Introduction Pirfenidone (Esbriet^®) is approved for mild/moderate idiopathic pulmonary fibrosis (IPF). PASSPORT is a post-authorisation safety registry required by the European Medicine Agency.

Objective To present interim data from PASSPORT.

Method Up to 140 EU sites will enrol 1000 patients. Safety data are recorded at routine clinic visits for 2 years. Adverse drug reactions (ADR: a noxious, unintended drug response at therapeutic doses) and serious ADRs (SADR: ADRs that are life-threatening; cause death, disability, congenital anomaly; require hospitalisation or an intervention to prevent permanent impairment) are collected.

Results Data from 530 patients enrolled by 68 sites in 7 countries are included. Age was 69 ± 8.8 years (mean ± SD); IPF diagnosis duration was 1.8 ± 3.51 years; 81% were men. Median time in study was 5.5 months; total exposure was 284 person-years.

Of 311 patients with ADRs, 85 discontinued due to ADR and 41 discontinued for other reasons. Approximately 1/3 of patients with ADRs had their dose adjusted.

For patients who experienced an ADR:

1. 55% of patients without a dose adjustment were able to continue treatment, while 69% of those with a dose adjustment were able to continue treatment.

2. 20% discontinued due to the ADR after having a dose adjustment, but 31% discontinued due to the ADR without a dose adjustment.

When ADRs were managed by dose adjustment, dose adjustment was associated with continuing treatment.

Conclusion PASSPORT ADRs are comparable to those in clinical trials of pirfenidone in IPF. No new safety issues emerged. Dose adjustment may influence long-term tolerability of pirfenidone.