In the phase III INBUILD trial Nintedanib ( Ofev ) has slowed lung function decline by 57% across the overall study population, as assessed by the annual rate of decline in forced vital capacity ( FVC ) over 52 weeks in patients with fibrosing interstitial lung disease ( ILD ) with signs of progression.
The study was published in the New England Journal of Medicine ( NEJM ) and presented at the ERS Congress in Madrid, Spain.
The study has met its primary endpoint and demonstrated the efficacy and safety of Nintedanib in patients with a broad range of progressive fibrosing interstitial lung diseases other than idiopathic pulmonary fibrosis ( IPF ).
Chronic hypersensitivity pneumonitis, autoimmune ILDs such as rheumatoid arthritis-associated ILD, systemic sclerosis-associated ILD ( SSc-ILD ), mixed connective tissues disease-associated ILD, sarcoidosis and idiopathic forms of interstitial pneumonias, i.e. non-specific interstitial pneumonia, and unclassified idiopathic interstitial pneumonia, are among these diseases.
Nintedanib has shown to slow the rate of ILD progression independent of the fibrotic pattern seen on chest imaging.
The side effect profile was consistent with previous studies of Nintedanib in ILDs, with diarrhoea being the most common adverse event.
INBUILD is the first clinical trial in the field of ILDs to group patients based on the clinical behaviour of their disease, rather than the primary clinical diagnosis.
ILDs encompass a large group of more than 200 disorders that may involve the threat of pulmonary fibrosis – an irreversible scarring of lung tissue that negatively impacts lung function.
Patients with ILD can develop a progressive phenotype that causes pulmonary fibrosis, leading to lung function decline, deterioration in quality of life and early mortality similar to IPF, the most frequent form of idiopathic interstitial pneumonias.
The course of the disease and the symptoms are similar in progressive fibrosing ILDs regardless of the underlying disease.
In the INBUILD trial, Nintedanib slowed lung function decline by 57% across the overall study population, with an adjusted annual rate of decline over 52 weeks in FVC of -80.8 mL/year compared to -187.8 mL/year for placebo ( difference, 107.0 mL/year [ 95% CI, 65.4 to 148.5 ]; p less than 0.001 ).
Ofev demonstrated a consistent effect on lung function decline in patients with an usual interstitial pneumonia ( UIP ) like fibrotic pattern and those with other fibrotic patterns on HRCT.
The most common adverse event was diarrhoea, reported in 66.9% and 23.9% of patients treated with Nintedanib and placebo, respectively.
The safety profile observed in INBUILD was consistent to what has been seen in IPF and SSc-ILD patients treated with Nintedanib previously. ( Xagena )
Source: Boehringer Ingelheim, 2019