Pneumologie 2022; 76(S 01): S25-S26
DOI: 10.1055/s-0042-1747743
Abstracts

Continued nintedanib treatment in patients with progressive fibrosing ILDs: interim analysis of INBUILD-ON* 

Authors

  • F Bonella

    1   Center for Interstitial and Rare Lung Diseases, Pneumology Department, Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany

  • W A Wuyts

    2   Unit for Interstitial Lung Diseases, Department of Pulmonary Medicine, University Hospitals Leuven, Leuven, Belgium

  • N Chaudhuri

    3   North West Interstitial Lung Disease Unit, Manchester University Foundation Trust, Wythenshawe, Manchester, UK

  • F Varone

    4   Fondazione Policlinico A Gemelli Irccs, Roma, Italy

  • D Antin-Ozerkis

    5   Section of Pulmonary, Critical Care and Sleep Medicine, Yale University School of Medicine, New Haven, Ct, USA

  • H Mueller

    6   Boehringer Ingelheim Pharma GmbH & Co. Kg, Biberach, Germany

  • C Coeck

    7   Scs Boehringer Ingelheim Comm.V., Brussels, Belgium

  • K B Rohr

    8   Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany

  • V Cottin

    9   Coordinating Reference Center for Rare Pulmonary Diseases, Louis Pradel Hospital, University of Lyon, Inrae, Lyon, France
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Background In the INBUILD trial in patients with progressive fibrosing ILDs other than IPF, nintedanib reduced the rate of FVC decline with a safety profile characterised mainly by gastrointestinal events. Patients on treatment at the end of INBUILD could enter the open-label extension trial, INBUILD-ON.

Aim To assess the longer-term safety of nintedanib in patients with fibrosing ILDs.

Methods Patients who received nintedanib in INBUILD continued nintedanib in INBUILD-ON. Patients who received placebo in INBUILD initiated nintedanib in INBUILD-ON. A data snapshot was taken on 15 October 2020.

Results 434 patients were treated in INBUILD-ON. Median exposure to nintedanib in INBUILD-ON was 15.4 months. Diarrhoea was the most frequent adverse event (Table). Adverse events led to discontinuation of nintedanib in 9.0% and 19.8% of patients who continued nintedanib (n=212) and initiated nintedanib (n=222) in INBUILD-ON, respectively. The rate of decline in FVC in patients receiving nintedanib was similar during INBUILD and INBUILD-ON.

Conclusions The adverse event profile of nintedanib in INBUILD-ON was consistent with that reported in INBUILD, supporting its manageable safety profile over continued use in patients with fibrosing ILDs.

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Abb. 1 *previously presented at ERS 2021; presenting on behalf of the authors

Publication History

Article published online:
11 May 2022

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Zoom
Abb. 1 *previously presented at ERS 2021; presenting on behalf of the authors