title: Subgroup analysis of Asian patients in the INPULSIS®trials of nintedanib in idiopathic pulmonary fibrosis.
abstract: In the two-replicate randomized Phase III INPULSIS® trials in patients with idiopathic pulmonary fibrosis (IPF), nintedanib 150 mg bd significantly reduced the annual rate of decline in forced vital capacity (FVC) compared with placebo. The key secondary endpoints were time to first investigator-reported acute exacerbation and change from baseline in St George's Respiratory Questionnaire total score, both over 52 weeks. Here, we assessed the effect of nintedanib in Asian patients.
  
  
  
  Pre-specified subgroup analyses of the effect of nintedanib on the primary and key secondary endpoints in Asian versus White patients were undertaken based on pooled data from the two INPULSIS® trials. Safety data were analyzed descriptively.
  
  
  
  Of the treated patients, 322 were Asian (nintedanib n = 194; placebo n = 128) and 608 were White (nintedanib n = 360; placebo n = 248). In Asian patients, the nintedanib versus placebo difference in the adjusted annual rate of decline in FVC was 94.1 mL/year (95% CI: 33.7, 154.6). The treatment effect of nintedanib on the annual rate of decline in FVC in Asian and White patients was similar (treatment-by-subgroup interaction P = 0.72) and consistent with the overall population. No significant treatment-by-subgroup interaction was observed for the key secondary endpoints between Asian and White patients. In Asian patients, the most common adverse event in the nintedanib group was diarrhoea (56.2% of patients vs 15.6% for placebo).
  
  
  
  In pre-specified subgroup analyses of Asian versus White patients with IPF in the INPULSIS® trials, race did not influence the effect of nintedanib on disease progression.
authors.affiliation: Department of Respiratory Medicine and Allergy, Tosei General Hospital, Aichi, Japan. hiro-tosei-lung@kkd.biglobe.ne.jp.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Taniguchi
authors.affiliation: Peking Union Medical College Hospital, Beijing, China.
authors.forename: Zuojun
authors.initials: Z
authors.lastname: Xu
authors.affiliation: Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
authors.forename: Arata
authors.initials: A
authors.lastname: Azuma
authors.affiliation: Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Inoue
authors.affiliation: Shanghai Pulmonary Hospital, Shanghai, China.
authors.forename: Huiping
authors.initials: H
authors.lastname: Li
authors.affiliation: Nippon Boehringer Ingelheim Co., Ltd, Tokyo, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Fujimoto
authors.affiliation: Boehringer Ingelheim Ltd., Bracknell, UK.
authors.forename: Zelie
authors.initials: Z
authors.lastname: Bailes
authors.affiliation: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA.
authors.forename: Rozsa
authors.initials: R
authors.lastname: Schlenker-Herceg
authors.affiliation: Asan Medical Center, University of Ulsan, Seoul, South Korea.
authors.forename: Dong S
authors.initials: DS
authors.lastname: Kim
mesh_terms: D000368:Aged; D044466:Asian People; D018450:Disease Progression; D016903:Drug Monitoring / Q000379:methods; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000188:drug therapy* / Q000208:ethnology / Q000503:physiopathology; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014797:Vital Capacity / Q000187:drug effects
chemical_list: D004791:Enzyme Inhibitors; D007211:Indoles; C530716:nintedanib
keywords: clinical trials; interstitial lung disease