Improvement in Subjective Symptoms and Tolerability in Response to Nintedanib Treatment in Elderly Patients with Idiopathic Pulmonary Fibrosis

Abstract

The efficacy of nintedanib treatment in patients with idiopathic pulmonary fibrosis (IPF) was demonstrated in phase III trials. However, there is limited data on the significance of nintedanib in elderly patients aged ≥75 years. We have retrospectively evaluated 54 newly nintedanib-treated patients including 32 elderly individuals. Potential changes in modified medical research council (mMRC) grade and COPD (chronic obstructive pulmonary disease) assessment test (CAT) score, as well as in forced vital capacity (FVC) were obtained 6 months before, at the time of, and 6 and 12 months after initiation of nintedanib treatment. Significant differences were observed in CAT scores between 6 months before treatment and baseline (p < 0.001), and between baseline and 6 months (p < 0.001) and 12 months (p < 0.001) after treatment. If subjective improvement is defined as an improvement in mMRC grade or CAT score by 1 or 3 points, respectively, 25 patients (46.3%) have significantly improved after 6 months of treatment. Out of these, all have improved in CAT score. The tolerability of nintedanib was similar in elderly and younger patients. These findings suggest that CAT scores could be useful in the subjective assessment during nintedanib treatment, and that nintedanib is safe and efficient for the treatment of the elderly population.

Long-Term Follow-Up of Patients With Idiopathic Pulmonary Fibrosis Treated With Pirfenidone or Nintedanib: A Real-Life Comparison Study

“…It is surely interesting that, despite the age discrepancy, no significant differences were found between pirfenidone and nintedanib subgroups in terms of progression-free survival and mortality. These findings further support the substantial efficacy of antifibrotic drugs and specifically of nintedanib, also in elderly age, as already reported in literature ( Takeda et al, 2020 ).…”

Tolerability of nintedanib in the elderly with idiopathic pulmonary fibrosis: A single-center retrospective study

“…Additional post-hoc analysis of INPULSIS trials indicated that the efficacy of nintedanib was not affected by age (< 65, or ≥ 65 years old) [ 23 ]. Takeda et al reported that nintedanib also improves subjective improvement, as well as FVC decline in elderly IPF patients [ 18 ]. These studies suggest that nintedanib is effective for elderly IPF patients.…”

“…The mean age of onset is 70 (standard deviation [SD]: 9.0) years in Japan [ 6 ]. However, the available data on the tolerability and efficacy of nintedanib in elderly patients in the real-world are limited [ 18 ]. The mean age of patients who were treated with nintedanib in a real-world setting was 66.6 (SD: 8.1) years in the INPULSIS trials [ 11 ], 71 (SD: 8) years in the USA [ 19 ], and 71.8 (SD: 7.5) years in Greece [ 20 ].…”

Drugs that act on the respiratory tract

“…Nintedanib and pirfenidone are oral anti-fibrotic drugs used to slow the progression of idiopathic pulmonary fibrosis (IPF). A number of recent “real-world”, observational, and retrospective studies ( Antoniou et al, 2020 [C]; Cameli et al, 2020 [C]; Chung et al, 2020 [C]; Corral et al, 2020 [C]; Dhooria et al, 2020 [C]; Eaden et al, 2020 [C]; Harari et al, 2020 [c]; Justet et al, 2021 [c]; Lasky et al, 2020 [C]; Majewski et al, 2020 [C]; Senoo et al, 2020 [c]; Takeda et al, 2020 [c]; Uchida et al, 2021 [c]; Vianello et al, 2020 [c]), an open-label extension study ( Song et al, 2020 [C]), a small, prospective, patient-satisfaction study ( Moor et al, 2020 [c], and a post-hoc analysis ( Richeldi et al, 2020 [C]) further describe the safety profile of these drugs among patients with IPF from different nations, with more advanced disease, with advanced age, or who have been switched from nintedanib to pirfenidone. In these studies, the type, frequency, and severity of adverse drug events were similar to previously published clinical trial results and showed no new signals of adverse drug events with either nintedanib or pirfenidone.…”