Weight loss in nintedanib-treated patients with idiopathic pulmonary fibrosis

Nintedanib is approved for the treatment of idiopathic pulmonary fibrosis (IPF). Weight loss is recognized as an adverse event during nintedanib treatment, and is a common complication exploitable as a prognostic indicator of IPF. Here, we report a single-center, retrospective cohort study to assess body weight changes during ninte-danib therapy in patients with IPF. Sixty-one patients treated with nintedanib for 6 months were included (45 males, mean age +/- standard deviation 73.1 +/- 7.4 years). Baseline body weight and body mass index were 60.1 +/- 12.0 kg and 23.2 +/- 3.5 kg/m(2), respectively. Mean weight loss during the first 6 months of nintedanib treatment was significant (-3.2 +/- 3.4 kg, p < 0.0001) with Common Terminology Criteria for Adverse Events (CTCAE) grades 0,1,2 or 3 of 30, 17, 13 and 1, respectively. Pulmonary function test records 6 months before nintedanib administration were available in a subset of patients (n = 40). Significant differences in weight change over the 6 months before-vs-after nintedanib administration were also observed in these patients [mean differences -2.5 +/- 3.4 kg, 95% confidence interval (CI) -3.6,-1.4, p < 0.0001]. Multivariate analysis showed that only baseline body weight was significantly associated with weight loss of CTCAE grade >= 2 (odds ratio 0.921, 95% CI 0.854, 0.994). Median follow-up from starting nintedanib was 34.8 months. There was a sig-nificant difference in overall survival between patients with CTCAE grade >= 2-vs-grade<2 (median survival of 25.5 months and 55.2 months, p = 0.014). In the model adjusting for age, sex and lung function, weight loss CTCAE grade >= 2 was an independent predictor for all-cause mortality (hazard ratio 2.448, 95% CI 1.080-5.551). In conclusion, weight loss is an important issue for the management of patients with IPF treated with nintedanib.