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A 2-year observational study in patients suffering from idiopathic pulmonary fibrosis and treated with pirfenidone: A French Ancillary Study of PASSPORT

Respiration Apr 12, 2019

Jouneau S, et al. - In this French Ancillary Study (FAS), researchers evaluated the clinical outcomes of 192 subjects participating in PASSPORT, the European observational, prospective study that assessed the long-term safety of pirfenidone under real-world conditions in idiopathic pulmonary fibrosis (IPF), over up to 2 years following its initiation. At months 12 and 24, the observed mean absolute change in the percentage of predicted forced vital capacity (FVC) was –2.4% and –3.8%, respectively, and the mean change in 6-min walk test (6MWD) was 8.6 and 3.1 m, respectively, with a range of 23.4–51.7 m. The observed median progression-free survival and median exposure were 18.4 months and 16.3 months, respectively. Decreased weight (4.2%), rash (4.2%), and photosensitivity reactions (3.1%) led to pirfenidone discontinuation in most cases. They found that efficacy data of FAS were consistent with the efficacy results of published phase III clinical trials in IPF. Among IPF patients treated with pirfenidone in real-life settings, nearly one third were still under treatment 2 years following initiation. They found safety data were consistent with the known safety profile of pirfenidone.
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