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

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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 (placebo/nintedanib 50 mg qd) groups during periods 1 and 2. Results: Mean total duration of exposure was 14.2 months for nintedanib 150 mg bid and 16.8 months for comparator. The mean observed change from baseline in FVC over time was consistently lower in the nintedanib 150 mg bid group compared with comparator across periods 1 and 2. The absolute change from baseline in FVC % predicted at week 76 was -3.1% for nintedanib 150 mg bid versus -6.3% for comparator. The incidence of acute exacerbations was lower in the nintedanib 150 mg bid group compared with comparator (3.2 versus 13.4 per 100 patient-years). Overall, 14 patients (16.3%) died in the nintedanib 150 mg bid group and 19 patients (21.8%) died in the comparator group. The safety and tolerability of nintedanib 150 mg bid was similar between periods 1 and 2. The proportion of patients reporting an adverse event across periods 1 and 2 was similar in the nintedanib 150 mg bid and comparator groups (97.6% and 94.1%, respectively), as was the proportion of patients reporting a serious adverse event (32.9% and 37.6%, respectively). Conclusion: In the TOMORROW trial, the effect of nintedanib on slowing disease progression in patients with IPF was maintained up to week 76. No relevant changes in the safety and tolerability of nintedanib were observed with treatment up to week 76 compared with week 52.

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