title: Efficacy of Nintedanib in Idiopathic Pulmonary Fibrosis across Prespecified Subgroups in INPULSIS.
abstract: BACKGROUND
  In the two replicate, placebo-controlled, 52-week, phase III INPULSIS trials, nintedanib 150 mg twice daily significantly reduced the annual rate of decline in FVC, the primary endpoint, in subjects with idiopathic pulmonary fibrosis (IPF). It is unknown if this effect was uniform across all subjects treated with nintedanib.
  
  
  OBJECTIVE
  To investigate the potential association of demographic and clinical variables with the effect of nintedanib in subjects with IPF.
  
  
  METHODS
  Subgroup analyses of pooled data from the INPULSIS trials were prespecified. Subgroups were analyzed by sex, age (<65, ≥65 yr), race (white, Asian), baseline FVC percentage predicted (≤70%, >70%), baseline St. George's Respiratory Questionnaire (SGRQ) total score (≤40, >40), smoking status (never, ex/current), systemic corticosteroid use (yes/no), and bronchodilator use (yes/no).
  
  
  RESULTS
  A total of 1,061 subjects were treated (nintedanib n = 638, placebo n = 423). There was no statistically significant difference in the effect of nintedanib for the primary endpoint or the key secondary endpoints of change from baseline in SGRQ total score or time to first acute exacerbation in any subgroup. Treatment effects for the key secondary endpoints seemed more pronounced in subjects with baseline FVC ≤70% predicted, because the majority of acute exacerbations and a greater deterioration in SGRQ total score occurred in placebo-treated subjects in this subgroup.
  
  
  CONCLUSIONS
  Pooled data from the INPULSIS trials support a consistent effect of nintedanib across a range of IPF phenotypes by slowing disease progression across a number of prespecified subgroups.
authors.affiliation: 1 Ruhrlandklinik, University Hospital, University of Duisburg-Essen, Essen, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Costabel
authors.affiliation: 2 Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Inoue
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 Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of California San Francisco, San Francisco, California.
authors.forename: Harold R
authors.initials: HR
authors.lastname: Collard
authors.affiliation: 5 Boehringer Ingelheim France S.A.S., Reims, France.
authors.forename: Inga
authors.initials: I
authors.lastname: Tschoepe
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 Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
authors.forename: Arata
authors.initials: A
authors.lastname: Azuma
mesh_terms: D018450:Disease Progression; D004791:Enzyme Inhibitors / Q000494:pharmacology / Q000627:therapeutic use; D005260:Female; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000188:drug therapy*; D007211:Indoles / Q000494:pharmacology* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D014797:Vital Capacity / Q000187:drug effects*
chemical_list: D004791:Enzyme Inhibitors; D007211:Indoles; C530716:nintedanib
keywords: disease progression; forced vital capacity; quality of life