Nintedanib and immunomodulatory therapies in progressive fibrosing interstitial lung diseases

• DOI: 10.1186/s12931-021-01668-1
• Publication Date: 2021-03-16T08:05:39Z
• Authors: Vincent Cottin; Luca Richeldi; Ivan Rosas; Maria Otaola; Jin Woo Song; Sara Tomassetti; Marlies Wijsenbeek; Manuela Schmitz; Carl Coeck; Susanne Stowasser; Rozsa Schlenker-H...; Martin Kolb
• Keywords: Nintedanib; Lung Fibrosis

Abstract Background In the INBUILD trial in patients with chronic fibrosing interstitial lung diseases (ILDs) and a progressive phenotype, nintedanib reduced rate of ILD progression adverse events that were manageable for most patients. We investigated potential impact immunomodulatory therapies on efficacy safety nintedanib. Methods Subjects ILDs other than idiopathic pulmonary fibrosis, who had shown within prior 24 months despite management clinical practice, randomized to receive or placebo. Certain restricted first 6 months. analyzed post-hoc decline forced vital capacity (FVC) over 52 weeks subgroups by glucocorticoid use at baseline analyses excluding subjects FVC measurements taken after initiation antifibrotic therapies. Results Of 663 subjects, 361 (54.4%) taking glucocorticoids (353 dose ≤ 20 mg/day). placebo group, adjusted (mL/year) was numerically greater not (− 206.4 [SE 20.2] vs − 165.8 [21.9]). The difference between groups 133.3 (95% CI 76.6, 190.0) mL/year 76.1 (15.0, 137.2) (interaction P = 0.18). effect reducing similar primary analysis. event profile did prohibited during treatment drug. Conclusions ILDs, influenced Nintedanib can be used combination ILDs. Trial registration ClinicalTrials.gov, NCT02999178. Registered 21 December 2016, https://clinicaltrials.gov/ct2/show/NCT02999178