Informatics and Data Science

Baseline quantitative computed tomography scores in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) in the FIBRONEER-IPF and FIBRONEER-ILD trials

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First Author(s)

VC

Vincent Cottin, MD

Professor
National Reference Center for Rare Pulmonary Diseases, Louis Pradel Hospital, Hospices Civils de Lyon, Claude Bernard University Lyon 1, UMR 754, ERN-LUNG, Lyon, France, France

Co-Author(s)

LR

Luca Richeldi, MD

Professor
Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy, Italy
FR

Frank Risse, MD

Global Head of Corporate Marketing
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany, Germany
WS

Wibke Stansen, PhD

Principal Clinical Data Scientist
Boehringer Ingelheim GmbH & Co. KG, Ingelheim am Rhein, Germany, Germany
SS

Susanne Stowasser, MD

Head of Clinical Development Pulmonology/Rheumatology
Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, Germany
DZ

Donald F Zoz, MD

Executive Director/Clinical Development Lead, Nerandomilast
Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA, United States
JJ

Joseph Jacob, MD

Professional Research Fellow
University College London, London, UK, United Kingdom
AD

Anand Devaraj, MD

Professor
Brainomix, Royal Brompton Hospital, and National Heart and Lung Institute, Imperial College London, UK, United Kingdom
JG

Jonathan Goldin, MD

Professor
Department of Radiological Sciences, David Geffen School of Medicine, UCLA, Los Angeles, CA, USA, United States

Purpose: There is increasing interest in using quantitative computed tomography (QCT) parameters as measures of the severity and progression of interstitial lung disease (ILD) in clinical trials. The FIBRONEER-IPF and FIBRONEER-ILD trials in patients with IPF and PPF showed that nerandomilast significantly reduced decline in forced vital capacity (FVC) over 52 weeks vs placebo. We assessed QCT parameters, and correlations between QCT parameters and FVC, at baseline of these trials.

Methods/Materials: Participants in the FIBRONEER-IPF trial had IPF, FVC ≥45% predicted and diffusion capacity of the lungs for carbon monoxide (DLco) ≥25% predicted. Participants in the FIBRONEER-ILD trial had PPF, an extent of fibrotic lung disease >10% on a high-resolution CT taken ≤12 months prior to screening, FVC ≥45% predicted and DLco ≥25% predicted. Using baseline data, we evaluated QCT parameters (quantitative lung fibrosis [QLF] score; quantitative honeycomb cysts [QHC] score; quantitative ground glass opacities [QGGO] score; quantitative interstitial lung disease [QILD] score [total of QLF, QHC, QGGO scores]; and total lung capacity [TLC]) using an algorithm developed by the University of California Los Angeles (Clin Exp Rheumatol 2010;28:S26–35). We also analyzed correlations (r) between the QCT parameters and FVC % predicted.

Results: Data were analyzed from 1113 patients in the FIBRONEER-IPF trial, of whom 77.0% were taking nintedanib or pirfenidone, and 1099 patients in the FIBRONEER-ILD trial, of whom 44% were taking nintedanib. QCT parameters at baseline are shown in the Table. In both trials, there were moderate correlations between TLC (mL), QLF score (%) and QILD score (%) and FVC % predicted (Table). Correlations between other QCT parameters and FVC % predicted were weak.

Conclusions: Among patients with IPF and PPF, correlations between QCT assessments and FVC were weak to moderate, suggesting that QCT measures provide complementary information to that provided by FVC.