Ustekinumab is the first and only biologic that targets both cytokines interleukin (IL)-12 and IL-23.
The FDA has approved ustekinumab (Stelara; Johnson & Johnson) for the treatment of pediatric patients with active psoriatic arthritis (PsA).
Active PsA in pediatric patients is a rare disease that resembles adult PsA. It affects 5% to 8% of children and adolescents with chronic inflammatory arthritis, and symptoms often include joint inflammation and skin lesions. It can be particularly challenging to treat in younger populations and has a significant need for additional treatment options.
Ustekinumab is the first and only biologic that targets both cytokines interleukin (IL)-12 and IL-23, according to a press release. Two of the 4 indications for the drug now include pediatric patients, expanding its treatment profile since the first approval in 2009 for adults with moderate to severe plaque psoriasis.
Ustekinumab is a fully human monoclonal antibody that selectively inhibits both IL-12 and IL-23, which are believed to play a role in tempering the overactive inflammatory response in several autoimmune diseases. The drug is administered as a subcutaneous injection 4 times per year following 2 starter doses for pediatric patients 6 years of age and older with active PsA.
“We know active pediatric psoriatic arthritis is a challenging inflammatory disease given its rarity and that symptoms, such as swollen joints and skin lesions, can vary significantly in presentation and severity,” said Terence Rooney, MD, PhD, vice president of rheumatology and maternal fetal disease area at Janssen Research & Development, LLC, in the press release. “With this pediatric approval of Stelara, we’re pleased to help address the unmet needs of these young patients and provide physicians with a much-needed treatment option that has an established track record of safety and efficacy.”
The approval was based on pharmacokinetic data and extrapolation of the established efficacy and safety profile of ustekinumab in multiple phase 3 trials among adult and pediatric patients with moderate to severe plaque psoriasis, as well as adult patients with active PsA. Due to the limited availability of patients with pediatric psoriasis for inclusion in clinical trials, researchers used an extrapolation approach based on previous pharmacokinetic, efficacy, and safety observations from a population of pediatric patients with moderate to severe plaque psoriasis who also had active PsA, as well as adults with moderate to severe plaque psoriasis or active PsA.
An analysis of the data found that pharmacokinetic exposure of ustekinumab in these pediatric patients with active PsA was consistent with exposure in phase 3 clinical trials among pediatric plaque psoriasis patients without active PsA. It was also consistent with adult patients with moderate to severe plaque psoriasis or adult patients with active PsA, and data on common efficacy endpoints were similar in these pediatric plaque psoriasis patients with active 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 at Janssen Scientific Affairs, LLC, in the press release.
Janssen is also working to improve access to ustekinumab through the Stelara withMe program, which includes comprehensive support and helps patients get started on the treatment and stay on track. The program provides information on insurance coverage, potential out-of-pocket costs, and treatment support, and also identifies options that may help make treatment more affordable, including a savings program for eligible patients.
Stelara (ustekinumab) Approved by the US Food and Drug Administration to Treat Pediatric Patients with Active Psoriatic Arthritis. News release. Johnson & Johnson; August 1, 2022. Accessed August 1, 2022. https://www.jnj.com/stelara-ustekinumab-approved-by-the-u-s-food-and-drug-administration-to-treat-pediatric-patients-with-active-psoriatic-arthritis