Pneumologie 2017; 71(S 01): S1-S125
DOI: 10.1055/s-0037-1598506
Posterbegehung – Sektion Klinische Pneumologie
Interstitielle Lungenerkrankungen – Ulrich Costabel/Essen, Lars Hagmeyer/Solingen
Georg Thieme Verlag KG Stuttgart · New York

Effect of nintedanib on disease progression in the INPULSIS trials in patients with idiopathic pulmonary fibrosis (IPF)

J Behr
1  Klinikum der Universität München, Medizinische Klinik und Poliklinik V and Asklepios Lungenfachkliniken München-Gauting, Comprehensive Pneumology Center, Member of the German Center for Lung Research, Germany
,
G Raghu
2  University of Washington, Seattle, Washington, USA
,
Y Inoue
3  Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan
,
V Cottin
4  Louis Pradel Hospital, Claude Bernard University Lyon 1, Lyon, France
,
S Stowasser
5  Boehringer Ingelheim Pharma GmbH & Co. Kg, Ingelheim am Rhein, Germany
,
W Stansen
5  Boehringer Ingelheim Pharma GmbH & Co. Kg, Ingelheim am Rhein, Germany
,
TM Maher
6  Royal Brompton and Harefield NHS Foundation Trust, and National Heart and Lung Institute, Imperial College, London, UK
› Author Affiliations
Further Information

Publication History

Publication Date:
23 February 2017 (online)

 

Introduction:

The INPULSIS® trials assessed the efficacy and safety of nintedanib in patients with IPF. Compared with placebo, nintedanib significantly reduced the annual rate of decline in forced vital capacity (FVC).

Methods:

In a post-hoc analysis, we assessed the effect of nintedanib versus placebo on time to disease progression, defined as an absolute decline in FVC ≥10% predicted or death over 52 weeks, in the individual INPULSIS® trials and in pooled data from both trials.

Results:

In INPULSIS®-1, nintedanib significantly reduced the risk of disease progression versus placebo (HR 0.53 [95% CI: 0.39, 0.72]; p = 0.0001). The proportion of patients with disease progression was 24.3% in the nintedanib group and 40.7% in the placebo group. In INPULSIS®-2, the proportion of patients with disease progression was 29.8% in the nintedanib group and 42.0% in the placebo group; HR 0.67 [95% CI: 0.51, 0.89]; p = 0.0054. In pooled data from both trials, nintedanib significantly reduced the risk of disease progression versus placebo by 40% (HR 0.60 [95% CI: 0.49, 0.74]; p < 0.0001) (Figure). Disease progression occurred in 27.1% of patients in the nintedanib group and 41.4% of patients in the placebo group. Most patients who met the disease progression endpoint did so based on decline in FVC ≥10% predicted (23.2% with nintedanib, 36.2% with placebo) rather than death (3.9% with nintedanib, 5.2% with placebo). There was no significant difference in disease progression between subgroups of patients defined by baseline FVC % predicted (≤70% versus > 70%, ≤80% versus > 80% and ≤90% versus > 90%) in the individual trials or pooled data.

Conclusion:

In the pooled data from the INPULSIS® trials in patients with IPF, nintedanib reduced the risk of disease progression defined as an absolute decline in FVC ≥10% predicted or death over 52 weeks by about 40%.

Presented at ATS 2016.