Pneumologie 2017; 71(S 01): S1-S125
DOI: 10.1055/s-0037-1598509
Posterbegehung – Sektion Klinische Pneumologie
Interstitielle Lungenerkrankungen – Ulrich Costabel/Essen, Lars Hagmeyer/Solingen
Georg Thieme Verlag KG Stuttgart · New York

No effect of baseline diffusing capacity of lung for carbon monoxide on benefit of nintedanib

M Pfeifer
1  Donaustauf Hospital, Donaustauf, Germany
,
TM Maher
2  National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, and National Heart and Lung Institute, Imperial College, London, UK
,
KR Flaherty
3  University of Michigan Health System, Ann Arbor, Michigan, USA
,
Y Inoue
4  Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan
,
L Richeldi
5  National Institute for Health Research Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, University of Southampton, Southampton, UK
,
M Selman
6  Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico
,
W Stansen
7  Boehringer Ingelheim Pharma GmbH & Co. Kg, Ingelheim am Rhein, Germany
,
S Stowasser
7  Boehringer Ingelheim Pharma GmbH & Co. Kg, Ingelheim am Rhein, Germany
,
A Wells
2  National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, and National Heart and Lung Institute, Imperial College, London, UK
› Institutsangaben
Weitere Informationen

Publikationsverlauf

Publikationsdatum:
23. Februar 2017 (online)

 

Background:

The two replicate, 52-week, Phase III INPULSIS® trials investigated the efficacy and safety of nintedanib 150 mg twice daily (bid) in patients with idiopathic pulmonary fibrosis. Inclusion criteria included a diffusing capacity of the lung for carbon monoxide (DLco) of 30 – 79% predicted. In both trials, nintedanib significantly reduced the annual rate of decline in forced vital capacity (FVC), the primary endpoint, versus placebo.

Aim:

To assess the potential impact of DLco % predicted on the treatment effect of nintedanib.

Methods: Post-hoc analyses of patients with baseline DLco > 40% versus ≤40% predicted were conducted using pooled data from both INPULSIS® trials.

Results:

A total of 709 patients (nintedanib 428; placebo 281) had DLco > 40% predicted and 351 patients (nintedanib 210; placebo 141) had DLco ≤40% predicted. For patients with baseline DLco > 40% predicted, mean age was 66.4 years, 80.8% were male and mean FVC was 83.3% predicted. For patients with baseline DLco ≤40% predicted, mean age was 67.4 years, 76.4% were male and mean FVC was 72.1% predicted. In patients with baseline DLco > 40% predicted, the nintedanib versus placebo difference in adjusted annual rate of decline in FVC was 103.1 mL/year (95% CI: 63.6, 142.6); in patients with baseline DLco ≤40% predicted, it was 124.3 mL/year (95% CI: (56.2, 192.4). There was no significant treatment-by-time-by-subgroup interaction (p = 0.1468), indicating that the treatment effect of nintedanib was not different between the subgroups.

Conclusion:

In a subgroup analysis of pooled data from the INPULSIS® trials, nintedanib slowed disease progression irrespective of the level of gas exchange impairment at baseline.

Presented at ERS 2016.