Janssen’s Stelara Approved for Plaque Psoriasis in Children

The FDA has approved Janssen’s Stelara (ustekinumab) for the treatment of children ages 6-11 years old with skin lesions associated with moderate to severe plaque psoriasis.

The approval was based on the results of a phase 3 trial of 44 patients in which 77 percent of participants achieved clear or almost clear skin at week 12 after two doses.

Stelara targets interleukin (IL)-12 and IL-23, two inflammatory cytokines produced by the immune system.