Pneumologie 2018; 72(S 01): S47-S48
DOI: 10.1055/s-0037-1619244
Sektion 7 – Klinische Pneumologie
Posterbegehung – Titel: Interstitielle und granulomatöse Lungenerkrankungen II
Georg Thieme Verlag KG Stuttgart · New York

Analysis of patients with Idiopathic Pulmonary Fibrosis (IPF) with more severe lung function impairment treated with pirfenidone in RECAP

U Costabel
1   Ruhrlandklinik; University of Duisburg-Essen
,
C Albera
2   Department of Clinical and Biological Sciences, University of Turin
,
KU Kirchgaessler
3   F. Hoffmann-La Roche AG, Basel
,
F Gilberg
3   F. Hoffmann-La Roche AG, Basel
,
U Petzinger
4   Accovion GmbH, Eschborn
,
P Noble
5   Cedars Sinai Medical Center, Los Angeles
› Author Affiliations
Further Information

Publication History

Publication Date:
21 February 2018 (online)

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Purpose:

Idiopathic pulmonary fibrosis (IPF) is a debilitating, progressive, unpredictable and often rapidly fatal fibrosing lung disease requiring early intervention to improve outcomes. To improve clinical practice, controlled clinical studies are essential, which lack for patients with IPF whose percent predicted forced vital capacity (%FVC) was < 50% or percent predicted diffusing capacity for carbon monoxide (%DLCO) was < 35% due to exclusion from CAPACITY Phase III trials. Therefore, this analysis aimed 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 for %FVC at baseline in RECAP and their adverse events 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).These 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%, in non-severe patients, respectively. 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 a 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 profile 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 to 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.