8/29/2022
Ustekinumab (Stelara), a biologic medication that inhibits the IL-12 and IL-23 cytokines, has gained FDA approval for the treatment of juvenile psoriatic arthritis (JPsA).1 Ustekinumab was first approved for adults with psoriatic arthritis (PsA) in 2013.
Ustekinumab is now approved to treat children aged six and older with active JPsA. JPsA resembles adult PsA and affects some 5-8% of children and adolescents with chronic inflammatory arthritis.1
The FDA’s new approval was based on multiple Phase 3 clinical studies of ustekinumab in adults with PsA and plaque psoriasis, and juvenile patients with plaque psoriasis. Due to the limited availability of children with JPsA to take part in clinical trials, researchers extrapolated data from a closely related population of children and adolescents with moderate-to-severe plaque psoriasis who also had active JPsA.1 The CADMUS and CADMUS Jr. trials evaluated the efficacy and safety of ustekinumab in children aged 12-17 and 6-11, respectively.2
“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, Rheumatology and Maternal Fetal Disease Area, Janssen Research & Development, LLC. “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.”1
Ustekinumab, like other biologics, carries an increased risk of infections, a reduced ability to fight infections, as well as a slightly increased risk of certain cancers.
In those with JPsA, it is recommended that ustekinumab be given by a health care provider. The recommended dose is based on body weight and is administered via injection.2
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