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



Lisa Lancaster1, *
iD
, Jonathan Goldin2, Matthias Trampisch3, Grace Hyun Kim2, 4
iD
, Jonathan Ilowite5
iD
, Lawrence Homik6, David L. Hotchkin7, Mitchell Kaye8, Christopher J. Ryerson9, Nesrin Mogulkoc10, Craig S Conoscenti11
1 Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA
2 Department of Radiology, University of California, Los Angeles, California, USA
3 Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany
4 Department of Biostatistics, University of California, Los Angeles, California, USA
5 Division of Pulmonary and Critical Care Medicine, Department of Medicine, Hofstra North Shore-LIJ School of Medicine, New Hyde Park, New York
6 Department of Respiratory Medicine and Bronchoscopy, Winnipeg Clinic, Winnipeg, Manitoba, Canada
7 The Oregon Clinic, Division of Pulmonary, Critical Care & Sleep Medicine, Portland, Oregon, USA
8 Department of Pulmonary Medicine, Minnesota Lung Center, Ltd., Minneapolis, Minnesota, USA
9 Department of Medicine & Centre for Heart Lung Innovation, University of British Columbia, Vancouver, Canada
10 Department of Pulmonology, Ege University Hospital, Bornova, Izmir, Turkey
11 Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA


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Creative Commons License
© 2020 Lancaster etal.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: (https://creativecommons.org/licenses/by/4.0/legalcode). This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Correspondence: Address correspondence to this author at the Department of Medicine, Vanderbilt University Medical Center, 1301 22nd Avenue South, Suite B-817 TVC, Nashville, Tennessee 37232. Tel: +1 615 322 5879, E-mail: lisa.lancaster@Vanderbilt.Edu


Abstract

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.

Keywords: Disease progression, Tomography, Lung diseases, Interstitial, Exercise test, Therapeutics.