Two recent studies demonstrate that pirfenidone (Esbriet, Genentech) prolongs life expectancy by 2.47 years for IPF patients and that Esbriet and nintedanib (Ofev, Boehringer Ingelheim) reduce the decline in lung function.
Two recent studies show that pirfenidone (Esbriet, Genentech) prolongs life expectancy by 2.47 years for IPF patients and that Esbriet and nintedanib (Ofev, Boehringer Ingelheim) reduce the decline in lung function.
The first study, “Predicting Life Expectancy for Pirfenidone in Idiopathic Pulmonary Fibrosis,” was published in the March 23 issue of the Journal of Managed Care & Specialty Pharmacy.
“These findings suggested the benefit of Esbriet was substantial as it improves life expectancy by 2.47 years compared with best supportive care, and that it could represent a 25% recuperation of the years of life lost due to IPF compared with the life expectancy in a corresponding general population,” Steven Nathan, MD, medical director of the Advanced Lung Disease and Transplant Program at Inova Fairfax Hospital, told FormularyWatch.
In the first study, researchers used Kaplan-Meier survival data for both Esbriet and BSC from the randomized controlled clinical studies, an open-label extension study and the Inova Fairfax Hospital database. Data from the Inova registry were matched to the inclusion criteria of the clinical trials which measured the efficacy of Esbriet and led to its FDA approval.
”Because the clinical trials for approved IPF therapies ran from 52 to 150 weeks, we don’t have a randomized study analyzing results beyond this period of time. Therefore, we can use sophisticated models to look at what long-term survival with Esbriet could be by analyzing previous intermediate-term survival results,” Nathan said.
In the second study, “Systematic Review and Network Meta-analysis of Idiopathic Pulmonary Fibrosis Treatments,” also published in the March 23 issue of the Journal of Managed Care & Specialty Pharmacy, researchers showed that Esbriet and nintedanib reduce the decline in lung function over a year compared with a placebo.
Researchers utilized a Bayesian network meta-analysis of phase 2 and phase 3 studies to compare Esbriet and other treatments with respect to forced vital capacity (FVC) and mortality.
They found that pirfenidone and nintedanib were effective at reducing lung-function decline over a year, and that pirfenidone may reduce the odds of experiencing a decline in FVC of equal to or great than 10%, compared with placebo in the first year of treatment. They also found that pirfenidone improves survival.
The FDA approval of Esbriet and Ofev for IPF treatments are “just the start,” according to Nathan. “While people with IPF now have options for disease management, there is still a unmet need as we haven’t yet found a cure for IPF. Currently, there are a couple of therapies in phase 2 clinical trials. Moving forward, we’ll have an understanding of whether combination therapies will work to treat IPF.”
Read more: Top 3 additions to IPF treatment guidelines