Late Breaking Abstract - Safety of combined pirfenidone (PFD) and nintedanib (NIN) in patients with idiopathic pulmonary fibrosis (IPF)

Background: Safety data on combined PFD and NIN use are limited. Methods: A single-arm, open-label study (NCT02598193) assessed safety and tolerability of 24 weeks’ PFD (1602–2403 mg/day) and NIN (200–300 mg/day) in patients with IPF with FVC ≥50% and DLco ≥30%. Before initiating NIN, patients had received PFD for ≥16 weeks and tolerated a stable dose of ≥1602 mg/day PFD for ≥28 days. Investigators recorded treatment-emergent adverse events (TEAEs), attributing them to PFD, NIN, both or neither. Change from baseline FVC, DLco and K-BILD were assessed at 24 weeks. The study is monitored by a data monitoring committee. Results: Eighty-nine patients were enrolled. A pre-specified interim analysis was conducted once 63 patients (mean age 68.7 years, 85.7% male) completed (n=50) or discontinued (n=13) 24 weeks’ combination treatment. Fifty patients had 330 treatment-related TEAEs (Table); 11 patients discontinued due to TEAEs. Two patients had serious treatment-related TEAEs (Table) but none led to death. Final results for all 89 patients, including change from baseline FVC, DLco and K-BILD, will be presented at ERS. Conclusions: Combined PFD and NIN use for 24 weeks did not reveal a different safety profile to that expected for either treatment alone. Patients had tolerated a stable dose of PFD before initiation of NIN, which may explain why investigators attributed more TEAEs to NIN than PFD.