Efficacy of nintedanib on acute exacerbations reported as serious adverse events in the INPULSIS trials in idiopathic pulmonary fibrosis (IPF)
23 February 2017 (online)
The INPULSIS® trials assessed the effects of nintedanib in patients with IPF. Time to first investigator-reported acute exacerbation (AEx-IPF) over 52 weeks was a key secondary endpoint. Adverse events that were considered by an investigator to fulfil the pre-defined criteria for an AEx-IPF were categorised by an adjudication committee as a confirmed AEx-IPF, suspected AEx-IPF, or not an AEx-IPF. We assessed the effect of nintedanib on AEx-IPF reported as serious adverse events (SAE) and non-serious adverse events (non-SAE) and the impact of these events on survival.
A post-hoc analysis of AEx-IPF reported as SAE or non-SAE was undertaken using pooled data.
Of the 63 patients who had ≥1 investigator-reported AEx-IPF, 49 (77.8%) had an AEx-IPF reported as an SAE. Of these 49 patients, 31 (63.3%) had an adjudicated confirmed or suspected AEx-IPF reported as an SAE. A higher proportion of patients with investigator-reported AEx-IPF reported as SAE died than patients with AEx-IPF reported as non-SAE (30 of 49 patients [61.2%] versus 1 of 15 patients [6.7%]). Nintedanib significantly reduced the risk of a first investigator-reported AEx-IPF reported as an SAE versus placebo (HR 0.57 [95% CI: 0.32, 0.99]; p = 0.0476). Investigator-reported AEx-IPF reported as SAE occurred in 3.6% of patients in the nintedanib group and 6.1% in the placebo group. Nintedanib significantly reduced the risk of having a first adjudicated confirmed or suspected AEx-IPF reported as an SAE versus placebo (HR 0.30 [95% CI: 0.14, 0.64]; p = 0.0019). Adjudicated confirmed or suspected AEx-IPF reported as SAE occurred in 1.6% in the nintedanib group and 5.0% in the placebo group.
In pooled data from the INPULSIS® trials, nintedanib significantly reduced the risk of AEx-IPF reported as SAE. AEx-IPF reported as SAE were associated with a much higher risk of death than AEx-IPF reported as non-SAE.
Presented at ATS 2016.