Analysis of patients with idiopathic pulmonary fibrosis (IPF) with percent predicted forced vital capacity (FVC) < 50% treated with pirfenidone in RECAP

Background:

Patients (pts) with IPF with % predicted FVC< 50% were excluded from PFD Phase 3 trials. Thus, data on pts with more severe lung function impairment in controlled clinical studies are lacking to inform clinical practice.

Objective:

To assess PFD benefit in pts with more severe lung function impairment.

Methods:

Pts who entered the long-term extension study of the CAPACITY (CAP) trials (RECAP) with % predicted FVC< 50% were evaluated by % predicted FVC at baseline in RECAP and their AE profile using descriptive statistics.

Results:

54 CAP pts had FVC< 50% at baseline in RECAP (19 previously had PFD 2403 mg/d, 7 1197 mg/d, 28 placebo) and similar baseline demographics aside from lung function compared with pts with FVC> 50% (n = 530). Prior to RECAP, pts with FVC< 50% at baseline had an annual rate of decline of 5.1% (SE, 1.13) with PFD 2403 mg/d vs. 7.7% (SE, 0.95) with placebo. At entry into RECAP, mean FVC was 45.4% and mean diffusing capacity for carbon monoxide was 28.9% in pts with FVC< 50% vs. 73.5% and 42.2%, respectively, in pts with FVC> 50%. During RECAP, both groups declined similarly over 180 wk, independent of prior therapy, with an annual rate of decline of 2.09% (SE, 0.49) and 2.73% (SE, 0.47). Safety was similar, with a slightly higher rate of GI AEs (nausea, vomiting) but a lower rate of rash in pts with < 50% FVC at baseline.

Conclusions:

Long-term treatment with PFD resulted in a similar rate of decline in pts with baseline FVC< 50% compared with pts with more preserved lung function, with a comparable safety profile. This suggests that PFD is an acceptable treatment in pts with more severe lung function.