Pneumologie 2017; 71(S 01): S1-S125
DOI: 10.1055/s-0037-1598502
Posterbegehung – Sektion Klinische Pneumologie
Interstitielle Lungenerkrankungen – Ulrich Costabel/Essen, Lars Hagmeyer/Solingen
Georg Thieme Verlag KG Stuttgart · New York

Reduction in Non-Elective Respiratory-Related Hospitalizations in Patients Treated With Pirfenidone: Pooled Analyses from Three Phase 3 Trials of Pirfenidone in Idiopathic Pulmonary Fibrosis

U Costabel
1  Interstitielle und Seltene Lungenkrankheiten, Interstitial and Rare Lung Disease Unit, Ruhrlandklinik
,
JJ Swigris
2  National Jewish Health
,
B Ley
3  Department of Medicine, University of California
,
J Stauffer
4  Genentech Inc.
,
W Chou
5  Genentech Inc. South San Francisco
,
K Raimundo
4  Genentech Inc.
,
H Collard
3  Department of Medicine, University of California
› Author Affiliations
Further Information

Publication History

Publication Date:
23 February 2017 (online)

 

Rationale:

Patients with idiopathic pulmonary fibrosis (IPF) are frequently hospitalized for a variety of reasons. Respiratory-related hospitalizations may occur because of acute exacerbations of IPF, respiratory tract infections, respiratory failure and other causes. Regardless of cause, respiratory-related hospitalizations have been linked to poor outcomes in patients with IPF. We describe the proportion of patients from the three Phase 3 pirfenidone IPF trials with at least one non-elective hospitalization (all-cause, respiratory- related and non-respiratory-related) over 12 months. Methods:

In three Phase 3 randomized, placebo-controlled studies of pirfenidone for IPF (CAPACITY I/II and ASCEND), patients were randomized to pirfenidone (2403 mg/day) or placebo. In the two CAPACITY studies, respiratory-related hospitalizations were a pre-specified endpoint. In ASCEND, hospitalizations were reported as adverse events (AEs), and retrospectively categorized as respiratory-related or non-respiratory by case review. The pooled rates of patients experiencing ≥1 non-elective hospitalizations (all-cause, respiratory-related and non-respiratory-related) for pirfenidone and placebo patients over 12 months are summarized. Rate of death post-hospitalization was also reported.

Results:

A total of 1,247 patients (692 CAPACITY and 555 ASCEND) were included (Table 1). In pooled analyses, the proportion of patients experiencing ≥1 all-cause hospitalizations over 12 months was no different between pirfenidone and placebo-treated patients. The proportion of patients experiencing ≥1 respiratory-related hospitalizations was 12% in the placebo group vs. 7% in the pirfenidone group (odds ratio 0.56; P = 0.004). Deaths after hospitalization were numerically reduced in the pirfenidone group, most substantially for respiratory-related hospitalizations.

Tab. 1:

Non-elective Hospitalizations in Patients Treated With Pirfenidone or Placebo over 12 Months.

All-Cause Hospitalizations

Respiratory-Related

Hospitalizations

Non-Respiratory Hospitalizations

Hospitalizations

Pirfenidone

(N = 623)

Placebo

(N = 624)

Pirfenidone

(N = 623)

Placebo

(N = 624)

Pirfenidone

(N = 623)

Placebo

(N = 624)

Events, n

140

147

57

86

83

61

Patients with ≥1 event

n (%)

106 (17)

112 (18)

44 (7)

74 (12)

68 (11)

51 (8)

Odds ratio (95% CI)

0.94 (0.70, 1.26)

0.56 (0.38, 0.84)

1.38 (0.94, 2.02)

P-value

0.662

0.004

0.099

Died after

hospitalization, n (%)

18 (17)

37 (33)

12 (27)

34 (46)

7 (10)

9 (18)

Conclusion:

Patients with IPF frequently require hospitalization for a variety of reasons. Pirfenidone may reduce the risk of non-elective respiratory-related hospitalizations over 12 months.