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