FDA approves ustekinumab for pediatric psoriatic arthritis
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The FDA has approved ustekinumab for the treatment of children aged 6 years and older with active psoriatic arthritis, according to a Janssen press release.
“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,” Terence Rooney, MD, PhD, vice president of Janssen Research & Development’s Rheumatology and Maternal Fetal Disease Area, said in the 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.”
According to the company, the FDA decision was based on pharmacokinetic data and extrapolation of the “established efficacy and existing safety profile” of ustekinumab (Stelara, Janssen) in multiple phase 3 studies in adults and children with moderate-to-severe plaque psoriasis, as well as adults with active PsA.
Due to the limited availability of pediatric patients with PsA for clinical trials, researchers used an extrapolation strategy based on previous pharmacokinetic, efficacy and safety observations from a closely adjacent population of children with moderate-to-severe plaque psoriasis who also had active PsA, as well as adults with moderate-to-severe plaque psoriasis or active PsA.
According to the press release, the data demonstrated that pharmacokinetic exposure to ustekinumab in children with psoriasis and active PsA was consistent with that of phase 3 clinical trials of the drug in pediatric patients with psoriasis but without active PsA, as well as with adults with moderate-to-severe plaque psoriasis or active PsA. Data on common efficacy endpoints were similar in these pediatric patients with psoriasis and active PsA, according to the release.
Ustekinumab was first approved in 2009 for the treatment of moderate-to-severe plaque psoriasis in adults. It has since received expanded approvals for the treatment of active PsA in adults, moderate-to-severe active Crohn’s disease in adults, moderate-to-severe active ulcerative colitis in adults and moderate-to-severe plaque psoriasis in children aged 6 years and older.
“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.
Davidson added: “As a global leader in immunology, Janssen is dedicated to reducing the burden of chronic autoimmune diseases, and this additional approval for Stelara builds on our legacy of bringing important treatment options to younger patients.”
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