In:
Respiration, S. Karger AG, Vol. 98, No. 1 ( 2019), p. 19-28
Abstract:
〈 b 〉 〈 i 〉 Background: 〈 /i 〉 〈 /b 〉 The European observational, prospective PASSPORT study evaluated the long-term safety of pirfenidone under real-world conditions in idiopathic pulmonary fibrosis (IPF), over up to 2 years following its initiation. 〈 b 〉 〈 i 〉 Objectives: 〈 /i 〉 〈 /b 〉 The FAS (French Ancillary Study) assessed the clinical outcomes of IPF patients participating in PASSPORT ( 〈 i 〉 n 〈 /i 〉 = 192). 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 Efficacy data were collected retrospectively and prospectively. The primary efficacy endpoints were: change in percent predicted forced vital capacity (FVC) and change in the distance travelled during the 6-min walk test (6MWD). 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 The mean baseline FVC was 71.7% of predicted value. The mean absolute change in the percentage of predicted FVC was –2.4% and –3.8% at months 12 and 24. The mean change in 6MWD was 8.6 and 3.1 m at months 12 and 24, with a range of 23.4–51.7 m. Acute IPF exacerbation and pulmonary hypertension occurred in 20.0 and 8.4% of patients, respectively. The most common reasons for prematurely discontinuing PASSPORT were adverse drug reactions (ADRs) related to pirfenidone (31.3%), death (11.5%), and disease progression (10.9%). The median progression-free survival was 18.4 months (95% CI 12.9, not estimable). The median exposure was 16.3 months (0.5–28.5). The most frequently reported ADRs leading to pirfenidone discontinuation were decreased weight (4.2%), rash (4.2%), and photosensitivity reactions (3.1%). 〈 b 〉 〈 i 〉 Conclusions: 〈 /i 〉 〈 /b 〉 The efficacy data of FAS are consistent with the efficacy results of published phase III clinical trials in IPF. Approximately one third of IPF patients treated with pirfenidone in real-life settings were still under treatment 2 years after initiation. Safety data are consistent with the known safety profile of pirfenidone.
Type of Medium:
Online Resource
ISSN:
0025-7931
,
1423-0356
Language:
English
Publisher:
S. Karger AG
Publication Date:
2019
detail.hit.zdb_id:
1464419-8
