Ofev-Esbriet Combo Is as Safe as Individual Components as a Pulmonary Fibrosis Therapy, Trial Indicates

Ofev-Esbriet Combo Is as Safe as Individual Components as a Pulmonary Fibrosis Therapy, Trial Indicates

A combination of Ofev (nintedanib) and Esbriet (pirfenidone) is as safe a therapy for idiopathic pulmonary fibrosis as the individual components alone, a Phase 4 clinical trial indicates.

Preliminary trial findings also suggested that the combination might be more effective than either therapy alone, although researchers said this needs to be studied further.

The trial results were published in the American Journal of Respiratory and Critical Care Medicine under the title “Nintedanib with Add-on Pirfenidone in Idiopathic Pulmonary Fibrosis: Results of the INJOURNEY Trial.”

Boehringer Ingelheim makes Ofev, and Genentech Esbriet. Both slow IPF’s worsening, but do not stop its progression. This prompted researchers to wonder if a combination of the two would be better at slowing progression.

They decided to conduct a 12-week, open-label, randomized trial on the combo’s safety, effectiveness, pharmacokinetics and patients’ ability to tolerate it. Pharmacokinetics refers to the body’s effect on a drug.

The primary objective of the trial was to see how many gastrointestinal adverse events the combo generated. Those events are the most common side effects of treatment with the individual drugs.

Researchers randomized patients who had been on four or five weeks of Ofev, and did not need their dose reduced or their treatment interrupted, to continue receiving Ofev or to receive a combination of Ofev and Esbriet.

Seventy percent of the patients in the combo group had to be treated for gastrointestinal adverse events, compared with 53 in the group that took Ofev alone. Diarrhea, nausea and vomiting were the most common adverse events. Serious adverse events were uncommon in either group.

“Safety always comes first when considering the right medicine for the treatment of an individual IPF patient,”Carlo Vancheri, a respiratory medicine professor at the University of Catania in Italy, said in a press release. “The results from INJOURNEY help to close a gap on the questions of the safety, tolerability and possible interactions of adding pirfenidone to nintedanib background therapy in the treatment of IPF. Furthermore, the results are reassuring and supportive of future research on combination regimens with nintedanib in IPF.”

The combo also led to less reduction in lung function than Ofev alone, researchers said. The lung function measure they used was forced vital capacity, or the amount of air a person can forcibly exhale after taking the deepest breath possible.

But the team said more research is necessary to determine the combination’s effectiveness.

“These new results suggest a potential benefit of the combination treatment of nintedanib with add-on pirfenidone in people with IPF, but that will need to be further evaluated,” said Thomas Leonard, executive director for Clinical Development & Medical Affairs for IPF/ILD at Boehringer Ingelheim.

“As a company dedicated to respiratory care, we remain focused on continually uncovering new insights into IPF and to help support physicians as they have more informed treatment discussions with their patients,” he said.



  1. Isabel Mickle says:

    There had been a article in our newspaper which I showed to my pulmonologist. Right away he said no this would not work. It’s for idiopathic PF and he said he knows what caused mine. A type of pneumonia which I can’t pronounce and my pulmonary drs who I’ve had for 12+ years had no clue. This dr is supposed to be a specialist with unusual lung diseases. One of the top ones being PF. Who knows more minute walks and pft. I’ll keep everyone updated. Thanks for letting me talk or I should say a vent.
    Prayers to all, breath better and big hugs to all

  2. Ric Ellens says:

    Story image for fda ipf from Lung Disease NewsFDA Agrees with ProMetic’s Protocol for PBI-4050 in IPF Clinical Trials
    Lung Disease News – Apr 19, 2017

  3. Jack Scheiner says:

    Hi fellow IPF patients: I have been on Efev, 150 mil for a month. IPF was detected when I came down with pneumonia and had to be hospitalized for 8 days. the pulmanologist had me undergo a very strong CT scan and it showed that I had IPF. It was about a month before I started with Efev. I received a small grant from Opendoors. I called Medicare and they informed me that the drug was $10,240 dollars for 60 pills. My copay was over $2,000. The grant will last me another three refiles. I am going to follow up with the VA to see if I can receive any funding from them.
    I have been doing well with my reaction to the meds. no diarrhea, very slight nausea but it goes away quickley. Just make sure you eat breakfast and dinner so there is food in your stomach. I am happy to find people who are in the same situation as myself.

    • Maralyn Jullienne says:

      Hello Jack
      I have just read your note re your IPF and the meds you are taking! The info regarding your ability to tolerate Ofev was very helpful. I have just been diagnosed with IPF and told that this drug will slow down its progression! I’m in Canada and will have to apply for funding for this drug because I do not have a drug insurance plan and OHIP does not cover it. It is so overwhelming.
      I hope that you are able to receive help also going further!

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