STELARA

Key points

Favourable opinion for reimbursement only in the treatment of severe chronic plaque psoriasis in children aged 6 to 11 years, defined by :

-    failure (insufficient response, contraindication or intolerance) of at least two treatments including non-biological systemic treatments and light therapy

-    and an extensive form and/or significant psychosocial impact.

What therapeutic improvement ?

No clinical added value in the therapeutic strategy.

Role in the care pathway ?

In the paediatric population, treatment involves topical treatments (dermocorticosteroids and vitamin D3 analogues) and, in moderate to severe forms resistant to topical treatments, non-biological systemic treatments (retinoids, ciclosporin, methotrexate) and light therapy. In the event of failure of these second-line treatments, TNFα antagonists (etanercept and adalimumab) or ustekinumab are used.

Etanercept (ENBREL) has a marketing authorisation in plaque psoriasis in children from 6 years of age and adalimumab (HUMIRA) from 4 years of age. Until now, ustekinumab (STELARA) only had a marketing authorisation in adolescents from 12 years of age.

These treatments do not definitively cure the condition but can enable a transient and more or less complete disappearance of the lesions, and the care pathway is “rotational”, due, in particular to resistance phenomena.

Treatment in children is not very different to that in adults, but there are fewer validated treatments in children. For example, calcitriol is the only vitamin D3 analogue to have a marketing authorisation in children and methotrexate only has a marketing authorisation in adults.

Furthermore, the toxicity of these treatments limits their use over time and light therapy is not recommended in children.

As in adults and adolescents, the Commission recommends the use of biological medicinal products as second-line systemic therapy in the treatment of severe chronic paediatric plaque psoriasis, defined by :

• failure (insufficient response, contraindication or intolerance) of at least two treatments including non-biological systemic treatments and light therapy
• and an extensive form and/or significant psychosocial impact.

Role of the medicinal product in the care pathway

In children aged 6 to 11 years, STELARA (ustekinumab) is a second-line systemic therapy in the treatment of severe chronic paediatric plaque psoriasis, defined by :

• failure (insufficient response, contraindication or intolerance) of at least two treatments including non-biological systemic treatments and light therapy
• and an extensive form and/or significant psychosocial impact.

Special recommendations

Given the risk of hypersensitivity reactions with ustekinumab administered subcutaneously (see paragraph 4.4 of the SPC), but also with other biologics, the Transparency Committee recommends that the first subcutaneous injection of this drug be given in an appropriate care structure.