People living with asthma or chronic obstructive pulmonary disease may soon have a new treatment for their symptoms. A recent major clinical trial has shown that an antibody drug can prevent and reduce certain kinds of asthma and COPD flare-ups—even outperforming the only standard medication currently available.
Scientists in the UK, Australia, and Sweden conducted the double-blinded, controlled, and randomized phase II trial, which aimed to test the potential of benralizumab in treating a particular type of asthma or COPD attack. People at high risk of these attacks were randomized to receive steroids, the typical frontline treatment, or a single injectable dose of benralizumab (either alone or with steroids). The researchers found that people who took benralizumab were significantly less likely to need further treatment or to end up in a hospital. The findings could pave the way for the already approved benralizumab to become the first new drug to treat these potentially life-threatening attacks in 50 years, the researchers say.
Benralizumab is a lab-made antibody developed by the company AstraZeneca that is designed to target and reduce specific white blood cells known as eosinophils. While these cells normally help fend off bacterial and parasitic infections, they often play a role in causing allergy and asthma symptoms as well. Some people’s asthma, COPD, or other respiratory illnesses are also primarily instigated by high levels of eosinophils in the body. In 2017, the Food and Drug Administration approved benralizumab as an add-on treatment for people with severe eosinophilic asthma. But researchers have started to study whether the drug could also be used to treat more kinds of asthma or COPD instigated by eosinophils.
People with asthma or COPD can sometimes experience acute, worsening flare-ups (also called exacerbations) of their symptoms, which include wheezing, cough, and trouble breathing. These flare-ups, especially if not managed well, can eventually lead to permanent lung damage and raise the risk of critical illness. Nowadays, people are given steroids to tamp down their flare-ups, but these drugs often fail to work completely and many end up needing further treatment or hospitalization (a treatment failure). Steroids aren’t a risk-free option either, since they can cause unpleasant side-effects like weight gain or increase the odds of chronic complications like type 2 diabetes. Eosinophils are thought to help drive a third of COPD exacerbations and nearly half of asthma attacks, however—providing a possible opportunity for benralizumab to treat these episodes.
The researchers recruited 158 asthma or COPD patients who had recently experienced a flare-up, who were then randomized into three groups: those receiving the steroid prednisolone (taken daily for five days), those receiving benralizumab alone (a single injection), or those receiving prednisolone and benralizumab.
Over the next 28 days, people who took benralizumab reported significantly improved symptoms and higher quality of life than those only taking prednisolone. And over the next 90 days, people taking benralizumab were less likely to experience treatment failure (45% compared to 74% of steroid patients). It also took longer for treatment to fail in those taking benralizumab, leading to less doctor or hospital visits. The team’s findings were published last week in the The Lancet Respiratory Medicine.
While more meaningful than early phase I data, phase II trials still don’t provide definitive evidence of a treatment’s effectiveness. So it will take larger-scale studies to confirm that benralizumab can truly manage these difficult cases. But assuming that it does, the drug could offer a monumental improvement for many people living with these chronic ailments, the researchers say. Since benralizumab is already used to treat other conditions, that might also speed up the timeline for it to be approved for this new indication as well. Just this year, the FDA approved the drug for young children with severe asthma and for another condition tied to eosinophils.
“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,” said lead researcher Mona Bafadhel, a professor at King College London’s Center for Lung Health, in a statement from the university. “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.”
