First Data on Efficacy and Safety of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis and Forced Vital Capacity of aecurrency sign50 % of Predicted Value

In the Phase III INPULSISA (R) 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 INPULSISA (R) trials could receive nintedanib in an open-label extension trial (INPULSISA (R)-ON). Patients with FVC < 50 % predicted were excluded from INPULSISA (R), but could participate in INPULSISA (R)-ON. In patients with baseline FVC aecurrency sign50 % and > 50 % predicted at the start of INPULSISA (R)-ON, the absolute mean change in FVC from baseline to week 48 of INPULSISA (R)-ON was -62.3 and -87.9 mL, respectively (n = 24 and n = 558, respectively). No new safety signals were identified in INPULSISA (R)-ON compared with INPULSISA (R). The decline in FVC in INPULSISA (R)-ON in both subgroups by baseline FVC % predicted was similar to that in INPULSISA (R), suggesting that nintedanib may have a similar effect on disease progression in patients with advanced disease as in less advanced disease.