Abstract
Introduction: In the two INPULSIS trials in patients with IPF, the annual rate of decline in FVC was reduced in patients treated with nintedanib 150 mg twice daily versus placebo. Patients who completed an INPULSIS trial could receive open-label nintedanib in the extension trial INPULSIS-ON. The influence of medications commonly prescribed to treat comorbid conditions on the effect of nintedanib is unknown.
Aim: To assess whether concomitant medication use at the start of INPULSIS and INPULSIS-ON influenced the effect of nintedanib on FVC decline.
Methods: The annual rate of decline in FVC over 52 weeks in INPULSIS and over 48 weeks in INPULSIS-ON in subgroups defined by concomitant medication use at baseline was assessed descriptively.
Results: The annual rates of decline in FVC over 52 weeks in INPULSIS and over 48 weeks in INPULSIS-ON were consistent across subgroups by concomitant medication use at baseline, including anti-acid therapy and corticosteroids (Table). There was a numerical difference in the annual rate of decline in FVC between subgroups defined by use of N-acetylcysteine or bronchodilators in INPULSIS-ON; however, as the number of patients in some subgroups was small, these results should be interpreted with caution.
Conclusion: Data from INPULSIS and INPULSIS-ON demonstrated a consistent effect of nintedanib on the annual rate of decline in FVC in patients with IPF irrespective of concomitant medication use at baseline.
- Copyright ©the authors 2017
