2024-03-27 07:00:10
Recently authorized in infants from 6 months of age for the treatment of severe atopic dermatitisthe Dupixent (dupilumab) is now covered 65% in children aged 6 months to 5 years. We take stock.
Atopic dermatitis: insufficient treatment in young children
Atopic dermatitis (or atopic eczema) refers to a chronic inflammatory skin disease that mainly affects children. Occurring very early in life (around the age of 3 months in general), it affects 18% of children aged 6 months to 5 years and develops in outbreaks in babies and children before disappearing in adolescence.
To know ! Atopic dermatitis occurs on a particular genetic background subject to the development of allergies (atopy) during exposure to environmental allergens (mites, pollen, etc.).
Non-contagious, atopic dermatitis is responsible for itching causing excoriation lesions. These lesions are not trivial since they can lead to infectious complications (staphylococcus aureus or the herpes virus for example) as well as significant sleep disorders. 11% of children suffering from atopic dermatitis develop severe form of this condition.
Yet, atopic dermatitis remains undertreated in young children with only 4% of children aged 1 to 5 referred to a dermatologist for specialized care. As for treatment, it has until now been limited to local treatments or broad-spectrum immunosuppressive treatments used without marketing authorization (AMM). It must be said that due to a lack of sufficient scientific data, young children could not benefit from treatment with the Dupixent monoclonal antibody reimbursed in children over 6 years old, in adolescents and in adults.
To know ! The specialty Dupixent (dupilumab) is a fully human monoclonal antibody that blocks interleukin 4 (IL-4) and interleukin 13 (IL-13) signaling (molecules involved in inflammatory processes) without immunosuppressive effects.
Also read – Is it possible to identify babies at risk of eczema early?
Evaluation of the effectiveness of dupilumab in young children
A phase 3 study entitled Liberty AD Preschool was thus conducted to evaluate against placebo the effectiveness and safety of dupilumab in young children, in combination with low activity topical corticosteroids. The trial took place over 16 weeks on a sample of 162 children aged 6 months to 5 years and presenting moderate to severe atopic dermatitis insufficiently controlled by local treatments. Every 4 weeks, children treated with dupilumab received a dose based on their weight: 200 mg (for children 5 to 15 kg) or 300 mg (for children 15 to 30 kg).
The results of this study demonstrate the superiority of dupilumab compared to placebo with :
A reduction in overall severity of the disease 55% compared to inclusion compared to 10% for the placebo group. A rapid reduction in itching from the third week of treatment. A significant reduction in itching after sixteen weeks (on average 42%). Maintenance of significant reduction in itching at one year. Obtaining normal or near-normal skin with reduction in the overall severity of the disease, compared to the placebo group. Improved quality of sleep, relief of skin pain and improvement in quality of life in all patients, including those with the most severe forms of the disease.
This medication also presents a safety profile similar to that observed in the adolescent and adult population with the absence of increased risk of infections. It is planned that a new 5-year study will complete these results in order to evaluate the long-term safety and effectiveness of dupilumab.
Read also – What’s new in the treatment of atopic dermatitis
Dupilumab: usable and refundable from the age of 6 months
This phase 3 trial made it possible to demonstrate a significant clinical benefit and to obtain a reduction in type 2 inflammation. Dupilumab having demonstrated “ of a significant and clinically relevant additional effect amount”, its use from the age of 6 months has been authorized since March 2023.
Following this extension of indication, a request for support was filed with the Transparency Commission. Validated, the support was published in the Official Journal at the beginning of December 2023 with a reimbursement rate of 65%. In the treatment of severe atopic dermatitis in children aged 6 months to 5 years, only boxes of 1 pre-filled syringe of DUPIXENT 200 mg and DUPIXENT 300 mg are now covered. This unit presentation is sufficient for 1 month of treatment in accordance with the recommended dosage.
To know ! However, the box presentations of 2 pre-filled syringes of DUPIXENT 200 mg and 300 mg as well as the pre-filled pen presentations are not supported in this indication.
Read also – Atopic dermatitis, a cancer risk factor?!
Déborah L., Doctor in Pharmacy
Sources
– Dupixent, first biotherapy from the age of 6 months. www.lequotidiendumedecin.fr. Accessed March 20, 2024.
– DUPIXENT: extension of treatment for severe atopic dermatitis in children under 5 years old.www.vidal.fr. Accessed March 20, 2024.
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