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Pediatric PsA Treatment Approval

The U.S. FDA approves Cosentyx® for children 2 years and older.

On December 22, 2021, the U.S. Food and Drug Administration (FDA) approved Cosentyx® (secukinumab), an interleukin-17A inhibitor, for the treatment of active psoriatic arthritis (PsA) in patients 2 years and older, and active enthesitis-related arthritis (ERA) in patients 4 years and older.1

Although PsA typically presents after the onset of psoriasis in adults, “about 50% of children with psoriatic arthritis develop arthritis prior to the onset of psoriasis and are therefore diagnosed on the basis of supporting features such as dactylitis, nail pits, and a family history,” says Matthew Stoll, M.D., Associate Professor of Pediatric Rheumatology at the University of Alabama at Birmingham. “We will now be able to use secukinumab in this population.”

This approval is based on findings from the Phase 3 JUNIPERA study, which demonstrated that in children and adolescents ages 2 to 17 years old, patients with active juvenile PsA treated with Cosentyx® had a significantly longer time to flare, showing an 85% reduction in the risk of flare (P<0.001) versus placebo.1

In addition, safety in this pediatric population was consistent with the known safety profile of Cosentyx® for the treatment of plaque psoriasis, PsA, non-radiographic axial spondyloarthritis, and ankylosing spondylitis.1

“This is not simply a new therapeutic option, but additionally a novel therapeutic pathway that is now available for the management of juvenile spondyloarthritis including juvenile psoriatic arthritis,” says Dr. Stoll.

Cosentyx® will be administered as a subcutaneous injection by a pre-filled syringe or Sensoready® pen every four weeks after initial loading doses. The approved pediatric dosing for Cosentyx® in children and adolescents is 75 mg or 150 mg, depending on body weight.1

PsA can strike at any age

Genetics may be a risk factor for juvenile psoriatic arthritis, with more than half of children with PsA having at least one relative with psoriasis.

Learn more

Reference

1. Novartis Cosentyx® receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis. Novartis. Dec 22, 2021. Accessed 1/5/2022. https://www.novartis.us/news/media-releases/novartis-cosentyx-receives-fda-approval-treatment-children-and-adolescents-0.

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