The FDA has approved ustekinumab for the treatment of pediatric patients 6 years of age and older with psoriatic arthritis, according to a press release.

Ustekinumab, a monoclonal antibody targeting IL-12 and IL-23, is given by subcutaneous injection four times a year after two loading doses. Ustekinumab is also approved for pediatric patients with plaque psoriasis.

This approval is based on data from the phase 3 PSTELLAR, CADMUS, and CADMUS Jr studies in plaque psoriasis and from the phase 3 PSUMMIT I and II trials in psoriatic arthritis. Due to the rarity of pediatric psoriatic arthritis, extrapolation of existing pharmacokinetic, safety, and efficacy data was used from previous studies in order to assess success in endpoints for the pediatric psoriatic arthritis community.

"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 [ustekinumab], 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,” said Terence Rooney, MD, PhD, vice president of rheumatology and maternal-fetal disease area at Janssen.

Disclosures: Rooney is an employee of Janseen. The PSTELLAR, CADMUS, and CADMUS Jr studies were supported by Jansen.