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 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.
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.
| Original language | English |
|---|---|
| Article number | PA2538 |
| Journal | European Respiratory Journal |
| Volume | 58 |
| Issue number | Suppl 65 |
| DOIs | |
| Publication status | Published online - 25 Nov 2021 |
Bibliographical note
This abstract was presented at the 2021 ERS International Congress, in session “Prediction of exacerbations in patients with COPD”.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).
