FDA approves etanercept for pediatric psoriasis

November 8, 2016

The US Food and Drug Administration (FDA) approval of etanercept for treatment of children with moderate to severe plaque psoriasis will revolutionize the management of psoriasis in children.

The US Food and Drug Administration (FDA) approval of etanercept for treatment of children with moderate to severe plaque psoriasis will revolutionize the management of psoriasis in children. Although we have used it off-label for a number of years, the move by the FDA will allow this TN-alpha inhibitor to become part of the standard of care for children with resistant psoriasis.

Our 2 greatest concerns have always been efficacy and safety. The experience with etanercept over the last decade with treatment of pediatric arthritis and several years of study with pediatric psoriasis confirms both the efficacy and safety of this biologic agent. My hope is that this will lead to further study of other novel agents and expand our armamentarium for the management of this debilitating disease with multiple comorbidities including metabolic syndrome and cardiovascular disease.

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Primary treatments for children with psoriasis should continue to include topical agents and phototherapy. However, systemic agents may be considered when topical therapy and phototherapy fail to achieve good results. This was also the conclusion of an FDA Advisory Board Meeting in the spring of 2015, which also agreed that new agents being studied in adults should also be studied in children as soon as early study results support safety and efficacy issues. This should include methotrexate, phosphodiesterase inhibitors, cyclosporine, mycophenolate, and newer biologic agents.

In short, it is our task to introduce pediatric practitioners to the new data on etanercept (Paller AS, et al. Long-term safety and efficacy of etanercept in children and adolescents with plaque psoriasis. J Am Acad Dermatol. 2016;74[2]:280-287.e3) for children with resistant psoriasis and prepare them for other therapeutic options in the pipeline.

Other good resources include the National Psoriasis Foundation, Psoriasis/American Academy of Dermatology, and Clinical Guideline/American Academy of Dermatology

Dr Cohen, section editor for Contemporary Pediatrics’ Dermcase, is professor of Pediatrics and Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.