One year of treatment with Genentech‘s Esbriet (pirfenidone) significantly reduced the incidence of disease progression events — including decline in lung function and physical capacity, respiratory-related hospitalizations, and death — in people with idiopathic pulmonary fibrosis (IPF), a pooled analysis of data from Phase 3 trials shows.
Fewer patients receiving treatment with Esbriet had one or more disease-worsening signs than those receiving placebo over one year of treatment, the study found. These results suggest that continued treatment with Esbriet is of benefit to IPF patients, even if they have one manifestation of disease progression, the researchers said.
The study, “Efficacy of Pirfenidone in the Context of Multiple Disease Progression Events in Patients With Idiopathic Pulmonary Fibrosis,” was published in the journal CHEST. Some of the findings were previously presented at the European Respiratory Society (ERS) International Congress in September 2017.
To analyze the incidence of multiple signs of IPF disease worsening under Esbriet treatment, an international team, led by researchers at the Inova Fairfax Hospital in Virginia and the Royal Brompton Hospital in London, analyzed data from three Phase 3 clinical trials assessing the efficacy and safety of Esbriet in IPF patients, compared with placebo — the ASCEND (NCT01366209), CAPACITY 1 (NCT00287729), and CAPACITY 2 (NCT00287716) trials.
In total, the analysis included 623 IPF patients who received Esbriet three times a day, at a daily dose of 2,403 mg, and 624 patients who were given an identical regimen of a placebo.
Researchers assessed different types of events associated with disease progression over one year of treatment, namely a decline of at least 10% in percentage predicted forced vital capacity (FVC), as a measure of lung capacity; a reduction of at least 50 meters in the six minute walk test (6MWT), as a measure of exercise capacity; and the need for respiratory-related hospitalization, or death from any cause.
The cutoffs for declines in FVC and 6MWT considered as events of disease progression “were chosen to capture clinically meaningful changes,” the researchers wrote.
In the study, each patient could have experienced multiple events, which may or may not have been of the same type. Events that occurred on the same date were counted as a single event.
Results showed that Esbriet significantly lowered the risk of patients having a progression-related event. Consistent with this finding, fewer patients on Esbriet (17%) experienced more than one event, compared with the placebo group (30.1%).
Most often, disease progression was reflected by worsening breathing and physical capacity in patients. There were fewer patients on Esbriet experiencing any of these IPF progression signs — there were 202 events of percentage predicted FVC decline and 265 events of worse 6MWT performance in those given Esbriet, compared with 304 and 348 in those receiving placebo, respectively.
The number of deaths were also lower in the Esbriet-treated group over the one-year treatment period — 22 patients died, compared with 42 in the placebo group.
In addition, the researchers noted that the number of deaths increased with the number of progression-related events, especially in the placebo group. In line with this, there were fewer deaths following one or more disease-worsening events in the Esbriet group than in the placebo group (2.1% versus 6.3%).
The team concluded that Esbriet “significantly reduced the incidence of multiple progression events and death after a progression event over 12 months of treatment, compared with placebo.”
“These findings suggest that continued treatment with [Esbriet] confers a benefit despite the occurrence of any single disease progression event,” they added.
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