Pneumologie 2017; 71(S 01): S1-S125
DOI: 10.1055/s-0037-1598504
Posterbegehung – Sektion Klinische Pneumologie
Interstitielle Lungenerkrankungen – Ulrich Costabel/Essen, Lars Hagmeyer/Solingen
Georg Thieme Verlag KG Stuttgart · New York

Cumulative distribution of patients by change in FVC % predicted in the INPULSIS trials of nintedanib in patients with idiopathic pulmonary fibrosis

U Costabel
1  Ruhrlandklinik, University Hospital, University of Duisburg-Essen
,
KR Flaherty
2  University of Michigan Health System, Ann Arbor, Michigan, USA
,
KK Brown
3  National Jewish Health, Denver, Colorado, USA
,
W Stansen
4  Boehringer Ingelheim Pharma GmbH & Co. Kg, Ingelheim am Rhein, Germany
,
R Schlenker-Herceg
5  Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA
,
G Raghu
6  University of Washington, Seattle, Washington, USA
› 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:

We assessed the cumulative distribution of patients by absolute changes from baseline to week 52 in FVC % predicted using thresholds of ≥0%, ≥5% and ≥10%. Missing data were imputed using the worst decline from baseline at week 52 observed in all patients with available data regardless of treatment.

Results:

In INPULSIS®-1, a smaller proportion of patients treated with nintedanib than placebo had any decline in FVC % predicted (71% versus 82%; p = 0.002), an absolute decline in FVC ≥5% predicted (47% vs. 62%; p = 0.001) and an absolute decline in FVC ≥10% predicted (29% vs. 43%; p < 0.001) from baseline to week 52 based on the cumulative distribution of patients. In INPULSIS®-2, a smaller proportion of patients treated with nintedanib than placebo had any decline in FVC % predicted (70% vs. 88%; p < 0.001), an absolute decline in FVC ≥5% predicted (47% vs. 61%; p = 0.001) and an absolute decline in FVC ≥10% predicted (30% vs. 36%; p = 0.18) from baseline to week 52 based on the cumulative distribution of patients. In pooled data from both trials, the proportions of patients treated with nintedanib and placebo, respectively, who had any decline in FVC ≥0% predicted, an absolute decline in FVC ≥5% predicted and an absolute decline in FVC ≥10% predicted were 70% versus 85% (p < 0.001), 47% versus 61% (p < 0.001) and 30% versus 39% (p < 0.001). The proportions of patients with no decline or an improvement in FVC % predicted were 30% in the nintedanib group versus 15% in the placebo group.

Conclusion:

In the INPULSIS® trials in patients with IPF, a higher proportion of patients treated with nintedanib than placebo had no decline or an improvement in FVC, and smaller proportions of patients had absolute declines in ≥5% and ≥10% predicted over 52 weeks.

Presented at ATS 2016.