Changes in dyspnea and cough in real-world PPF patients treated with nintedanib – the INREAL study

<bold>Background:</bold> Chronic progressive fibrosing interstitial lung diseases (PF-ILD/PPF) are reflected by decline in FVC. Nintedanib (NIN) was shown to significantly slow this rate of FVC decline. However, there is limited evidence on the effects of NIN on symptoms related to PPF. The INREAL study aimed to assess changes in FVC and dyspnea and cough in a real-world patient cohort treated with NIN. <bold>Methods:</bold> INREAL was a prospective non-interventional real-world study. During 52 weeks of NIN treatment, changes in FVC were monitored and cough and dyspnea scores were assessed using the Living with Pulmonary Fibrosis (L-PF) questionnaire and subsequently correlated to baseline values (<ext-link>NCT04702893</ext-link>). A descriptive snapshot-analysis as of JAN 2024 is presented here. <bold>Results:</bold> Overall, 101 PPF patients (63.4% male) with an average age of 70.4 ± 10.7 years initiated NIN treatment. At baseline, mean FVC (% pred.) and mean FVC (ml) were 67.1 ± 19.8 % and 2254.1 ± 773.4 ml, respectively. Mean DLco was 49.0 ± 17.6% pred. Mean L-PF dyspnea symptom score was 24.6 ± 18.8 and mean L-PF cough symptom score was 37.5 ± 25.8. A current analysis of 38 completers demonstrated a change in mean FVC from baseline to week 52 of -6,1 ± 18.9 % pred. and -114.1 ± 480.6 ml; and for mean DLco -6,3 ± 15.5 % pred. The difference in mean L-PF dyspnea symptom score was 8.1 ± 19.3 and in mean L-PF cough symptom score 2.9 ± 26.5 (n=29). <bold>Conclusions:</bold> For patients with PPF in a real-world setting, our current analysis supports insights from clinical trials regarding the effects of NIN treatment on the course of PPF. The magnitude of observed changes in lung function was in line with assumptions based on clinical trials.

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Published
2024-09-14
DOI
https://doi.org/10.1183/13993003.congress-2024.pa693
Primary Topic
Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
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article
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article

Changes in dyspnea and cough in real-world PPF patients treated with nintedanib – the INREAL study

Ioana Andreica, Susanne Fischer, Tim Oqueka, Hubert Wirtz et al.
Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
article

Changes in dyspnea and cough in real-world PPF patients treated with nintedanib – the INREAL study

Ioana Andreica, Susanne Fischer, Tim Oqueka, Hubert Wirtz, Lars Hagmeyer, Sven Gläser, A. Marseille, Thomas Bitter, G. Aßmann, Michael Westhoff, Marlene Hechtner, Michael Dreher, Dirk Koschel, Christina Bergmann, Claus Keller, Sven Stieglitz, Anke Kondla, Sven Gregor, Michael W. Hess, Michael Kreuter, M Brandes, Joerg H W Distler, Benjamin Löh
article en

Abstract

<bold>Background:</bold> Chronic progressive fibrosing interstitial lung diseases (PF-ILD/PPF) are reflected by decline in FVC. Nintedanib (NIN) was shown to significantly slow this rate of FVC decline. However, there is limited evidence on the effects of NIN on symptoms related to PPF. The INREAL study aimed to assess changes in FVC and dyspnea and cough in a real-world patient cohort treated with NIN. <bold>Methods:</bold> INREAL was a prospective non-interventional real-world study. During 52 weeks of NIN treatment, changes in FVC were monitored and cough and dyspnea scores were assessed using the Living with Pulmonary Fibrosis (L-PF) questionnaire and subsequently correlated to baseline values (<ext-link>NCT04702893</ext-link>). A descriptive snapshot-analysis as of JAN 2024 is presented here. <bold>Results:</bold> Overall, 101 PPF patients (63.4% male) with an average age of 70.4 ± 10.7 years initiated NIN treatment. At baseline, mean FVC (% pred.) and mean FVC (ml) were 67.1 ± 19.8 % and 2254.1 ± 773.4 ml, respectively. Mean DLco was 49.0 ± 17.6% pred. Mean L-PF dyspnea symptom score was 24.6 ± 18.8 and mean L-PF cough symptom score was 37.5 ± 25.8. A current analysis of 38 completers demonstrated a change in mean FVC from baseline to week 52 of -6,1 ± 18.9 % pred. and -114.1 ± 480.6 ml; and for mean DLco -6,3 ± 15.5 % pred. The difference in mean L-PF dyspnea symptom score was 8.1 ± 19.3 and in mean L-PF cough symptom score 2.9 ± 26.5 (n=29). <bold>Conclusions:</bold> For patients with PPF in a real-world setting, our current analysis supports insights from clinical trials regarding the effects of NIN treatment on the course of PPF. The magnitude of observed changes in lung function was in line with assumptions based on clinical trials.

Goethe University Frankfurt (DE), Siemens (Germany) (DE), Boehringer Ingelheim (Germany) (DE), Universität Hamburg (DE), Johannes Gutenberg University Mainz (DE), Universitätsklinikum Erlangen (DE), Düsseldorf University Hospital (DE), Rheumazentrum Ruhrgebiet (DE), University Medical Center of the Johannes Gutenberg University Mainz (DE), Accadis Hochschule Bad Homburg (DE), Städtisches Klinikum Solingen (DE), University Hospital Münster (DE), University Medical Center Hamburg-Eppendorf (DE), Vivantes Klinikum (DE), Klinikum Braunschweig (DE), Helios Universitätsklinikum Wuppertal (DE), Universitätsklinikum Aachen (DE), Lungenklinik Hemer (DE), Klinikum Chemnitz (DE), Johannes Wesling Klinikum Minden (DE), Heinrich Heine University Düsseldorf (DE), Technische Universität Dresden (DE), RWTH Aachen University (DE), Leipzig University (DE)
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