Esbriet’s Efficacy in Severe IPF Seen to Diminish 6-12 Months After Treatment’s Start, Study Shows

Esbriet’s Efficacy in Severe IPF Seen to Diminish 6-12 Months After Treatment’s Start, Study Shows

Esbriet (pirfenidone) seems to have diminishing therapeutic effect after six months of treatment and possibly no benefit after one year in idiopathic pulmonary fibrosis (IPF) patients with advanced disease, a Greek retrospective study shows.

The study, “Safety and efficacy of pirfenidone in severe Idiopathic Pulmonary Fibrosis: A real-world observational study,” appeared in the journal Pulmonary Pharmacology & Therapeutics.

Esbriet, developed by Genentech, is an anti-fibrotic therapeutic whose efficacy was proven in five randomized multicenter clinical trials with IPF patients of mild-to-moderate disease severity. However, its efficacy in patients with more advanced disease requires further studies.

Researchers at the Sotiria Medical School — a division of the University of Athens — performed a retrospective multicenter study of IPF patients with severe lung function impairment to investigate Esbriet’s safety and efficacy in this particular patient population.

Patients who had been treated with Esbriet before or showed significant comorbidities such as cancer, liver failure or renal failure were excluded from the study.

The team analyzed the results of 34 males and nine females with severe lung function impairment who received Esbriet (2.403 mg/daily) for between six months and one year. Patients’ mean age was 66.3 years, and most were ex-smokers.

The analysis showed that Esbriet administered for six months was associated with a trend for halting functional decline when compared to patients’ lung function in the six months before beginning treatment. These effects appear to then start diminishing.

“However, pirfenidone failed to show any benefit or even halt disease progression after one year of treatment,” the researchers wrote.

Even when researchers analyzed patients’ response according to the duration of Esbriet treatment, after one year the therapy had no effect on disease progression.

But results also showed that Esbriet maintained the safety profile observed in previous large randomized controlled clinical trials. The most common adverse events included gastrointestinal disorders such as nausea and vomiting (34.9 percent), fatigue (23.2 percent) and photosensitivity or rash (18.6 percent). Nine patients had to discontinue treatment due to severe adverse events.

During the study, 21 patients died – 18 patients after 12 months and three patients after six months of Esbriet therapy – due to disease progression or exacerbation.

“Our data suggest an acceptable safety and efficacy profile of pirfenidone treatment in real-life IPF patients with severe lung function impairment. Our preliminary findings indicate a time-limited therapeutic profile of pirfenidone in IPF patients with rapid disease progression,” the researchers concluded, noting that treatment effects “may diminish” after six months of treatment.

“Further prospective studies will help us identify subgroups of patients with different responses to pirfenidone” for more precise treatment approaches, 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. Kathy says:

    I have been on Esbriet for 16 months & have remained stable. My cough has lessened, but I have a lot of fatigue. I have had IPF for 2 1/2 years and I am not on oxygen. Esbriet seems to be working for me. Thank God & Esbriet.

    • Vic says:

      If you are not on oxygen, you are not a severe patient with pulmonary fibrosis, so the results of this study do not apply to you. Esbriet works for patients with mild to moderate pulmonary fibrosis. Not all patients are so lucky. My 53 year-old husband was diagnosed in April 2017 with pulmonary fibrosis. His condition is advanced and the lung transplant doc said in June he had 12 months. He does not want a lung transplant. He has lost over 30% lung function since April. So God Bless soon to be a single mother raising two young sons and not Esbriet.

    • Cathleen Miller says:

      I keep trying to take the Esbriet but keep getting so sick from it and have to start titrations again. I feel worse and don’t want to die trying to just to be able to talk or eat. Where are comfort measures for us. I have not been placed on oxygen because my o2 sat is still in the nineties but I struggle to catch my breath and all day long I cough and expectorate even with Tessalon pearls, Benadryl to get rest. I’m exhausted. I don’t have the strength to do even a dog walk or a shower. My husband has stage 4 cancer and he takes care of me. We moved to Mexico last March to see if I would do better. I am still struggling. I never smoked and was a health nut. I am so angry with what I have to deal with.

  2. Bob says:

    I have only started Esbriet myself three weeks ago. Too early to say anything really, but I feel somewhat more comfortable all the way around. I have read many positives about it and am certain it will help me out. And no side effects so far. I am surprised someone would share such a negative headline. Best to just let it pass.

    • Vic says:

      Negative headline? No, it’s an honest headline. Esbriet has been shown to work for mild to moderate patients with pulmonary fibrosis, NOT patients with severe pulmary fibrosis. My husband was diagnosed with the disease in April 2017. I read all the published research on both Esbriet and OPEV, and it was clear that there was not medical evidence to support the use of either for my husband’s advanced case (FVC 33%, DLCO 29%). So maybe articles like this are good for people. It confirms that our family didn’t waste our time applying for a expensive grant for a drug our insurance didn’t cover, that my husband did not have have to suffer side effects of intentional discomfort for months needlessly with non results to show for it, and he could fish on our favorite lake without excessive sun protection. Thank you for Pulmonary Fibrosis News for sharing this article. False hope would be worse than the reality facing my husband with severe pulmonary fibrosis, myself, and two young sons.

  3. Azul says:

    I’ve had IPF for over 2yrs. I was living in the Rockie Mountains at over 5000′ it became very hard to breathe. Just before I was to be put on oxegen I moved in with my sister in Texas where it’s 500′ above sea level. I’m able to breath better at this lower altitude but the East Texas humidity heat and pollen is a difficult challenge on my lungs. I now understand why people back in the day with TB moved to desert dry climate. Besides that, the doctors here are awesome and it’s good to be with family and old friends I haven’t seen in many years. Good support, laughter and love are better medicine than any pill(s). Less side effects and little to no copay or out of pocket cost. A wiser person than myself told me years ago, it still rings true now more than ever, “don’t count the days but make the days count”- Mohammed Ali

  4. My brother was on Esbriet for IPF. He had so many side effects for 2 years. He would go off of it for a couple months and then the Dr. would put him back on it. He had stomach problems, lost alot of weight, he could not have any sun because it would burn up his skin. Was very tired all the time. He lived almost 3 years but his quality of life was horrible. I am sure looking back he would of rather lived 2 years without this strong medicine and had a better quality of life. My only comment is if it works for you great but if you are having bad side effects its not worth it. My brother kept trying to go back on it but within a couple months was getting sick all over again.

  5. Kathy Bruner says:

    I have has IPF for 3 years, but it was only diagnosed two years ago, after an MRI for something else. I have been on Esbriet for two years and my tests have remained stable. I can only take two pills at each meal, to maintain a good quality of life. Three Esbriet cause heartburn, nausea, fatigue, & insomnia. Prilosec helps the heartburn. I have photosensitivity & can’t be in the sun. I still have fatigue, but can function pretty normally. The only time I’ve needed oxygen was when flying or going to Colorado. Medicare will not pay for oxygen until it drops below 88. Mine goes to 91 on the 6 minute walk. I, also, take turmeric & do water aerobics. My physician & I are very happy with the results of
    Esbriet. The important thing with the Esbriet is to eat enough to coat the stomach. Shakes help.

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