Medical specialists say a shot used to treat eczema might be a breakthrough for Chronic Obstructive Pulmonary Disorder (COPD) – which affects millions of people worldwide – and potentially, be the biggest stride made in decades for treating the condition.
Dupilumab is currently used to treat severe eczema, but a clinical trial has shown it cuts hospital admissions in some patients with COPD – an umbrella term for incurable and disabling lung diseases like emphysema and chronic bronchitis.
Patients on the drug were about a third less likely to suffer serious flare-ups that required hospital treatment, reports Daily Mail.
The results, published in the New England Journal of Medicine, also show it boosted lung capacity, reducing breathlessness and making simple tasks such as walking to the shops or climbing stairs much easier.
Dr Surya Bhatt, associate professor at the University of Alabama at Birmingham Division of Pulmonary, Allergy, and Critical Care Medicine, and a co-principal investigator of the trial, said: “I've seen patients with uncontrolled chronic obstructive pulmonary disease struggle for far too long with the debilitating symptoms of this progressive disease – with limited, incremental improvement on current treatment options.
“This trial showed that dupilumab has the potential to impact the vicious cycle of exacerbations and lung function decline in patients with uncontrolled COPD with type 2 inflammation, and significantly improve respiratory symptoms. Dupilumab also helped improve health-related quality of life measures, which, from my years of experience as a physician, are just as meaningful for patients as being able to breathe easier.”
Professor Sir Peter Barnes, from the National Heart and Lung Institute at Imperial College London, said: “Most of the treatments currently used in COPD only relieve the symptoms, such as breathlessness, persistent coughing and wheezing.
“But this is the first one to tackle the underlying mechanism that drives the disease.”
COPD, which causes inflamed, damaged or obstructed lungs, is the fourth-leading cause of death in the world. It affects an estimated 1.2m people in the UK, mostly over 65, and NHS England has said that is set to rise by another 40% by the end of the decade due to increased life expectancy.
The condition already accounts for one in eight of all emergency hospital admissions.
The main cause is smoking, responsible for up to 90% of cases, but studies suggest even ex-smokers are still at risk up to 30 years after quitting. However, air pollution and genetics have also been implicated.
In some types of COPD, the walls of the airways thicken over time and mucus is produced, leaving less space for air to get in and out.
One of the first signs is a cough, but it eventually causes extreme breathlessness and wheezing. Patients can end up needing to wheel an oxygen cylinder around with them just to breathe.
Current treatment involves medication to dilate the airways or exercise programmes to bolster lung capacity, but there have been no new medicines for more than a decade.
Although the treatment works for some patients, it’s much less effective in those who have a particularly severe type of COPD caused by type 2 inflammation – swelling in the airways as a result of the immune system going into overdrive, causing sudden breathlessness in nearly 200 000 patients in the UK.
Type 2 inflammation is also a major trigger in eczema and some people with hard-to-treat asthma.
Dupilumab was initially developed to tackle these conditions by blocking the process that leads to severe inflammation. However, the latest results show the drug can also transform the lives of many COPD sufferers where inflammation is a trigger.
Doctors tested 939 patients and put half on fortnightly jabs of dupilumab and the rest on a placebo, before following them up for at least a year.
The results showed there were a third fewer flare-ups in those on the drug. Some patients started to see an improvement within just two weeks.
Most patients more than doubled the amount of air they could blow out of their lungs in one second – the standard test for the condition.
Although the drug, which costs about £600 a jab, will work only for those where type 2 inflammation is a trigger, doctors say it is still the biggest advance in years.
“This is a very big development,” said Ian Pavord, professor of respiratory medicine at Oxford University. “The results are really exciting and better than anyone had expected. It’s long been somewhat of a desert when it comes to treatment for COPD.”
He said another big dupilumab trial in COPD was due to report next year, and at least six other similar drugs in the pipeline are expected to be just as good.
The drug could be recommended by NHS watchdog the National Institute for Health and Care Excellence – and available to patients – within two years.
Study details
Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts
Surya Bhatt, Klaus Rabe, Naimish Patel, et al.
Published in the NEJM on 21 May 2023
Abstract
Background
In some patients with chronic obstructive pulmonary disease (COPD), type 2 inflammation may increase exacerbation risk and may be indicated by elevated blood eosinophil counts. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and interleukin-13, key drivers of type 2 inflammation.
Methods
In a phase 3, double-blind, randomised trial, we assigned patients with COPD who had a blood eosinophil count of at least 300 per microlitre and an elevated exacerbation risk despite the use of standard triple therapy to receive dupilumab (300 mg) or placebo subcutaneously once every 2 weeks. The primary end point was the annualised rate of moderate or severe exacerbations of COPD. Key secondary and other end points that were corrected for multiplicity were the change in the prebronchodilator forced expiratory volume in 1 second (FEV1) and in the scores on the St. George’s Respiratory Questionnaire (SGRQ; range, 0 to 100, with lower scores indicating a better quality of life) and the Evaluating Respiratory Symptoms in COPD (E-RS–COPD; range, 0 to 40, with lower scores indicating less severe symptoms).
Results
A total of 939 patients underwent randomisation: 468 to the dupilumab group and 471 to the placebo group. The annualised rate of moderate or severe exacerbations was 0.78 (95% confidence interval [CI], 0.64 to 0.93) with dupilumab and 1.10 (95% CI, 0.93 to 1.30) with placebo (rate ratio, 0.70; 95% CI, 0.58 to 0.86; P<0.001). The prebronchodilator FEV1 increased from baseline to week 12 by a least-squares (LS) mean of 160 ml (95% CI, 126 to 195) with dupilumab and 77 ml (95% CI, 42 to 112) with placebo (LS mean difference, 83 ml; 95% CI, 42 to 125; P<0.001), a difference that was sustained through week 52. At week 52, the SGRQ score had improved by an LS mean of −9.7 (95% CI, −11.3 to −8.1) with dupilumab and −6.4 (95% CI, −8.0 to −4.8) with placebo (LS mean difference, −3.4; 95% CI, −5.5 to −1.3; P=0.002). The E-RS–COPD score at week 52 had improved by an LS mean of −2.7 (95% CI, −3.2 to −2.2) with dupilumab and −1.6 (95% CI, −2.1 to −1.1) with placebo (LS mean difference, −1.1; 95% CI, −1.8 to −0.4; P=0.001). The numbers of patients with adverse events that led to discontinuation of dupilumab or placebo, serious adverse events, and adverse events that led to death were balanced in the two groups.
Conclusions
Among patients with COPD who had type 2 inflammation as indicated by elevated blood eosinophil counts, those who received dupilumab had fewer exacerbations, better lung function and quality of life, and less severe respiratory symptoms than those who received placebo.
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