Weight loss in nintedanib-treated patients with idiopathic pulmonary fibrosis

Abstract

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 nintedanib 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/m², 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 significant 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.