Efficacy of pirfenidone and disease severity of idiopathic pulmonary fibrosis: Extended analysis of phase III trial in Japan

Terada, Yoshio; Ebina, Masahito; Hashimoto, Seishu; Ogura, Takashi; Azuma, Arata; Taniguchi, Hiroyuki; Kondoh, Yasuhiro; Suga, Moritaka; Takahashi, Hiroki; Nakata, Kohei; Sugiyama, Yukihiko; Kudoh, Shoji; Nukiwa, Toshihiro

doi:10.1016/j.resinv.2015.06.002

Cited by 31 publications

(24 citation statements)

References 34 publications

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“…The results showing the higher efficacy of pirfenidone in the advanced group might be associated with a more rapid decline in FVC before treatment in the advanced group than in the non-advanced group. However, Taguchi et al[25], in an extended analysis of a Japanese phase 3 trial of pirfenidone, suggested that pirfenidone exerted better therapeutic effects in patients with milder IPF; pirfenidone markedly attenuated vital capacity (VC) decline (relative difference with placebo: 74.1%, p = 0.045) in patients with mild IPF compared with its effects in moderate (35.2%) or severe IPF (27.0%). However, they defined the severity of IPF using baseline % FVC, oxygen saturation on exertion, and % DLco (Shah’s classification), and the severe group showed moderate lung function impairment (mean VC: 66.4 ± 17.6%, mean DLco: 39.2 ± 12.6%).…”

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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“…Although prophylactic medications such as proton pump inhibitors for gastrointestinal AE were reportedly effective for long‐term intake of pirfenidone, these medications were not enough to prevent gastrointestinal AE in the present study. Regarding administered dose of pirfenidone, 1200 mg (low dose) of pirfenidone has been shown to decrease the decline in vital capacity to the same extent as 1800 mg (high dose) in Japanese patients with IPF . Therefore, lower doses of pirfenidone may reduce pirfenidone‐related AE and ensure continuous and effective treatment, even in patients with advanced IPF, although the precise dose adjustment strategy for pirfenidone has not yet been established.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2017

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“…Safety profiles were comparable between the two patient populations (U. Costabel, Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany; personal communication). Furthermore, preliminary data from observational studies by other groups have suggested a similar efficacy of pirfenidone in severe IPF [28][29][30][31][32][33]; however, the results were quite preliminary.…”

Section: Pirfenidone and Nintedanib: What Role In Severe Ipf?mentioning

confidence: 95%

Severe idiopathic pulmonary fibrosis: what can be done?

2017

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Idiopathic pulmonary fibrosis (IPF) remains a challenging disease to manage. Two drugs are now available that can slow disease progression in patients with mild-to-moderate IPF. This means that early diagnosis is mandatory, because there are no proven effective therapies for severe IPF. This lack of proven therapies may be at least partially due to the fact that severe IPF patients are usually not enrolled in randomised, prospective, multicentre, international trials. Clinical observation experiences and preliminary results of long-term, open-label extensions of clinical trials suggest that both pirfenidone and nintedanib may also slow or decrease progression in patients with severe IPF. However, data are sparse and obtained from a relatively small number of patients. Lung transplantation should be taken into account early and discussed with patients, when indicated. Rehabilitative strategies are important and effective supportive therapies. The needs of patients with severe IPF are similar to those of patients with an advanced neoplastic disease. Palliative care and psychological support play an important role in the relief of symptoms of anxiety and depression. Accordingly, these therapeutic approaches should start early in IPF patients.

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Efficacy of pirfenidone and disease severity of idiopathic pulmonary fibrosis: Extended analysis of phase III trial in Japan

Cited by 31 publications

References 34 publications

Efficacy and Safety of Pirfenidone in Advanced Idiopathic Pulmonary Fibrosis

Efficacy and Safety of Pirfenidone in Advanced Idiopathic Pulmonary Fibrosis

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

Severe idiopathic pulmonary fibrosis: what can be done?

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