Pneumologie 2018; 72(S 01): S46
DOI: 10.1055/s-0037-1619238
Sektion 7 – Klinische Pneumologie
Posterbegehung – Titel: Interstitielle und granulomatöse Lungenerkrankungen II
Georg Thieme Verlag KG Stuttgart · New York

Long-term nintedanib treatment in idiopathic pulmonary fibrosis (IPF): new data from INPULSIS-ON

M Kreuter
1   Department of Pneumology, Thoraxklinik, University of Heidelberg, and Translational Lung Research Center Heidelberg; German Center for Lung Research
,
B Crestani
2   Pneumologie, Hôpital Bichat, Paris
,
M Quaresma
3   Department of 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
,
M Kaye
4   Minnesota Lung Center, Ltd., Minneapolis
,
W Stansen
5   Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein
,
S Stowasser
5   Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein
› Author Affiliations
Further Information

Publication History

Publication Date:
21 February 2018 (online)

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Introduction:

The efficacy and safety of nintedanib 150 mg twice daily in patients with IPF were assessed in the two Phase III INPULSIS trials. Patients who completed the 52-week treatment period and follow-up visit 4 weeks later in INPULSIS could receive open-label nintedanib in the extension trial INPULSIS-ON.

Aim:

To assess the long-term efficacy and safety of nintedanib based on an interim analysis of INPULSIS-ON in October 2016.

Methods:

Patients treated with placebo in INPULSIS initiated nintedanib in INPULSIS-ON; patients treated with nintedanib continued nintedanib.

Results:

734 patients were treated in INPULSIS-ON (430 continuing nintedanib; 304 initiating nintedanib). At this interim analysis, mean (SD) exposure in INPULSIS-ON was 27.7 (15.1) months. Mean (SD; minimum-maximum) total exposure for patients treated with nintedanib in INPULSIS and INPULSIS-ON was 40.7 (14.6; 11.9 – 63.1) months. In INPULSIS, mean (SD) change in FVC from baseline to week 52 was –89 (264) mL in the nintedanib group and -203 (293) mL in the placebo group; the annual rate (SE) of decline in FVC was –114 (11) mL/year and –224 (13) mL/year in these groups, respectively. In all patients treated in INPULSIS-ON, mean (SD) change in FVC from baseline of INPULSIS-ON to week 144 of INPULSIS-ON was –305 (365) mL; the annual rate (SE) of decline in FVC over 144 weeks was –131 (6) mL/year. The adverse event profile of nintedanib in INPULSIS-ON was consistent with that in INPULSIS.

Conclusion:

Data from INPULSIS-ON indicated that the effect of nintedanib on reducing disease progression is maintained over the long term. Nintedanib treatment (up to 63 months) had an acceptable safety and tolerability profile.