A study participated by Vall d'Hebron made possible the approbation of a new treatment for severe pediatric asthma

An international clinical trial has demonstrated the effectiveness of dupilumab in reducing patients’ asthmatic exacerbations, improving their and their relatives quality of life

02/05/2022

An international phase III clinical trial has proved the effectiveness of dupilumab to control moderate and severe pediatric asthma. The results have been published in The New England Journal of Medicine. The study has been developed simultaneously in fourteen centers of eight different countries and is signed by 25 researchers; including Dr. Inés de Mir, coordinator of the Vall d'Hebron University Hospital’ Asthma Unit within the Paediatric Pneumology and Cystic Fibrosis Unit and a researcher in the Vall Hebron Research Institute (VHIR) Growth and Development group. Using the results as a baseline, the European Medicines Agency (EMA) has approved the use of this monoclonal antibody in asthmatic patients from age six upwards. 

Dupilumab is a monoclonal antibody that inhibits the signals between cells of the immune system transmitted by interleukin-4 (IL-4) and interleukin-13 (IL-13). These signals are involved in type 2 inflammation, which is linked to cases of Atopic Dermatitis (AD) and a majority of asthmas in children. Initially, the use of dupilumab was approved to treat cases of severe Atopic Dermatitis, and later, it was extended to cases of severe asthma in adult and teenage patients from the age of twelve. Currently, the authotization of this medicine for asthma paediatric patients is being processed by the Spanish state and therefore it is not possible to be prescribed yet. However, when the EMA approves a drug it can already be administered as "compassive use".

408 children participated in the clinical trial, led by Dr. Leonard Bacharier of the Vanderbilt University Medical Center in Nashville, United States, All had moderate or severe asthma and had suffered of at least a serious exacerbation during the twelve months prior to the beginning of the study. Dupilumab was administered as a supplement to traditional treatment. The participants were randomly divided and double-blinded divided into two groups; 273 participants were injected with the antibody and 135 were given a placebo. The trial lasted one year and consisted of a subcutaneous injection every fortnight.

Results showed that patients who received the treatment had, statistically,  fewer asthmatic crises and better lung function than the control group. In total, 78% of patients with dupilumab had no exacerbation throughout the period, in the control group the percentage was 60%. In some cases, the improvement was so positive that patients reduced or even stopped the traditional treatment, maintaining only the dupilumab injection. This significantly improved their and their relatives quality of life.

Dr. de Mir emphasizes the importance of early treatment to avoid the inflammatory and structural changes that patients can develop at bronchial level: "It seems that there is a small window of opportunity in the early ages to slow down the disease and prevent its evolution towards a severe asthma with loss of pulmonary function in adulthood". In fact, patients with serious childhood asthma, who experience reduced growth in pulmonary function, have a greater risk of evolving into a fixed obstruction of the airway and prematurely developing a Chronic Obstructive Pulmonary Disease (COPD). Currently, it must be assessed whether dupilumab is effective in the long term "This possibility, and if the appreciable improvements in children are maintained once treatment is stopped, are the two major questions to be resolved", Dr. de Mir concludes. If the results are positive, the dupilumab can mean a qualitative improvement in patients' current and future lives.

Dr. De Mir reminds that although asthma is perceived as a mild pathology, actually it is a chronic disease that it may have serious or even fatal consequences. It is calculated that 10-15% of the children have some kind of asthmatic pathology. Of these, a 5 to 8% have an uncontrolled moderate-to-severe version which means frequent stays in the hospital and a loss of life quality for the patients and their relatives. It is estimated that in Catalonia, where Vall d'Hebron is the referrall hospital, there are currently about 5,000 children under the age of fourteen suffering moderate-to-severe asthma. Treatments such as dupilumab aspire to achieve better control of pathology and eliminate or at least reduce the serious exacerbations of these patients.

"There could be a small window of opportunity in the early ages to slow down the disease and prevent its evolution towards a severe asthma"

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