TY - JOUR T1 - Long-term safety of pirfenidone: results of the prospective, observational PASSPORT study JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00084-2018 VL - 4 IS - 4 SP - 00084-2018 AU - Vincent Cottin AU - Dirk Koschel AU - Andreas Günther AU - Carlo Albera AU - Arata Azuma AU - C. Magnus Sköld AU - Sara Tomassetti AU - Philip Hormel AU - John L. Stauffer AU - Indiana Strombom AU - Klaus-Uwe Kirchgaessler AU - Toby M. Maher Y1 - 2018/10/01 UR - http://openres.ersjournals.com/content/4/4/00084-2018.abstract N2 - Real-world studies include a broader patient population for a longer duration than randomised controlled trials (RCTs) and can provide relevant insights for clinical practice.PASSPORT was a multicentre, prospective, post-authorisation study of patients who were newly prescribed pirfenidone and followed for 2 years after initiating treatment. Physicians collected data on adverse drug reactions (ADRs), serious ADRs (SADRs) and ADRs of special interest (ADRSI) at baseline and then every 3 months. Post hoc stepwise logistic regression models were used to identify baseline characteristics associated with discontinuing treatment due to an ADR.Patients (n=1009, 99.7% with idiopathic pulmonary fibrosis) had a median pirfenidone exposure of 442.0 days. Overall, 741 (73.4%) patients experienced ADRs, most commonly nausea (20.6%) and fatigue (18.5%). ADRs led to treatment discontinuation in 290 (28.7%) patients after a median of 99.5 days. Overall, 55 (5.5%) patients experienced SADRs, with a fatal outcome in six patients. ADRSI were reported in 693 patients, most commonly gastrointestinal symptoms (38.3%) and photosensitivity reactions/skin rashes (29.0%). Older age and female sex were associated with early treatment discontinuation due to an ADR.Findings were consistent with the known safety profile of pirfenidone, based on RCT data and other post-marketing experience, with no new safety signals observed.Real-world safety results from 1009 patients in PASSPORT were consistent with the known pirfenidone safety profile http://ow.ly/oXjv30lrzAf ER -