Pneumologie 2018; 72(S 01): S44-S45
DOI: 10.1055/s-0037-1619235
Sektion 7 – Klinische Pneumologie
Posterbegehung – Titel: Interstitielle und granulomatöse Lungenerkrankungen II
Georg Thieme Verlag KG Stuttgart · New York

FVC decline over 1 year predicts mortality but not subsequent FVC decline in patients with IPF

U Costabel
1   Ruhrlandklinik, University Hospital, University of Duisburg-Essen
,
L Richeldi
2   Catholic University of the Sacred Heart, Rome
,
M Kolb
3   Mcmaster University, Hamilton, Ontario
,
A Azuma
4   Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo
,
W Stansen
5   Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein
,
M Quaresma
6   Center for Interstitial and Rare Lung Diseases, Pneumology, Thoraxklinik, University of Heidelberg, and Translational Lung Research Center Heidelberg; German Center for Lung Research; Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein
,
S Stowasser
5   Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein
,
B Crestani
7   Hôpital Bichat, Pneumologie, Paris
› Author Affiliations
Further Information

Publication History

Publication Date:
21 February 2018 (online)

Also available at
 

Introduction:

In the INPULSIS trials, nintedanib reduced disease progression by reducing FVC decline vs. placebo in patients with IPF. Patients who completed an INPULSIS trial could receive open-label nintedanib in the extension trial INPULSIS-ON.

Aim:

Assess the impact of FVC decline in INPULSIS on FVC decline and mortality in INPULSIS-ON.

Methods:

Descriptive analysis of the proportions of nintedanib-treated patients who had FVC decline < 10% or ≥10% predicted (pred) from baseline to week 52 of INPULSIS and the proportions of patients in these groups who had FVC decline < 10% pred, ≥10% pred, or died in the first year of INPULSIS-ON.

Absolute decline in FVC from

baseline to week 52 of INPULSIS

in patients treated with nintedanib

(first year of treatment)

Outcome in the first year of

INPULSIS-ON (second year of

treatment)*

n (%)

< 10% predicted (n = 383)

Absolute decline in FVC < 10%

predicted†

301 (78.6)

Absolute decline in FVC ≥10%

predicted

64 (16.7)

Death

18 (4.7)

≥10% predicted (n = 47)

Absolute decline in FVC < 10%

predicted†

31 (66.0)

Absolute decline in FVC ≥10%

predicted

8 (17.0)

Death

8 (17.0)

*Patients who discontinued INPULSIS-ON without having an absolute decline in FVC ≥10% predicted or having died were counted in the category "absolute decline in FVC < 10% predicted". †Includes patients with an increase, no decline, or an absolute decline in FVC > 0% but < 10% predicted in the first year of INPULSIS-ON.

Results:

430 patients received nintedanib in both INPULSIS and INPULSIS-ON. Of these, 89.1% had FVC decline < 10% pred from baseline to week 52 of INPULSIS. FVC decline from baseline to week 52 in patients treated with nintedanib in INPULSIS did not predict FVC decline in the first year of INPULSIS-ON. Most patients (77.2%) had FVC decline < 10% pred in the first year of INPULSIS-ON. Patients who had FVC decline ≥10% pred in INPULSIS had higher mortality in INPULSIS-ON than patients with FVC decline < 10% pred.

Conclusion:

Independent of FVC decline in the first year, most patients had FVC decline < 10% pred with continued nintedanib for a second year. FVC decline ≥10% pred over 1 year did not predict subsequent FVC decline, but was associated with higher mortality.