Drugs, in Italy the first refractory severe eosinophilic anti-asthma in children

To each his own care: being able to offer each patient the most suitable treatment for his case means optimizing the results of the treatment, improve therapeutic appropriateness and patient adherence. This rule is particularly valid for children, which are not ‘small adults’ but have specific characteristics, both for physical development and for the manifestations of diseases such assevere asthma, which presents with different phenotypes. On this front, there is a therapeutic novelty: mepolizumab, anti-IL-5 monoclonal antibody (Interleukin-5), is the first drug approved by the Italian Medicines Agency (Aifa) for the treatment of children and adolescents in case of severe refractory eosinophilic asthma. This was reported by GlaxoSmithKline (Gsk) in a note.

The pharmaceutical company specifies that the drug should only be prescribed by the specialist, because it is necessary that the child has been adequately studied, with a consequent certain diagnosis of severe asthma. “Lbronchial asthma is constantly increasing in the pediatric population: in about 5 cases out of 100 of the total pediatric asthmatic population the disease takes on the characteristics of severe asthmave, which must be recognized and followed up at a specialized center “, explains Gian Luigi Marseglia, president of Siaip (Italian Society of Pediatric Allergology and Immunology).

In the child older than 6 years – continues the specialist – asthma is defined as severe if it requires continued high dose inhaled steroid treatment for at least one year, or a treatment with systemic steroids, and despite this the symptoms are not controlled, or worsen as the therapy itself decreases. Therefore, care must be taken in the diagnosis, avoiding confusing the so-called ‘difficult to treat’ asthma which is estimated to affect 39-55% of children with uncontrolled asthma and classified as ‘severe’. “

In case of ‘out of control’ asthma despite treatment, it is necessary that the child is evaluated and followed by a specialist for an adequate period, that any elements that may affect the management of the disease such as adherence to treatment are eliminated and that the to a diagnosis of real ‘severe’ asthma. At this point, thanks to research, it is now possible to offer, when the indication exists, also the therapy with mepolizumab, from 6 years of age, in the case of a disease characterized by eosinophilia (i.e. increase in a particular type of white blood cell)

In the child, as in the adult, the key word is appropriateness: it is necessary to recognize severe asthma, develop a treatment path and include the biological drug in the therapeutic strategy when it is indicated “, he says Giorgio Piacentini, full professor of Pediatrics at the University of Verona. “In the case of severe eosinophilic asthma, having a monoclonal antibody specifically indicated for this pathology available means being able to deal with it effectively and safely: the control of the disease translates into the well-being of the child, who can lead a life similar to that of his peers, and of the family”. “Mepolizumab should be used with specific dosages – the expert points out – tailored to the age. From the age of 12, administration with an auto-injection pen is available”.

Children with severe eosinophilic asthma are at risk of potentially life-threatening acute asthma attacks and consequent hospitalizations. “Failing to control severe asthma in a child will severely affect his or her family, school and social life: for this reason it is essential that the specialist investigates the clinical picture, makes sure that there is adequate adherence to the prescribed therapies and in case of their ineffectiveness ‘phenotypes’ (i.e. identifies the mechanism underlying the altered immunological response) to identify the biological drug useful in individual cases “, he concludes Mariangela Tosca, head of the Allergy Center of the Gaslini Institute in Genoa.

“In the most severe allergic forms of children aged 6 and up we already had omalizumab – underlines Mariangela Tosca – and today with mepolizumab we can deal with cases of severe refractory eosinophilic asthma. In our clinical experience we have seen how this therapy can ‘change life’ for children who regain the ability to breathe, play, do what the life of their age proposes. The efficacy and safety of mepolizumab has been demonstrated in adolescents and young adults and also in patients aged 6 to 11 years ”.

“That of GSK with Italian pneumology and allergology is a long journey over 50 years – he remembers Sara De Grazia, Medical Lead of Gsk – mepolizumab arrived in Italy for about 4 years thanks to our commitment to offer innovative therapeutic solutions to patients, trying to satisfy more and more their needs and requirements and, in this case, also the specificities and characteristics of a patient such as a child for whom the safety and tolerability profile is particularly important. Mepolizumab has obtained initial approval by EMA of the extension of the indication for the treatment of children and adolescents from 6 years of age thanks to an approach of partial extrapolation of the available data and to an efficacy and safety study. The pediatric indication, from 6 to 17 years old, was adopted by Aifa “.

“Finally – concludes De Grazia -” the molecule is produced in our factory in Parma, which serves 28 markets and supplied 700,000 bottles in 2020, which makes us proud to be able to contribute to improving the lives of our patients, even the smallest ones. directly on our territory “.


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