Efficacy and safety of nintedanib for older adults with idiopathic pulmonary fibrosis or progressive fibrosing interstitial lung disease: A multicenter retrospective study in Japan

Background: Nintedanib is widely used for idiopathic pulmonary fibrosis (IPF) and progressive fibrosing interstitial lung disease (PF-ILD). However, real-world data regarding its efficacy and safety in patients aged 75 years or older remain limited. This study aimed to evaluate these parameters in an older Japanese population. Methods: We retrospectively enrolled patients who initiated nintedanib for IPF or PF-ILD between August 2019 and July 2023 across 15 institutions. Patients were stratified into the older group (≥75 years) and the younger group (<75 years). Clinical outcomes, including annual forced vital capacity (FVC) decline and the incidence of adverse events, were compared. Results: The older and younger groups comprised 191 and 222 patients, respectively. The median survival time after nintedanib initiation was significantly shorter in the older group (1054 vs. 1400 days). The annual FVC change after nintedanib initiation was −61.3 and −61.4 mL/year for the younger and older groups, respectively. Although older patients frequently required dose reductions or had shorter treatment durations, the overall adverse events incidence remained similar (65.4% in the older group vs. 68.9% in the younger group). No significant differences were observed in the time to adverse events onset or severity. Conclusions: In real-world clinical practice, nintedanib demonstrated comparable efficacy in attenuating pulmonary function decline and a similar safety profile in older patients compared to younger patients. The shorter survival in older patients likely reflects diminished physiological reserve against respiratory events rather than reduced therapeutic efficacy. These findings support nintedanib use for interstitial lung disease in older populations.