Rome, 30 March (beraking latest news Health) – 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, improving the therapeutic appropriateness and adherence by the patient. This rule is particularly valid for children, who are not ‘small adults’ but have specific characteristics, both for physical development and for the manifestations of diseases such as severe 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 asthma. severe refractory eosinophilic. 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. “Bronchial asthma is constantly increasing in the pediatric population: in about 5 cases out of 100 of the total pediatric asthmatic population the disease assumes the characteristics of severe asthma, 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 over the age of 6 – continues the specialist – asthma is defined as severe if it requires continuous treatment with a high dose of inhaled steroids for at least a year, or treatment with systemic steroids, and despite this the symptoms do not are controlled, or worsen as the therapy itself decreases. Care must therefore 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 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, starting from 6 years of age, in case of pathology characterized by eosinophilia (i.e. increase in a particular type of blood cell whites).
“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”, says Giorgio Piacentini, full professor of Pediatrics at the u 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 peers, and family “.” Mepolizumab should be used with specific dosages – the expert points out – tailored to 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. “Not controlling severe asthma in children means having a heavy influence on his 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 ‘phenotyping’ (ie identifying the mechanism underlying the altered immunological response) to identify the biological drug useful in the individual case “, concludes Mariangela Tosca, head of the Allergology Center of the Gaslini Institute in Genoa.
“In the most severe allergic forms of children aged 6 and over 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 to children who regain the ability to breathe, play, do what life of their age proposes. The efficacy and safety of mepolizumab has been demonstrated in adolescents and young adults and also in patients aged between 6 and 11 years “.
“Gsk’s path with Italian pulmonology and allergology is over 50 years long – 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 the child for whom the safety and tolerability profile is particularly important. Mepolizumab has obtained initial approval from part of the 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. at 17, it was received 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 “.