Risk factors for disease progression in idiopathic pulmonary fibrosis

Ganesh Raghu; Brett Ley; Kevin K Brown; Vincent Cottin; Kevin F Gibson; Robert J Kaner; David J Lederer; Paul W Noble; Jin Woo Song; Athol U Wells; Timothy P Whelan; David A Lynch; Stephen M Humphries; Emmanuel Moreau; Krista Goodman; Scott D Patterson; Victoria Smith; Qi Gong; John S Sundy; Thomas G O'Riordan; Fernando J Martinez

doi:10.1136/thoraxjnl-2019-213620

Risk factors for disease progression in idiopathic pulmonary fibrosis

Thorax. 2020 Jan;75(1):78-80. doi: 10.1136/thoraxjnl-2019-213620. Epub 2019 Oct 14.

Authors

Ganesh Raghu¹, Brett Ley², Kevin K Brown³, Vincent Cottin⁴, Kevin F Gibson⁵, Robert J Kaner⁶, David J Lederer⁷, Paul W Noble⁸, Jin Woo Song⁹, Athol U Wells¹⁰, Timothy P Whelan¹¹, David A Lynch¹², Stephen M Humphries¹², Emmanuel Moreau¹³, Krista Goodman¹⁴, Scott D Patterson¹⁴, Victoria Smith¹⁴, Qi Gong¹⁵, John S Sundy¹⁴, Thomas G O'Riordan¹⁴, Fernando J Martinez¹⁶

Affiliations

¹ Center for Interstitial Lung Diseases, Department of Medicine, University of Washington, Seattle, Washington, USA graghu@uw.edu.
² Division of Pulmonary and Critical Care Medicine, University of California San Francisco, San Francisco, California, USA.
³ Division of Pulmonary and Critical Care Medicine, National Jewish Health, Denver, Colorado, USA.
⁴ Center for Rare Pulmonary Diseases, Hospices Civils de Lyon, University of Lyon, UMR754, Lyon, France.
⁵ Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
⁶ Department of Clinical Medicine and Genetic Medicine, Weill Cornell Medicine, New York, New York, USA.
⁷ Division of Pulmonary, Allergy, and Critical Care, Columbia University Medical Center, New York, New York, USA.
⁸ Department of Medicine, Cedars Sinai Medical Center, Los Angeles, California, USA.
⁹ Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
¹⁰ Department of Medicine, National Heart & Lung Institute, Royal Brompton Hospital, Imperial College, London, UK.
¹¹ Department of Medicine, Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.
¹² Department of Radiology, National Jewish Health, Denver, Colorado, USA.
¹³ Research and Development, bioMérieux, Lyon, France.
¹⁴ Clinical Research, Gilead Sciences, Inc, Seattle, Washington, USA.
¹⁵ Biostatistics, Gilead Sciences, Inc, Foster City, California, USA.
¹⁶ Department of Medicine, Cornell University, New York City, New York, USA.

PMID: 31611341
DOI: 10.1136/thoraxjnl-2019-213620

Abstract

In this retrospective study of a randomised trial of simtuzumab in idiopathic pulmonary fibrosis (IPF), prodromal decline in forced vital capacity (FVC) was significantly associated with increased risk of mortality, respiratory and all-cause hospitalisations, and categorical disease progression. Predictive modelling of progression-free survival event risk was used to assess the effect of population enrichment for patients at risk of rapid progression of IPF; C-index values were 0.64 (death), 0.69 (disease progression), and 0.72 (adjudicated respiratory hospitalisation) and 0.76 (all-cause hospitalisation). Predictive modelling may be a useful tool for improving efficiency of clinical trials with categorical end points.

Keywords: idiopathic pulmonary fibrosis.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Aged
Antibodies, Monoclonal, Humanized / therapeutic use*
Clinical Trials, Phase II as Topic
Disease Progression
Female
Humans
Idiopathic Pulmonary Fibrosis / drug therapy*
Idiopathic Pulmonary Fibrosis / physiopathology*
Male
Randomized Controlled Trials as Topic
Respiratory Function Tests
Retrospective Studies
Risk Factors
Treatment Failure

Substances

Antibodies, Monoclonal, Humanized
simtuzumab