Zuojun Xu1, Huiping Li2, Fuqiang Wen3, Chunxue Bai4, Ping Chen5, Feng Fan6, Na Hu6, Susanne Stowasser7, Jian Kang8. 1. Department of Respiratory Diseases, Peking Union Medical College Hospital, Beijing, China. 2. Department of Respiratory Diseases, Shanghai Pulmonary Hospital, Shanghai, China. 3. Department of Respiratory Diseases, West China Hospital, Sichuan University, Chengdu, China. 4. Department of Respiratory Diseases, Zhongshan Hospital, Fudan University, Shanghai, China. 5. Department of Respiratory Diseases, The General Hospital of Shenyang Military Region, Shenyang, China. 6. Boehringer Ingelheim (China) Investment Co Ltd, Shanghai, China. 7. Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany. 8. Department of Respiratory Diseases, The First Hospital of China Medical University, Shenyang, China. kangjian58@163.com.
Abstract
PURPOSE: To investigate the efficacy and safety of nintedanib versus placebo in Chinese patients with idiopathic pulmonary fibrosis (IPF). METHODS: The INPULSIS® trials consisted of two replicate, randomized, placebo-controlled, double-blind trials comparing nintedanib 150 mg bid with placebo over a 52-week treatment period. The primary endpoint was annual rate of decline in forced vital capacity (FVC); key secondary endpoints were change from baseline in Saint George's Respiratory Questionnaire's total score and time to first investigator-reported acute exacerbation. Data from both trials were pooled for the Chinese subgroup analyses. RESULTS: A total of 101 Chinese patients (nintedanib/placebo: 61/40) were treated. The demographic characteristics were generally balanced between treatment arms. Over 52 weeks, the rate of decline in FVC was lower in nintedanib-treated patients compared with placebo-treated patients in the Chinese subgroup [- 126.43 vs. - 229.82 mL/year; ∆ = 103.39 mL/year (95% confidence interval, CI: - 19.40 to 226.18)]. The proportion of patients with adverse events (AEs) over 52 weeks was similar between treatment arms. The most commonly reported AEs with nintedanib treatment were gastrointestinal symptoms (diarrhoea, nausea, and vomiting). CONCLUSIONS: Nintedanib is clinically efficacious in Chinese patients with IPF with approximately 50% reductions in the rate of decline in FVC, demonstrating slowed disease progression. Similar to the overall INPULSIS® population, nintedanib has a favourable benefit/risk profile in Chinese patients with IPF. CLINICALTRIALS. GOV IDENTIFIERS: NCT01335464, NCT01335477. FUNDING: Boehringer Ingelheim. Plain language summary available for this article.
RCT Entities:
PURPOSE: To investigate the efficacy and safety of nintedanib versus placebo in Chinese patients with idiopathic pulmonary fibrosis (IPF). METHODS: The INPULSIS® trials consisted of two replicate, randomized, placebo-controlled, double-blind trials comparing nintedanib 150 mg bid with placebo over a 52-week treatment period. The primary endpoint was annual rate of decline in forced vital capacity (FVC); key secondary endpoints were change from baseline in Saint George's Respiratory Questionnaire's total score and time to first investigator-reported acute exacerbation. Data from both trials were pooled for the Chinese subgroup analyses. RESULTS: A total of 101 Chinese patients (nintedanib/placebo: 61/40) were treated. The demographic characteristics were generally balanced between treatment arms. Over 52 weeks, the rate of decline in FVC was lower in nintedanib-treated patients compared with placebo-treated patients in the Chinese subgroup [- 126.43 vs. - 229.82 mL/year; ∆ = 103.39 mL/year (95% confidence interval, CI: - 19.40 to 226.18)]. The proportion of patients with adverse events (AEs) over 52 weeks was similar between treatment arms. The most commonly reported AEs with nintedanib treatment were gastrointestinal symptoms (diarrhoea, nausea, and vomiting). CONCLUSIONS:Nintedanib is clinically efficacious in Chinese patients with IPF with approximately 50% reductions in the rate of decline in FVC, demonstrating slowed disease progression. Similar to the overall INPULSIS® population, nintedanib has a favourable benefit/risk profile in Chinese patients with IPF. CLINICALTRIALS. GOV IDENTIFIERS: NCT01335464, NCT01335477. FUNDING: Boehringer Ingelheim. Plain language summary available for this article.