Secukinumab Now Approved for Psoriatic Arthritis in Pediatric Patients

The FDA announced that secukinumab, an IL-17A inhibiting human biologic, received approval for the treatment of active psoriatic arthritis (PsA) in patients aged 2 years and older.

Data from the phase 3 trial JUNIPERA, a 2-year, three-part, double-blind, placebo-controlled, randomized-withdrawal trial, demonstrated that secukinumab was overall efficacious and safe for this patient population. Patients with active juvenile PsA treated with secukinumab had a 85% reduction in the risk of flare vs placebo. Additionally, safety was consistent with previous reports for plaque psoriasis, PsA, nonradiographic axial spondyloarthritis, and ankylosing spondylitis.

This approval is the second for pediatric patients in dermatology this year, with the biologic receiving approval for plaque psoriasis in patients aged 6 years and older in June 2021. Dosing for secukinumab in children and adolescents is 75 mg (body weight 15 kg to <50kg) or 150 mg (body weight >50kg), and it is administered by subcutaneous injection every 4 weeks after initial loading doses.

Reference
Novartis Cosentyx^® receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis. Press release. Novartis Pharmaceuticals Corporation; December 22, 2021. Accessed December 23, 2021. https://prnmedia.prnewswire.com/news-releases/novartis-cosentyx-receives-fda-approval-for-the-treatment-of-children-and-adolescents-with-enthesitis-related-arthritis-and-psoriatic-arthritis-301450193.html