Abstract
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 who completed INBUILD could enter the open-label extension trial INBUILD-ON.
Aim: To assess the 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 2021.
Results: 434 patients were treated in INBUILD-ON. Median exposure to nintedanib was 22.0 months. The most frequent adverse event was diarrhoea (Table). Adverse events led to discontinuation of nintedanib in 17.9% and 29.3% of patients who continued nintedanib (n=212) and initiated nintedanib (n=222) in INBUILD-ON, respectively. The observed change in FVC during INBUILD-ON over time was consistent with the rate of decline in INBUILD.
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.
Aim: To assess the 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 2021.
Results: 434 patients were treated in INBUILD-ON. Median exposure to nintedanib was 22.0 months. The most frequent adverse event was diarrhoea (Table). Adverse events led to discontinuation of nintedanib in 17.9% and 29.3% of patients who continued nintedanib (n=212) and initiated nintedanib (n=222) in INBUILD-ON, respectively. The observed change in FVC during INBUILD-ON over time was consistent with the rate of decline in INBUILD.
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.
| Original language | English |
|---|---|
| Article number | 604 |
| Journal | European Respiratory Journal |
| Volume | 60 |
| Issue number | Suppl 66 |
| DOIs | |
| Publication status | Published online - 1 Dec 2022 |
Bibliographical note
This article was presented at the 2022 ERS International Congress, in session “-”.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
