Effects of nintedanib on symptoms in patients with progressive pulmonary fibrosis

Abstract

Dyspnoea and cough can have a profound impact on the lives of patients with pulmonary fibrosis. We investigated the effects of nintedanib on the symptoms and impact of pulmonary fibrosis in patients with progressive pulmonary fibrosis (PPF) in the INBUILD trial using the Living with Pulmonary Fibrosis (L-PF) questionnaire.Patients had a fibrosing interstitial lung disease (ILD) (other than idiopathic pulmonary fibrosis) of >10% extent on HRCT and met criteria for ILD progression within the prior 24 months. Patients were randomised 1:1 to receive nintedanib or placebo. Changes in L-PF questionnaire scores from baseline to week 52 were assessed using mixed models for repeated measures.A total of 663 patients were treated. Compared with placebo, there were significantly smaller increases (worsenings) in adjusted mean L-PF questionnaire total (0.5versus5.1), symptoms (1.3versus5.3), dyspnoea (4.3versus7.8), and fatigue (0.7versus4.0) scores in the nintedanib group at week 52. L-PF questionnaire cough score decreased in the nintedanib group and increased in the placebo group (−1.8versus4.3). L-PF questionnaire impacts score decreased slightly in the nintedanib group and increased in the placebo group (−0.2versus4.6). Similar findings were observed in patients with a usual interstitial pneumonia (UIP)-like fibrotic pattern on HRCT and in patients with other fibrotic patterns on HRCT.Based on changes in L-PF questionnaire scores, nintedanib reduced worsening of dyspnoea, fatigue and cough and impacts of ILD over 52 weeks in patients with PPF.