FDA expands approval of STELARA to treat pediatric plaque psoriasis

August 4, 2020

The US Food and Drug Administration (FDA) has approved STELARA for treating moderate-to-severe plaque psoriasis in children.

The US Food and Drug Administration expanded the indication for STELARA® (ustekinumab) to treat moderate-to-severe plaque psoriasis in children aged 6 to 11 years.1 The drug targets interleukin (IL)-12 and IL-23, which is key to moderating the overactive inflammatory response. The drug is given as an injection under the skin 4 times a year, following 2 starter doses.

The approval of the drug was based on the results from the CADMUS Junior study, which was an open-label, single-arm, multicenter phase 3 clinical trial. The study included 44 children who had moderate-to-severe plaque psoriasis and 77% of them had clear or almost clear skin at week 12, after receiving 2 doses. The study results showed that 84% achieved a Psoriasis Area and Severity Index (PASI) 75 response and 64% achieved a PASI 90 response.

Overall, the safety in the pediatric population was similar to the safety results seen in the adult population. Common adverse events include nasal congestion, sore throat, itching, tiredness, and headache. One potentially mitigating factor in the study was that the participants were aware that they were receiving ustekinumab.

Reference

1. Janssen Johnson. US Food and Drug Administration approves STELARA® (ustekinumab) for treatment of pediatric patients with moderate to severe plaque psoriasis. Prnewswire.com. Published July 30, 2020. Accessed July 31, 2020. https://www.prnewswire.com/news-releases/us-food-and-drug-administration-approves-stelara-ustekinumab-for-treatment-of-pediatric-patien