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International study supports dupilumab for treatment of moderate-to-severe asthma in children

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A new drug has been added to the treatment options for children with moderate to severe asthma. In late-stage clinical trials, the biopharmacy dupilumab reduced the incidence of severe asthma attacks and improved lung function and asthma control in children aged 6 to 11 years.

The results of the international multicenter Liberty asthma VOYAGE trial were reported on 9 December. New England Journal of MedicineSupports approval of dupilumab for moderate to severe treatment asthma In this age group by the Food and Drug Administration in October.

“This is a very important advance for children with moderate to severe asthma and their families,” said Leonardo Bacarier Medicine, an asthma specialist and international principal investigator at the Monroe Karel Junior Children’s Hospital in Vanderbild. The doctor says.

Asthma, a condition that affects the airways of the lungs and makes it difficult to breathe, is the most common chronic disorder in childhood and affects more than 5 million children under the age of 18, according to the Center for Disease Control and Prevention. doing.It is the main cause of hospitalization of children and children with moderate to severe asthma may have decreased Lung function Bakarier, chairman of Janie Robinson and John Moore Lee in the Department of Pediatrics at Vanderbilt University School of Medicine, said the risk of lung disease is high in adulthood.

“As asthma becomes more and more severe, the burden increases, affecting children and the whole family,” he said. “We have very good asthma treatments available, but there is no perfect cure to get rid of the severe exacerbations.”

Dupilumab, a monoclonal antibody that targets type 2 inflammation, has been approved for several years for the treatment of asthma in adults and adolescents. Based on its established safety and efficacy, researchers have conducted Phase 3 clinical trials in 408 children aged 6 to 11 years with uncontrolled moderate to severe asthma. We conducted a test.

Children were randomized to receive subcutaneous injections of dupilumab or placebo in addition to standard treatment every two weeks for one year. Neither the researchers nor the participants knew who was actively treated for the placebo (double-blind study design).

Most of the children who participated in the study showed elevated levels of type 2 inflammation, a marker of immune cells called eosinophils, and / or elevated levels of nitric oxide in the exhaled breath. In patients with these markers, dupilumab reduced the rate of severe exacerbations (symptoms requiring systemic steroid treatment, emergency medical care or hospitalization) by almost 60%.

In addition, dupilumab improved lung function as measured by forced exhalation and improved asthma control as assessed by standardized questionnaires performed by trained interviewers.

“This is the first study of this kind in children aged 6 to 11 years, showing that biopharmacy improves asthma exacerbations, lung function, and asthma control,” Bakarier said. I am saying. “Dupilumab Clinical trials Although adults and adolescents, they are happy with the results and the hopes they bring to their children and their families. ”

Dupilumab, in agreement with expectations, was ineffective in a small number of children in trials with no evidence of type 2 inflammation, he added.

Studies have shown that dupilumab is safe. Some children receiving active drugs showed elevated or mild but manageable parasite infections (type 2 immunity fights parasites), but side effects Few participants had to discontinue dupilumab because of it.

Patients in the VOYAGE trial were invited to an additional one-year extended trial and all participants received dupilumab. Extended trials focus on both efficacy and long-term safety. Results should be available in mid-2022.

Although two other biopharmaceuticals targeting type 2 inflammation have been approved for the treatment of asthma Children, Both worsening asthma, lung function, and Asthma control— In a controlled clinical trial, Bakarier said.

Bakarier plans to explore the potential of dupilumab to improve the onset of asthma. “Can this drug be used early in life to change the way the disease develops? I think that’s the next frontier,” he said.

Bakarier PrecISE network (Precision intervention for severe asthma), a network funded by the National Institutes of Health, testing very new asthma treatments for patients Severe asthma..

Liberty Asthma VOYAGE Trial (NCT02948959) With the support of dupilumab makers Sanofi and Regeneron Pharmaceuticals. Dupilumab is also FDA approved for atopic dermatitis and chronic sinusitis with nasal polyps.


Voyage Phase 3: Dupilumab significantly reduced asthma exacerbation in 6-11 year old children


For more information:
Dupilumab, in children with uncontrolled moderate to severe asthma, New England Journal of Medicine (2021). DOI: 10.1056 / NEJMoa2106567

Quote: International studies of children (2021, December 8, 2021) obtained from https: //medicalxpress.com/news/2021-12-international-dupilumab-treatment-moderate-to on December 8, 2021. Supports dupilumab for the treatment of moderate to severe asthma-severe-asthma.html

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