Institution: | 1. Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan;2. Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan;3. Department of Respiratory Medicine, Hiratsuka Kyosai Hospital, Kanagawa, Japan;4. Department of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences, Tokushima University, Tokushima, Japan;5. Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan;6. Division of Respirology, Neurology and Rheumatology, Kurume University School of Medicine, Fukuoka, Japan;7. Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan;8. Boehringer Ingelheim International GmbH, Ingelheim, Germany;9. Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan |
Abstract: | BackgroundA previous subgroup analysis of data from the INBUILD trial showed that nintedanib reduced the annual rate of decline in forced vital capacity (FVC) in Japanese patients with progressive fibrosing interstitial lung diseases (PF-ILDs). The safety profile of nintedanib over 52 weeks in Japanese patients was similar to that of the overall population.MethodsUsing data from 108 Japanese patients with PF-ILDs who had received at least 1 dose of study medication in the INBUILD trial, we evaluated the effect of nintedanib on disease progression and assessed the safety profile over the whole trial period (i.e., a longer duration than the prior analysis) compared with placebo. ILD progression was defined as an absolute decline in FVC ≥10% predicted vs baseline.ResultsOver the whole trial, in Japanese patients with PF-ILDs, nintedanib numerically lowered the risk of progression of ILD or death (hazard ratio HR], 0.66; 95% confidence intervals CI]: 0.37, 1.16), acute exacerbation of ILD or death (HR, 0.28; 95% CI: 0.09, 0.83), and death (HR, 0.41; 95% CI: 0.11, 1.51). The most common adverse event over the whole trial in nintedanib-treated Japanese patients was diarrhea, which was manageable for most patients by dose reduction and interruption. The safety profile of nintedanib in this longer duration analysis was consistent with that previously reported.ConclusionsIn this analysis of data from Japanese patients with PF-ILDs, nintedanib nominally reduced the risk of clinically meaningful outcomes reflecting disease progression, including death, over the whole trial, and no new safety concerns were observed.Clinical trial registrationClinicalTrials.gov NCT02999178. |