Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis (IPF) beyond week 52: Data from the Phase II TOMORROW trial

Background: Period 1 of the TOMORROW trial was a phase II, randomised, placebo-controlled trial of four doses of nintedanib (50 mg qd, 50 mg bid, 100 mg bid, 150 mg bid) in patients with IPF over 52 weeks. After completing period 1, patients had the option to continue treatment in a further blinded treatment phase (period 2). Methods: In period 2, patients receiving nintedanib in period 1 continued their dose, and placebo-treated patients were switched to nintedanib 50 mg qd. Here we present descriptive data on FVC, acute exacerbations, mortality and adverse events for the nintedanib 150 mg bid and comparator (p…