FDA Approved Biologics: Can Etanercept and Ustekinumab be Considered a First-Line Systemic Therapy for Pediatric/Adolescents in Moderate to Severe Psoriasis? A Systematic Review

Abstract

Psoriasis is a chronic immune-mediated skin disorder. Due to lack of clarity in its pathogenesis, a cure with existing treatment is a big challenge. Biologics, a revolutionary treatment, are potent immunomodulators that explicitly target the culprit cells of the immune system to achieve the maximum level of Psoriasis Area and Severity Index (PASI) score (75 to 90) and clear or almost clear skin in moderate to severe psoriasis. They have been a successful therapy in adult severe psoriasis for a decade. In recent years, biologics have unprecedently sought the attention of the pediatric psoriatic population by proving an efficacious and safe option. The aim of the study is to provide a systematic review of efficacy, safety, and impact on the quality of life of Food and Drug Administration (FDA)-approved biologics, namely etanercept and ustekinumab, and their use as a "first-line systemic therapy" in the moderate to severe pediatric and adolescent psoriatic population. We explored PubMed, Cochrane Library, Google Scholar, American Academy of Dermatology website, ClinicalTrials.gov, the FDA site, and the National Psoriasis Foundation USA site as major database searches. Psoriasis, pediatric, etanercept, and ustekinumab were keywords used to find the relevant literature. Clinical trials and observational studies were retrieved and analyzed to assess the efficacy and safety of FDA-approved biologics as first-line systemic therapy in pediatric psoriasis. The relevant evidence-based studies and the Joint American Academy of Dermatology-National Psoriasis Foundation (AAD-NPF) guideline have shown that etanercept and ustekinumab biologics are significantly effective and safe systemic therapies in dealing with moderate to severe psoriasis in pediatric and adolescent patients and have unprecedently improved their quality of life. Thus, they can be confidently considered as first-line systemic therapy in moderate to severe pediatric and adolescent psoriatic patients by applying the specific criteria and proper monitoring. However, health practitioners and dermatologists must educate pediatric patients and their caretakers about their adverse effects, success/failure chance, careful monitoring, and follow-up plan to achieve the desired result.

Keywords: etanercept; pediatric; psoriasis; ustekinumab.