Real-world Study in Britain Confirms Ofev Is Safe and Effective IPF Treatment

Real-world Study in Britain Confirms Ofev Is Safe and Effective IPF Treatment

A real-world study in Britain confirms that Ofev (nintedanib) is a safe and effective treatment for idiopathic pulmonary fibrosis, or IPF.

The research, “Early clinical experiences with nintedanib in three UK tertiary interstitial lung disease centres,” was published in the journal Clinical and Translational Medicine.

IPF treatments were limited to supportive care and lung transplants until regulators approved Boehringer Ingelheim’s Ofev and Genentech’s Esbriet (pirfenidone) in 2014.

Three clinical trials showed that Ofev slows the progression of IPF and improves patients’ lung function — two Phase 3 INPULSIS studies (NCT01335464 and NCT01335477) and the Phase 2 TOMORROW (NCT00514683) study.

A lot of IPF patients fail to meet the strict criteria required for them to take part in clinical trials of therapies or even to use approved treatments. This limits the amount of information available on Ofev’s use in real-world settings.

British researchers decided to learn more about Ofev’s real-world use by reviewing the records of 187 IPF patients at three centers in the United Kingdom. The patients, whose median age was 72, had received 150 mg of Ofev twice day before British regulators approved it in 2016. The median length of treatment was eight months.

Ofev improved or stabilized many patients’ lung function.

In terms of safety, fewer than 5 percent of the patients experienced serious adverse events. The most common events were diarrhoea, which affected 50 percent of the patients; nausea, 36 percent; loss of appetite, 24 percent; fatigue, 20 percent; and acid reflux, 18 percent. Most of the adverse events could be managed well enough that patients did not have to discontinue treatment.

The real-world findings were consistent with clinical trial results.

“In conclusion, our real-world data focusing on AEs [adverse events] and their impact on treatment with nintedanib, is similar to the findings of the INPULSIS clinical trials,” researchers wrote. ” This is one of the largest to date real-world cohort studies of nintedanib use in IPF patients.

“No new serious safety concerns have been identified,” they wrote. “Nintedanib is tolerated by the majority of patients,” and a number of patients’ lung function “remained stable or improved on treatment.”

8 comments

  1. Mark Maguire says:

    This article says OFEV “improved … many patients’ lung function.” That implies that with OFEV scarring was reversed. Is that true? My understanding is that OFEV only slowed progression of scarring. Could you clarify?

    • Marta Figueiredo says:

      Hello Mark,

      In this study, the researchers observed that “a statistically significant greater proportion of patients remained stable or improved”, after treatment with Ofev, compared to before treatment. These results were based on forced vital capacity (FVC) changes. FVC lung function was considered as follow: stable [minimal (0–4%) or no change in FVC over time], improved (improvement in FVC > 5% over time), or declined (decline in FVC > 5% over time).

      Hope this helps.

  2. Colin Mortlock says:

    The reply from Marta seems to account for about 15% of results . Can you say what the results were for the other 85%?

  3. Lorraine says:

    I tried OFEV for my IPF but the adverse effects far outweighed any benefits. A year later I tried Esbriet with the same results. Nausea, diarrhea, lack of appetite, vomiting, indigestion etc.. Even at a lower dose I had the same effects. I wish they could find something that I could tolerate.

    • Dibah says:

      Lorraine: There is hope yet. Prometic’s PBI-4050 and Ryplazim have been designated Orphan Drugs and are in trials with encouraging initial data.

  4. Rosie Llewellyn says:

    What criteria is used to prescribe Ofev as opposed to perfenidone. Also, have any studies been made as to the efficacy of perfenidone?

  5. Ric ellens says:

    Good article but Prometic is running lead on IPF plus

    This is indeed new info for the public. We have been waiting for a while for the orphan drug designation and finally received it.

    If demonstrated efficacious in IPF, plasminogen would be used in IPF patients that are undergoing Acute exacerbations…just like patients with Acute Lung Injury…
    In other words, plasminogen would be used in the Hospitals / ICUs whilst PBI-4050 would be chronic / once daily therapy.

    When we say that “we are the company that can effectively address the entire healing process in a ground-breaking way using both small molecule drugs
    and plasma protein therapies…” this is not a joke, we really do have a deep understanding of the healing process…

  6. Carl says:

    I have been on OFEV for over 20 months with good tolerance after the first few.This is much better than Esbiriet,which caused great fatigue and gastrointestinal problems and elevated liver enzymes,discontinued after 2 months.
    My IPF progression is very gradual though my oxygen saturation and FVC have declined over the past 7 years since my initial diagnosis.

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