In a press release on August 1, 2022, the manufacturer, Janssen Pharmaceutical Companies of Johnson & Johnson, announced the FDA approval of Stelara (ustekinumab) for the treatment of pediatric patients aged 6 years and older with active psoriatic arthritis (PsA). It is the first and only biologic targeting both cytokines IL-12 and IL-23 and provides a new therapeutic option for children aged 6 years and older living with PsA.
Ustekinumab was first approved in 2009 for treating moderate-to-severe plaque psoriasis (PsO) 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 FDA’s approval was based on pharmacokinetic (PK) data and extrapolation of the established efficacy and existing safety profile of ustekinumab in multiple phase III studies in adult and pediatric patients with moderate-to-severe PsO (PSTELLAR, CADMUS, and CADMUS Jr) and adult patients with active PsA (PSUMMIT I and II).
Due to the limited availability of pediatric PsA patients for inclusion in clinical trials, researchers employed an extrapolation approach based on previous PK, efficacy, and safety observations from a closely adjacent population of pediatric patients with moderate-to-severe plaque PsO who also had active PsA, as well as adult patients with moderate-to-severe plaque PsO or active PsA.
An examination of the data demonstrated that PK exposure of Stelara in these pediatric PsO patients with active PsA was consistent with that of phase III clinical trials of ustekinumab in pediatric PsO patients without active PsA, as well as with adult patients with moderate-to-severe plaque PsO or adult patients with active PsA; data on common efficacy endpoints were comparable in these pediatric PsO patients with active PsA.
Terence Rooney, MD, PhD, vice president of rheumatology and maternal fetal disease area at Janssen Research & Development, LLC, stated, “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. 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.”
Jennifer Davidson, DO, vice president of immunology medical affairs at Janssen Scientific Affairs, LLC, stated, “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.”
Dr. Davidson also stated, “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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