Benefit of treatment with pirfenidone (PFD) persists over time in patients with idiopathic pulmonary fibrosis (IPF) with limited lung function impairment
23 February 2017 (online)
Antifibrotic therapy for IPF is often started when lung function has declined below certain levels, such as 80% predicted FVC or when GAP stage II is reached. Long-term benefits of therapy when lung function is still relatively well preserved, compared with delayed intervention, are unknown.
To assess the benefit of early treatment with PFD.
Patients in RECAP, a long-term extension study of the CAPACITY (CAP) trials, who entered CAP-004 in GAP stage I and received PFD 2403 mg/d were compared with those in GAP stage I who initially received placebo and then switched to PFD 2403 mg/d in RECAP. Annual rate of change in FVC and safety and tolerability of PFD were assessed.
144 patients in CAP-004 in GAP stage I entered RECAP; 71 initially received PFD 2403 mg/d and 73 received placebo for ≈1.5 y. Prior to RECAP, PFD-treated patients had an annual rate of decline of 3.4% (SE, 0.61) and placebo patients had an annual rate of decline of 5.2% (SE, 0.60). When entering RECAP, PFD- and placebo-treated patients had a baseline mean % predicted FVC of 75.4% vs. 76.3%, respectively. During RECAP, both groups declined similarly over 180 wk, with an annual rate of decline of 4.5% (SE = 0.486) and 3.9% (SE = 0.473; P= 0.440). Safety and tolerability of PFD were similar in both groups.
Patients with IPF in GAP I stage may benefit from early treatment with PFD, as the reduction in decline with treatment is maintained over 180 wk. This supports treatment initiation irrespective of GAP stage.