Esbriet Enables Stable Lung Function Over 2 Years in IPF Patients, Real-World Study Confirms

Esbriet Enables Stable Lung Function Over 2 Years in IPF Patients, Real-World Study Confirms

Treatment of idiopathic pulmonary fibrosis (IPF) with Esbriet (pirfenidone) leads to stable lung function over two years, according to a real-world study. The data matches previous results from Phase 3 trials.

The research, “Functional decline over time in patients with IPF treated with pirfenidone: the PROOF registry,” was presented at the European Respiratory Society (ERS) International Congress 2018, held in Paris, France, Sept. 15-19.

Although the effectiveness and safety of IPF treatment with the anti-fibrotic drugs Esbriet (marketed by Genentech) or Ofev (nintedanib, marketed by Boehringer Ingelheim) is supported by data from Phase 3 trials, long-term data in real-world IPF populations are still lacking.

Aiming to address this gap, the PROOF registry was started in 2013 to track disease progression in a real-world population of patients with IPF. The registry includes adult patients with a diagnosis of probable or definite IPF from eight centers in Belgium and Luxembourg.

The study, sponsored by Roche, which owns Genentech, assessed changes in lung function over 24 months in IPF patients treated with Esbriet. Specifically, lung function was determined at the time of study inclusion (month 0) and at months 3, 6, 12 and 24, through percent predicted forced vital capacity (%FVC) and percent predicted diffusing capacity for carbon monoxide (%DLco), which is a test of the lungs’ capacity to transfer oxygen from the air sacs into the blood.

Results showed that 233 (84.1%) of 277 IPF patients in the PROOF registry received Esbriet for any duration of treatment. Mean duration of treatment was 20.1 months, with 87.1% of patients treated without interruption until discontinuation or end of follow-up.

Of the Esbriet-treated patients, 223 (95.7%) had a definite diagnosis of IPF, while 10 (4.3%) had a probable diagnosis.

Interested in Pulmonary Fibrosis research? Sign up for our forums and join the conversation!

Data of both %FVC and %DLco showed that lung function remained stable in patients treated with Esbriet.

Specifically, mean %FVC was 81.2% at month 0, 77.8% at month 3, 80.9% at month 6, 82.1% at month 12, and 78.3% at month 24. In turn, mean %DLco was 47.0%, 46.1%, 45.1%, 45.4% and 45.0% at months 0, 3, 6, 12 and 24, respectively.

The analyses also revealed a 10% or greater absolute %FVC decline compared to month 0 (baseline) in 11.1%, 16.6%, 19.1%, and 31.0% of patients at 3, 6, 12 and 24 months, respectively. In turn, 4.4%, 6.6%, 6.6% and 23.2% of patients experienced a 15% or greater absolute decline in %DLco vs. study start.

The mean time to­ achieve a 10% absolute decline in %FVC was 20.1 months, while 15% or greater absolute decline in %DLco was seen after a mean period of 23.4 months.

Based on the results, the team concluded: “pulmonary function remained largely stable during 24 months of follow-up in the majority of ever-treated patients who received pirfenidone [Esbriet] for any duration of treatment in PROOF.”

Also, the team noted that the rates of disease progression were largely comparable with those of Phase 3 trials (NCT01366209, NCT00287729 and NCT00287716) assessing Esbriet use over 12 months.

Among the study’s limitations, the researchers mentioned the relatively small group of patients from a limited geographic area. Missing data due to patients lost, to follow-up, or data not collected at all time points for all patients, were additional limitations.

Of note, the study was sponsored by Roche and two of the study’s authors are either in speakers bureau or received consulting and/or lecture fees from Roche and Boehringer Ingelheim.

6 comments

  1. I too am learning to hold things loosely, including IPF. I am trying to not let it dictate my life and walk with God.He still has plans and purpose for my life, talents and gifting.Thank you for your encouragement.

  2. Pierre Grandmaître says:

    I’ve been on Esbriet for close to three years now and the results have astounded my doctors. I was told almost four years ago that I needed a transplant within the next six months otherwise i wouldn’t make it. Then I started Esbriet and I was fortunate that my body responded really well to side effects. I’ve had ups and downs with many infections but we’ve managed to overcome everyone of them. My IPF has stabilized and at one point we even had a slight improvement to everyone’s surprise. Hanging in there.

    • Pat Glanville says:

      I have been on Esbriet since March 2018 after diagnosis in Feb… I do not seem to have any side effects apart from difficulty in sleeping. I swim at least 30 lengths a day without any problem
      I live in Spain so am hopeful that this medication will really help
      I am 72 years old

  3. Jackie Doran says:

    I was Diagnosed in Sep/Oct 2014 with IPF. I was given Esbriet to take of 3 tablets 3 times per day. I found that prescription too strong and reduced the tablets to 2 3x per day. In July2018 told by doc I wud
    Have to go on oxygen asked if I cud wait a little and he agreed but by Aug 27/2018 I told him I wud need need oxygen and I take 4 litres per minute
    For walking around only.
    I have seen 2 respiroligists from the oxygen co who
    On testing me do not recommend the pulse machine I
    Have been reading ads and see people who are on the
    Pulsators . Any opinion from someone using same
    Would be appreciated.

    For short times such as visiting.

Leave a Comment

Your email address will not be published. Required fields are marked *