December 14th 2016

FDA approves Enbrel® (etanercept) to treat children with psoriasis

On November 4, 2016, the FDA approved a supplemental biologics license application for the expanded use of the TNFα inhibitor Enbrel® (etanercept) to treat children, aged 4 years and older, with chronic moderate to severe plaque psoriasis.

The approval makes etanercept the only systemic drug approved in the USA to treat the condition in children, and follows its European approval in December 2008, and extension in 2011, for the treatment of chronic severe plaque psoriasis in children aged 6 years and older.

The social stigma surrounding psoriasis has a profound effect on children who have the condition and their families. This stigma leads to impaired school functioning and emotional distress, the cumulative effect of which may result in failure to achieve full life potential. Until now, access to effective systemic treatments for these patients has been limited in the USA and Canada due to lack of data on biologic therapy in pediatric patients and no licensed systemic therapies. Previously, FDA-approved therapies for the treatment of pediatric psoriasis have included a handful of topical agents, with labelled indications for children aged 12 years and older. These topical therapies may be impractical or ineffective for children with extensive psoriasis. 

The FDA’s decision to extend the approval of etanercept to pediatric use was based on safety and efficacy data from a 48-week Phase 3 study1 and its 5-year open-label extension2 in pediatric patients aged 4 to 17 years of age. Safety is of particular concern when administering biologic therapies to children, but the 5-year extension study is, to date, the largest and longest study of a biologic in pediatric patients with psoriasis, and the data reveal a reassuring safety profile for etanercept. Over the 5-year study period, the most commonly reported adverse event was upper respiratory tract infection (23.2 events per 100 patient-years), which is also common in adult patients treated with biologic therapy. Importantly, there were no opportunistic infections or malignancies. Overall, the risk-benefit profile of etanercept in children with psoriasis appears to be very good, and its availability to dermatologists in the USA should significantly reduce the burden of this condition that is so devastating for young people.

Richard G.B. Langley MD, FRCPC, Professor of Dermatology