An injection given during some asthma and COPD attacks is more effective than the current treatment of steroid tablets, reducing the need for further treatment by 30%.
The findings, published today in The Lancet Respiratory Medicine, could be "game-changing" for millions of people with asthma and COPD around the world, scientists say.
Asthma attacks and COPD flare-ups (also called exacerbations) can be deadly. Every day in the UK four people with asthma and 85 people with COPD will tragically die. Both conditions are also very common, in the UK someone has an asthma attack every 10 seconds. Asthma and COPD costs the NHS £5.9B a year.
The type of symptom flare-up the injection treats are called 'eosinophilic exacerbations' and involve symptoms such as wheezing, coughing and chest tightness due to inflammation resulting from high amounts of eosinophils (a type of white blood cell). Eosinophilic exacerbations make up to 30% of COPD flare-ups and almost 50% of asthma attacks. They can become more frequent as the disease progresses, leading to irreversible lung damage in some cases.
Treatment at the point of an exacerbation for this type of asthma has barely changed for over fifty years, with steroid drugs being the mainstay of medication. Steroids such as prednisolone can reduce inflammation in the lungs but have severe side-effects such as diabetes and osteoporosis. Furthermore, many patients 'fail' treatment and need repeated courses of steroids, re-hospitalisation or die within 90 days.
Results from the phase two clinical trial ABRA study, led by scientists from King's College London and sponsored by the University of Oxford, show a drug already available can be re-purposed in emergency settings to reduce the need for further treatment and hospitalisations. The multi-centre trial was conducted at Oxford University Hospitals NHS Foundation Trust and Guy's and St Thomas' NHS Foundation Trust.
Benralizamab is a monoclonal antibody which targets specific white blood cells, called eosinophils, to reduce lung inflammation. It is currently used for the treatment of severe asthma. The ABRA trial has found a single dose can be more effective when injected at the point of exacerbation compared to steroid tablets.
The study investigators randomized people at high risk of an asthma or COPD attack into three groups, one receiving benralizumab injection and dummy tablets, one receiving standard of care (prednisolone 30mg daily for five days) and dummy injection and the third group receiving both benralizumab injection and standard of care. As a double-blind, double-dummy, active-comparator placebo-controlled trial, neither the people in the study, or the study investigators knew which study arm or treatment they were given.
After 28 days, respiratory symptoms of cough, wheeze, breathlessness and sputum were found to be better with benralizumab. After ninety days, there were four times fewer people in the benralizumab group that failed treatment compared to standard of care with prednisolone.
Treatment with the benralizumab injection took longer to fail, meaning fewer episodes to see a doctor or go to hospital. There was also an improvement in the quality of life for people with asthma and COPD.
This could be a game-changer for people with asthma and COPD. Treatment for asthma and COPD exacerbations have not changed in fifty years despite causing 3.8 million deaths worldwide a year combined.
Benralizumab is a safe and effective drug already used to manage severe asthma. We've used the drug in a different way – at the point of an exacerbation - to show that it's more effective than steroid tablets which is the only treatment currently available. The big advance in the ABRA study is the finding that targeted therapy works in asthma and COPD attacks. Instead of giving everyone the same treatment, we found targeting the highest risk patients with very targeted treatment, with the right level of inflammation was much better than guessing what treatment they needed."
Mona Bafadhel, lead investigator of the trial, professor, King's College London
The benralizumab injection was administered by healthcare professionals in the study but can be potentially administered safely at home, in the GP practice, or in the Emergency Department. Benralizumab was safe in the study and similar in safety to many past studies.
Professor Mona Bafadhel said, "We hope these pivotal studies will change how asthma and COPD exacerbations are treated for the future, ultimately improving the health for over a billion people living with asthma and COPD across the world."
Dr Sanjay Ramakrishnan, Clinical Senior Lecturer at the University of Western Australia, who is the first author of the ABRA trial and started the work while at the University of Oxford, said: "Our study shows massive promise for asthma and COPD treatment. COPD is the third leading cause of death worldwide but treatment for the condition is stuck in the 20th century. We need to provide these patients with life-saving options before their time runs out.
"The ABRA trial was only possible with collaboration between the NHS and universities and shows how this close relationship can innovate healthcare and improve people's lives."
Geoffrey Pointing, 77 from Banbury, who took part in the study, said: "Honestly, when you're having a flare up, it's very difficult to tell anybody how you feel - you can hardly breathe. Anything that takes that away and gives you back a normal life is what you want. But on the injections, it's fantastic. I didn't get any side effects like I used to with the steroid tablets. I used to never sleep well the first night of taking steroids, but the first day on the study, I could sleep that first night, and I was able to carry on with my life without problems. I want to add that I'm just grateful I took part and that the everyone involved in the ABRA study are trying to give me a better life."
Dr Samantha Walker, Director of Research and Innovation, at Asthma + Lung UK, said: "It's great news for people with lung conditions that a potential alternative to giving steroid tablets has been found to treat asthma attacks and chronic obstructive pulmonary disease (COPD) exacerbations. But it's appalling that this is the first new treatment for those suffering from asthma and COPD attacks in 50 years, indicating how desperately underfunded lung health research is.
"Every four minutes in the UK, someone dies from a lung condition. Thousands more live with the terror of struggling to breathe every day. With your help, we're fighting for more life-changing, life-saving research to transform the future for everyone living with breathing problems. Together, we'll make sure that families everywhere never face a lung condition without the best treatment and care.
"Our vision is a world where everyone has healthy lungs. We can only get there with your help."
This research was conducted with support from AstraZeneca UK Limited.
The paper, titled Monoclonal antibody better than standard treatment for some types of asthma attacks and COPD flare-ups, phase II clinical trial results suggest, is published in The Lancet Respiratory Medicine.
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