INPULSIS
Nintedanib in Idiopathic Pulmonary Fibrosis
Patient / Population Intervention / Exposure Comparison Outcome
In 1,066 patients with idiopathic pulmonary fibrosis, nintedanib 150 mg twice daily slowed annual FVC decline compared with placebo.
N
1,066
Design
Two replicate 52-week RCTs
Endpoint
Annual rate of FVC decline
Relevance
1
Result-115 vs -240 mL (INPULSIS-1) and -114 vs -207 mL (INPULSIS-2); both p<0.001. Diarrhoea >60%.
Richeldi L, et al. N Engl J Med. 2014;370(22):2071-2082. 10.1056/NEJMoa1402584
Discussion & critique
Anchored FDA approval of nintedanib for IPF.