Roche (SIX: RO, ROG; OTCQX: RHHBY) today 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, (1) reduction in patient-reported breathlessness,(2) and longer progression-free survival (PFS) with fewer respiratory-related hospitalisations compared to placebo.(3) 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.(4)
"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)1 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.(1)
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).(2) In addition, a lower proportion of patients on Esbriet experienced more pronounced increases in UCSD-SOBQ scores at one year.(2)
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.(3) 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.(5)
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.(4)
About idiopathic pulmonary fibrosis
Idiopathic pulmonary fibrosis (IPF) is a fatal disease caused by irreversible, progressive scarring (fibrosis) of the lungs, which makes breathing difficult and prevents the heart, muscles and vital organs from receiving enough oxygen to work properly.(6) The disease can advance quickly or slowly, but eventually the lungs will harden and stop working altogether.6 People with IPF experience a more rapid decline than most cancer patients; in a recent study, only people with lung and pancreatic cancer were shown to have worse survival.(7)
Approximately 100,000 people in the United States(8) and 110,000 people in Europe have IPF.(9) The cause is unknown, and there is no cure. A limited number of people with IPF undergo lung transplantation. IPF inevitably causes shortness of breath and destruction of healthy lung tissue. Half of IPF people fail to survive just three years following diagnosis, and the five-year survival rate is approximately 20-30%.(10) IPF typically occurs in people over the age of 45, and tends to affect more men than women.(11,12)
About Esbriet
Esbriet is an oral medicine app...
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