Long-term treatment with nintedanib in patients with IPF: an update from INPULSIS-ON
23 February 2017 (online)
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.
To assess the long-term efficacy and safety of nintedanib in INPULSIS®-ON based on a data snapshot in October 2015.
Patients treated with placebo in INPULSIS® initiated nintedanib in INPULSIS®-ON; patients treated with nintedanib continued nintedanib.
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®.
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.
No conflict of interest has been declared by the author(s).