Advances in Therapy 2019-Mar
Subgroup Analysis for Chinese Patients Included in the INPULSIS® Trials on Nintedanib in Idiopathic Pulmonary Fibrosis.
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Keywords
Abstract
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.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.