Abstract
Introduction: The CAPACITY (CAP) trials were randomized controlled studies evaluating pirfenidone (PFD) in patients with IPF. Pooled data from these studies support a treatment effect on forced vital capacity, progression-free survival, and 6-minute walk distance. To examine the long-term safety of PFD, an open-label extension study for eligible CAP patients was initiated (RECAP). An interim analysis of safety data from RECAP is presented.
Aims and objectives: Examine the long-term safety of PFD in patients with IPF.
Methods: Safety data from the RECAP study through Wk 72 were analyzed and compared to pooled safety data from the CAP trials.
Results: In the CAP studies, 779 patients were randomized to treatment with PFD or placebo for ≥72 weeks. Of these, 603 enrolled in RECAP. At Wk 72 in RECAP, mean exposure to PFD 2403 mg/d across both studies was 2.9 yrs (range, 1–4); 114 patients had received PFD 2403 mg/d for ≥3 yrs. In RECAP, 98.2% of patients reported ≥1 treatment-emergent adverse event (TEAE) compared to 98.6% in CAP, and 32.8% of patients had a serious TEAE compared to 32.8% during CAP. Common AEs in RECAP were similar to those observed in CAP and were generally mild to moderate in severity. The overall incidence of photosensitivity or rash was lower in RECAP than CAP (19.7% vs. 44.4%); however, patients who received placebo during CAP had a higher incidence than those who received PFD (28.1% vs. 12.3%).
Conclusions: Long-term safety data demonstrate that PFD is safe and generally well tolerated in patients with IPF. Given the unmet medical need and efficacy results from 3 Phase III studies, PFD has a clear role in the treatment of IPF.
- © 2011 ERS