Body size‐adjusted dose analysis of pirfenidone in patients with interstitial pneumonia

Uehara, Masahiro; Enomoto, Noriyuki; Oyama, Yoshiyuki; Suzuki, Yuzo; Kono, Masato; Furuhashi, Kazuki; Fujisawa, Tomoyuki; Inui, Naoki; Suda, Takafumi

doi:10.1111/resp.13145

Cited by 26 publications

(23 citation statements)

References 28 publications

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“…Uehara et al[33] suggested that patients who experienced pirfenidone-related AEs tend to have higher body surface area or body weight-adjusted doses of pirfenidone than patients without AE. Since advanced IPF patients tend to have lower BMI than non-advanced IPF patients [34], pirfenidone may cause more frequent AEs in the advanced group at the same dose.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Pirfenidone in Advanced Idiopathic Pulmonary Fibrosis

Yoon

Kim

Song³

2018

Respiration

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Background: Although phase 3 trials showed significant efficacy and acceptable safety profiles for pirfenidone in mild-to-moderate idiopathic pulmonary fibrosis (IPF), data on advanced IPF are limited. Objectives: The study aimed to evaluate the efficacy and safety of pirfenidone in advanced IPF patients. Methods: The clinical data of 138 IPF patients (advanced group: 27%) treated with pirfenidone were retrospectively reviewed and compared between advanced and non-advanced groups. Advanced IPF was defined as (1) forced vital capacity (FVC) < 50% predicted or (2) diffusing capacity for carbon monoxide < 30% predicted. Results: The mean treatment duration was 51.3 weeks, and lung function analysis was performed in 81 patients (17 in the advanced group). Changes in FVC and total lung capacity (TLC) were significantly reduced at 6 months after treatment in both the advanced (ΔFVC [6 months]: –6.3 [before] vs. 0.7% predicted [after]; ΔTLC: –5.3 vs. 0.8) and non-advanced (ΔFVC: –3.4 vs. 0.5; ΔTLC: –3.1 vs. –0.9) groups. The rate of decline in FVC and TLC was significant before treatment, but not after treatment in the advanced (FVC: –1.27 [before] vs. 0.21% predicted/month [after]; TLC: –0.89 vs. –0.15) and non-advanced (FVC: –0.60 vs. –0.20; TLC: –0.54 vs. –0.17) groups. The advanced group showed a similar rate of adverse events (AEs) (78.4 vs. 88.1%, p = 0.270), but more serious AEs (40.5 vs. 10.9%, p < 0.001) including death (24.3 vs. 5.0%, p = 0.002). Conclusions: In advanced IPF, pirfenidone showed similar efficacy and safety to non-advanced IPF except for serious AEs, which may be due to the advanced status itself.

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Pirfenidone in Advanced Idiopathic Pulmonary Fibrosis

Yoon

Kim

Song³

2018

Respiration

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“…In a study from Japan, changes in %FVC (Δ%FVC) at 12 months were not significantly different between patients taking 1200 mg and those taking 1800 mg of pirfenidone. However, when patients were divided into groups based on body surface area-adjusted dose of pirfenidone (876 mg/m 2 ), the Δ%FVC of patients taking higher doses was significantly greater than that of patients taking lower doses (8). In this study, patients in the standard dose group received 1017 mg/m 2 of pirfenidone, a body surface-adjusted dose, and patients in the non-standard dose group received 719 mg/m 2 or less.…”

Section: Discussionmentioning

confidence: 56%

“…However, few studies have investigated the effect of a lower dose of pirfenidone in a real-world situation (8).…”

Section: Introductionmentioning

confidence: 99%

Efficacy of lower dose Pirfenidone for idiopathic pulmonary fibrosis in real practice: a retrospective cohort study

Hwang

Lee

Choi

et al. 2020

Preprint

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Background Pirfenidone slows the progression of idiopathic pulmonary fibrosis. We investigated the efficacy and safety of pirfenidone by dose and disease severity in real-world patients with idiopathic pulmonary fibrosis.Methods This multi-centre retrospective cohort study investigated 338 patients treated with pirfenidone between July 2012 and March 2018. Demographics, pulmonary function, mortality, and pirfenidone-related adverse events were recorded. Efficacy was analysed according to pirfenidone dose and disease severity using linear mixed-effects models to assess the annual decline rate of forced vital capacity (FVC) and diffusing capacity (DL CO ) of the lungs for carbon monoxide.Results The mean %FVC predicted and %DL COpredicted were 72.6±13.1% and 61.4±17.9%, respectively. Pirfenidone treatment lasted 16.1±9.0 months. In the standard-dose (1800 mg/day) group, the mean %FVC predicted was -6.56% (95% CI -9.26, -3.87) per year pre-pirfenidone treatment, but -4.43% (95% CI -5.87, -3.00) per year post-treatment. In the lower-dose group, the mean %FVC predicted was -4.96% (95% CI -6.82, -3.09) per year pre-pirfenidone treatment, but -1.79% (95% CI -2.75, -0.83) per year post-treatment. The FVC decline rate was significantly reduced regardless of GAP stage. However, the DL CO decline rate was significantly reduced in the GAP stage II–III group, but not stage I group. Adverse events and mortality were similar across dose groups, but were more frequent in the GAP stage II–III group than in the stage I group.Conclusions The effect of pirfenidone on reducing disease progression persisted even with a consistent lower dose of pirfenidone.Trial registration Retrospectively registered

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“…Nowadays, real‐life data about safety and functional stabilization are fully available for both drugs . Particular caution should be taken when the antifibrotic therapy is started because the current dose adjustment guidance is not considering patient’s size and weight: one retrospective study showed that pirfenidone, adjusted for body surface area (BSA) or body weight (BW), had significantly higher doses when an adverse effect was identified. Besides antifibrotics, there is increasing evidence that the use of glucocorticoid therapy could worsen the forced vital capacity (FVC) decline in suspected IPF when radiological ‘inconsistent’ UIP pattern is diagnosed along with a UIP pattern on biopsy .…”

Section: Idiopathic Pulmonary Fibrosismentioning

confidence: 99%