Esbriet (pirfenidone) preserves more lung function for patients with IPF 2,14
Esbriet had a significant impact on lung function vs placebo
ASCEND: Lung function preserved from baseline at 52 weeks with Esbriet vs placebo (P<0.001)*
*Rank ANCOVA with lowest rank imputation for missing data due to death. Patients who died were counted in the ≥10% decline category. 1,2
No decline or an increase in lung function is defined as a ≥0% decline in %FVC from baseline at 52 weeks 2
Disease progression as measured by FVC decline was considered a high-value, patient-important outcome [ATS/ERS/JRS/ALAT Clinical Practice Guideline] 16
ASCEND: Significant difference in
reducing risk of lung function decline for Esbriet vs placebo at 52
weeks (P=0.001)
2,14
Meaningful decline in lung function is defined as a ≥10% decline in %FVC at 52 weeks
According to ATS guidelines, ≥10% FVC decline is an established measure of IPF disease progression and may be predictive of mortality 9
CAPACITY 004: Significant difference in reducing risk of lung function decline as measured by %FVC for Esbriet vs placebo at 72 weeks (P=0.001) 1,15,†
† P value is from Cochran-Mantel-Haenszel (CMH) row mean scores test.
In CAPACITY 004, patients on Esbriet also maintained significantly
more lung function vs placebo, as measured by mean change in FVC (157
mL), P=0.004
In CAPACITY 006, from baseline to 72 weeks, no statistically significant difference vs placebo was observed in change in %FVC or decline in FVC volume 15
Esbriet delays disease progression 1,2,14
Esbriet delayed progression of IPF vs placebo through a sustained impact on reducing lung function decline
ASCEND: Mean change from baseline in FVC vs placebo at 52 weeks
Adapted from N Engl J Med, King TE Jr, et al.
A phase 3 trial of pirfenidone in patients with idiopathic pulmonary
fibrosis, 370(22):2083-2092. Copyright © 2014 Massachusetts Medical
Society. Reprinted with permission from Massachusetts Medical
Society.
‡ P value is from rank ANCOVA on the % change in FVC volume.
Impact of Esbriet on FVC volume was assessed at week 13, week 26, and week 39, with the primary endpoint at week 52 1,2
Patients taking Esbriet maintained almost double (1.8x) the amount of lung function as patients on placebo at 52 weeks 1
In CAPACITY 006, from baseline to 72 weeks, no statistically
significant difference vs placebo was observed in decline in FVC
volume. 1,2
Change in FVC over time is a widely accepted assessment of disease progression in IPF, with even small declines believed to be clinically important 17,18
