Janssen's Stelara (ustekinumab) has been approved in the US as a treatment for paediatric patients (six-11 years of age) who struggle with the skin lesions or plaques associated with moderate to severe plaque psoriasis.
Stelara targets both interleukin (IL)-12 and IL-23, two cytokines thought to play an important role in modulating the overactive inflammatory response in a number of autoimmune conditions, including plaque psoriasis.
The drug is administered as an injection given under the skin, dosed four times per year after two starter doses.
“We are thrilled that the latest approval for Stelara will bring an alternative class of medication to this patient population and that we are able to deliver on our promise to find meaningful solutions for people afflicted with immune-mediated diseases,” said Lloyd Miller, VP, Immunodermatology Disease Area Leader, Janssen Research & Development.
“While Stelara is currently available for adults and adolescents 12 years and older, children with plaque psoriasis have had more limited treatment options.”
The approval for paediatric use is based on results from the CADMUS Junior study, in which 77% of patients achieved clear or almost clear skin, at week 12 after two doses.