FDA Approves First Treatment for Active Psoriatic Arthritis in Pediatric Patients
The US Food and Drug Administration (FDA) approved the first and only biologic medication—ustekinumab (STELARA)—for the treatment of pediatric patients aged 6 years or older with active psoriatic arthritis (PsA).
Ustekinumab is a monoclonal antibody that targets both interleukin (IL)-12 and IL-23. Following 2 starter doses, the medication is to be administered 4 times per year as a subcutaneous injection.
The FDA’s approval comes after using an extrapolation approach in looking at pharmacokinetic data in multiple Phase 3 studies. The researchers in each study examined the efficacy and safety of ustekinumab in adult and pediatric patients with moderate to severe plaque psoriasis, and adult patients with active PsA. With there being limited data on pediatric PsA, researchers opted to use the extrapolation approach when analyzing the previous pharmacokinetic data.
Upon analyzing the data, the researchers found that pharmacokinetic exposure of ustekinumab in pediatric patients with PsO and active PsA was consistent with that of Phase 3 clinical trials of ustekinumab in pediatric patients with plaque PsO without active PsA. Additionally, the data was consistent with adult patients with moderate to severe plaque PsO or adult patients with active PsA. In terms of the efficacy and safety of ustekinumab, the data endpoints were similar in pediatric PsO patients with active PsA.
Common adverse effects include nasal congestion, sore throat, upper respiratory infection, and sinus infection, among others.
“The approval of STELARA for use in children six 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 a press release.
STELARA® (ustekinumab) approved by the U.S. food and drug administration to treat pediatric patients with active psoriasis arthritis. News Release. Johnson & Johnson; August 1, 2022. Accessed August 23, 2022. www.jnj.com/stelara-ustekinumab-approved-by-the-u-s-food-and-drug-administration-to-treat-pediatric-patients-with-active-psoriatic-arthritis