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Dupilumab safe, effective for treatment of uncontrolled asthma
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Dupilumab, a drug typically used to treat moderate-to-severe eczema, may assist in reducing the rate of severe exacerbation in those aged 12 years and older with uncontrolled asthma.
According to the study, published in The New England Journal of Medicine, this drug also can improve forced expiratory volume in 1 second (FEV1) for these patients.
“This drug not only reduced severe symptoms of asthma, it improved the ability to breathe,” Mario Castro, MD, the Alan A. and Edith L. Wolff Distinguished Professor of Pulmonology and Critical Care Medicine at the Washington University School of Medicine, said in a press release. “This is important because these patients have a chronic, disabling disease that worsens over time with loss of lung function. So far, we do not have a drug for asthma that changes the course of the disease. Current drugs for severe asthma help reduce trips to the emergency room, for example, but they do not improve lung function.”
To examine the safety and efficacy of subcutaneous dupilumab in patients aged 12 years and older with uncontrolled asthma, Castro and colleagues conducted a trial in which patients were randomly assigned to treatment groups with a ratio of 2:2:1:1. Some received 200 or 300 mg doses of the drug, whereas others received matched-volume placebos. All interventions were used every 2 weeks for 52 weeks total.
Once data were collected, the researchers assessed the annual rate of severe asthma exacerbations and the changes observed in FEV1 from baseline to week 12, which was examined before bronchodilator use in the overall trial population.
Additionally, the researchers calculated the rate of exacerbation and FEV1 of patients who demonstrated an eosinophil count of at least 300/mm3.
Of the 1,902 patients included in the study, the rate of severe asthma exacerbations was 0.46 for patients receiving 200 mg of dupilumab every 2 weeks (95% CI, 0.39-0.53). The rate of severe asthma exacerbations was higher among patients who received a placebo (0.87; 95% CI, 0.72-1.05). The researchers calculated that the rate of severe exacerbation was 47.7% lower for patients taking dupilumab than those taking a placebo. Comparable results were reported for those taking 300 mg of dupilumab every 2 weeks.
When Castro and colleagues assessed FEV1, those who took 200 mg of dupilumab demonstrated an 0.32-L increase (difference vs. matched placebo, 0.14 L; P < .001). Those who took 300 mg of the drug demonstrated similar results regarding FEV1.
For those who had an eosinophil count of at least 300/mm3, the annual rate of severe asthma exacerbation was 0.37 for those who took 200 mg of the drug (95% CI, 0.29-0.48). Those who received a matched placebo had a significantly higher annual rate of exacerbation, with researchers observing a rate of 1.08 (95% CI, 0.85-1.38; 65.8% lower rate with dupilumab; 95% CI, 52.0-75.6). Castro and colleagues also observed comparable results when patients received 300 mg doses of dupilumab.
Those who took the drug were more likely to experience blood eosinophilia after beginning treatment (n = 52 patients; 4.1%) when compared with those who received a placebo (0.6%).
“I have patients who have had to stop working and go on disability because their asthma symptoms are so severe that they can no longer function in the workplace,” Castro said in the release. “I am excited about the potential of dupilumab because I have so many patients who have maxed out on available therapies, and they still cannot breathe. [Asthma] can become a very disabling disease.” – by Katherine Bortz
Disclosures: Castro reports receiving support for this study from Sanofi and Regeneron Pharmaceuticals, Inc. The authors also received writing and editorial support in the preparation of the manuscript from Adam J. Beech, PhD, of Excerpta Medica, funded by Sanofi Genzyme and Regeneron Pharmaceuticals. Please see the study for a full list of other authors’ relevant financial disclosures.
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