title: Effect of Nintedanib in Subgroups of Idiopathic Pulmonary Fibrosis by Diagnostic Criteria.
abstract: In the absence of a surgical lung biopsy, patients diagnosed with idiopathic pulmonary fibrosis (IPF) in clinical practice could participate in the INPULSIS trials of nintedanib if they had honeycombing and/or traction bronchiectasis plus reticulation, without atypical features of usual interstitial pneumonia (UIP), on high-resolution computed tomography (HRCT). Thus, the patients in these trials represented patients with definite UIP and a large subgroup of patients with possible UIP.
  
  
  
  To investigate the potential impact of diagnostic subgroups on the progression of IPF and the effect of nintedanib.
  
  
  
  We conducted a post hoc subgroup analysis of patients with honeycombing on HRCT and/or confirmation of UIP by biopsy versus patients without either, using pooled data from the INPULSIS trials.
  
  
  
  Seven hundred twenty-three (68.1%) patients had honeycombing and/or biopsy, and 338 (31.9%) patients had no honeycombing or biopsy. In these subgroups, respectively, the adjusted annual rate of decline in FVC in patients treated with placebo was -225.7 and -221.0 ml/yr, and the nintedanib versus placebo difference in the adjusted annual rate of decline in FVC was 117.0 ml/yr (95% confidence interval, 76.3-157.8) and 98.9 ml/yr (95% confidence interval, 36.4-161.5). There was no significant treatment-by-subgroup interaction (P = 0.8139). Adverse events were similar between the subgroups.
  
  
  
  Patients with IPF diagnosed in clinical practice who had possible UIP with traction bronchiectasis on HRCT and had not undergone surgical lung biopsy had disease that progressed in a similar way, and responded similarly to nintedanib, to that of patients with honeycombing on HRCT and/or confirmation of UIP by biopsy.
authors.affiliation: 1 Department of Medicine, University of Washington, Seattle, Washington.
authors.forename: Ganesh
authors.initials: G
authors.lastname: Raghu
authors.affiliation: 2 Royal Brompton and Harefield NHS Foundation Trust and National Heart and Lung Institute, Imperial College, London, United Kingdom.
authors.forename: Athol U
authors.initials: AU
authors.lastname: Wells
authors.affiliation: 2 Royal Brompton and Harefield NHS Foundation Trust and National Heart and Lung Institute, Imperial College, London, United Kingdom.
authors.forename: Andrew G
authors.initials: AG
authors.lastname: Nicholson
authors.affiliation: 3 National Institute for Health Research Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, University of Southampton, Southampton, United Kingdom.
authors.forename: Luca
authors.initials: L
authors.lastname: Richeldi
authors.affiliation: 4 University of Michigan Health System, Ann Arbor, Michigan.
authors.forename: Kevin R
authors.initials: KR
authors.lastname: Flaherty
authors.affiliation: 5 Boehringer Ingelheim France S.A.S., Reims, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Le Maulf
authors.affiliation: 6 Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany; and.
authors.forename: Susanne
authors.initials: S
authors.lastname: Stowasser
authors.affiliation: 7 Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut.
authors.forename: Rozsa
authors.initials: R
authors.lastname: Schlenker-Herceg
authors.affiliation: 2 Royal Brompton and Harefield NHS Foundation Trust and National Heart and Lung Institute, Imperial College, London, United Kingdom.
authors.forename: David M
authors.initials: DM
authors.lastname: Hansell
mesh_terms: D000368:Aged; D001706:Biopsy; D018450:Disease Progression; D005260:Female; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000175:diagnosis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D007211:Indoles / Q000627:therapeutic use*; D008168:Lung / Q000000981:diagnostic imaging / Q000473:pathology; D008297:Male; D011505:Protein-Tyrosine Kinases / Q000037:antagonists & inhibitors*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D007211:Indoles; D011505:Protein-Tyrosine Kinases; C530716:nintedanib
keywords: HRCT; diagnosis; high-resolution computed tomography; honeycombing; traction bronchiectasis