Reason for request

Extension of Inclusion

No demonstrated clinical benefit in the management of severe chronic plaque psoriasis in children from 4 years of age and adolescents

  • HUMIRA now has marketing authorisation in the treatment of severe chronic plaque psoriasis in children from 4 years of age and adolescents and in the case of insufficient response to a topical treatment and to phototherapy or when these treatments are inappropriate.
  • It should be reserved for treatment of severe chronic plaque psoriasis defined by:

            - failure (insufficient response, contraindication or intolerance) to at least two treatments including nonbiologic systemic treatments and phototherapy

            - an extensive form and/or substantial psychosocial impact.

  • The safety profile of adalimumab is similar in adults, children and adolescents.




Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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