FDA Approves STELARA® For Use in Pediatric Patients With PsA

On August 1, 2022, the U.S. Food and Drug Administration (FDA) approved STELARA® (ustekinumab) for the treatment of pediatric patients ages 6 years and older, who have active psoriatic arthritis (PsA). STELARA® is the first and only biologic that targets interleukin (IL)-12 and IL-23, which are cytokines thought to be involved in tempering an overactive inflammatory response in some autoimmune and immune-mediated diseases. [1]

Using pharmacokinetic (PK) data, this approval is based on the established efficacy and existing safety profile of STELARA® from the PSTELLAR, CADMUS, and CADMUS Jr Phase 3 studies (examined adult and pediatric psoriasis (PsO)) and PSUMMIT I and II (examined active adult PsA). A statement from Janssen Pharmaceutical Companies of Johnson & Johnson said, “An analysis of the data demonstrated that PK exposure of STELARA® in these pediatric PsO patients with active PsA was consistent with that of Phase 3 clinical trials of STELARA® 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, while data on common efficacy endpoints were similar in these pediatric PsO patients with active PsA.” [1]

PsA is estimated to affect between 5% and 8% of children and adolescents with chronic inflammatory arthritis. [1]