Authors
Luca Richeldi, Roland M Du Bois, Ganesh Raghu, Arata Azuma, Kevin K Brown, Ulrich Costabel, Vincent Cottin, Kevin R Flaherty, David M Hansell, Yoshikazu Inoue, Dong Soon Kim, Martin Kolb, Andrew G Nicholson, Paul W Noble, Moisés Selman, Hiroyuki Taniguchi, Michèle Brun, Florence Le Maulf, Mannaïg Girard, Susanne Stowasser, Rozsa Schlenker-Herceg, Bernd Disse, Harold R Collard
Publication date
2014/5/29
Journal
New England Journal of Medicine
Volume
370
Issue
22
Pages
2071-2082
Publisher
Massachusetts Medical Society
Description
Background
Nintedanib (formerly known as BIBF 1120) is an intracellular inhibitor that targets multiple tyrosine kinases. A phase 2 trial suggested that treatment with 150 mg of nintedanib twice daily reduced lung-function decline and acute exacerbations in patients with idiopathic pulmonary fibrosis.
Methods
We conducted two replicate 52-week, randomized, double-blind, phase 3 trials (INPULSIS-1 and INPULSIS-2) to evaluate the efficacy and safety of 150 mg of nintedanib twice daily as compared with placebo in patients with idiopathic pulmonary fibrosis. The primary end point was the annual rate of decline in forced vital capacity (FVC). Key secondary end points were the time to the first acute exacerbation and the change from baseline in the total score on the St. George's Respiratory Questionnaire, both assessed over a 52-week period.
Results
A total of 1066 patients were randomly assigned in a 3:2 ratio to …
Total citations
Scholar articles
L Richeldi, RM Du Bois, G Raghu, A Azuma, KK Brown… - New England Journal of Medicine, 2014