Pneumologie 2017; 71(S 01): S1-S125
DOI: 10.1055/s-0037-1598507
Posterbegehung – Sektion Klinische Pneumologie
Interstitielle Lungenerkrankungen – Ulrich Costabel/Essen, Lars Hagmeyer/Solingen
Georg Thieme Verlag KG Stuttgart · New York

Long-term treatment with nintedanib in patients with IPF: an update from INPULSIS-ON

M Kreuter
1  Pneumologie und Beatmungsmedizin, Thoraxklinik am Universitätsklinikum Heidelberg und Translationales Zentrum für Lungenforschung Heidelberg (Tlrc), Mitglied des Deutschen Zentrums für Lungenforschung (Dzl)
,
B Crestani
2  Hôpital Bichat, Pneumologie, Paris, France
,
M Quaresma
3  Boehringer Ingelheim Pharma GmbH & Co. Kg, Ingelheim am Rhein, Germany
,
M Kaye
4  Minnesota Lung Center, Ltd., Minneapolis, Minnesota, USA
,
W Stansen
3  Boehringer Ingelheim Pharma GmbH & Co. Kg, Ingelheim am Rhein, Germany
,
S Stowasser
3  Boehringer Ingelheim Pharma GmbH & Co. Kg, Ingelheim am Rhein, Germany
› 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 idiopathic pulmonary fibrosis (IPF). Patients who completed the 52-week treatment period and follow-up visit 4 weeks later in INPULSIS® could receive open-label nintedanib in INPULSIS®-ON.

Aim:

To assess the long-term efficacy and safety of nintedanib in INPULSIS®-ON based on a data snapshot in October 2015.

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). Baseline characteristics were similar between groups. Mean (SD) exposure in INPULSIS®-ON was 22.9 (10.9) months. Mean (SD; minimum-maximum) total exposure for patients treated with nintedanib in INPULSIS® and continuing nintedanib in INPULSIS®-ON was 35.7 (10.5; 11.9 – 51.1) 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. For patients treated with nintedanib in both INPULSIS® and INPULSIS®-ON, mean (SD) change in FVC was – 96 (237) mL from baseline to week 48 of INPULSIS®-ON and – 124 (248) mL from week 48 to week 96 of INPULSIS®-ON. The adverse event profile of nintedanib in INPULSIS®-ON was similar to that in INPULSIS®.

Conclusion:

A recent data snapshot from INPULSIS®-ON indicated that the effect of nintedanib on reducing disease progression observed in INPULSIS® was maintained over long-term treatment. Nintedanib treatment (up to 51 months) had an acceptable safety and tolerability profile with no new safety signals identified.

Presented at ERS 2016.