The Open Respiratory Medicine Journal




ISSN: ― Volume ,
CLINICAL TRIAL STUDY

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



Lisa Lancaster1, *, Jonathan Goldin2, Matthias Trampisch3, Grace Hyun Kim2, 4, Jonathan Ilowite5, 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

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.


Article Information


Identifiers and Pagination:

Year: 2020
Volume: 14
First Page: 22
Last Page: 31
Publisher Id: TORMJ-14-22
DOI: 10.2174/1874306402014010022

Article History:

Received Date: 31/03/2020
Revision Received Date: 17/06/2020
Acceptance Date: 02/07/2020
Electronic publication date: 22/09/2020
Collection year: 2020

© 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



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