HUMIRA (adalimumab) - Plaque psoriasis in children and adolescents

Reassessment.

Key points

Favourable opinion on reimbursement in its MA indication.

Role in the care pathway?

In view of the maintenance of the medium-term (W52) indeed long-term efficacy of etanercept (5 years) and of the absence of new signs related to tolerance observed after several years of use, the Committee now considers that HUMIRA (adalimumab) is a second-line systemic treatment for use in the severe forms of chronic plaque psoriasis in children and adolescents from 4 years of age in the event of failure (insufficient efficacy, contraindication or intolerance) with a first-line non-biological systemic treatment or possibly phototherapy.

The decision to initiate treatment must take account of the history of the disease, patient characteristics, treatment history and disease severity, which is appraised in terms of the appearance of the lesions as well as in terms of their extent, the impact of the disease on quality of life and the extent of its psychosocial impact.

The summary of product characteristics (SmPC) and the Risk Management Plan (RMP) must be respected.

The use of this medicinal product in pregnant or breastfeeding women must comply with the SmPC (http://lecrat.fr/).