- Trial found those on tezepelumab had 61% to 71% fewer exacerbations
- Drug is a biological therapy, which stimulates immune system to defend itself
- In 15% of patients, the condition is not controlled with inhaled medications
- Severe asthma sufferers are forced to take high dose steroids with side effects
- Researchers say ‘a new era’ has begun in developing drugs for severe asthma
A breakthrough drug reduces the rate of serious asthma attacks by around two-thirds, new research suggests.
The new injectable medication has been hailed as the most ‘promising’ hope for patients with persistent, uncontrolled symptoms.
A trial found those on tezepelumab had 61 percent to 71 percent fewer exacerbations that needed a hospital visit or change in medication dose compared with those who took a placebo.
Tezepelumab is a biological therapy, which work by stimulating the body’s immune system to defend itself.
If approved, the drug could join a group of costly medications that appear to help when nothing else offers relief in severe cases.
A new injectable drug called tezepelumab was shown to reduce serious attacks by around two-thirds in a clinical trial
‘A new era has begun in which many new drugs are being developed for patients with severe asthma,’ said Dr Elisabeth Bel, study author and a professor of respiratory medicine at the University of Amsterdam in the Netherlands.
‘Similar to what has happened for rheumatoid arthritis, I expect that in a few years effective treatments will be available for almost all patients with severe asthma.’
Asthma is a long-term condition that affects the airways. Symptoms include wheezing, coughing, breathlessness and having a tight chest.
In an estimated 15 percent of patients, it is not controlled with current inhaled medications.
There were 338,000 people killed by asthma worldwide in 2015 – yet two in three deaths are said to be preventable.
Around one in 12 adults in the UK is being treated for asthma with an average of three patients dying a day. In the US, cases have been increasing since the early 1980s and now 25million – 7.4 percent of adults – have it.
Key findings
In this phase II trial, researchers took 584 patients with severe asthma who were nonsmokers, aged 18 to 75, and who used asthma inhalers.
They had all suffered at least one asthma attack that required hospitalisation within the past year, or had two attacks that forced physicians to increase their medication level.
They were randomly divided into low-dose, medium-dose or high-dose groups, or assigned to take a sham (‘placebo’) drug.
Tezepelumab ‘demonstrated improvements’ in lung function at all doses and achieved ‘asthma control’ at the two higher doses, said study co-author Dr Rene van der Merwe.
The authors said the research did not reveal any ‘unexpected’ safety concerns. However, 62 per cent of patients reported side effects and 9 per cent reported ‘serious’ side effects.
Researchers reported one death from the trial but it is not clear from the report if this was linked to the drug.
Most ‘promising’ drug
In the commentary of the study, which was published in the journal The New England Journal of Medicine, Dr Bel wrote that ‘tezepelumab appears to be the broadest and most promising biologic for the treatment of persistent uncontrolled asthma to date.’
The drug works by blocking a molecule that is key to the development of swelling in the airway.
People with moderate to severe asthma can struggle to get their condition under control with inhaled medications and are forced to take high doses of steroids which can have serious side effects
She said patients with severe asthma suffer greatly and risk admission to the intensive care unit and death.
‘They have very poor quality of life and have much difficulty in functioning and cannot go to work,’ she said.
‘Many of them have to take oral corticosteroids – prednisone – on a daily basis and suffer from the serious side effects.’
Adverse affects of these steroid drugs include weight gain, high blood pressure, muscle weakness, vomiting and problems sleeping.
However, she warned that tezepelumab is only effective in certain subtypes of asthma.
Asthma UK said the findings were ‘very exciting’.
Dr Erika Kennington, head of research at the charity, said: ‘For far too long, research into treatments for people with moderate to severe asthma has been far and few between.
‘This is an area that Asthma UK has been calling for increased investment in as current, and even the latest drugs, do not work for a significant proportion of people with moderate to severe asthma.
‘This is a very exciting and well-designed research study, and the results at this early stage are promising.
‘We very much welcome and look forward to the next phase of trials in a larger number of people, which could give hope and a better quality of life to people with severe asthma.’
The causes of asthma – which is incurable – are not completely understood. However, risk factors for developing it include inhaling ‘triggers’, such as allergens, tobacco smoke and chemical irritants.
The researchers said it is too soon to estimate how much the drug may cost, however, similar biologic asthma drugs cost $25,000 to $30,000 a year.
A third phase of research is required before the drug, being developed by MedImmune, AstraZeneca’s global biologics research and development arm, in collaboration with Amgen, could be approved in the US.