Real-life experience with pirfenidone in idiopathic pulmonary fibrosis

Abstract

Objective: To evaluate the efficacy and safety of pirfenidone (PFD) in idiopathic pulmonary fibrosis (IPF) in real-life world. Methods: 47 consecutive patients with IPF taking PFD for at least 12 months (PFD group) were included for analysis, with 47 patients with IPF who did not take PFD as controls. Data were collected from clinical charts to evaluate the lung function parameters and the adverse reactions of PFD. Results: In the PFD group, the percent predicted forced vital capacity (FVC%) and diffusing capacity of carbon monoxide (D(L)CO%) increased by (3.5±7.2)% and (1.1±6.1)% after 6 months of PFD treatment compared with the baseline, while the mean decline of FVC% and D(L)CO% was(2.3±6.7)% and (4.7±6.2)% in the controls (t=2.166, P=0.041; t=2.519, P=0.018). After 12 months of treatment, FVC% increased by (2.3±7.0)% and D(L)CO% decreased by(1.3±12.2)% compared with the baseline, while the mean decline of FVC% and D(L)CO% was (3.3±6.2)% and (5.3±9.8)% in the controls (t=2.292, P=0.030; t=1.047, P=0.303). In the PFD group, 17 patients regularly received pulmonary function test per 6 months. The mean decline in FVC% and D(L)CO% was(6.0±8.2)% and(7.0±13.3)% from 6 month before treatment to baseline when PFD was started, while the FVC% increased by (3.9±7.8)% and D(L)CO% increased by(1.3±6.6)% after 6 months of treatment compared with the baseline (Z=-2.897, P=0.004; Z=-2.151, P=0.031). The proportion of patients with more than 5% or 10% decline in FVC% decreased significantly after 6 months therapy (P=0.010 and 0.018, respectively). Adverse events were commonly seen in 30 patients while taking pirfenidone. The most common adverse events were gastrointestinal symptoms and skin reactions. Conclusions: In real-life world, PFD therapy for 12 months showed good effectiveness on pulmonary functions in patients with mild to severe IPF. Adverse events were common but mild.