Risk factors for disease progression in idiopathic pulmonary fibrosis.

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.

• Authors: 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
• Journal: Thorax (Thorax) Vol. 75 Issue 1 Pg. 78-80 (01 2020) ISSN: 1468-3296 [Electronic] England
• PMID: 31611341 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.

Chemical References

• Antibodies, Monoclonal, Humanized
• simtuzumab

Topics

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