Nintedanib in patients with chronic fibrosing interstitial lung diseases with progressive phenotype: the INBUILD trial

Abstract

Introduction: Nintedanib is an approved treatment for idiopathic pulmonary fibrosis (IPF). Pre-clinical data suggest that nintedanib inhibits processes fundamental to progression of lung fibrosis irrespective of the aetiology.

Aim: The INBUILD trial was designed to investigate the efficacy and safety of nintedanib in patients with various non-IPF chronic fibrosing ILDs with progressive phenotype.

Methods: Eligible patients had diffuse fibrosing lung disease of >10% extent on HRCT, FVC ≥45% predicted, DLco ≥30–<80% predicted, and met ≥1 of 4 criteria for ILD progression (Table) in the 24 months before screening, despite treatment of ILDs in clinical practice. Patients with IPF were excluded. Subjects were randomised to receive nintedanib 150 mg bid or placebo. The primary endpoint is the annual rate of decline in FVC (mL/yr) assessed over 52 weeks. There will be two co-primary analysis populations: all subjects and subjects with a UIP-like fibrotic pattern only on HRCT.

Results: 663 patients were randomised and treated (Table). Mean (±SD) age was 65.8±9.8 years, FVC was 69.0±15.7% predicted, DLco was 47.6±32.2% predicted.

Conclusions: The INBUILD trial will provide insights into the natural history and role of nintedanib in treating patients with various progressive fibrosing ILDs. Results will be presented at the congress.