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S99 Efficacy of nintedanib on acute exacerbations reported as serious adverse events in the inpulsis® trials in idiopathic pulmonary fibrosis (IPF)
  1. L Richeldi1,
  2. H Koegler2,
  3. M Trampisch2,
  4. S Geier2,
  5. M Kreuter3
  1. 1National Institute for Health Research Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, University of Southampton, Southampton, UK
  2. 2Boehringer Ingelheim Pharma GmbH and Co. KG, Ingelheim am Rhein, Germany
  3. 3Centre for Interstitial and Rare Lung Diseases, Department of Pneumology, Thoraxklinik, University of Heidelberg, and Translational Lung Research Centre Heidelberg, German Centre for Lung Research Germany, Heidelberg, Germany

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.

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