The Food and Drug Administration (FDA) has expanded the approval of Stelara® (ustekinumab) to include treatment of pediatric patients 6 years of age and older with active psoriatic arthritis (PsA).
The approval is supported by evidence from adequate and well-controlled studies of Stelara in adults with psoriasis and PsA, pharmacokinetic (PK) data from adult patients with psoriasis, adult patients with PsA and pediatric patients with psoriasis, and safety data from 2 clinical studies in 44 patients 6 to 11 years old with psoriasis and 110 patients 12 to 17 years old with psoriasis.
An analysis of data showed that the observed pre-dose (trough) concentrations were generally comparable between adults with psoriasis, adults with PsA and pediatric patients with psoriasis, and that PK exposure is expected to be comparable between adult and pediatric patients with PsA.
“The approval of Stelara for use in children 6 years of age and older with active psoriatic arthritis, which follows the 2020 approval for moderate to severe plaque psoriasis in this population, is complemented by more than 12 years of clinical trial and real-world evidence across all approved indications demonstrating the safety and efficacy of this biologic therapy,” said Jennifer Davidson, DO, Vice President of Immunology Medical Affairs, Janssen Scientific Affairs, LLC.
In pediatric patients, it is recommended that Stelara be administered by a health care provider. The recommended dose is based on body weight and is administered subcutaneously in this patient population.
- Stelara® (ustekinumab) approved by the US Food and Drug Administration to treat pediatric patients with active psoriatic arthritis. News release. Janssen Pharmaceutical Companies of Johnson & Johnson. Accessed August 1, 2022. https://www.prnewswire.com/news-releases/stelara-ustekinumab-approved-by-the-us-food-and-drug-administration-to-treat-pediatric-patients-with-active-psoriatic-arthritis-301596940.html
- Stelara. Package insert. Janssen Biotech, Inc.; 2022. Accessed August 1, 2022. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf