Adalimumab for treating childhood plaque psoriasis: a clinical trial evaluation

ABSTRACT

Introduction: Most systemic therapies have not been systematically investigated in moderate to severe childhood plaque psoriasis. Evidence on the efficacy and safety of systemic treatments is limited and therapeutic guidelines are lacking. Recently adalimumab, a fully human monoclonal antibody that binds tumor necrosis factor (TNF)- alpha, was investigated in childhood psoriasis. Adalimumab is licensed for many inflammatory conditions including chronic plaque psoriasis in adults.

Areas covered: A randomized phase III study published provided favourable efficacy and safety data of adalimumab in childhood psoriasis. The active comparator was methotrexate. After 16 weeks of treatment, a PASI 75 score was achieved in 58% of patients within the adalimumab 0.8 mg/kg group compared with 32% of patients within the methotrexate group. Safety data gave no evidence of drug-related serious adverse events and no organ toxicity. This is the first randomised controlled study of either adalimumab or methotrexate in children and adolescents with psoriasis.

Expert opinion: The aforementioned trial was the first to provide clinical data on adalimumab’s efficacy and safety in the short term when treating children and adolescents with psoriasis. Through the use of an active comparator, this study has opened the way for the future assessment of systemic therapies in children and adolescent with this condition.

KEYWORDS:

• Childhood
• adolescence
• psoriasis
• treatment
• adalimumab
• TNF

Article highlights

• Evidence on efficacy and safety of conventional systemic treatments in moderate-to-severe pediatric psoriasis is limited.

• Etanercept was the first drug investigated in a randomized controlled trial versus placebo for the treatment of psoriasis in children.

• Etanercept was the first biological licensed for the treatment of chronic severe plaque psoriasis in children aged ≥ 6 years in Europe and ≥ 4 years in USA.

• Adalimumab, another TNF- α inhibitor, has recently been investigated in a randomized clinical trial versus methotrexate for the treatment of pediatric psoriasis

• The aforementioned study is the first head–to-head study in pediatric psoriasis.

• Adalimumab received approval in 2015 by European Medicines Agency for the treatment of severe psoriasis in children aged ≥ 4 years of age as a first line systemic treatment.

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Declaration of interest

V Di Lernia was a principal investigator for clinical studies sponsored by Sanofi, Regeneron and Coherus as well as in observational studies sponsored by AbbVie. He was also an advisory board member for AbbVie. He has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This manuscript has not been funded.