Trelegy Ellipta Reduces COPD Exacerbations, Improves Lung Function and Quality of Life, Trial Shows

Trelegy Ellipta Reduces COPD Exacerbations, Improves Lung Function and Quality of Life, Trial Shows

Treatment with the triple-combination therapy Trelegy Ellipta reduced exacerbations in chronic obstructive pulmonary disease (COPD) and improved patients’ lung function and quality of life, according to a Phase 3 trial.

The Phase 3 IMPACT study compared Trelegy to other common COPD medications in 10,355 patients in 37 countries, according to GlaxoSmithKline (GSK) and Innoviva.

Findings from the study, titled “Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD,” were recently published in the New England Journal of Medicine.

Trelegy Ellipta was approved as a maintenance treatment for patients with COPD in both the U.S. and the E.U. in 2017.

The treatment, marketed by GSK, contains the inhaled corticosteroid fluticasone furoate, the long-acting muscarinic antagonist umeclidinium, and the long-acting beta2-adrenergic agonist (LABA) vilanterol.

A dose of Trelegy contains 100 micrograms (mcg) of fluticasone furoate, 62.5 mcg of umeclidinium, and 25 mcg of vilanterol.

The IMPACT study (NCT02164513) compared Trelegy Ellipta with GSK’s once-daily COPD therapies Breo Ellipta (fluticasone furoate/vilanterol) and Anoro Ellipta (umeclidinium/vilanterol). All three treatments were delivered in the same dose and inhaler.

Patients enrolled in the trial had moderate to very severe COPD and a history of exacerbations in the previous 12 months. The trial’s more than 10,000 patients were from 1,035 study centers globally.

Results revealed that treatment with the triple therapy Trelegy Ellipta significantly reduced the number of COPD hospitalizations due to severe exacerbations by 34% compared to Anoro Ellipta. Compared to Breo Ellipta, the reduction was of 13%, but this difference was not statistically significant.

The data also showed that Trelegy and Breo, the two medications containing the corticosteroid fluticasone furoate, lowered the risk of on-treatment mortality compared to Anoro.

Specifically, Trelegy decreased this risk by 42.1% compared to Anoro. However, off-treatment data should be analyzed to fully understand the benefits in mortality risk, the team emphasized.

Results further revealed improvements in other clinically relevant parameters, including lung function and health-related quality of life. Additional results will be presented at future scientific meetings.

“Reducing exacerbations to keep patients out of hospital is a key goal of COPD management alongside improving lung function and quality of life,” Dave Allen, head of Respiratory Therapy Area Research and Development at GSK, said in a press release. “The IMPACT study shows how Trelegy Ellipta can help patients with a history of exacerbation achieve these goals.”

Ted Witek, senior vice president and chief scientific officer at Innoviva, said that the “role of inhaled corticosteroids (ICS) in COPD have long been debated, and this landmark trial provides further evidence of their benefit in the population studied and compelling data towards clarifying the role of ICS containing regimens in the COPD treatment paradigm.”

The trial also showed that Trelegy had a similar safety profile as its individual components. Among the most frequent adverse events in the study were viral upper respiratory tract infection, COPD worsening, pneumonia, and headache.

In February 2018, GSK and Innoviva submitted results from the IMPACT study to the European Medicines Agency to support the label expansion of Trelegy Ellipta for European patients with moderate to severe COPD who are at risk of an exacerbation and require triple therapy. A similar submission was filed in the U.S.

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6 comments

  1. Doug Brown says:

    What average person can afford this price. You people need to realize that we live from pay day to pay day. You would sell a lot more by making it available to all that need it. But because of your greed people have to go without medicine that helps them survive. One day you greedy bastards will have to answer for it all.

    • Barbara Solenick says:

      I am on medicare and my insurance co. has not approved this (yet). it was going to cost over $300 (I think). the ins. co. approved it for me but it was still going to be about $100. I go to the doctor in a month’s time and will get her to approve another ellipta product (Breo?) similar I think. then I will be a mail order supply to cut down the cost to about $25/mth. but for this month waiting for my appt., I would rather not be able to breathe, than to pay $100 for Trilegy. I can’t afford it. there is a coupon you can find, but it excludes people on Medicare. with the coupon, it would cost $10. the whole drug industry has made it impossible to live comfortably for the average person. now Trump is talking about the drug industry. God Bless….

  2. John Polachek says:

    In Shanghai China they made have thin Bronchi, grown alveoli, by using SOX9+BCs stem cells. There are 15 people that now can breathe almost normally. We will see it here when FDA and big pharma makes all their monies.You can google and read but it will just show, what bastards we have in our medical community.

  3. George Glassner says:

    Have there been any test to compare the two medications I take, Spiriva Resprimat, and Symbicort to your new medication Trelegy Ellipta?

  4. Paul E Rawlins says:

    After experiencing no effect from different inhalers, my doctor recommended Trelegy. My breathing has improved along with my energy level throughout the day. (no side effects after 14 days of use)

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