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