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

Lisa Lancaster; Jonathan Goldin; Matthias Trampisch; Grace Hyun Kim; Jonathan Ilowite; Lawrence Homik; David L Hotchkin; Mitchell Kaye; Christopher J Ryerson; Nesrin Mogulkoc; Craig S Conoscenti

doi:10.2174/1874306402014010022

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

Open Respir Med J. 2020 Sep 22:14:22-31. doi: 10.2174/1874306402014010022. eCollection 2020.

Authors

Affiliations

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; Exercise test; Interstitial; Lung diseases; Therapeutics; Tomography.