Abstract
Introduction: Pirfenidone (PFD) is an antifibrotic agent approved in mild-to-moderate idiopathic pulmonary fibrosis (IPF). The long-term safety of PFD is being assessed in the open-label RECAP study in IPF patients (pts) who completed the CAPACITY trials.
Objectives: To compare the safety of PFD in the long- (RECAP) and short-term (CAPACITY).
Methods: Of 628 pts who completed CAPACITY, 603 enrolled in RECAP. An interim analysis of RECAP from enrolment (September 2008) to August 2013 is presented.
Results: The median PFD (2403 mg/day) exposure in RECAP was 163 weeks (range 1–257). The cumulative total exposure was 1,727 person exposure years. 99% of pts reported at least 1 treatment-emergent adverse event (TEAE, Table 1). Rash and photosensitivity were less prominent in RECAP (16% and 9%) than in CAPACITY (32% and 12%). TEAEs led to treatment discontinuation in 45% of pts. Discontinuations (>1.0% of pts) were due to IPF (16%), respiratory failures (3.2%), rash (1.5%) and nausea (1.3%). Serious TEAEs were reported in 62% of pts; the most common was IPF (23%). Of the 141 (23%) TE-deaths, the most common was from IPF (13%).
Conclusions: Safety data from IPF pts receiving PFD for up to 163 weeks demonstrate that long-term PFD treatment is safe and generally well tolerated.
- © 2014 ERS