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.

5 comments

  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.

  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.

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