Diffuse Lung Disease: Treatment of IPF |

Analysis of Patients With Idiopathic Pulmonary Fibrosis (IPF) With More Severe Lung Function Impairment Treated With Pirfenidone in Recap FREE TO VIEW

Ulrich Costabel; Carlo Albera; Klaus-Uwe Kirchgaessler; Frank Gilberg; Ute Petzinger; Paul Noble
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Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany

Copyright 2016, American College of Chest Physicians. All Rights Reserved.

Chest. 2016;150(4_S):537A. doi:10.1016/j.chest.2016.08.551
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SESSION TYPE: Original Investigation Slide

PRESENTED ON: Monday, October 24, 2016 at 07:30 AM - 08:30 AM

PURPOSE: Idiopathic pulmonary fibrosis (IPF) is a debilitating, progressive, unpredictable and often rapidly fatal fibrosing lung disease requiring early intervention to improve outcomes. Patients with IPF whose percent predicted forced vital capacity (%FVC) was < 50% or percent predicted diffusing capacity for carbon monoxide (%DLCO) was < 35% were excluded from the CAPACITY Phase III trials. Therefore, data on such patients in controlled clinical studies are lacking to inform clinical practice. The objective of this analysis was to assess pirfenidone benefits in this subgroup of patients with more severe lung function impairment.

METHODS: Patients who entered the long-term extension study of the CAPACITY trials (RECAP) with either %FVC < 50% or %DLCO < 35% (severe patients) were compared with patients with both %FVC ≥ 50% and %DLCO ≥ 35%, or if one of these measurements was missing, either %FVC ≥ 50% or %DLCO ≥ 35% (non-severe patients). Both groups were evaluated by %FVC at baseline in RECAP and their adverse events profiled using descriptive statistics.

RESULTS: 187 CAPACITY patients were classified as severe at baseline in RECAP (84 patients previously received pirfenidone 2403 mg/day, 16 patients received pirfenidone 1197 mg/day and 87 received placebo) based on the above definition and had similar baseline demographics aside from lung function compared with non-severe patients (N = 409). At entry into RECAP, mean %FVC was 59.8% and mean %DLCO was 29.2% in severe patients vs. 76.1% and 47.0%, respectively, in non-severe patients. Prior to RECAP, severe patients at baseline had an annual rate of %FVC decline (standard error) of 2.9% (0.34) with pirfenidone 2403 mg/day vs. 4.2% (0.34) with placebo. During RECAP, both severe and non-severe patient groups experienced similar %FVC decline over 180 weeks, independent of prior therapy, with an annual rate of decline of 1.03% (0.09) and 1.11% (0.05), respectively. Safety of pirfenidone was similar between the 2 patient groups.

CONCLUSIONS: Long-term treatment with pirfenidone resulted in a similar rate of decline in lung function in patients with more severe lung function impairment compared with patients with more preserved lung function, with a comparable safety profile.

CLINICAL IMPLICATIONS: These data support the use of pirfenidone as a treatment in patients with more severe lung function impairment.

DISCLOSURE: Ulrich Costabel: Grant monies (from industry related sources): Boehringer Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: Roche, Consultant fee, speaker bureau, advisory committee, etc.: Bayer, Consultant fee, speaker bureau, advisory committee, etc.: Gilead, Consultant fee, speaker bureau, advisory committee, etc.: GSK, Consultant fee, speaker bureau, advisory committee, etc.: Centocor Carlo Albera: Consultant fee, speaker bureau, advisory committee, etc.: Roche Klaus-Uwe Kirchgaessler: Employee: F. Hoffmann-LaRoche Ltd. Frank Gilberg: Employee: F. Hoffmann-LaRoche Ltd. Ute Petzinger: Employee: Accovion GmbH The following authors have nothing to disclose: Paul Noble

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