The Italian Medicines Agency (AIFA) has published in the Official Journal the determination of reimbursement of dupilumab for the treatment of severe atopic dermatitis (AD) in children aged between 6 and 11 years who are candidates for systemic therapy. Atopic dermatitis is a chronic inflammatory skin disease in which type 2 inflammation is the main etiopathogenetic mechanism. Atopic dermatitis has an overall prevalence in pediatric age ranging between 5 and 20% with an age of onset less than 5 years in 85-90% of cases. In 40-60% of cases it tends to disappear during adolescence, but there can also be relapses or onset of pathology in adulthood. In Italy at least 35,000 people suffer from it, of which about 8,000 are affected by the severe form of the disease. In pediatric age, atopic dermatitis, especially in severe forms, can have a significant impact on many aspects of the life of children and their families. Until now, the standard of care for children with severe atopic dermatitis has been limited to topical treatments that leave the disease poorly controlled. These children are often forced to live with intense itching and skin lesions that can cover much of the body, resulting in skin cracking, redness or hyperpigmentation, crusting and exudation. This can have a substantial emotional and psychosocial impact, causing sleep disturbances, symptoms of anxiety and depression, and feelings of isolation. Until now, the standard of care for children with severe atopic dermatitis has been limited to topical treatments that leave the disease poorly controlled. These children are often forced to live with intense itching and skin lesions that can cover much of the body, resulting in skin cracking, redness or hyperpigmentation, crusting and exudation. This can have a substantial emotional and psychosocial impact, causing sleep disturbances, symptoms of anxiety and depression, and feelings of isolation. Until now, the standard of care for children with severe atopic dermatitis has been limited to topical treatments that leave the disease poorly controlled. These children are often forced to live with intense itching and skin lesions that can cover much of the body, resulting in skin cracking, redness or hyperpigmentation, crusting and exudation. This can have a substantial emotional and psychosocial impact, causing sleep disturbances, symptoms of anxiety and depression, and feelings of isolation. redness or hyperpigmentation, crusting and exudation. This can have a substantial emotional and psychosocial impact, causing sleep disturbances, symptoms of anxiety and depression, and feelings of isolation. redness or hyperpigmentation, crusting and exudation. This can have a substantial emotional and psychosocial impact, causing sleep disturbances, symptoms of anxiety and depression, and feelings of isolation.
“This further indication for children aged 6 to 11 represents an important milestone – said Mariangela Amoroso, Country Medical lead of Sanofi in Italy – because it opens up access to an innovative drug such as dupilumab even to an age group currently deprived of targeted therapeutic approaches. It is a further concrete example of how much thanks to our commitment we can transform the practice of medicine and bring about a change in the lives of patients and their families “. The results of a study published in the Journal of the American Academy of Dermatology confirm that the management of the disease is very complex when it is affected by pediatric patients. Families, in fact, spend up to 19 hours per week caring for the specific needs of children and / or adolescents with moderate to severe atopic dermatitis. Up to 91% of caregivers report having lost at least one day of work in the previous month and 36% suffering from anxiety and / or depression, demonstrating how onerous the emotional burden and impact of this disease is on the whole. family.
Dupilumab is the only biologic drug to be approved in the EU and reimbursed in Italy both for the treatment of adults and adolescents with moderate to severe atopic dermatitis who are candidates for systemic therapy, and for children aged six years and above with severe atopic dermatitis. In Italy, dupilumab had obtained reimbursement from the National Health Service as early as September 2018 for adults, receiving recognition as an innovative drug from the Italian Medicines Agency. The recognition of the innovation criterion demonstrates the high unmet medical need that characterizes the pathology even in the age group between 6 and 11 years. Dupilumab is a fully human monoclonal antibody that inhibits interleukins 4 and 13 (IL-4 and IL-13), two key proteins in type 2 inflammation and play a key role in atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and eosinophilic esophagitis (EoE). Dupilumab is not an immunosuppressive drug and does not require routine laboratory monitoring. Dupilumab is currently approved in more than 60 countries. Overall, of all indications, over 260,000 patients are treated with dupilumab worldwide. The favorable safety and tolerability profile observed in adult patients treated for up to 3 years is consistent with that demonstrated in Phase 3 studies. In the adult population,

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