TY - JOUR T1 - Effects of nintedanib in patients with idiopathic pulmonary fibrosis by GAP stage JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00127-2018 VL - 5 IS - 2 SP - 00127-2018 AU - Christopher J. Ryerson AU - Martin Kolb AU - Luca Richeldi AU - Joyce Lee AU - Daniel Wachtlin AU - Susanne Stowasser AU - Venerino Poletti Y1 - 2019/04/01 UR - http://openres.ersjournals.com/content/5/2/00127-2018.abstract N2 - We conducted a post hoc analysis to assess the potential impact of GAP (gender, age, physiology) stage on the treatment effect of nintedanib in patients with idiopathic pulmonary fibrosis.Outcomes were compared in patients at GAP stage I versus II/III at baseline in the INPULSIS® trials.At baseline, 500 patients were at GAP stage I (nintedanib 304, placebo 196), 489 were at GAP stage II (nintedanib 296, placebo 193) and 71 were at GAP stage III (nintedanib 38, placebo 33). In nintedanib-treated patients, the annual rate of decline in forced vital capacity (FVC) was similar in patients at GAP stage I and GAP stage II/III at baseline (−110.1 and −116.6 mL·year−1, respectively), and in both subgroups was lower than in placebo-treated patients (−218.5 and −227.6 mL·year−1, respectively) (treatment-by-time-by-subgroup interaction p=0.92). In the nintedanib group, the number of deaths was 43.8% of those predicted based on GAP stage (35 versus 79.9). In the placebo group, the number of deaths was 59.8% of those predicted based on GAP stage (33 versus 55.2).In conclusion, data from the INPULSIS® trials suggest that nintedanib has a similar beneficial effect on the rate of FVC decline in patients at GAP stage I versus II/III at baseline.Nintedanib provides a similar benefit versus placebo on the rate of decline in forced vital capacity in patients with idiopathic pulmonary fibrosis irrespective of GAP stage at baseline http://ow.ly/HfJ730nNkRT ER -