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.