Recommended by the ATS/ERS/JRS/ALAT Clinical Practice Guideline for the treatment of IPF.
Conditional recommendation, moderate confidence in estimates of effect. 15*

Esbriet preserves more lung function for patients with IPF

Esbriet had a significant impact on lung function vs placebo 1,2

ASCEND: Significant difference in maintaining baseline lung function for Esbriet vs placebo at 52 weeks (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. 1,14

  • No decline or an increase in lung function is defined as a ≥0% decline in %FVC from baseline at 52 weeks 1

Disease progression as measured by FVC decline was considered a high-value, patient-important outcome [ATS/ERS/JRS/ALAT Clinical Practice Guideline] 15

ASCEND: Significant difference in reducing risk of lung function decline for Esbriet vs placebo at 52 weeks (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. 1,14

  • Meaningful decline in lung function is defined as a ≥10% decline in %FVC at 52 weeks 1    

According to ATS guidelines, ≥10% FVC decline is an established measure of IPF disease progression and may be predictive of mortality 8

Esbriet delays disease progression

Esbriet delayed progression of IPF vs placebo through a sustained impact on reducing lung function decline 1,2,14

ASCEND: Mean change from baseline in FVC vs placebo over 52 weeks

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 1,14

Change in FVC over time is a widely accepted assessment of disease progression in IPF, with even small declines believed to be clinically important 11,16

Significant effect on lung function for up to 72 weeks with Esbriet

Significantly fewer patients on Esbriet had a meaningful decline in lung function (≥10% decline in %FVC) vs placebo 3,14

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)§

§ 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 1,14

In CAPACITY 006, no statistically significant difference vs placebo in change in %FVC or decline in FVC volume from baseline to 72 weeks was observed 1,3

 

*Recognize that different choices will be appropriate for individual patients and that you must help each patient arrive at a management decision consistent with his or her values and preferences.

 

EXPERT PERSPECTIVE:
EFFICACY AND SAFETY

Watch Steven Nathan, MD, discuss the clinical efficacy and safety of Esbriet

ESBRIET TABLETS    

Help your patients start and stay on Esbriet with 267 mg and 801 mg tablets 

ESBRIET SAFETY AND TOLERABILITY

Learn more about the safety and tolerability profile of Esbriet