Pirfenidone post-authorization safety registry (PASSPORT) – Interim analysis of IPF treatment

Introduction Pirfenidone (Esbriet®) is approved for mild/mod idiopathic pulmonary fibrosis (IPF). PASSPORT is a post-authorization safety registry required by the European Medicine Agency. Objective Present interim data from PASSPORT Method Up to 140 EU sites will enroll 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 hospitalization 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 (1.8 ± 3.51 years); 81% were men. Median time in study was 5.5 months; total exposure was 284 person-years. View this table: Of 311 patients with ADRs, 85 discontinued due to ADR and 41 for other reasons. Dosing of patients discontinuing due to ADR compared to those continuing pirfenidone showed a significant association between dose adjustment (reduction or brief interruption) and remaining on therapy. When ADRs were managed by dose adjustment, patients were less likely to discontinue (24.7% vs 75.3%; chi2=5.210, df=1, p=0.02). 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.