NICE approves 3 drugs for treating plaque psoriasis in children

The National Institute for Health and Care Excellence (NICE) has published final guidance recommending adalimumab (Humira, AbbVie), etanercept (Enbrel, Pfizer) and ustekinumab (Stelara, Janssen) for treating plaque psoriasis in children and young people. 

The guidance recommends all 3 drugs as options for children and young people, according to their age, whose psoriasis is severe and has not improved with other treatments, for example, ciclosporin, methotrexate or phototherapy, or where these can’t be used.

Adalimumab

Adalimumab (Humira, AbbVie) is a fully human immunoglobulin G1 monoclonal antibody that inhibits the activity of tumour necrosis factor alpha (TNF‑alpha). Adalimumab has marketing authorisation for treating ‘severe chronic plaque psoriasis in children and adolescents from 4 years of age who have an inadequate response to or are inappropriate candidates for topical therapy and phototherapies’.

Study M04‑717 compared adalimumab with methotrexate in children and young people (n=114) aged 4 years to 17 years. At 16 weeks adalimumab had improved Psoriasis Area and Severity Index 75 (PASI 75; a 75% reduction in PASI response) more than methotrexate (relative risk [RR] 1.79, 95% confidence interval [CI] 1.04 to 3.06).

Etanercept

Etanercept (Enbrel, Pfizer) is a recombinant human TNF‑alpha receptor fusion protein that inhibits the activity of TNF‑alpha. Biosimilars for etanercept are also available. Etanercept has a marketing authorisation for treating ‘chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies’.

Study 20030211 compared etanercept with placebo in children and young people (n=211) aged 6 years to 17 years. At 12 weeks, etanercept had improved PASI 75 more than placebo (RR 4.95, 95% CI 2.84 to 8.65).

Ustekinumab

Ustekinumab (Stelara, Janssen) is a fully human monoclonal antibody that acts as a cytokine inhibitor by targeting interleukin‑12 and interleukin‑23. Ustekinumab has a marketing authorisation for treating ‘moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies’.

Study CADMUS compared ustekinumab with placebo in children and young people (n=110) aged 12 years to 17 years. At 12 weeks, ustekinumab had improved PASI 75 more than placebo (RR 7.5, 95% CI 2.9 to 19.1).