New retrospective data analyses for Esbriet (pirfenidone) found that the drug may reduce mortality risk and reduce dyspnea in patients with idiopathic pulmonary fibrosis (IPF).
Three post hoc analyses of the pooled phase III ASCEND and CAPACITY studies indicated that IPF patients treated with Esbriet may experience a reduction in the risk of death, reduction in patient-reported breathlessness, and longer progression-free survival (PFS) with fewer respiratory-related hospitalizations compared to placebo. In a fourth, real-world analysis of US claims data on persistency, patients overall had a good adherence. 76.2% of the Esbriet patients persisted on therapy.
In the first post hoc analysis of the pooled phase III studies, Esbriet was associated with a 72% reduction in the risk of all-cause mortality in patients with more advanced lung function impairment over one year compared to placebo (4 versus 12 deaths) and a 56% relative reduction in the proportion of patients with a ?10% absolute decline in FVC or death at one year compared to placebo.
In the second post hoc analysis of the pooled phase III studies, treatment with Esbriet was associated with reduced progression of breathlessness in patients with moderate lung function impairment, as measured by the University of California, San Diego Shortness of Breath Questionnaire (UCSD-SOBQ).
The third post hoc analysis of the pooled phase III studies was conducted on the effect of Esbriet on disease progression over one year, using a novel definition of PFS that includes respiratory-related hospitalizations. The novel definition resulted in a hazard ratio of 0.49 for progression-free survival in favor of Esbriet compared to placebo.
Finally, in the first retrospective study of real-world adherence and persistence data with antifibrotic therapies for the treatment of IPF, patients on Esbriet had a high rate of adherence during the follow-up period of the study. Of the patients on Esbriet, 76.2% persisted on therapy.
“These data expand our understanding of how Esbriet may help people with IPF by slowing disease progression,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “The data also provide insights on management of IPF in real-world settings.”