Does Esbriet improve survival?

Clinical studies have reported that Esbriet (pirfenidone) may prolong overall survival in patients with idiopathic pulmonary fibrosis (IPF) by 2.5 to 5 years when compared to patients receiving best supportive care or no antifibrotic treatment.

Treatment results with Esbriet can vary between patients, so you should always speak with your healthcare provider about your individual healthcare circumstances With or without Esbriet, your lung function may still continue to decline.

What is Esbriet?

Esbriet (generic name: pirfenidone) is an oral maintenance medicine used long-term for the treatment of idiopathic pulmonary fibrosis (IPF), a rare and fatal type of interstitial lung disease (ILD). IPF is not a contagious lung disease.

Esbriet was first approved in 2014 and is manufactured by Genentech. Esbriet appears to prevent lung scarring that worsens the ability to breath, and slows IPF progression, but is not considered a cure.

In studies, people taking Esbriet for 1 to 1.5 years have seen better lung breathing capacity and preserved lung function.

Learn More: How long can you take Esbriet for?

How long do people usually live with idiopathic pulmonary fibrosis (IPF)?

In patients with a diagnosis of IPF, only 20% to 40%, on average, are expected to survive for 5 years without treatment. Lung transplant is the only cure for patients with IPF.

In addition, long-term, prospective survival studies in IPF can be hard to complete due to the rare and fatal nature of the disease and ethical considerations for active treatment in studies.

Survival Studies with Esbriet

Study 1. In one survival analysis study, Esbriet was predicted to extend survival by about 2.5 years on average in patients with idiopathic pulmonary fibrosis (IPF), ranging from a mean of 1.3 to 4.2 years compared with a group receiving best supportive care (BSC). BSC focuses on symptom management (pulmonary rehabilitation, supplemental oxygen therapy) and treatment of disease complications, but is not expected to prolong survival.

• The results showed that the median life expectancy was 7.25 years in patients taking Esbriet vs. 4.67 years in those receiving BSC.
• As a result, Esbriet improved life expectancy by about 2.5 years compared to BSC.
• As noted by the researchers, the mean 95% confidence interval (CI) suggests treatment with Esbriet could lead to improvements ranging from 1 year to 4 years compared with BSC.

Study 2. In an exploratory analysis of three Phase 3 studies conducted by the manufacturer (ASCEND, CAPACITY 004, and CAPACITY 006 vs. placebo), Esbriet achieved a numerical difference in all-cause mortality but no statistical difference over the study and follow-up period (up to 120 weeks for some patients).

• At 52 weeks, Esbriet led to a 47% reduced risk of death when compared to a placebo (an agent that contains no active ingredient), or a 3.2% absolute difference (3.6% Esbriet vs. 6.8% placebo).
• At 72 weeks, patients receiving Esbriet had a 31% reduced risk of death compared to placebo, or a 3% absolute difference (6.6% Esbriet vs. 9.6% placebo).
• At 120 weeks, there was a 0.8% absolute difference (17.1% Esbriet vs. 16.3% placebo).

Study 3. In a 5-year cohort study completed in the Czech Republic, patient data was collected from the EMPIRE registry, a European database of idiopathic pulmonary fibrosis (IPF) patients.

• In these patients, Esbriet was shown to increase 1-year, 2-year and 5-year overall survival (OS) compared to a group receiving no antifibrotic treatment (P = 0.002).
• At 5 years, 55.9% of those receiving Esbriet vs. 31.5% of those receiving no antifibrotic treatment were alive.

Study 4. In a long-term, Phase 3, extension safety study (RECAP), 1,058 of 1,334 patients who participated in regulatory Phase 3 trials entered RECAP.

• The median survival time of patients with IPF from the day they started Esbriet treatment was 77.2 months (about 6.5 years).
• The authors conclude that the data supports the long-term efficacy and treatment benefit of Esbriet in patients who continued receiving therapy.

Clinical Effectiveness of Esbriet

Esbriet was approved by the FDA based on three Phase 3 clinical studies that evaluated its effectiveness and safety in over 1,400 patients. More than 170 of these patients were treated with Esbriet for over 5 years.

In the Phase 3 studies, Esbriet has been associated with increased lung function as measured by forced vital capacity (FVC). FVC measures the amount of air you can forcefully breath out after you inhale as deeply as possible.

In a 1-year long clinical study, people who took Esbriet had better breathing capacity compared to those who did not take Esbriet (193 mL difference in forced vital capacity). In two other 72-week long studies, one study showed similar results and one did not.

Treatment for IPF is important because lung function that is lost cannot be restored. Treatment may help you maintain more lung function by slowing down the progression of idiopathic pulmonary fibrosis (IPF).

• In a study, Esbriet preserved baseline lung function in 23% of people vs. 10% of people who did not use the medicine.
• In two other 72-week long studies, one study showed similar results and one did not.

Learn More: Warnings, Precautions and Side Effects with Esbriet (in more detail)

This is not all the information you need to know about Esbriet for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.