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news.Results from the Phase III INPULSIS trials, published online in the New England Journal of Medicine (NEJM), show nintedanib significantly slowed disease progression in patients with idiopathic pulmonary fibrosis (IPF).
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Nintedanib is the first targeted treatment for IPF to consistently meet the primary endpoint in two international Phase III trials with identical design.
In the two 52 week INPULSIS trials, involving 1,066 patients, nintedanib significantly reduced the annual decline in FVC by approximately 50% compared to patients taking placebo.
The annual rate of FVC decline in the two trials was: INPULSIS-1: -114.7ml (nintedanib) vs. -239.9ml (placebo); and INPULSIS-2: -113.6ml (nintedanib) vs. -207.3ml (placebo)
Both key secondary endpoints were met in the INPULSIS-2 trial. There was significantly less deterioration in quality of life (measured by the St. George’s Respiratory Questionnaire) and a reduced risk of a first acute exacerbation in patients taking nintedanib versus placebo.
In INPULSIS-1, there was no statistically significant difference between the nintedanib and placebo groups in the key secondary endpoints.
In both trials, the most common adverse events were gastrointestinal in nature, of mild to moderate intensity, generally manageable, rarely leading to treatment discontinuation.
The most frequent adverse event in the nintedanib groups was diarrhoea, which was reported in 62% vs. 19% (INPULSIS-1) and 63% vs. 18% (INPULSIS-2) of patients in the nintedanib vs. placebo groups, respectively). Less than 5% of patients in the nintedanib groups of INPULSIS-1 and INPULSIS-2 discontinued treatment due to this event.
The proportion of patients with serious adverse events was similar in all groups.