Pirfenidone a ‘feasible treatment option’ for advanced IPF
medwireNews: A post-hoc analysis of the RECAP study suggests that pirfenidone-treated patients with idiopathic pulmonary fibrosis (IPF) experience similar rates of lung function decline irrespective of whether they have more or less advanced disease.
Ulrich Costabel (University of Duisburg-Essen, Germany) and colleagues analysed data from 596 individuals with available lung function data who received pirfenidone in the RECAP long-term extension study after completing CAPACITY, a randomised controlled trial comparing pirfenidone with placebo.
Patients with more advanced disease are “usually excluded from clinical trials in IPF”, with the CAPACITY trial excluding patients with carbon monoxide diffusing capacity (DLco) of less than 35% at the time of enrolment, but “there were no restrictions on disease severity for entry into RECAP”, explain the study authors.
The team reports in Respiratory Research that lung function – measured by percent predicted forced vital capacity (FVC) – declined to a similar degree over 180 weeks of follow-up among the 187 patients with more advanced disease at the time of entry into RECAP (FVC <50% predicted and/or DLco <35% predicted) and the 409 participants with less advanced disease.
Specifically, the average annual rate of decline in percent predicted FVC among patients with more advanced disease was 3.8% for those treated with pirfenidone in CAPACITY and RECAP, and 3.4% for those initially assigned to the placebo group in CAPACITY. The rate in patients with less advanced disease was 3.9% for both the pirfenidone and placebo groups.
The mean annual decline in FVC volume in the more advanced subgroup was 146.1 mL for patients given pirfenidone in CAPACITY and 137.6 mL for those initially given placebo, with comparable declines of 151.7 mL and 156.0 mL, respectively, among patients with less advanced disease.
Costabel et al say that “the safety profile of pirfenidone was generally similar between patients with more and less advanced disease”, with overall adverse event rates (AEs) of 100.0% and 99.8%, respectively. However, patients with more advanced disease were more likely than those with less advanced disease to discontinue treatment due to any reason (71.7 vs 43.3%), AEs related to IPF progression (13.9 vs 5.1) or death (10.7 vs 3.2%).
These higher rates of discontinuation “could reflect the higher severity of IPF in the more advanced versus less advanced disease subgroup”, write the researchers.
They conclude that overall, “the data suggest that pirfenidone is efficacious, well tolerated, and a feasible treatment option in patients with more advanced IPF.”
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