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Long‐term treatment with nintedanib in Asian patients with idiopathic pulmonary fibrosis: Results from INPULSIS®‐ON
Author(s) -
Song Jin Woo,
Ogura Takashi,
Inoue Yoshikazu,
Xu Zuojun,
Quaresma Manuel,
Stowasser Susanne,
Stansen Wibke,
Crestani Bruno
Publication year - 2020
Publication title -
respirology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.857
H-Index - 85
eISSN - 1440-1843
pISSN - 1323-7799
DOI - 10.1111/resp.13647
Subject(s) - nintedanib , medicine , idiopathic pulmonary fibrosis , placebo , pathology , lung , alternative medicine
Background and objective The efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis (IPF) were investigated in the placebo‐controlled INPULSIS® trials. All patients who completed an INPULSIS® trial could receive open‐label nintedanib in the extension trial INPULSIS®‐ON. Methods We assessed the long‐term efficacy and safety of nintedanib in patients of Asian race who were treated in INPULSIS®‐ON. Analyses were descriptive. Results A total of 215 Asian patients were treated in INPULSIS®‐ON, of whom 121 continued nintedanib in INPULSIS®‐ON and 94 initiated nintedanib in INPULSIS®‐ON having received placebo in an INPULSIS® trial. At baseline of INPULSIS®‐ON, the mean (SD) age of Asian patients was 66.3 (7.5) years, 80.5% were males and mean (SD) forced vital capacity (FVC) was 78.9 (19.3) % predicted. Median total exposure to nintedanib in both INPULSIS® and INPULSIS®‐ON was 42.2 months; maximum exposure was 64.1 months. In INPULSIS®, the annual rate (SE) of decline in FVC over 52 weeks in Asian patients was −124 (20) mL/year in the nintedanib group and −218 (24) mL/year in the placebo group. In INPULSIS®‐ON, the annual rate (SE) of decline in FVC over 192 weeks in Asian patients was −127 (11) mL/year. Diarrhoea was reported in Asian patients at event rates of 58.8 and 82.5 events per 100 patient exposure–years in patients who continued and initiated nintedanib in INPULSIS®‐ON, respectively. Conclusion The effect of nintedanib on slowing disease progression in Asian patients with IPF is sustained over the long term. Long‐term treatment with nintedanib has an acceptable safety and tolerability profile.