INPULSIS
Trial question
What is the effect of nintedanib in patients with idiopathic pulmonary fibrosis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
21.0% female
79.0% male
N = 1066
1066 patients (220 female, 841 male)
Inclusion criteria: patients with idiopathic pulmonary fibrosis
Key exclusion criteria: liver transaminases or bilirubin above 1.5-fold ULN, myocardial infarction within 6 months or unstable angina within 1 month of randomization, taking full-dose anticoagulant therapy or high-dose antiplatelet therapy at screening, or treatment with NAC or prednisone > 15 mg/day or equivalent within 2 weeks of screening
Interventions
N=638 nintedanib (150 mg BID for 52 weeks)
N=423 placebo (matching placebo for 52 weeks)
Primary outcome
Incidence of decline in forced vital capacity, in INPULSIS-1
-114.7
-239.9
0.0 mL/year
-60.0 mL/year
-120.0 mL/year
-179.9 mL/year
-239.9 mL/year
Nintedanib
Placebo
Significant
increase ▲
Significant increase in the incidence of decline in FVC, in INPULSIS-1 (-114.7 mL/year vs. -239.9 mL/year; AD 125.3 mL/year, 95% CI 77.7 to 172.8)
Secondary outcomes
Significant increase in the incidence of change in FVC, in INPULSIS-2 (-113.6 mL/year vs. 207.3 mL/year; AD 93.7 mL/year, 95% CI 44.8 to 142.7)
Safety outcomes
Significant difference in adverse event related to diarrhea in INPULSIS-1 (61.5% vs. 18.6%) and INPULSIS-2 (63.2% vs. 18.3%).
Conclusion
In patients with idiopathic pulmonary fibrosis, nintedanib was superior to placebo with respect to the incidence of decline in FVC, in INPULSIS-1.
Reference
Richeldi L, du Bois RM, Raghu G et al. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2071-82.
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