Pirfenidone post-authorization safety registry (PASSPORT) update

Background: PASSPORT is a post-authorization safety registry for pirfenidone to collect “real-world” data in EU patients with idiopathic pulmonary fibrosis (IPF). Objectives: 1) Assess the safety of pirfenidone as monotherapy and with N-acetylcysteine (NAC) and/or corticosteroids (CS); 2) examine country-specific differences. Methods: 109 EU sites dosed 1009 patients; largest enrolling countries were Germany (N = 452), France (N = 214) and UK (N = 184). Safety data were recorded at routine clinic visits for up to 2yrs. Adverse drug reactions (ADR: noxious, unintended drug response) were collected. Results: At ba…