Esbriet Extends IPF Patient Survival, Real-world Study Reports

Esbriet Extends IPF Patient Survival, Real-world Study Reports

Esbriet (pirfenidone) can improve survival rates of idiopathic pulmonary fibrosis (IPF) patients by 30 percent, a real-world retrospective analysis shows.

The study, “Pirfenidone improves survival in IPF: results from a real-life study,” was published in the journal BMC Pulmonary Medicine.

Genentech’s Esbriet is an approved IPF treatment that slows the decline in lung function. Results from Phase 3 trials, namely the ASCEND (NCT01366209) and CAPACITY (NCT00287716 and NCT00287729) trials, showed that treatment with Esbriet significantly reduced IPF disease progression. In particular, the therapy reduced IPF patients’ decline in lung function and physical capacity, the number of respiratory-related hospitalizations, and the risk of death, compared with a placebo.

In fact, a 2014 study reported that Esbriet could reduce the risk of death at one year by 48 percent in IPF patients enrolled in the ASCEND trial.

To further study the impact of Esbriet on patient survival outside the restrictions of a clinical trial, researchers performed a retrospective analysis of a group of 82 IPF patients enrolled in an outpatient clinic at the University Hospital of Heraklion (UHH) in Greece.

According to the team, this type of real-world study in which “patients with advanced disease and comorbidities are included, are needed to shed light to the mortality benefit of pirfenidone in the general IPF population.”

All 82 patients analyzed had not had any previous treatment before the study and had completed at least three months of treatment with Esbriet (2403 mg/day) by the time of the analysis. Their mean age was 74.9 years, and they were followed for up to three years.

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Lung function tests, such as spirometry and diffusing capacity of the lung for carbon monoxide (DLCO; the ability of the lungs to transfer oxygen from inhaled air to the blood), were performed at the time of IPF diagnosis, and thereafter at three, six, 12, 24, and 36 months from the start of Esbriet treatment.

In total, 15 patients died during the study period. The three-year survival rate of patients was 73 percent.

To better understand the effects of Esbriet on survival rates, researchers compared the data from their UHH group to a group of IPF patients followed at the Royal Brompton Hospital (RBH) in the United Kingdom who had not received anti-fibrotic treatment.

“Nowadays, it is not ethical to withhold pirfenidone therapy to establish a true control group, and therefore we chose to use a historical cohort as a control group,” the researchers wrote.

This final analysis included 136 patients from the RBH group and 75 patients from the UHH group.

After the exclusion of severe cases (those with a DLCO below 30 percent), results showed that the survival rate was higher in the UHH group than in the RBH group. This difference in survival rate remained even after adjusting for age, gender, and forced vital capacity, a measure of lung function.

An age-matched model comparing survival between the two groups showed that the mortality rate was reduced in the UHH group, with a hazard ratio of 0.30, meaning a 30% reduction compared with the RBH group.

Researchers detected no new safety issues with Esbriet treatment; all events reported were in line with the known safety profile of the therapy. Of note, 30 patients reported gastrointestinal discomfort, and 17 patients experienced photosensitivity.

These results showed an “increased 3 years survival rate in patients treated with pirfenidone, and a survival benefit of 30% compared to patients treated with no antifibrotic agents,” the researchers wrote.

“The effect of pirfenidone on survival is remarkable if ones takes into account that patients with comorbidities and severe disease have been included in the UHH cohort unlike what happens in pharmaceutical trials,” they added.

Patricia holds a Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She has also served as a PhD student research assistant at the Department of Microbiology & Immunology, Columbia University, New York.
Patricia holds a Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She has also served as a PhD student research assistant at the Department of Microbiology & Immunology, Columbia University, New York.
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  1. Harry Penders says:

    I’m early in my Dx. of ‘IPF’ by a Bx. done at Kaiser Portland Dr Rettmann. This was confirmed on my birthday in July of this year 2018. I had lowering ‘IPPB’ values over 3 years prior. I was started on Pirfenidone on Sept. 1 of this year by the VA in Portland at 3 capsules every 8 hours. I just had my 3-month evaluation of ‘Pirfenidone’ at Kaiser which is working with the VA. Also did the 6 min. walk along with various labs. All results showed a remarkable stop to the advancing disease of ‘IPF.’ No, it doesn’t cure this disease (by the way I never smoked). Nothing does. But I can breathe a little deeper and I have a productive cough. I can do 6 miles on the treadmill but have a tough time just bending over to plant in the garden. Though I get my ‘air’ back within minutes. I don’t know how I got this terrible disease, but I won’t lie down and die until it’s time.

    • Robert McGrath says:

      I was in phase 3 trial for Perfenidone. What I do currently is to take 3 drugs. Ofev, Perfenidone, and Metformin. I had my doc switch my rx from Perfenidone to Ofev which insurance covers mostly. Then I purchased Perfenidone from Canada and then later Metformin. Through Canada the Perfenidone is about $300.00 a month and Metformin negligible. A mouse study found metformin to halt and in some cases reversed IPF. my doc said it couldn’t hurt me but, of course, he said no true clinical evidence of efficacy. So, in short, I pay my copay for Idea, $300 for Perfenidone and a few bucks for Metformin. I was diagnosed end of 2013. on 4 liters of oxygen at rest and 8 walking and up to 15 with moderate exertion like gardening. Although the Perfenidone is manufactured in India, it is made by one of the US major drug companies. I hope this is helpful for you.

  2. J. T. says:

    After 4 years’ treatment with Esbriet, Kaiser of CO discontinued our regimen while claiming that the onset of osteoarthritis made the diagnosis of IPF “moot”. Instead, they prescribed the old treatment for “interstitial lung diseases” (of which IPF is one specific disease) of prednisone — the old pre-Esbriet standby. That, in spite of our confirmed diagnosis of IPF by the U.S.’s preeminent pulmonary center National Jewish here.

    Although my patient has had no adverse effects from Esbriet in the last three years of treatment, Kaiser attributed this sudden discontinuing of the admittedly high-priced Esbriet to their “misdiagnosis”, as one Kaiser/CO doctor stated. The prednisone regimen has resulted in bloating of the feet and face, hair loss and a general malaise not present previously.

    Worthy of note is that Kaiser/CO’s fortunes have deteriorated markedly in the last two years:

    — resulting in layoffs, threats of possible lawsuits against high-priced for-profit CO hospitals, suddenly dropping 2500 Medicaid patients and refocusing of out-patient resources on a more concerted use of their mail-order pharmacy instead of personal OTC service, etc.

    Of course, this economic downturn for Kaiser/CO and any retrenching in the prescribing of costlier and more effective med’s. may just be coincidental…

  3. Carol Handy says:

    Thank you for this report. It fills me with hope. I have just begun Esbriet and will not reach full dose until Dec. 12th. Had diagnosis of stable IPF in 2012, but it became active 2017 in April. There has been some progression since then. Am still on 2 liters of O2 with light activity and am
    hopeful the esbriet will keep me going a while longer. No significant side effects thus far. I will have my 90th birthday in March of 2019.

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