Roche has announced new retrospective data analyses for Esbriet (pirfenidone) in idiopathic pulmonary fibrosis (IPF) that were presented at the American Thoracic Society (ATS) 2017 International Conference. 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 hospitalisations 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.
“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.”
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; HR 0.28 [95% CI 0.09, 0.86]; P = 0.018) 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).2 In patients with less preserved lung function (GAP stage II/III), the median UCSD-SOBQ score for patients receiving Esbriet was 9.2, whereas for patients receiving placebo it was 13.0 (median difference -3.67, 95% CI, -6.50, -1.00; p=0.009). In addition, a lower proportion of patients on Esbriet experienced more pronounced increases in UCSD-SOBQ scores at one year.
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 hospitalisations. The novel definition resulted in a hazard ratio of 0.49; (95% CI 0.38, 0.64; p<0.0001) for progression-free survival in favour of Esbriet compared to placebo. Data recently published in the American Journal of Respiratory and Critical Care Medicine (AJRCCM) also showed retrospectively that Esbriet reduced the risk of respiratory-related hospitalisation compared to placebo (7% vs 12%, HR 0.52, 95% CI 0.36-0.77, p-value=0.001).5 Among those hospitalised for any reason, Esbriet was associated with a lower risk of death following hospitalisation.
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.4 Of the patients on Esbriet, 76.2% persisted on therapy.