Observational, Multicenter Study on the Efficacy, Tolerability, and Safety of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis Older than 80 Years

Abstract

<b><i>Background:</i></b> Idiopathic pulmonary fibrosis (IPF) primarily affects old patients. Old age is a predictor of mortality. Nintedanib, the only antifibrotic drug approved in Italy for patients aged &#x3e;80 years, can slow the progression of IPF by reducing the rate of decline in forced vital capacity (FVC) and the risk of exacerbations. <b><i>Objectives:</i></b> The primary aim of the study was to compare the decline of FVC after 12 months of nintedanib in patients aged &#x3e;80 years versus younger patients. Differences related to other functional data, safety, tolerability, hospitalizations, exacerbations, and mortality were evaluated. <b><i>Methods:</i></b> An observational, retrospective, multicenter study was carried out in Italy. <b><i>Results:</i></b> 159 (122 [76.7%] males) patients were recruited: 106 (66.7%) aged ≤80 years and 53 (33.3%) aged &#x3e;80 years. FVC decline after 12 months of therapy was not significantly different (−45 mL [−170; 75] vs. −20 mL [−138; 110] mL; <i>p</i>: 0.51). No differences were found for other functional data. Diarrhea was the most frequent adverse event (AE). Rate and type of any AEs, permanent/temporary dose reduction, or drug discontinuation were not significantly different between patients aged ≤80 vs. &#x3e;80 years. Furthermore, acute exacerbations, hospitalization, and mortality were not significantly different. <b><i>Conclusions:</i></b> Nintedanib is effective and safe in patients with IPF aged &#x3e;80 years, and no significant differences were found when clinical outcomes were compared with those of younger patients. Thus, older age should not be a barrier for the early prescription of antifibrotic treatment in IPF patients.