Nintedanib (Ofev° - Boehringer Ingelheim) inhibits a variety of tyrosine kinases. It has antifibrotic and antiangiogenic effects. It was already authorised in the European Union for idiopathic pulmonary fibrosis (a type of fibrosing interstitial lung disease) and systemic sclerosis-associated interstitial lung disease. It has now also been authorised for use in other forms of fibrosing interstitial lung disease in which the cause of progression is unknown . Nintedanib was evaluated in this clinical situation in a double-blind randomised placebo-controlled trial in 663 adults. After 52 weeks (the primary analysis according to the protocol), there was no statistically significant difference between the groups in the proportion of patients who died (about 5%) or in the incidence of exacerbations (5% versus 7%), nor in patients' self-reported health status. The mean decline in forced vital capacity was lower in the nintedanib group. But the clinical relevance of the difference is highly uncertain (about 100 ml, for a mean forced vital capacity of 2330 ml at baseline). According to data obtained after a few more months of follow-up, the proportion of patients who were still alive and had not had an exacerbation was slightly higher in the nintedanib group, but this difference was not statistically significant.
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