First Data on Efficacy and Safety of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis and Forced Vital Capacity of ≤50 % of Predicted Value

Lung. 2016 Oct;194(5):739-43. doi: 10.1007/s00408-016-9912-1. Epub 2016 Jul 4.

Abstract

In the Phase III INPULSIS(®) trials, 52 weeks' treatment with nintedanib reduced decline in forced vital capacity (FVC) versus placebo in patients with idiopathic pulmonary fibrosis (IPF). Patients who completed the INPULSIS(®) trials could receive nintedanib in an open-label extension trial (INPULSIS(®)-ON). Patients with FVC <50 % predicted were excluded from INPULSIS(®), but could participate in INPULSIS(®)-ON. In patients with baseline FVC ≤50 % and >50 % predicted at the start of INPULSIS(®)-ON, the absolute mean change in FVC from baseline to week 48 of INPULSIS(®)-ON was -62.3 and -87.9 mL, respectively (n = 24 and n = 558, respectively). No new safety signals were identified in INPULSIS(®)-ON compared with INPULSIS(®). The decline in FVC in INPULSIS(®)-ON in both subgroups by baseline FVC % predicted was similar to that in INPULSIS(®), suggesting that nintedanib may have a similar effect on disease progression in patients with advanced disease as in less advanced disease.

Keywords: Clinical trial; Disease progression; Interstitial lung diseases; Tyrosine kinase.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Diarrhea / chemically induced
  • Disease Progression
  • Dyspnea / chemically induced
  • Enzyme Inhibitors / adverse effects*
  • Enzyme Inhibitors / therapeutic use
  • Female
  • Humans
  • Idiopathic Pulmonary Fibrosis / drug therapy*
  • Idiopathic Pulmonary Fibrosis / physiopathology*
  • Indoles / adverse effects*
  • Indoles / therapeutic use
  • Male
  • Middle Aged
  • Vital Capacity / drug effects*

Substances

  • Enzyme Inhibitors
  • Indoles
  • nintedanib