title: First Data on Efficacy and Safety of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis and Forced Vital Capacity of ≤50 % of Predicted Value.
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.
authors.affiliation: Unit for Interstitial Lung Diseases, Department of Respiratory Medicine, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium. wim.wuyts@uzleuven.be.
authors.forename: Wim A
authors.initials: WA
authors.lastname: Wuyts
authors.affiliation: McMaster University, 50 Charlton Ave East, Hamilton, ON, L8N 4A6, Canada.
authors.forename: Martin
authors.initials: M
authors.lastname: Kolb
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Str. 173, 55216, Ingelheim Am Rhein, Germany.
authors.forename: Susanne
authors.initials: S
authors.lastname: Stowasser
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Str. 173, 55216, Ingelheim Am Rhein, Germany.
authors.forename: Wibke
authors.initials: W
authors.lastname: Stansen
authors.affiliation: Medical University of South Carolina, 96 Jonathan Lucas Street, Charleston, SC, 29425, USA.
authors.forename: John T
authors.initials: JT
authors.lastname: Huggins
authors.affiliation: University of Washington, 1959 N.E. Pacific, Campus Box 356175, Seattle, WA, 98195-6522, USA.
authors.forename: Ganesh
authors.initials: G
authors.lastname: Raghu
mesh_terms: D000368:Aged; D003967:Diarrhea / Q000139:chemically induced; D018450:Disease Progression; D004417:Dyspnea / Q000139:chemically induced; D004791:Enzyme Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000188:drug therapy* / Q000503:physiopathology*; D007211:Indoles / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D014797:Vital Capacity / Q000187:drug effects*
chemical_list: D004791:Enzyme Inhibitors; D007211:Indoles; C530716:nintedanib
keywords: Clinical trial; Disease progression; Interstitial lung diseases; Tyrosine kinase