FDA Approves Ustekinumab for Pediatric Patients with Psoriatic Arthritis

Janssen announced the US Food and Drug Administration (FDA) approval of ustekinumab (STELARA) for the treatment of pediatric patients, aged 6 years and older, with active psoriatic arthritis (PsA). The drug has an established track record of both efficacy and safety from a number of studies in both adults and pediatric patients with psoriasis (PsO) and PsA. Patients with pediatric PsA, which affects up to 8% of children with chronic inflammatory arthritis, will now have access to a first-in-class treatment option. The drug is the first and only biologic that targets both cytokines interleukin 12 (IL-12) and IL-23, which may play a critical role in the inflammatory response in several autoimmune diseases.

"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 Rheumatology and Maternal Fetal Disease Area at Janssen Research & Development, LLC, stated. "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."

Ustekinumab, first approved in 2009 for adults with moderate-to-severe plaque PsO, now holds 4 approved indications, 2 of which include pediatric patients. Due to the limited availability of pediatric patients with PsA in clinical trials, the approval was based on pharmacokinetic (PK) data as well as efficacy and safety information from multiple phase 3 studies in both adults and an adjacent population of pediatric patients with moderate-to-severe plaque PsO (CADMUS, CADMUS Jr, and PSTELLAR) as well as adult patients with PsA (PSUMMIT I and PSUMMIT II).

Analysis demonstrated that data from trials evaluating pediatric patients with PsO and active PsA were consistent with other clinical trials of ustekinumab in pediatric patients with PsO without active PsA, in addition to adults with moderate-to-severe plaque PsO or active PsA. The efficacy endpoints were also similar in pediatric patients with PsO and 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," Jennifer Davidson, DO, Vice President of Immunology Medical Affairs at Janssen Scientific Affairs, LLC, concluded. "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."

The drug is administered as a subcutaneous injection delivered 4 times per year after an initial 2 “starter doses.” Pediatric PsA, which includes symptoms of joint inflammation and skin lesions, can be a challenging disease to treat, thus underlining the need for additional treatment options, such as ustekinumab.