Introduction: Data on risk factors for discontinuation of nintedanib in patients with interstitial lung diseases (ILDs) are limited. The differences in tolerability between patients with idiopathic pulmonary fibrosis (IPF) and those with progressive fibrotic interstitial lung diseases (PF-ILDs), as well as between different severities, remain unclear. The aim of this study was to investigate the clinical characteristics associated with discontinuation of nintedanib, including severity and the presence of IPF or PF-ILDs, in patients with ILDs.
Methods: A multicenter, retrospective study was conducted. Patients with IPF and PF-ILDs who had been treated with nintedanib from August 2015 to December 2023 were analyzed. Severity at baseline was assessed using the gender-age-physiology (GAP) model. Clinical characteristics were compared between the nintedanib discontinuation within 12 months group and the nintedanib continuation over 12 months group.
Results: A total of 212 ILD patients were included in the analysis, of whom 165 (77.8%) had IPF, and 47 (22.2%) had PF-ILDs. Fifty-five (25.9%) patients discontinued nintedanib within 12 months. The risk of nintedanib discontinuation was associated with higher GAP stage, lower body mass index (BMI), and no dose reduction. Patients with a higher GAP stage and lower BMI also had poor overall survival. There were no significant differences between IPF and PF-ILDs in both nintedanib discontinuation and mortality.
Conclusions: GAP stage and BMI can be useful for predicting prognosis and future nintedanib discontinuation in patients with IPF and PF-ILDs. Nintedanib treatment may be considered in patients with IPF and PF-ILDs in an earlier stage of the disease.
Keywords: Idiopathic pulmonary fibrosis; Nintedanib; Progressive fibrotic interstitial lung disease.
© 2025. The Author(s).