Effects of Nintedanib on Quantitative Lung Fibrosis Score in Idiopathic Pulmonary Fibrosis.

Autor:	Lancaster L; Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Goldin J; Department of Radiology, University of California, Los Angeles, California, USA., Trampisch M; Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany., Kim GH; Department of Radiology, University of California, Los Angeles, California, USA.; Department of Biostatistics, University of California, Los Angeles, California, USA., Ilowite J; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Hofstra North Shore-LIJ School of Medicine, New Hyde Park, New York., Homik L; Department of Respiratory Medicine and Bronchoscopy, Winnipeg Clinic, Winnipeg, Manitoba, Canada., Hotchkin DL; The Oregon Clinic, Division of Pulmonary, Critical Care & Sleep Medicine, Portland, Oregon, USA., Kaye M; Department of Pulmonary Medicine, Minnesota Lung Center, Ltd., Minneapolis, Minnesota, USA., Ryerson CJ; Department of Medicine & Centre for Heart Lung Innovation, University of British Columbia, Vancouver, Canada., Mogulkoc N; Department of Pulmonology, Ege University Hospital, Bornova, Izmir, Turkey., Conoscenti CS; Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA.
Jazyk:	angličtina
Zdroj:	The open respiratory medicine journal [Open Respir Med J] 2020 Sep 22; Vol. 14, pp. 22-31. Date of Electronic Publication: 2020 Sep 22 (Print Publication: 2020).
DOI:	10.2174/1874306402014010022
Abstrakt:	Background: Nintedanib slows disease progression in patients with Idiopathic Pulmonary Fibrosis (IPF) by reducing decline in Forced Vital Capacity (FVC). The effects of nintedanib on abnormalities on high-resolution computed tomography scans have not been previously studied. Objective: We conducted a Phase IIIb trial to assess the effects of nintedanib on changes in Quantitative Lung Fibrosis (QLF) score and other measures of disease progression in patients with IPF. Methods: 113 patients were randomized 1:1 to receive nintedanib 150 mg bid or placebo double-blind for ≥6 months, followed by open-label nintedanib. The primary endpoint was the relative change from baseline in QLF score (%) at month 6. Analyses were descriptive and exploratory. Results: Adjusted mean relative changes from baseline in QLF score at month 6 were 11.4% in the nintedanib group (n=42) and 14.6% in the placebo group (n=45) (difference 3.2% [95% CI: -9.2, 15.6]). Adjusted mean absolute changes from baseline in QLF score at month 6 were 0.98% and 1.33% in these groups, respectively (difference 0.35% [95% CI: -1.27, 1.96]). Adjusted mean absolute changes from baseline in FVC at month 6 were -14.2 mL and -83.2 mL in the nintedanib (n=54) and placebo (n=54) groups, respectively (difference 69.0 mL [95% CI: -8.7, 146.8]). Conclusion: Exploratory data suggest that in patients with IPF, 6 months' treatment with nintedanib was associated with a numerically smaller degree of fibrotic change in the lungs and reduced FVC decline versus placebo. These data support previous findings that nintedanib slows the progression of IPF. (© 2020 Lancaster etal.)
Databáze:	MEDLINE
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