Esbriet Can Prolong Pulmonary Fibrosis Patients’ Lives, Review of Several Studies Reports

Esbriet Can Prolong Pulmonary Fibrosis Patients’ Lives, Review of Several Studies Reports

Esbriet (pirfenidone) can prolong idiopathic pulmonary fibrosis (IPF) patients’ survival, according to a review of clinical trials covering the anti-inflammatory and anti-fibrotic agent.

Researchers also said that Esbriet is safe, but does not help every IPF patient.

The study, “Role of pirfenidone in the management of pulmonary fibrosis,” appeared in the journal Therapeutics and Clinical Risk Management. It was conducted by Keith C. Meyer of the University of Wisconsin Lung Transplant and Advanced Lung Disease Program and Catherine A. Decker of the University of Wisconsin School of Medicine and Public Health.

Pulmonary fibrosis is the most common interstitial lung disease, or ILD, a group of disorders that involve scarring of lung tissue. It can lead to progressive decline in lung function, poor quality of life, and early death.

IPF affects up to one in 200 older people. Patients’ median survival rate is only three to five years after diagnosis.

The disease’s progression can be worsened by comorbidities, or other disorders, including pulmonary hypertension and sleep-disordered breathing. Scientists believe it is triggered by damage to protective epithelial cells in the alveoli, the tiny air sacs at the end of the lungs’ respiratory tree, and the release of cytokines that trigger inflammation. Cytokines are molecules that promote cell to cell communication in immune responses and stimulate the movement of cells toward sites of inflammation, infection and injury.

Previous studies have indicated that IPF fails to respond to immunotherapy. Recent clinical trials have demonstrated that novel anti-fibrotic agents have improved lung function over time, however. Anti-fibrotics ameliorate lung-tissue thickening and scarring.

Esbriet slows IPF patients’ decline in respiratory function and increases their progression-free survival, according to the review. It also reduces mortality, which other anti-fibrotic therapies such as Ofev (nintedanib) are unable to do, researchers said.

Based on these findings, the United States Food and Drug Administration (FDA) approved Esbriet for treating IPF in 2014.

More recently, the ASCEND phase 3 clinical trial (NCT01366209) supported Esbriet’s effectiveness. The study involving 555 patients showed that Esbriet improved respiratory function, progression-free survival, and ability to exercise.

Importantly, a combined analysis of two clinical trials — ASCEND (NCT00287716) and CAPACITY (NCT00287729) — indicated that factors such as patient age, race, smoking status and geographic origin had no impact on Esbriet’s effectiveness.

The clinical trials have also shown that prolonged treatment — that is, beyond six months — continued to reduce the risk of IPF patients’ respiratory decline and death. In addition, pooled data from five clinical studies covering 1,299 patients supported a previous finding that Esbriet is well-tolerated.

Another significant finding was that a combination of Esbriet and the amino acid N-acetylcysteine worsened IPF patients’ respiratory function, compared with Esbriet alone. The discovery came out of the recent PANORAMA phase 2 trial (2012-000564-14).

Although the results on Esbriet are encouraging, the researchers who did the review said doctors should approach its use with caution. That’s because not all IPF patients have better respiratory function and live longer after taking it.

But “individuals with more rapidly declining lung function prior to beginning pirfenidone treat­ment are more likely to experience benefit,” the researchers wrote.

Side effects of Esbriet include gastrointestinal problems, skin reactions, weight loss, anorexia and fatigue, according to the review. Patients taking it should avoid smoking and drugs that inhibit Esbriet’s metabolism in the liver, the researchers said.

Those taking Esbriet should be carefully monitored, particularly those with severe liver or kidney dysfunction, they said.

The benefits of early treatment with Esbriet, compared with the risks, have yet to be investigated, the researchers said. They also called for studies on the potential benefits of using a combination of Esbriet and Ofev, and on whether Esbriet can help patients with advanced cases of IPF.

“Prior to initiating treatment with pirfenidone, a thor­ough dialogue with the patient, which includes an educational overview of the benefits, risks, and limitations of therapy, is recommended,” the researchers concluded.



José is a science news writer with a PhD in Neuroscience from Universidade of Porto, in Portugal. He has also studied Biochemistry at Universidade do Porto and was a postdoctoral associate at Weill Cornell Medicine, in New York, and at The University of Western Ontario in London, Ontario, Canada. His work has ranged from the association of central cardiovascular and pain control to the neurobiological basis of hypertension, and the molecular pathways driving Alzheimer’s disease.
José is a science news writer with a PhD in Neuroscience from Universidade of Porto, in Portugal. He has also studied Biochemistry at Universidade do Porto and was a postdoctoral associate at Weill Cornell Medicine, in New York, and at The University of Western Ontario in London, Ontario, Canada. His work has ranged from the association of central cardiovascular and pain control to the neurobiological basis of hypertension, and the molecular pathways driving Alzheimer’s disease.
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  1. Ric ellens says:

    Story image for pirfenidone pbi-4050 from Lung Disease News
    FDA Agrees with ProMetic’s Protocol for PBI-4050 in IPF Clinical Trials
    Lung Disease News-2 hours ago
    We are very pleased that the FDA concurs with our decision to exclude a combined pirfenidone [Esbriet] and PBI-4050 treatment arm in the …

    • Ric Ellens says:

      Canada NewsWire

      LAVAL, QC, Feb. 22, 2017

      Early evidence of efficacy of PBI-4050 as a monotherapy and in combination with one of the commercially available drugs confirmed
      PBI-4050 continues to be very well tolerated, whether used alone or in combination with nintedanib or pirfenidone
      LAVAL, QC, Feb. 22, 2017 /CNW Telbec/ – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) announced today positive results from its completed open label Phase 2 clinical trial in subjects suffering from idiopathic pulmonary fibrosis (“IPF”). In addition to demonstrating that PBI-4050 is safe and very well tolerated, an objective of this study was to seek early evidence of a clinical benefit with PBI-4050 treatment, whether administered alone or in addition to either of the drugs approved for the treatment of IPF, nintedanib or pirfenidone. These results confirm the preliminary results previously announced by Prometic on November 17, 2016, following the first 30 subjects’ completion of 12 weeks of treatment.


      The comparisons shown herein between the results in this study and other larger phase 3 clinical studies are only made to provide some provisional guidance in terms of the potential clinical benefits of PBI-4050 for IPF patients. (CNW Group/ProMetic Life Sciences Inc.)

      A total of 40 subjects were enrolled in the study conducted in 6 sites across Canada and all have completed the 12 weeks of treatment; 9 subjects received PBI-4050 alone, 16 received PBI-4050 & nintedanib and 15 received PBI-4050 & pirfenidone. The baseline characteristics of the subjects enrolled in this study were similar to those enrolled in prior IPF randomized controlled studies conducted by other pharmaceutical companies, namely ASCEND and INPULSIS.

      As was demonstrated in these previously mentioned large clinical trials, IPF subjects typically experience a progressive decline in respiratory function. In contrast, in the ProMetic clinical study, the respiratory function of the subjects, measured as the forced vital capacity (FVC (ml)), remained stable after 12 weeks of treatment, in subjects treated with PBI-4050 alone and in those receiving PBI-4050 combined with one of the two approved drugs for the treatment of IPF (“Combi-1”) and was superior to that of those subjects treated with PBI-4050 combined with the other approved drug for the treatment of IPF (“Combi-2”).

      “PBI-4050, either used alone or in Combi-1, demonstrated very promising early indications of efficacy, considering that current drugs approved for IPF only slow (but do not reverse) the decline in lung respiratory function”, commented Dr. John Moran, Chief Medical Officer of ProMetic. “It is also important to note that during our clinical trial, there were no deaths nor did we see any subjects experiencing a decrease in FVC of 10% or more, contrary to the outcomes in the other IPF trials. There were no serious adverse events requiring PBI-4050’s discontinuation. The most frequent adverse event seen in all groups was diarrhea, but this was clearly much less significant in the subjects treated with PBI-4050 alone than in the groups receiving either of the currently approved drugs for the treatment of IPF, which are well-known for their significant side effect profiles”, added Dr. Moran.

      Pierre Laurin, ProMetic’s President and Chief Executive Officer commented: “These positive results support the rationale and clinical study design for the placebo controlled, pivotal Phase 2/3 IPF clinical trial we intend to initiate in Q2 2017. We expect to see PBI-4050, alone or in combination with one of the commercially approved IPF drugs, continue to outperform the current drugs in terms of efficacy, safety and tolerability”.

      The comparisons shown herein between the results in this study and other larger phase 3 clinical studies are only made to provide some provisional guidance in terms of the potential clinical benefits of PBI-4050 for IPF patients.

      Please note that the complete data set for ProMetic’s open label Phase 2 clinical trial will be presented at an upcoming pertinent scientific conference, notice of which will be given by the Corporation.


  2. Diann says:

    I began taking Esbriet two months after FDA released it, and it has literally saved my life. My lungs were in rapid decline, and I was not expected to live another three months, but thanks to Esbriet, my condition actually reversed for several months. Now, 29 months later, I am waiting for a lung transplant, which is something I would not have lived long enough to receive had Esbriet not been released when it was. I can’t say enough good things about this life-saving drug.

    • Jose Marques Lopes, PhD says:

      Dear Diann, I am very happy to read such good news. I hope everything goes well with your transplant.

      • Diann Dillingham says:

        Thanks to my wonderful donor, my transplant took place July 19, 2017. I am happily breathing without supplemental oxygen and working to rebuild the strength I had lost during the IPF decline.

        • Diann says:

          I would not combine this drug with anything else without the recommendation from my physician and/or the pharmaceutical company. My transplant team and the pharmacy need to know every prescription and supplement I take. I have changed my diet considerably, which has helped, but everyone should do that to eliminate sugar and white flour.

          I haven’t even participated in any trials that involve taking experimental drugs because I don’t want to mess up a good thing.

      • Diann says:

        Eileen, Medicare and my insurance covered most of it, and my physician had me complete a grant request in his office, which he submitted. The grant covered the co-pay for the first two years, and the pharmaceutical company has been working with me since then. A friend of ours was recently diagnosed after a lung biopsy, and he is in mitigation with his insurance company. When I heard the cost initially, I immediately dismissed it until my physician prescribed it. It is well worth fighting for!

    • Sophie says:

      Hello Diann,

      My dad has been taking Esbriet for a few weeks and he’s been experiencing many unpleasant side effects. Did you ever experience any in the beginning? Please share. He is a bit dicouraged.



      • Diann says:

        I’m so sorry your dad is experiencing difficulty, Sophie. I did experience nausea if I didn’t eat something with each dose. Initially, I had to eat something, take the dose, and then eat more–so literally take the dose in the middle of a meal. Also, I didn’t think I needed sun screen the first time I was in the sun, and my arms blistered so badly it took three months before they began to look decent again. Is your dad taking one initially, then two, and a while later, three at a time? If it helps, he could cut back to a previous amount and try that until his body stablizes. What other unpleasant side effects is he experiencing?

        I was very determined at the first that this was going to work because I had no other alternative. After a few months, I experienced no unpleasant side effects. Now, after having been on it for 2 1/2 years, I don’t even worry about sun screen if I’m going to be in the sun for a short period of time. I definitely wouldn’t push it, though.

        • Sophie says:

          Thank you for getting back to me.

          At the moment he is at two tablets at a time. Starting mid-week, will have to increase to three. Like you were, he is experiencing a decrease in apetite, nausea, reflux and stomach pain.
          Were you able to take anything for symptoms? Did you have any other than nausea?
          My dad has no other alternative. We also have an appointment with a medical team mid-June to discuss potential lung transplant. I shared your story with him and it gave him hope. Thank you so much!

    • Mica says:

      My dad has ipf and has been giving only weeks/months to live but has started this drug reading this has giving me some hope 🙏🏻

  3. Barry Gauthier says:

    I’ve been on Esbriet for one month. Get my first liver test next week. So far, no problems. Don’t even notice that I’m taking the drug. Breathing has improved. Terrible cough is gone, but my stamina hasn’t returned.

  4. Aish says:

    I just received my first rx of Esbriet today. I am nervous about taking it but also hopeful. Diann, thank you for the above comments about eating and taking the medi in the middle of a meal. My stomach tends to be sensitive so this is good to know. I will make sure to take my meds in the middle of meals.

  5. I have recently been diagnosed with IPF and have an appt. with my Pulmonologist tomorrow. During phone conversation with him to inform me of the results of the Lung Scan, he kind of hinted that he probably would not be putting me on any meds. I am an 86yo F. and have some kidney failure. I have been very active both mentally and physically til last year, when I started a dry cough and shortness of breath on exertion. Are there certain Pulmonologists who specialize in this condition? The medication sounds like it effective and I think I would like to try it. thanks for any comments.

  6. Ross DUSTING says:

    I was diagnosed with IPF after lung biopsy in 2013 although i am sure i had it a number of years before that. I have had a pretty good run i know but i had a severe exacerbation last September and ended up in hospital where i met my current lung specialist who got me well and got me onto Esbriet which only became available in Australia last year . He said i was eligible for it under our Medicare scheme even though he thought the ‘horse had bolted’. So i eventually started on 26/1/18. I had no real problems with it for eight weeks until i got a severe sunrash because i didnt put on my +50 block out because it was such a dull day.DONT BE FOOLED. U.V. rays are about even on dull days. I rang my lung man and he told me to stop the Esbriet and put me on Prednisone for a week and get a lung function test and go and see him. He was very pleased with my LFT results and said i had got no worse since last October Even a small reversal. I was so filthy on Esbriet after the pain and crazy itch of the sun rash that when he asked me did i want to go back on Esbriet i said emphatically NO WAY. So he said thats ok and see him in six months.. But a week after that day i started getting more breathless moving around and my resting SO2 levels had dropped from 93 to 89. I am thinking that the further i am getting away from my Esbriet days the worse i am getting .I have now made an appointment to see him next week to discuss a possible return to Esbriet. It should be a lot easier in the winter over here. So who knows. Hope this has been of some use to somebody. Watch this space.

    • Mary t Brown says:

      Hello Ross have just read your comments. I assume you are the same person
      I met recently at the short
      Pants meeting !??????
      From Mary Brown

  7. Peter Blake says:

    I have been on Esbriet for 5 weeks now and tolerating quite well. When I started after a week I had a reduction in my cough,witch did not last long.When I went to 2 tabs I had the cough reduction again for a short time,and again when I went to 3 tabs. Last week I coughed so much I thought I had an infection. Friday afternoon I couldn’t get to see my doctor or contact anyone so started antibiotics,which did no good saw doctor GP who suggested no infection but to continue with antibiotics as I had started them. Two days later friday again reviewing my papers on the cough and exsaserbation I remembered the prednisone,so I started the 5 day course, I felt mediate relief. Having read earlier reports on this site wonder if I should have stopped the Esbriet?
    Thanks for reading Peter

  8. James Dvorak says:

    I was diagnosed with IPF in January 2017. I went through numerous protocols and eventually was acccepted as an Esbriet patient and began the procedures for a lung transplant. During the testing period at the transplant center it was determined I also had a paralyzed right diaphragm reducing my breathing ability and also knocking me out if the transplant program. After 18 months I am convinced the Esbriet has slowed down the IPF progression with minimal side effects. I get regular kidney and liver scans and have had no negative impact on them. I watch my diet, use sun protection and try to live a normal life. So far it has worked for me. Good luck to all!

  9. Janice Jonatschick says:

    Help I have started the 9 pills a day and have been experiencing nausea and vomiting for three days now. I have been reading the experiences other people are having so I am trying to be patient and not give up

    • Hamid Sarpash says:

      I am a 77 year old male and live in Canada. I have been on Esbriet since October 2014. I have not had any liver or kidney side effects.
      As for sharing my other experiences:
      I had a heart attack in May 2017 and had a stent put in my artery for which I was prescribed antiplatelet Aspirin and Ticagrelor. The latter, after a few weeks caused more breathing problems and after 6 weeks had to change to Clopidogrel. I believe the damage was done and now I have to walk with supplementary oxygen.l asked for the change because I found out that included in the side effects of Ticagrelor were ” shortness of breath” and ” Can cause lung fibrosis”. After I had the stent put in, and before the blood thinner prescription, the hospital got a list of my medication including the Esbriet and the dosage I was taking. I like to know if anybody else has had a similar experience.

      • Flora Armstrong says:

        I had a heart attack..stent..was put on a drug called brelintral..i got very short of breath..was taken off it 2 weeks later..and put on plavix..felt better..enough to get out off bed..i felt maybe the drug gave me the diagnosis of ipf..But they said i had it for a very long time..😣

  10. Reto says:

    I never knew how many people suffer from IPF it is also very interesting to read all the positive comments as i have just started with Esbrite. Keep you up to speed how i go on them

  11. Marie says:

    I am a 33 year old female was diagnosed with end stage IPF and started ESBRIET 3 months ago. I only experienced the tiredness from ESBRIET. I cant say if it’s made my breathing better or if it has slowed down my progression but I hope 2 find out in November when I return to my pulmonary doctor. Oh and I am on o2 resting o2 is 3 and moving around o2 is 5.

  12. Patricia Davidson says:

    I have IPF and stage 3 non small cell lung cancer, will Esbriet help me. My Dr wants me to try it. I just don’t know.

  13. mary lou eldridge says:

    my husband has been on esbriet since last sept. 2018 his complaint right now is skin is flaking off on face, back of neck back etc. is this a side effect?

  14. Barbara Aiello says:

    Ny husband was diagnosed with IPF and today began Esbriet. We are hoping for a good result. He is 77 years old, former athlete and in good physical shape. He had a heart attack and stent surgery in 2012 and was told he wasn’t a candidate for lung transplant. The diagnosis was a shock but we hope for the best. Thanks to everyone who comments. We live in Italy and the care is marginal.

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