Humira, approved in Europe for children and adolescents from four years of age with severe chronic plaque psoriasis
The European Commission ( EC ) has granted marketing authorization for Humira ( Adalimumab ) for the treatment of severe chronic plaque psoriasis in children and adolescents from four years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
The marketing authorization is based on the positive results of a phase 3 study.
With the approval from the European Commission, Humira is now the only biologic approved in Europe to treat children with this condition starting at four years of age.
According to estimates from the World Health Organization ( WHO ), pediatric psoriasis occurs in 0.70% of the pediatric population, with no significant difference by gender.
The chronic autoimmune disease is characterized by the rapid and excessive accumulation of skin cells, which form thick patches of inflamed, scaly skin.
Pediatric psoriasis has similar characteristics to adult psoriasis, but in children, the psoriatic lesions are typically smaller, thinner, and less scaly.
Beyond the physical challenges of managing the chronic skin disorder, it is also considered to have significant emotional and psychological effects.
Humira is contraindicated in patients with active tuberculosis or other severe infections and in patients with moderate to severe heart failure.
The use of Humira increases the risk of developing serious infections which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with a TNF-antagonist. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death.
A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded.
The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache, abdominal pain, nausea, rash and musculoskeletal pain. ( Xagena )
Source: Abbvie, 2015