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.
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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- U.S. Food and Drug Administration Approves STELARA® (ustekinumab) for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis. https://www.prnewswire.com/news-releases/us-food-and-drug-administration-approves-stelara-ustekinumab-for-treatment-of-pediatric-patients-with-moderate-to-severe-plaque-psoriasis-301103505.html. Accessed July 31, 2020.
- Stelara [package insert]. Janssen Pharmaceuticals; Revised 7/2020.