Good news for families
The Italian Medicines Agency (AIFA) has published in the Official Gazette the reimbursement determination of dupilumab for the treatment of severe atopic dermatitis (AD) in children aged 6 to 11 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 they suffer from it at least 35 thousand people, of which about 8 thousand suffering from 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 impactcausing sleep disturbances, symptoms of anxiety and depression, and feelings of isolation.Mariangela Amoroso Sanofi Country Medical Lead in Italy: “This further indication for children aged 6 to 11 represents an important milestone because it opens access to an innovative drug such as dupilumab even to an age group currently lacking 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, they spend up to 19 hours a week to address 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 e 36% suffer from anxiety and / or depressiondemonstrating how onerous is the emotional burden and impact of this disease on the entire family unit.
What is Dupilumab
Dupilumab is the only biological 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 from six years of age with severe atopic dermatitis. In Italydupilumab had obtained reimbursement from the National Health Service already in September 2018 for the adult, receiving from the Italian Medicines Agency the recognition of innovative drug.
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.
Atopic dermatitis
Atopic dermatitis is one chronic inflammatory pathology affecting the skin of the face and body of infants, children and adults. Symptoms and disease severity levels change with age. In the first years of life, the areas of the cheeks and chin, the fold of the neck, the arms and legs are mainly affected. After the first year of age, atopic dermatitis mainly affects the face, hands, folds of the elbows and knees.
In moderate to severe forms, it is characterized by lesions that can cover most of the body, often accompanied by dryness, fissuring, exudates, and intense and persistent itching, one of the most difficult symptoms for patients to endure. Due to itching and lesions, often localized in sensitive and visible areas, atopic dermatitis severely compromises the quality of life of patients, with sleep disturbances and an increase in symptoms of anxiety and depression.
Furthermore, it has recently been understood that atopic dermatitis is not just a skin disease: the lesions on the skin, typical of atopic dermatitis, in fact, are only the visible manifestation of an underlying systemic type 2 inflammation.
Furthermore, the “epidermal barrier defect” is often only the starting point of what is defined “Atopic march”: the correlation and consequent or simultaneous occurrence between different atopic diseases, such as asthma, allergic rhinitis, food allergies, etc.