WMR, DSM, and EQW are employees of Analysis Group, Inc., which received funding from Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) to conduct this study. SDN is a consultant for BIPI, Celgene, Genetech, Gilead, and Intermune. He has also received research funding from Actelion, BIPI, Fibrogen, Intermune, Sanofi-Aventis and Veracyte for IPF studies. YFY is an employee of BIPI. This study was funded by BIPI.
WMR and DSM contributed to the study design, data acquisition, statistical analysis, and drafted the manuscript. EQW and YFY contributed to the study design and conception, interpretation of the data, and critically revised the manuscript. SDN contributed to the interpretation of the data and critically revised the manuscript. All authors read and approved the final manuscript.
Idiopathic pulmonary fibrosis (IPF) is a rare and serious disease characterized by progressive lung-function loss. Limited evidence has been published on the impact of lung-function loss on subsequent patient outcomes. This study examined change in forced vital capacity (FVC) across IPF patients in the 6 months after diagnosis and its association with clinical and healthcare resource utilization (HRU) outcomes in a real-world setting in the U.S.
A retrospective chart review was conducted of patients diagnosed with IPF by U.S. pulmonologists. Patient eligibility criteria included: 1) 40 years or older with a confirmed date of first IPF diagnosis with high-resolution computed tomography and/or lung biopsy between 01/2011 and 06/2013; 2) FVC results recorded at first diagnosis (±1 month) and at 6 months (±3 months) following diagnosis. Based on relative change in FVC percent predicted (FVC%), patients were categorized as stable (decline <5 %), marginal decline (decline ≥5 % and <10 %), or significant decline (decline ≥10 %). Physician-reported clinical and HRU outcomes were assessed from ~6 months post-diagnosis until the last contact date with the physician and compared between FVC% change groups. Multivariable Cox proportional-hazards models were constructed to assess risk of mortality, suspected acute exacerbation (AEx), and hospitalization post-FVC% change. Generalized estimating equations were used to account for multiple patients contributed by individual physicians.
The sample included 490 IPF patients contributed by 168 pulmonologists. The mean (SD) age was 61 (11) years, 68 % were male, and the mean (SD) baseline FVC% was 60 % (26 %). 250 (51 %) patients were categorized as stable, 98 (20 %) as marginal decline, and 142 (29 %) as significant decline. The mean (SD) observation time was 583 (287) days. In both unadjusted analysis and multivariable models, significantly worse clinical outcomes and increased HRU were observed with greater lung-function decline.
These findings suggest that nearly half of IPF patients experienced decline in FVC% within ~6 months following IPF diagnosis. Greater FVC% decline was associated with an increased risk of further IPF progression, suspected AEx, mortality, and higher rate of HRU. Management options that slow FVC decline may help improve future health outcomes in IPF.
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- Change in forced vital capacity and associated subsequent outcomes in patients with newly diagnosed idiopathic pulmonary fibrosis
William M. Reichmann
Yanni F. Yu
Eric Q. Wu
Steven D. Nathan
- BioMed Central
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