Patients under Esbriet (pirfenidone) treatment for idiopathic pulmonary fibrosis (IPF) have a lower risk of hospitalization due to respiratory symptoms or respiratory complications, researchers reported.
The findings were published in the American Journal of Respiratory and Critical Care Medicine, in an article titled “Pirfenidone Reduces Respiratory-related Hospitalizations in Idiopathic Pulmonary Fibrosis.”
Esbriet, a therapy developed by Genentech, has been shown to have the capacity to reduce inflammation and fibrosis simultaneously, and to effectively improve respiratory capacity in IPF patients. But the treatment’s impact on hospitalization rates for patients has never before been detailed. Hospitalizations, in particular those related to respiratory reasons, are associated with increased financial burden and poorer patient outcome.
To address this failing, researchers collected information from three placebo-controlled Phase 3 clinical studies of Esbriet as a treatment for IPF — the CAPACITY (NCT00287729 and NCT00287716) and ASCEND (NCT01366209) trials — and evaluated the impact on hospitalization rates upon 52 weeks of Esbriet treatment compared to placebo. Records of 1,247 patients were analyzed.
A total of 139 hospitalizations were reported in the Esbriet-treated patients, among which 54 were respiratory-related and 85 non-respiratory related; in the placebo group, 151 hospitalizations were reported, 87 respiratory-related and 64 non-respiratory related.
A more detailed analysis showed that about 7 percent of treated patients experienced at least one respiratory-related hospitalization compared to 12 percent in the placebo group. However, a higher percentage of treated patients experienced at least one non-respiratory-related hospitalization — 11 percent in the Esbriet-treated group, compared to 9 percent in the placebo group.
These findings were consistent even after evaluation of hospitalization rates upon two weeks of treatment, suggesting that Esbriet reduces the risk of respiratory-related hospitalizations.
The overall evaluation of the IPF patient outcomes showed that Esbriet treatment was associated with reduced mortality after 52 weeks of therapy, a recorded 17 percent in the Esbriet group and 32 percent among placebo-treated patients. This protective effect was found to be largely due to a decrease in respiratory-related hospitalizations.
However, the protective effect of Esbriet was not observed when the analysis was extended up to 72 weeks of treatment, indicating that mortality at this stage may not be due to respiratory complication but other IPF comorbidities.
“In a pooled analysis of three phase 3 IPF clinical trials, patients receiving pirfenidone [Esbriet] had a lower risk of non-elective respiratory-related hospitalization over 1 year. [However] the effect of pirfenidone on death after hospitalization is uncertain,” the researchers concluded.
“Future studies will be needed to examine the long-term effects of pirfenidone [Esbriet] on hospitalization rates, outcomes of hospitalization, and health care costs in IPF,” the team added.
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