Pneumologie 2017; 71(S 01): S1-S125
DOI: 10.1055/s-0037-1598508
Posterbegehung – Sektion Klinische Pneumologie
Interstitielle Lungenerkrankungen – Ulrich Costabel/Essen, Lars Hagmeyer/Solingen
Georg Thieme Verlag KG Stuttgart · New York

Twenty-four week decline in forced vital capacity (FVC) predicts mortality at week 52 in the INPULSIS trials

C Neurohr
1  Ludwig-Maximilians-Universität, Member of the German Center of Lung Research (Dzl), Munich, Germany
,
L Richeldi
2  National Institute for Health Research Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, University of Southampton, Southampton, UK
,
A Azuma
3  Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan
,
M Selman
4  Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico
,
W Tang
5  Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA
,
J Capapey
6  Boehringer Ingelheim Pharma GmbH & Co. Kg, Ingelheim am Rhein, Germany
,
S Stowasser
6  Boehringer Ingelheim Pharma GmbH & Co. Kg, Ingelheim am Rhein, Germany
,
V Cottin
7  Louis Pradel Hospital, Claude Bernard University Lyon 1, Lyon, France
› Author Affiliations
Further Information

Publication History

Publication Date:
23 February 2017 (online)

 

Background:

In a pooled analysis of data from the Phase III INPULSIS® trials, a significantly lower proportion of patients with idiopathic pulmonary fibrosis (IPF) treated with nintedanib vs. placebo (PBO) had disease progression defined as absolute decline in FVC of ≥5% or ≥10% predicted at week 52.

Aim:

To explore the impact of change in FVC over 24 weeks on subsequent FVC decline and mortality.

Methods: Post-hoc descriptive analysis of proportions of patients with absolute FVC declines of < 5%, ≥5%,or ≥10% predicted from baseline to week 24 and changes in FVC % predicted and mortality between weeks 24 and 52 in these groups conducted using pooled data from both INPULSIS® trials.

Results:

1061 patients (nintedanib 638, PBO 423) were included. FVC decline of ≥5% or ≥10% predicted from baseline to week 24 did not predict FVC decline of ≥5% or ≥10% predicted, respectively, from week 24 to 52. Among patients with FVC decline < 5% predicted from baseline to week 24, 30.0% and 42.5% of patients in the nintedanib and placebo groups, respectively, had FVC decline ≥5% predicted from week 24 to 52. Among patients with FVC decline ≥5% predicted from baseline to week 24, 33.6% and 30.1% of patients in the nintedanib and placebo groups, respectively, had FVC decline ≥5% predicted from week 24 to 52. Among patients with FVC decline ≥10% predicted from baseline to week 24, 19.6% and 18.9% of patients in the nintedanib and placebo groups, respectively, had FVC decline ≥10% predicted from week 24 to 52. In total, 1.8% and 2.3% of patients with FVC decline < 5% predicted, 7.7% and 10.3% of patients with FVC decline ≥5% predicted, and 10.9% and 13.2% of patients with FVC decline ≥10% predicted in the first 24 weeks died between weeks 24 and 52 in the nintedanib and placebo groups, respectively.

Conclusion:

FVC declines of ≥5% or ≥10% predicted in the first 24 weeks of the INPULSIS® trails did not predict FVC decline but were associated with higher mortality in the following 24 weeks.

Presented at ERS 2016.