About 20 percent of people with asthma have uncontrolled, moderate-to-severe symptoms that persist despite standard-of-care treatment. Lung function in persons with asthma may decrease over the long term. And roughly 45 percent of those with severe asthma control their symptoms with oral steroids, which may cause serious side effects such as diabetes, osteoporosis, stunted growth and cataracts.
Two studies suggest that dupilumab, a drug used to treat eczema, may relieve asthma symptoms and improve patients’ ability to breathe better than standard treatments. Based on the results of these studies, presented at the American Thoracic Society conference, scientists think dupilumab may reverse the course of moderate-to-severe asthma, and improve patients’ quality of life.
“So far, we do not have a drug for asthma that changes the course of the disease,” said Mario Castro, lead author of one of the two studies of dupilumab, in a statement. Current treatments for severe asthma may reduce the number of trips to the emergency room, but they don’t improve lung function, said Castro.
Dupilumab improved lung function and lessened asthma symptoms among participants in both studies. It is an injectable biologic drug that reduces the type 2 inflammation present in about 50 percent of patients with asthma and was approved last year by the U.S. Food and Drug Administration for the treatment of eczema.Dupilumab may reverse the course of moderate-to-severe asthma, and improve patients’ quality of life.
Over 1900 people with moderate-to-severe asthma were enrolled in the Castro team's study. Participants were at least 12 years old, and had required at least three different inhaled asthma medications to control their symptoms. Participants were randomly placed in one of three groups: receiving either 200 mg of dupilumab, 300 mg of dupilumab or a placebo every two weeks for 52 weeks.
Those people receiving dupilumab, regardless of dose, had significantly improved lung function. Their results on the Forced Expiratory Volume (FEV1) test improved by about 130 to 200 milliliters more compared to those assigned to placebo. People who took dupilumab also had about half the number of emergency room visits compared to those receiving placebo.
A second German study of dupilumab enrolled 210 patients who used the same inhaled medications as those in the first study, as well as oral steroids such as prednisone to control more severe symptoms. They received either 300 mg of dupilumab or a placebo every two weeks for 24 weeks.
Almost half of those receiving dupilumab were able to completely eliminate oral steroids, compared to 25 percent of those receiving placebo. About 80 percent of those who took dupilumab were able to cut their dose of steroids by at least in half, compared to 50 percent of those who were given a placebo.
Patients may have to take steroids for decades just so they can breathe, explained Castro, the Alan A. and Edith L. Wolff Distinguished Professor of Pulmonology at Washington University School of Medicine. Because long-term use of oral steroids can raise blood pressure and blood sugar, suppress growth, cause weight gain and thin bones, among other problems, doctors work to help patients reduce or completely eliminate their use for symptom control.
“I have patients who have had to stop working and go on disability because their symptoms are so severe, they cannot function in the workplace,” Castro said. Because many of his patients have exhausted the currently available therapies and still cannot breathe, the potential for dupilumab is exciting.
The Castro study, the German study, and a related editorial are published in The New England Journal of Medicine.