FDA Approves STELARA for Pediatric Patients with Moderate to Severe Plaque Psoriasis

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for STELARA® (ustekinumab) as a treatment for pediatric patients (6-11 years of age) with the skin lesions or plaques associated with moderate to severe plaque psoriasis (PsO). Plaque psoriasis is the most common form of psoriasis in adults and children. 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 PsO. STELARA 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, M.D., Ph.D., Vice President, 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 FDA approval of STELARA for pediatric use is based on results from the CADMUS Junior study, an open-label, single-arm, multicenter phase 3 clinical trial, of 44 patients with moderate to severe plaque psoriasis in which 77 percent of patients achieved clear or almost clear skin, at week 12 after two doses. Secondary endpoints included the proportion of patients achieving 75 percent or 90 percent improvement in their Psoriasis Area and Severity Index (PASI) score at week 12 compared to baseline. Study results showed 84 percent and 64 percent of patients achieved a PASI 75 response and PASI 90 response, respectively. In general, the safety profile observed in CADMUS Junior was similar to the safety profile from studies in adults with plaque psoriasis. Patients knew they were on STELARA for the entirety of the study, which may affect results.