<p><b><i>Background:</i></b> RECAP (NCT00662038) was an open-label
extension study in patients with idiopathic pulmonary fibrosis (IPF) who
completed either the Assessment of Pirfenidone to Confirm Efficacy and
Safety in Idiopathic Pulmonary Fibrosis (ASCEND) 016 phase 3 trial or
the Clinical Studies Assessing Pirfenidone in Idiopathic Pulmonary
Fibrosis: Research of Efficacy and Safety Outcomes (CAPACITY) 004/006
phase 3 trials. <b><i>Objective:</i></b> To obtain long-term safety data for pirfenidone in patients with IPF in RECAP. <b><i>Methods:</i></b>
Of the 1,334 patients who participated in the phase 3 trials, 1,058
entered RECAP. The final analysis from enrollment (September 2008) to
June 2015 is presented. <b><i>Results:</i></b> Mean (SD) and median
(range) pirfenidone exposures in RECAP were 122 (98) weeks and 88 (>0
to 349) weeks, respectively, with a mean daily dose of 2,091.1 mg.
Cumulative total exposure was 2,482 patient exposure years (PEY). The
treatment-emergent adverse event (TEAE) rate was 701.9 per 100 PEY. The
serious TEAE rate was 53.5 per 100 PEY, with the most common serious
TEAE being IPF (11.1 per 100 PEY). Of the 231 deaths (9.3 per 100 PEY),
the most common cause was IPF (5.4 per 100 PEY). The treatment
discontinuation rate due to a TEAE was 17.9 per 100 PEY;
discontinuations were due to IPF (7.2 per 100 PEY), pneumonia,
respiratory failure, acute respiratory failure, rash (0.5 per 100 PEY
each), and nausea (0.4 per 100 PEY). For patients from CAPACITY 004/006
who entered RECAP, the mean change in percent predicted forced vital
capacity from RECAP baseline at 180 weeks was -9.6%. Median on-treatment
survival from the first pirfenidone dose in RECAP was 77.2 months. <b><i>Conclusions:</i></b>
RECAP provides long-term follow-up and safety data for pirfenidone that
were consistent with the known profile, with no new safety signals
observed.</p
