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FDA Approves Secukinumab for Children with Enthesitis-Related Arthritis & PsA

Michele B. Kaufman, PharmD, BCGP  |  Issue: April 2022  |  February 2, 2022

At the end of the study, patients with active juvenile PsA who received secukinumab had a significantly longer time to flare, with an 85% reduction in the risk of flare (P<.001) compared with those patients who received placebo. Patients with active ERA treated with secukinumab also had a longer time to flare, with a 53% reduction in the risk of flare compared with patients who received placebo. The patients treated with secukinumab had sustained improvements in signs and symptoms up to week 100.

No new safety signals were identified.

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Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

  1. Novartis Cosentyx receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis. Novartis AG. 2021 Dec 23.
  2. Shih Y, Yang Y, Lin C, et al. Enthesitis-related arthritis is the most common category of juvenile idiopathic arthritis in Taiwan and presents persistent active disease. Pediatr Rheumatol Online J. 2019 Aug 23;17(1):58.
  3. Ruperto N, Foeldvari I, Alexeeva E, et al. Efficacy and safety of secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: Primary results from a randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 study (JUNIPERA). Ann Rheum Dis. 2021;80:201–202.

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Filed under:ConditionsDrug UpdatesPediatric Conditions Tagged with:enthesitis-related arthritis (ERA)FDAFDA approvalPediatricPediatric RheumatologyPsAPsoriatic ArthritissecukinumabU.S. Food and Drug Administration (FDA)

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