title: Nintedanib in Japanese patients with idiopathic pulmonary fibrosis: A subgroup analysis of the INPULSIS® randomized trials.
abstract: Idiopathic pulmonary fibrosis (IPF) is a specific form of chronic, progressive fibrosing interstitial pneumonia. Nintedanib significantly reduced the annual rate of decline in forced vital capacity (FVC) compared with placebo in patients with IPF in two replicate trials (INPULSIS®). We examined the efficacy and safety of nintedanib in Japanese patients.
  
  
  
  We conducted pre-specified subgroup analyses of the annual rate of decline in FVC, time to first acute exacerbation (AE), change from baseline in St George's Respiratory Questionnaire (SGRQ) total score and safety using pooled data from the INPULSIS® trials for Japanese patients.
  
  
  
  In the overall population, 76 of 638 and 50 of 423 patients in the nintedanib and placebo groups, respectively, were Japanese. Results in Japanese patients were consistent with those in the overall population. In Japanese patients, the adjusted annual rate of decline in FVC was -135.9 mL/year in the nintedanib group and -267.7 mL/year in the placebo group (difference (95% CI): 131.9 (50.7, 213.1) mL/year); the hazard ratio for the time to first AE was 0.25 (0.06, 1.02); and the adjusted mean change from baseline in SGRQ total score at week 52 was 5.81 in the nintedanib group and 9.68 in the placebo group (difference: -3.87 (-8.51, 0.76)). Diarrhoea and liver-related adverse events were the most common events in the nintedanib group, but were reversible following dose reduction, drug interruption or symptomatic therapy.
  
  
  
  The present results indicate that the efficacy and safety of nintedanib in Japanese patients are comparable with those in the overall population.
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: Department of Respiratory Medicine and Allergy, Tosei General Hospital, Aichi, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Taniguchi
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: Department of Respiratory Medicine and Allergy, Tosei General Hospital, Aichi, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Kondoh
authors.affiliation: Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Kanagawa, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Ogura
authors.affiliation: Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo, Japan.
authors.forename: Sakae
authors.initials: S
authors.lastname: Homma
authors.affiliation: Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Fujimoto
authors.affiliation: Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.
authors.forename: Wataru
authors.initials: W
authors.lastname: Sakamoto
authors.affiliation: Division of Pulmonary Medicine, Department of Medicine, Jichi Medical University, Tochigi, Japan.
authors.forename: Yukihiko
authors.initials: Y
authors.lastname: Sugiyama
authors.affiliation: Research Institute of Tuberculosis, Japan Anti-tuberculosis Association, Tokyo, Japan.
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Nukiwa
mesh_terms: D000368:Aged; D044466:Asian People; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000188:drug therapy*; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014797:Vital Capacity / Q000187:drug effects*
chemical_list: D004791:Enzyme Inhibitors; D007211:Indoles; C530716:nintedanib
keywords: Japanese; forced vital capacity; idiopathic pulmonary fibrosis; nintedanib