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




First Data on Efficacy and Safety of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis and Forced Vital Capacity of ≤50 % of Predicted Value - Download this document for free, or read online. Document in PDF available to download.

Lung

, Volume 194, Issue 5, pp 739–743

First Online: 04 July 2016Received: 30 March 2016Accepted: 14 June 2016

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.

KeywordsInterstitial lung diseases Clinical trial Disease progression Tyrosine kinase  Download fulltext PDF



Author: Wim A. Wuyts - Martin Kolb - Susanne Stowasser - Wibke Stansen - John T. Huggins - Ganesh Raghu

Source: https://link.springer.com/



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