Introduction: In the INBUILD trial in patients with progressive fibrosing ILDs other than IPF, nintedanib reduced the rate of decline in FVC with a safety profile characterised mainly by gastrointestinal events. Patients who completed the INBUILD trial 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.
Results: Median exposure to nintedanib in INBUILD-ON was 22.0 months. Maximum exposure was 38.3 months. The most frequent adverse event was diarrhoea (Table). The rates (per 100 patient?years) of adverse events leading to permanent discontinuation of nintedanib were 13.8 and 19.8 in patients who continued nintedanib (n=212) and initiated nintedanib (n=222) in INBUILD-ON, respectively. The rates of serious adverse events were 31.6 and 43.6in patients who continued and initiated nintedanib in INBUILD-ON, respectively.
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 progressive pulmonary fibrosis.
| Continued nintedanib | Initiated nintedanib | |
| Diarrhoea | 43.2 | 90.4 |
| Nausea | 7.6 | 14.2 |
| Cough | 9.6 | 10.5 |
| Dyspnoea | 10.1 | 8.8 |
| Weight decreased | 8.7 | 10.3 |
| Vomiting | 4.8 | 9.9 |
| Progression of ILD | 6.0 | 7.7 |
| Pneumonia | 6.7 | 6.3 |
| Bronchitis | 5.5 | 7.8 |
| Decreased appetite | 4.7 | 7.3 |
| Alanine aminotransferase increased | 3.4 | 8.5 |
| Aspartate aminotransferase increased | 2.9 | 7.4 |
| Gamma-glutamyltransferase increased | 1.7 | 6.7 |
Data are rates per 100 patient?years.