The biologic drug dupilumab (Dupixent) is now indicated for treatment of adolescents 12 year and over with moderate-to- severe atopic dermatitis (AD), according to manufacturer Sanofi Genzyme.
The company says the registration of dupilumab has been extended from adults to include patients aged 12-17 years.
It is now seeking PBS listing for the biologic in adults before submitting for a subsidy for children, and in the meantime the drug is being made available via private prescription at a cost of $1,615.38 for two 300 mg injections – the monthly dose after an initial 600 mg loading dose.
The announcement was welcomed by Associate Professor Saxon Smith from the Department of Dermatology at Sydney’s Royal North Shore Hospital, who said it would allow earlier intervention and offer a useful additional option for children whose AD had not responded to other treatments.
“It’s an opportunity to intervene early in patients with severe AD and to truncate the effects that have very significant impact on their quality of life such as loss of sleep and school performance,” he said.
Dr Smith said a recent consensus statement published in the Australasian Journal of Dermatology advise that mild to moderate AD in children could be treated with moisturisers, and topical corticosteroids, and the options for moderate to severe disease included phototherapy and systemic therapies such as methotrexate and mycophenolate.
However the current treatment options in patients with moderate–severe disease were limited, with many medications being used off-label, and each having drawbacks such as adverse effects.
“They’re not for everyone and for some individuals there is simply no improvement,” he said.
The consensus statement for adults advises that “Considering currently available data and the safety profiles of systemic therapies that are approved by the Australian TGA to treat AD, it is recommended that dupilumab could be considered as a first-line systemic treatment option in adults with moderate-to-severe AD who are uncontrolled with topical therapies.”
Dr Smith said that unlike broad-spectrum immunosuppressants dupilumab was a more selectively targeted treatment acting on the cytokines IL-4 and IL-13, which are key drivers in the TH2 response in atopic disease. Its selectivity meant that it appeared to have a good safety profile, with few contraindications, he added.
“Dermatologists are well versed in prescribing biologics for psoriasis, but this marks the first targeted biologic agent for moderate-to-severe atopic dermatitis,” he said.
Patients generally required medium to long term treatment with the biologic, and their eczema would tend to creep back over time after the drug was stopped, he said.
Dr Smith declared interests of receiving educational grant honoraria from Sanofi Genzyme.