Analysis of patients with idiopathic pulmonary fibrosis (IPF) with percent predicted forced vital capacity (FVC) < 50% treated with pirfenidone in RECAP
23 February 2017 (online)
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.
To assess PFD benefit in pts with more severe lung function impairment.
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.
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.
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.