FDA Approves Stelara for Plaque Psoriasis

The US Food and Drug Administration (FDA) has approved ustekinumab (Stelara) for the treatment of adolescents with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, announced Janssen.

This marks a significant milestone for adolescents as about 1/3 of individuals who develop plaque psoriasis do so before the age of 20, and there’s a limited amount of treatment options those 12—18 years of age and older.

The approval is based on data from a phase 3 study designed to evaluate the efficacy and safety of subcutaneous administration of Stelara in patients aged 12 years or older. At least 2/3 of patients received the drug were responders at the week 12 primary endpoint after just 2 doses at weeks 0 and 4, defined by achieving a Physician’s Global Assessment (PGA) score of 0 or 1 — cleared or minimal psoriasis.

Safety findings were consistent with those seen in studies in adults.

Stelara, a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines, has been approved for treatment of adults with moderate to severe plaque psoriasis since September 2009 in the US. It’s become a leading therapeutic option for dermatologists and patients, with only 4 doses a year after 2 starter doses.

A study is currently recruiting participants to monitor the long-term safety of Stelara in pediatric patients, through monitoring for the following adverse effects potentially related to immune modulation: serious infections, malignancies and autoimmunity; and to monitor the long-term effects on growth — weight, height and body mass index — and development. The data is estimated to be collected September 2026.

A press release has been made available.