Stelara Approved for Pediatric Plaque Psoriasis

The approval of ustekinumab in pediatric patients was based on data from a phase 3 open-label, single-arm study (CADMUS Junior).

The Food and Drug Administration (FDA) has expanded the approval of Stelara® (ustekinumab; Janssen) to include treatment of pediatric patients aged 6 to 11 years with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Previously, the monoclonal antibody, which targets both interleukin (IL)-12 and IL-23, had only been approved for psoriasis patients 12 years and older.

The approval of ustekinumab in pediatric patients was based on data from a phase 3 open-label, single-arm, efficacy, safety and pharmacokinetics study (CADMUS Junior). Patients (n=44) received subcutaneously administered ustekinumab at weeks 0 and 4, followed by every 12 weeks dosing with the last dose at week 40; those who were eligible continued into a long-term extension period where they received treatment every 12 weeks beginning at week 56 up to week 248.

Results of the study showed that 77% of patients achieved clear or almost clear skin at week 12 (primary end point; as measured by Physician’s Global Assessment [PGA] score).  Additionally, 84% of patients achieved 75% improvement in the Psoriasis Area and Severity Index (PASI 75) score and 64% achieved PASI 90. The safety profile in pediatric patients was also found to be similar to that from studies in adults with plaque psoriasis.

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In pediatric patients, it is recommended that Stelara® be administered by a healthcare provider.  The recommended dose is based on body weight and is administered subcutaneously in this patient population.

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  1. U.S. Food and Drug Administration Approves STELARA® (ustekinumab) for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis. Accessed July 31, 2020.
  2. Stelara [package insert]. Janssen Pharmaceuticals; Revised 7/2020.