlled trial, the INMARK trial, to determine the ability of alterations in neoepitopes (free-circulating protein fragments generated by degradation of extracellular matrix) in predicting disease progression in patients with idiopathic pulmonary fibrosis and to evaluate the influence of nintedanib on these biomarkers. Eligible patients were randomly allocated (1:2) to receive oral nintedanib 150 mg twice a day or placebo for 12 weeks in a double-blind fashion, followed by open-label nintedanib for 40 weeks. In the intention-to-treat population, the rate of alteration in C-reactive protein degraded by matrix metalloproteinases 1 and 8 (CRPM) from baseline to week 12 was assessed as the primary endpoint. They found that the rate of forced vital capacity decline was reduced but the rate of change in CRPM was not altered by treatment with nintedanib vs placebo for 12 weeks in patients with idiopathic pulmonary fibrosis and preserved lung function. Change in CRPM was refuted as a marker of response to nintedanib in patients with idiopathic pulmonary fibrosis.
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