Abstract
PurposeIn the INBUILD trial in patients with progressive pulmonary fibrosis (PPF), nintedanib slowed the decline in forced vital capacity (FVC) versus placebo, with a safety profile characterised mainly by gastrointestinal events. INBUILD-ON, the open-label extension of INBUILD, assessed the safety of nintedanib during longer-term treatment. Data on FVC were collected.Study design and methodsAdverse events and changes in FVC in INBUILD-ON were assessed descriptively in all patients and in two subgroups: patients who received nintedanib in INBUILD and continued nintedanib in INBUILD-ON ("continued nintedanib" group) (n = 212) and patients who received placebo in INBUILD and initiated nintedanib in INBUILD-ON ("initiated nintedanib" group) (n = 222). Changes in FVC were based on observed values.ResultsMedian exposure to nintedanib in INBUILD-ON was 22.0 months. Diarrhoea was the most frequent adverse event. Amongst patients who had diarrhoea, 90.0% experienced only events of mild or moderate severity. Adverse events led to discontinuation of nintedanib at a rate of 16.7 per 100 patient-years. Serious and fatal adverse events were reported at rates of 37.2 and 9.5 per 100 patient-years. Mean (SE) changes in FVC from baseline to week 48 were - 71.6 (16.1) mL [- 128.5 (25.5) mL in continued nintedanib group (n = 106), - 14.8 (18.2) mL in initiated nintedanib group (n = 106)].ConclusionThe safety profile of nintedanib in INBUILD-ON was consistent with that in INBUILD. Change in FVC in INBUILD-ON was consistent with decline in FVC in the nintedanib group of INBUILD. These results support the use of nintedanib in the long-term treatment of PPF.Clinical trial registrationClinicalTrials.gov; NCT03820726; registered January 29, 2019.
Original language | English |
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Article number | 25 |
Pages (from-to) | 1-9 |
Number of pages | 9 |
Journal | Lung |
Volume | 203 |
Issue number | 1 |
Early online date | 9 Jan 2025 |
DOIs | |
Publication status | Published online - 9 Jan 2025 |
Bibliographical note
© 2025. The Author(s).Data Access Statement
To ensure independent interpretation of clinical study results and enable authors to fulfil their roles and obligations under the ICMJE criteria, Boehringer Ingelheim grants all authors access to relevant clinical study data. In adherence with the Boehringer Ingelheim Policy on Transparency and Publication of Clinical Study Data, scientific and medical researchers can request access to clinical study data, typically one year after the approval has been granted by major regulatory authorities or after termination of the development program. Researchers should use the https://vivli.org/ link to request access to study data and visit https://www.mystudywindow.com/msw/datasharing for further information.Keywords
- Drug tolerance
- Vital Capacity
- Pulmonary Function Tests
- Clinical Trial
- Interstitial Lung Disease
- Lung
- Humans
- Pulmonary Fibrosis
- Disease Progression
- Diarrhea
- Indoles
- Protein Kinase Inhibitors
- Treatment Outcome
- Time Factors
- Aged
- Middle Aged
- Female
- Male
- Idiopathic Pulmonary Fibrosis
- Antifibrotic Agents
- Pulmonary function tests
- Vital capacity
- Interstitial lung disease
- Clinical trial
- Pulmonary Fibrosis/drug therapy
- Antifibrotic Agents/therapeutic use
- Diarrhea/chemically induced
- Protein Kinase Inhibitors/adverse effects
- Lung/physiopathology
- Indoles/adverse effects
- Idiopathic Pulmonary Fibrosis/drug therapy