&lt;p&gt;Differences in tolerability of pirfenidone between elderly and younger patients with idiopathic pulmonary fibrosis&lt;/p&gt;

Sakayori, Masashi; Terada, Jiro; Abe, Mitsuhiro; Hirasawa, Yasutaka; Suzuki, Kenichi; Yoshioka, Keiichiro; Tsushima, Kenji

doi:10.2147/dddt.s208733

Cited by 14 publications

(6 citation statements)

References 21 publications

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“…Disease progression itself might induce nausea. In elderly IPF patients, reduced gastrointestinal and metabolic function associated with aging, as well as irregular mealtimes, may be associated with nausea [ 29 ]. The management of nausea is important as it may deter patients from continuing pharmacotherapy, which could worsen the disease.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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Idiopathic pulmonary fibrosis (IPF), a fibrosing interstitial lung disease, predominantly affects the elderly and is associated with a high mortality risk. Nintedanib, a tyrosine kinase inhibitor, significantly reduces IPF progression. However, data on the tolerability and efficacy of nintedanib in the elderly with IPF are limited. Therefore, this study aimed to examine the tolerability and efficacy of nintedanib in the elderly with IPF in a real-world setting. Medical records of 19 elderly IPF patients (≥ 75 years) and 46 non-elderly IPF patients (< 75 years) newly administered nintedanib were retrospectively analyzed. We compared the forced vital capacity (FVC) level, incidence and severity of adverse events, and continuation rates of nintedanib between the two groups. FVC and percent predicted diffusing capacity of the lung for carbon monoxide (DLco) were lower in the elderly IPF group at baseline. Although the elderly IPF patients had a significantly higher incidence of adverse events, such as diarrhea, nausea, and elevation of hepatic enzymes, the rate of discontinuation of nintedanib owing to adverse events was not different between the groups. The continuation rates of nintedanib treatment at 6 months and 1 year in the elderly IPF group were equivalent. Furthermore, there was a similar trend in the reduction of the annual FVC decline after nintedanib initiation between the groups. Our study demonstrated that nintedanib was tolerable in both the IPF patient groups in a real-world setting. Proper management of adverse events in the elderly with IPF would lead to a better clinical outcome.

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Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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“…We found that although the safety profile of nintedanib in patients aged ≥ 75 years was similar to that observed in younger patients, discontinuations of nintedanib due to adverse events occurred in a greater proportion of the older age group (26.4% vs 16.0%). Previous studies have also found that older patients are more likely to discontinue antifibrotic therapy [ 17 – 20 ]. The reasons for this are not known, but may reflect older patients being less able to tolerate the side-effects of antifibrotic therapy due to worse overall health, or to a difference in the perceived risk–benefit of treatment in older patients.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities

Glaspole¹,

Bonella²,

Bargagli³

et al. 2021

Respir Res

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Background Idiopathic pulmonary fibrosis (IPF) predominantly affects individuals aged > 60 years who have several comorbidities. Nintedanib is an approved treatment for IPF, which reduces the rate of decline in forced vital capacity (FVC). We assessed the efficacy and safety of nintedanib in patients with IPF who were elderly and who had multiple comorbidities. Methods Data were pooled from five clinical trials in which patients were randomised to receive nintedanib 150 mg twice daily or placebo. We assessed outcomes in subgroups by age < 75 versus ≥ 75 years, by < 5 and ≥ 5 comorbidities, and by Charlson Comorbidity Index (CCI) ≤ 3 and > 3 at baseline. Results The data set comprised 1690 patients. Nintedanib reduced the rate of decline in FVC (mL/year) over 52 weeks versus placebo in patients aged ≥ 75 years (difference: 105.3 [95% CI 39.3, 171.2]) (n = 326) and < 75 years (difference 125.2 [90.1, 160.4]) (n = 1364) (p = 0.60 for treatment-by-time-by-subgroup interaction), in patients with < 5 comorbidities (difference: 107.9 [95% CI 65.0, 150.9]) (n = 843) and ≥ 5 comorbidities (difference 139.3 [93.8, 184.8]) (n = 847) (p = 0.41 for treatment-by-time-by-subgroup interaction) and in patients with CCI score ≤ 3 (difference: 106.4 [95% CI 70.4, 142.4]) (n = 1330) and CCI score > 3 (difference: 129.5 [57.6, 201.4]) (n = 360) (p = 0.57 for treatment-by-time-by-subgroup interaction). The adverse event profile of nintedanib was generally similar across subgroups. The proportion of patients with adverse events leading to treatment discontinuation was greater in patients aged ≥ 75 years than < 75 years in both the nintedanib (26.4% versus 16.0%) and placebo (12.2% versus 10.8%) groups. Similarly the proportion of patients with adverse events leading to treatment discontinuation was greater in patients with ≥ 5 than < 5 comorbidities (nintedanib: 20.5% versus 15.7%; placebo: 12.1% versus 10.0%). Conclusions Our findings suggest that the effect of nintedanib on reducing the rate of FVC decline is consistent across subgroups based on age and comorbidity burden. Proactive management of adverse events is important to reduce the impact of adverse events and help patients remain on therapy. Trial registration: ClinicalTrials.gov NCT00514683, NCT01335464, NCT01335477, NCT02788474, NCT01979952.

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“…Of note, there were significant differences concerning the drug distribution between age groups: while pirfenidone was more often used in nonelderly, nintedanib was more common in elderly IPF which might be explained by different side effect profiles and tolerability of the individual drugs. Recently, it has been shown that over 1 year follow up patients with IPF ≥75 years are more likely to discontinue pirfenidone and have a higher incidence of gastrointestinal disorders ( 30 ). In our study, dose reduction and discontinuation of therapy occurred equally often in both age groups.…”

Section: Discussionmentioning

confidence: 99%

Idiopathic Pulmonary Fibrosis in Elderly Patients: Analysis of the INSIGHTS-IPF Observational Study

et al. 2020

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Background: An association between idiopathic pulmonary fibrosis (IPF) and advancing age is suspected since IPF occurs primarily in patients over 60 years of age. Though, little is known about the disease in the elderly. The aim of this study was to characterize elderly IPF patients using data from the longitudinal, German-wide INSIGHTS-IPF registry.Methods: Patients were grouped into elderly (≥75 years) and nonelderly IPF (<75 years) at the time of enrollment into the study. Baseline clinical characteristics, comorbidities, health related quality of life (HRQoL), medical therapy and survival were compared between age groups. Effects of antifibrotic therapy on forced vital capacity (FVC) were analyzed over 24 months.Results: Of 1,009 patients, 350 (34.7%) were ≥75 years old. Elderly IPF patients compared to younger patients had a higher number of comorbidities (3.6 ± 2.5 vs. 2.8 ± 2.3; p < 0.001). The mean ± SD EQ-5D score (0.64 ± 0.21 vs. 0.69 ± 0.21; p = 0.005), and the overall WHO-5 score (13.1 ± 5.9 vs. 14.3 ± 6.0; p = 0.015) were significantly lower while the UCSD-SOBQ (52.6 ± 31.2 vs. 45.5 ± 31.2; p = 0.030) was significantly higher in elderly patients, indicating a more impaired HRQoL and more breathlessness. At baseline, 55.4% of elderly and 56.8% of nonelderly patients with IPF were treated with antifibrotic therapy (p = 0.687). For FVC decline after initiation of antifibrotic therapy, there was neither a significant difference between age groups at the different time points over 24 months (beta: 0.41; 95%-CI: −0.98 to 1.81; p = 0.563) nor over the whole course of time (beta: −0.05; 95%-CI: −0.20 to 0.09; p = 0.478). All-cause mortality was higher in elderly patients (49.1 vs. 37.9%; HR 1.65; 95%-CI 1.36–2.00; p < 0.001). Antifibrotic therapy was associated with improved survival in IPF patients, independent from age (<75 years: beta 0.76; 95%-CI: 0.59–0.99; p = 0.049; ≥75 years: beta 0.71; 95%-CI: 0.51–0.98; p = 0.043).Conclusion: In real life, a significant proportion of IPF patients are ≥75 years old, characterized by higher number of comorbidities and global reduced HRQoL. However, the effect of an antifibrotic therapy was similar between age groups and associated with a survival benefit emphasizing the importance for an early antifibrotic therapy in IPF, independent from age.

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<p>Differences in tolerability of pirfenidone between elderly and younger patients with idiopathic pulmonary fibrosis</p>

Cited by 14 publications

References 21 publications

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

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

Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities

Idiopathic Pulmonary Fibrosis in Elderly Patients: Analysis of the INSIGHTS-IPF Observational Study

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