FDA approves biologic for treating psoriasis in those as young as 12

| Joe Doolen

Adolescents with moderate to severe plaque psoriasis have a new option for treatment. On Oct. 13, 2017, the U.S. Food and Drug Administration (FDA) approved the use of Stelara (ustekinumab) for treating psoriasis in youth ages 12 and older. 

Stelara is a biologic (a drug made in a lab from living cells) that blocks proteins interleukin-12 and interleukin-23 from attaching to other cells, thus preventing an undesired inflammatory response – raised, red patches of skin that are often itchy and painful. Stelara is administered in two initial injections followed by an additional injection every 12 weeks, the fewest doses of any biologic option for plaque psoriasis treatment. Adolescents also must be candidates for phototherapy (skin exposure to UV light) or systemic therapy (pills or injections).

This new approval affects a crucial age group among those with plaque psoriasis, roughly one-third of whom develop the disease before age 20. In adolescents, psoriasis commonly affects the face and scalp. 

In a Phase 3 clinical trial, two-thirds of adolescents receiving injections at week 0 and week 4 showed total clearance or minimal coverage of psoriasis at week 12. Treatment involves injections every 12 weeks after the initial two. Safety findings in adolescents were consistent with those of adults.

Stelara, manufactured by Janssen, has been FDA-approved for treating adults with psoriasis and/or psoriatic arthritis since 2009.

 


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