FDA Clears Ustekinumab (Stelara) for Plaque Psoriasis in Teens

Megan Brooks


October 16, 2017

The US Food and Drug Administration (FDA) has approved ustekinumab (Stelara, Janssen Biotech, Inc) for the treatment of patients aged 12 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

The interleukin-12/23 inhibitor was approved in 2009 for the treatment of adults with moderate to severe plaque psoriasis.

The approval of ustekinumab in adolescents is based on a phase 3 study that showed that in at least two thirds of patients aged 12 to 17 who were treated with ustekinumab, cleared skin or minimal psoriasis was achieved at week 12. The safety profile was similar to that seen in studies of adults with plaque psoriasis. Ustekinumab is administered subcutaneously at weeks 0 and 4, and every 12 weeks thereafter.

Roughly one third of individuals who develop plaque psoriasis do so before 20 years of age, the company noted in a news release.

"Psoriasis is a highly visible disease, and it is essential that these younger patients and their caregivers have options that can effectively reduce the difficult-to-conceal and often misunderstood plaques," Michael Siegel, PhD, senior vice president of research and clinical affairs for the National Psoriasis Foundation, said in the release. "It is encouraging to have new treatment options where few exist for adolescents living with psoriasis during such formative times in their lives."

Ustekinumab has also been approved in the United States for the treatment of adults with active psoriatic arthritis and moderately to severely active Crohn's disease that is refractory to other therapies and in patients who are intolerant of other treatments.

Full prescribing information and a medication guide are available online.

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