Effect of pirfenidone on mortality: pooled analyses and meta-analyses of clinical trials in idiopathic pulmonary fibrosis

Nathan, Steven D.; Albera, Carlo; Bradford, Williamson Z.; Costabel, Ulrich; Glaspole, Ian; Glassberg, Marilyn K.; Kardatzke, David; Daigl, Monica; Kirchgaessler, Klaus-Uwe; Lancaster, Lisa; Lederer, David J.; Pereira, Carlos Alberto de Castro; Swigris, Jeffrey J.; Valeyre, Dominique; Noble, Paul W.

doi:10.1016/s2213-2600(16)30326-5

Cited by 260 publications

(190 citation statements)

References 18 publications

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“…Pooled analysis demonstrated a reduction of all-cause mortality at 1 year by 48% (hazard ratio (HR) 0.52, 95% CI 0.31-0.87; p=0.01) in the group treated with pirfenidone compared to placebo, as well as a reduction of the risk in treatment-emergent IPF-related mortality at 1 year by 68% (HR 0.32, 95% CI 0.14-0.76; p=0.006) compared to placebo [23]. These first positive results were also recently confirmed in an article by NATHAN et al [24], which included data from the two CAPACITY trials, from the ASCEND trial and also from two other Japanese studies (Shinogi Phase II and Shinogi Phase III trials). More complex analyses ( pooled and meta-analysis) and a different statistical approach were also performed to assess the outcomes, with new landmark results.…”

Section: Milestones From Clinical Trialssupporting

confidence: 53%

“…More complex analyses ( pooled and meta-analysis) and a different statistical approach were also performed to assess the outcomes, with new landmark results. Both analyses demonstrated a significantly lower risk for all mortality outcomes (all-cause mortality, treatment-emergent all-cause mortality, IPF-related mortality and treatment-emergent IPF-related mortality) at week 52 in the pirfenidone group compared to placebo [24]. Recently, data from the TOMORROW and INPULSIS trials were also pooled (1231 patients), confirming a significant reduction in the annual rate of decline in FVC (112.4 mL·year −1 with nintedanib and 223.3 mL·year −1 with placebo; p<0.0001).…”

Section: Milestones From Clinical Trialsmentioning

confidence: 95%

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When to start and when to stop antifibrotic therapies

Torrisi¹,

Pavone²,

Vancheri³

et al. 2017

Eur Respir Rev

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Idiopathic pulmonary fibrosis (IPF) is characterised by progressive changes of the lung architecture causing cough and dyspnoea and ultimately leading to lung failure and death. Today, for the first time, two drugs that may reduce the inexorable progression of the disease are available, suggesting that treatment with specific drugs for IPF should be started as soon as diagnosis is made. This applies to any disease and particularly to IPF, which is marked by a 5-year survival comparable or even worse than many cancers. However, despite common sense and even worse, in spite of scientific data coming from clinical trials, post hoc analysis, long-term safety studies and real-life experiences, the question of when to start and when to stop treatment with antifibrotics is still debated. In IPF, particularly when the disease is diagnosed at an early stage, "wait and watch" behaviour is not rare to observe. This is largely due to the lack of awareness of both patients and clinicians regarding the progression of the disease and its prognosis. Another important issue is when treatment should be stopped. In general, there are two main reasons to stop a therapy: unbearable side-effects and/or lack of efficacy. According to current (although preliminary) evidence, antifibrotic drugs should not be discontinued except for safety issues.

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Section: Milestones From Clinical Trialssupporting

confidence: 53%

Section: Milestones From Clinical Trialsmentioning

confidence: 95%

When to start and when to stop antifibrotic therapies

Torrisi¹,

Pavone²,

Vancheri³

et al. 2017

Eur Respir Rev

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show abstract

“…Similarly, pooled and meta-analyses of clinical trials of pirfenidone have shown that the relative risk of death in IPF is reduced over 120 weeks of treatment [35]. It seems that continued treatment with pirfenidone in those whose disease has progressed, defined as ⩾10% absolute decline in FVC during the first 6 months of treatment, can still be beneficial as reflected in a lower risk of subsequent FVC decline or death [36].…”

Section: Clinical Physiological and Functional Markers Of Disease Sementioning

confidence: 99%

Evaluating disease severity in idiopathic pulmonary fibrosis

et al. 2017

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Accurate assessment of idiopathic pulmonary fibrosis (IPF) disease severity is integral to the care provided to patients with IPF. However, to date, there are no generally accepted or validated staging systems. There is an abundance of data on using information acquired from physiological, radiological and pathological parameters, in isolation or in combination, to assess disease severity in IPF. Recently, there has been interest in using serum biomarkers and computed tomography-derived quantitative lung fibrosis measures to stage disease severity in IPF. This review will focus on the suggested methods for staging IPF, at baseline and on serial assessment, their strengths and limitations, as well as future developments.

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“…This RCT corroborated the initial findings, again showing a reduction in FVC decline in patients using pirfenidone compared to placebo. In a pre-specified pooled analysis of CAPACITY and ASCEND, both all-cause and IPF related mortality were significantly reduced with the use of pirfenidone (hazard ratio 0.52 and 0.32 respectively) (12).…”

Section: Antifibrotic Therapy: Pirfenidonementioning

confidence: 99%

Idiopathic pulmonary fibrosis: a holistic approach to disease management in the antifibrotic age

Shaw¹,

Marshall²,

Morris³

et al. 2017

J. Thorac. Dis.

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Idiopathic pulmonary fibrosis (IPF) is the most common cause of interstitial lung disease (ILD) and carries a worse prognosis than many cancers. Until recently, there were no active treatment options available for patients with IPF, meaning palliation or lung transplantation in selected patients were the only options. The management of IPF has changed dramatically over the last decade with the advent of two antifibrotic agents; pirfenidone and nintedanib. These new agents have been shown to reduce decline in lung function and pirfenidone has been shown to reduce mortality. The changing landscape of IPF diagnosis and management present a number of issues that may be encountered including management of side effects related to antifibrotic therapy. This article aims to give an overview of the holistic approach to the management of patients with IPF, including antifibrotic management, symptom management and the invaluable role of the ILD specialist nurse.

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Effect of pirfenidone on mortality: pooled analyses and meta-analyses of clinical trials in idiopathic pulmonary fibrosis

Cited by 260 publications

References 18 publications

When to start and when to stop antifibrotic therapies

When to start and when to stop antifibrotic therapies

Evaluating disease severity in idiopathic pulmonary fibrosis

Idiopathic pulmonary fibrosis: a holistic approach to disease management in the antifibrotic age

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