Real-world changes in lung function and symptoms among PPF patients treated with nintedanib: insights from the INREAL study
Pneumologie, vol. 79
Abstract
Background Progressive pulmonary fibrosis (PPF) is characterized by progressive decline in FVC and persistent symptoms such as dyspnea and cough. In the INBUILD trial nintedanib (NIN) has shown to significantly reduce the annual rate of decline in FVC [ml/year] over 52 weeks in PPF patients. The INREAL study aimed to assess correlations between changes from baseline at week 52 in FVC and changes from baseline at week 52 in dyspnea and cough in a real-world cohort of PPF patients treated with NIN. Methods INREAL (NCT04702893) was a prospective, single-arm, open-label, non-interventional real-world study that observed PPF patients over 52 weeks of NIN treatment. FVC measurements were documented, and the Living with Pulmonary Fibrosis (L-PF) questionnaire was used to assess cough and dyspnea scores. For the primary objective, changes from baseline at week 52 in FVC were correlated to changes in L-PF symptom scores. Results In total, 102 PPF patients (62.8% male) with an average age of 70.5±10.7 years were treated with NIN. Autoimmune ILD (44.1%), unclassifiable IIP (20.6%), HP (16.7%), and INSIP (10.8%) were the most common underlying ILD diagnoses. At baseline, mean FVC was 65.2±18.9% predicted and 2296.4±769.8 ml (N=98). Absolute change from baseline in FVC at week 52 was -59.9±471.8 ml (N=47). Mean dyspnea symptom score was 24.7±18.6 and mean cough symptom score was 37.5±25.7 at baseline (N=101). Absolute change from baseline in dyspnea and cough symptom score at week 52 was 6.8±18.5 and 2.5±24.0 (N=45), respectively. The primary objective was analyzed in 38 patients who had FVC% pred. values and L-PF scores available at baseline and at week 52. The Pearson correlation coefficient between the change in FVC% pred. and the change in dyspnea symptom score was -0.26 (p-value: 0.12), and between the change in FVC% pred. and the change in cough symptom score -0.11 (p-value: 0.51). Conclusions INREAL demonstrates that antifibrotic therapy for PPF is a valid therapeutic option and lung function changes align with clinical trial expectations. Over 52 weeks of NIN treatment, L-PF dyspnea and cough symptom scores indicate that symptoms remain stable overall. There was insufficient evidence for correlations between changes from baseline at week 52 in FVC% pred. and changes from baseline at week 52 in dyspnea or cough symptom scores. Publication History Article published online: 18 March 2025 © 2025. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
Authors 19
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Johannes Gutenberg University Mainz · University Medical Center of the Johannes Gutenberg University Mainz
Affiliation as printed
Mainz Center for Pulmonary Medicine, Departments of Pneumology, Mainz University Medical Center of Pulmonary, Critical Care & Sleep Medicine, Marienhaus Clinic Mainz
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Düsseldorf University Hospital · Heinrich Heine University Düsseldorf
Affiliation as printed
Direktor der Klinik für Rheumatologie; Universitätsklinikum Düsseldorf Klinik für Rheumatologie; Department Rheumatology and Hiller Research Center
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Affiliation as printed
Pneumologische Praxis
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Rheumazentrum Ruhrgebiet · Ruhr University Bochum
Affiliation as printed
Ruhr-Universität Bochum; Rheumazentrum Ruhrgebiet; Rheumazentrum Ruhrgebiet
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University Medical Center Hamburg-Eppendorf
Affiliation as printed
Universitätsklinikum Hamburg- Eppendorf; Pneumologie
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Affiliation as printed
Medizinische Klinik 3 – Rheumatologie und Immunologie; Ulmenweg 18; Hochschulambulanz
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Affiliation as printed
Lungenklinik Hemer; Abteilung Pneumologie; Pneumologie
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Affiliation as printed
Klinikum Braunschweig; Städtisches Klinikum Braunschweig; Klinik für Pneumologie und Beatmungsmedizin
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Affiliation as printed
Klinik für Pneumologie und Allergologie; Hospital Bethanien Solingen
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Johannes Wesling Klinikum Minden · Ruhr University Bochum
Affiliation as printed
Mkk; Universitätsklinik der Ruhr-Universität Bochum; Johannes-Wesling-Klinikum Minden; Klinik für Rheumatologie
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Helios Universitätsklinikum Wuppertal
Affiliation as printed
Petrus Krankenhaus Wuppertal; Klinik für Pneumologie, Allergologie, Schlaf- und Intensivmedizin; Medizinische Klinik I
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Affiliation as printed
Klinik für Innere Medizin – Pneumologie und Infektiologie; Netzwerk für Gesundheit Gmbh; Le-Register e.V
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Affiliation as printed
Pneumologie; Pneumologie, Mk Ii, Universitätsklinikum Leipzig
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Affiliation as printed
Facharzt für Innere Medizin & Pneumologie; Pneumologische Praxis
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Michael Dreher Aachen Department of Pneumology and Intensive Care Medicine Klinik für Pneumologie und Internistische Intensivmedizin Medizinische Klinik V (Pneumologie und Internistische Intensivmedizin)
Universitätsklinikum Aachen · RWTH Aachen University
Affiliation as printed
Universitätsklinikum Aachen; Department of Pneumology and Intensive Care Medicine, University Hospital RWTH Aachen, Aachen, Germany; Klinik für Pneumologie und Internistische Intensivmedizin, Medizinische Klinik V, Uniklinik RWTH Aachen
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Affiliation as printed
Clemenshospital
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Boehringer Ingelheim (Germany)
Affiliation as printed
Boehringer Ingelheim Pharma GmbH & Co. Kg; Global Biostatistics & Data Sciences
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Boehringer Ingelheim (Germany)
Affiliation as printed
Boehringer Ingelheim Pharma GmbH & Co. Kg; Medical Affairs
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University Hospital Carl Gustav Carus
Affiliation as printed
Fachkrankenhaus Coswig, Ostdeutsches Lungenzentrum Coswig-Dresden, Universitätsklinik Carl Gustav Carus; Bereich Pneumologie, Medizinische Klinik 1
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