Esbriet Seen to Offer Significant Benefits to IPF Patients in Pooled Analysis of Phase 3 Trials
A post-hoc analysis of data from Phase 3 studies shows that Esbriet (pirfenidone) can significantly reduce the incidence of disease progression events in people with idiopathic pulmonary fibrosis (IPF) — including respiratory-related hospitalizations, decline in lung function and physical capacity, and the risk of death — compared to placebo.
These results were reported in the presentation, “Incidence of Multiple Progression Events in Patients With Idiopathic Pulmonary Fibrosis (IPF) in the Pooled CAPACITY and ASCEND Trials,” given by Dr. Steven Nathan at the European Respiratory Society (ERS) International Congress 2017, held this month in Milan, Italy.
Nathan, director of the Advanced Lung Disease and Lung Transplant Programs at Inova Fairfax Hospital in Virginia, told Pulmonary Fibrosis News in an interview these results were of particular “value” because they gave a “more global” sense of benefit, and supported continuing with treatment “even in the event of disease progression.”
The analysis pooled data from three trials, CAPACITY (NCT00287716 and NCT00287729) and ASCEND (NCT01366209), involving a total of 1,247 IPF patients randomly assigned to receive either 2,403 mg of Esbriet or placebo daily for up to 52 weeks.
Among the 623 people given Esbriet, an FDA-approved IPF treatment by Genentech, significantly fewer progressive events were recorded than among the 624 on placebo. Specifically, 17.0% of the Esbriet-treated patients had more than one disease progression event compared to 30.1% in the placebo group during the 12-month study period.
Progressive events were defined as a relative decline in percent-predicted forced vital capacity ≥10% (FVC is a measure of lung function), an absolute decline of 50 meters or more in the 6-minute walk distance test (assessing physical capacity), respiratory-related hospitalizations, or death from any cause.
Treatment wth Esbriet, compared to placebo, was seen over the 12 months to lessen the number of events marking a decline in lung function by 34 percent, events marking hospitalizations for respiratory problems by 38 percent, and events marking a decline in physical capacity by 24 percent.
Further, 6.3 percent of people in the placebo-treated group died during the study period after at least one progressive event, compared to 2.1 percent in the Esbriet group.
In the interview, Nathan said “this analysis suggests the durability of the treatment benefit of Esbriet: continued treatment confers a benefit despite the occurrence of any single disease progression event.
“There was reduced mortality following one progression event when patients were treated with Esbriet, compared to placebo,” he said. “These data support the continuation of treatment with Esbriet even in the event of disease progression.”
Nathan and other researchers, in their presentation, also voiced support for this type of analysis, noting that a “multiple events-driven approach may have relevance for the design of future IPF clinical trials.”
He came back to this point in the interview, noting: “The value of this analysis is that patients do not stop contributing to the dataset with the first progression event, but all events are accounted for. Therefore, a more global depiction of the benefits of pirfenidone are presented.”
And, in a comment directed to September being PF Awareness Month, Nathan concluded the interview with this message to readers:
“It has been almost three years since the approval of the two antifibrotic medications for IPF [Esbriet and Ofev (nintedanib)] and we continue to learn about their role and benefits,” he said. “It is an exciting time in the field of IPF, with many different compounds in various stages of development to further impact the course of this potentially devastating disease.”