Pneumologie 2023; 77(S 01): S72
DOI: 10.1055/s-0043-1761037
Abstracts

INREAL – Nintedanib for changes in dyspnea and cough in chronic PF-ILD patients in everyday clinical practice: a real-world evaluation* 

Authors

  • M Kreuter

    1   Zentrum für Interstitielle und Seltene Lungenerkrankungen, Pneumologie und Beatmungsmedizin, Thoraxklinik; Universitätsklinikum Heidelberg und Translationales Zentrum für Lungenforschung Heidelberg (Tlrc); Mitglied des Deutschen Zentrums für Lungenforschung (Dzl)

  • J Distler

    2   Klinik für Rheumatologie, Universitätsklinikum Düsseldorf

  • M Hechtner

    3   Boehringer Ingelheim Pharma GmbH & Co. Kg, Ingelheim

  • A Kondla

    3   Boehringer Ingelheim Pharma GmbH & Co. Kg, Ingelheim

  • D Koschel

    4   Innere Medizin/Pneumologie, Lungenzentrum Fachkrankenhaus Coswig; Medizinische Klinik I, Universitätsklinikum Dresden
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    Background Nintedanib was shown to significantly slow the annual rate of decline in FVC in patients with chronic progressive fibrosing interstitial lung diseases (PF-ILD/PPF). The effects on the patient reported outcomes (PRO) dyspnea or cough have only been investigated scarcely, especially in a real-world cohort.

    Aim We hypothesize that in a 1-year observational study a correlation between changes in lung function (FVC) and changes in the PROs dyspnea and cough of the Living with Pulmonary Fibrosis (L-PF) questionnaire will be confirmed in a real-world patient population as shown in the recent INBUILD trial.

    Study Design After a shared decision making in a patient with PF-ILD/PPF nintedanib will be initiated as standard of care. Within this prospective, single-arm, open-label, non-interventional (NIS), real-world study 100 patients with PF-ILD/PPF in approximately 20 specialized centers (pulmonologists, rheumatologists) throughout Germany will be recruited. Adults≥18 years with physician’s diagnosis of PF-ILD, (except idiopathic pulmonary fibrosis) with a need of antifibrotic treatment, not currently hospitalized and with a life expectancy>12 months per investigator’s assessment will be included. Exclusion criteria are physician diagnosed exacerbation of ILD, current lung cancer or respiratory failure (pH<7.35 and/or respiratory rate>30/min). Changes from baseline over 52 weeks after initiation of nintedanib treatment in FVC (Δ FVC% predicted and mL) and changes in cough and dyspnea scores (Δ cough, Δ dyspnea, absolute change) as measured with the L-PF questionnaire will be correlated to baseline values, including a snapshot-analysis at the time of last patient in (NCT04702893).

    Outlook The study started in 02/2021 and first results are expected for 2024. Main baseline characteristics will be described. Data from this real-world patient population with PF-ILD will help to understand the impact of antifibrotic treatment on PROs in patients with PF-ILD/PPF.

    * Presenting on behalf of the authors


     

    Publication History

    Article published online:
    09 March 2023

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