Esbriet (pirfenidone) can be used as a long-term therapy in idiopathic pulmonary fibrosis (IPF) patients with more severe loss of lung function, according to results presented at the American College of Chest Physicians (CHEST 2016), held in Los Angeles from Oct. 22–26.
The findings were described in the oral presentation, “Analysis of Patients With Idiopathic Pulmonary Fibrosis (IPF) With More Severe Lung Function Impairment Treated With Pirfenidone in Recap,” given by a research team led by Ulrich Costabel with the University of Duisburg-Essen, Germany.
Esbriet is an oral antifibrotic medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of IPF in 2014, based on Phase 3 clinical studies of its safety and efficacy in enrolled patients. But IPF patients with more severe loss of lung function were not included among the starting group of patients in those trials.
For this reason, the researchers focused on people whose predicted forced vital capacity (FVC; a measure of lung function) was below 50 percent, or who had a predicted diffusing capacity for carbon monoxide (DLCO) below 35 percent. These patients were part of the RECAP study (NCT00662038), which evaluated the long-term safety of Esbriet in a large group of patients who had completed the CAPACITY trials (NCT00287716 and NCT00287729). Researchers compared results obtained in patients who went on to have severe loss of lung function, with results seen in IPF patients who retained greater lung function capacity (FVC of at least 50 percent and DLCO of at least 35 percent).
At the start of RECAP, 187 patients were considered as having severe IPF (mean FVC of 59.8 percent and mean DLCO of 29.2 percent), and 409 as non-severe (mean FVC 76.1 percent and mean DLCO 47 percent). Among those with severe IPF, 84 kept with the 2,403 mg/day Esbriet dose given them in CAPACITY trials, 16 received pirfenidone at 1,197 mg/day, and 87 were given placebo.
Severe patients at the study’s start had an annual rate of FVC decline (and, therefore, lung function loss) of 2.9 percent with Esbriet 2,403 mg/day and 4.2 percent with placebo. Both severe and non-severe patient groups experienced similar FVC decline over the trial’s more than three years, regardless of previous treatment, presenting an annual rate of decline of 1.03 percent and 1.11 percent, respectively.
The safety profile of Esbriet was similar between the two groups (severe and non-severe IPF).
“These data support the use of pirfenidone [Esbriet] as a treatment in patients with more severe lung function impairment,” the researchers concluded.