RT Journal Article
SR Electronic
T1 Long-term treatment with nintedanib in patients with IPF: An update from INPULSIS®-ON
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP OA4960
DO 10.1183/13993003.congress-2016.OA4960
VO 48
IS suppl 60
A1 Bruno Crestani
A1 Manuel Quaresma
A1 Mitchell Kaye
A1 Wibke Stansen
A1 Susanne Stowasser
A1 Michael Kreuter
YR 2016
UL http://erj.ersjournals.com/content/48/suppl_60/OA4960.abstract
AB 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® andINPULSIS®-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.