The Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of active enthesitis-related arthritis (ERA) in patients 4 years of age and older and active juvenile psoriatic arthritis (JPsA) in patients 2 years of age and older.
The approval was based on data from the 2-year, 3-part, randomized, double-blind, placebo-controlled phase 3 JUNIPERA study (ClinicalTrials.gov Identifier: NCT03031782), which included 86 patients aged 2 to 17 years with a confirmed diagnosis of ERA (n=52; mean age, 13.7 years) or JPsA (n=34; mean age, 12.2 years). Cosentyx’s weight-based dosing in pediatric patients 2 years of age and older recommends 75mg for patients weighing 15kg to less than 50kg and 150mg for patients weighing greater than 50kg.
In treatment period 1, patients received open-label Cosentyx until week 12. Patients who achieved at least 30% improvement in juvenile idiopathic arthritis American College of Rheumatology (JIA ACR30) response moved on to treatment period 2, where they were randomly assigned to receive either weight-dosed Cosentyx or placebo until week 104. The primary endpoint was time to flare in treatment period 2 from week 12 to week 104.
Findings showed that among patients with JPsA, treatment with Cosentyx achieved an 85% reduction in the risk of flare compared with placebo (hazard ratio [HR], 0.15; 95% CI, 0.04-0.56; P <.001). For patients with ERA, treatment with Cosentyx achieved a 53% reduction in the risk of flare compared with placebo (HR, 0.47; 95% CI, 0.17-1.32).
The safety profile of Cosentyx was consistent with that seen in previous studies across indications.
“Prior research suggests that despite receiving treatment, some children and adolescents with PsA or ERA can continue to experience symptoms,” said Hermine Brunner, MD, Cincinnati Children’s Hospital. “The findings from the Phase III JUNIPERA trial show that pediatric patients treated with secukinumab demonstrated marked responses throughout the treatment period. This approval is positive news for some patients who continue to struggle with painful symptoms like inflammation of the joints and swollen fingers and toes.”
Cosentyx, an interleukin-17A antagonist, is also indicated for the treatment of active psoriatic arthritis, ankylosing spondylitis, active non-radiographic axial spondyloarthritis, and moderate to severe plaque psoriasis.
- Novartis Cosentyx® receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis. News release. Novartis Pharmaceuticals Corp. March 30, 2004. Accessed April 30, 2020. https://www.globenewswire.com/news-release/2021/12/22/2357096/0/en/Novartis-Cosentyx-receives-FDA-approval-for-the-treatment-of-children-and-adolescents-with-enthesitis-related-arthritis-and-psoriatic-arthritis.html
- Cosentyx. Package insert. Novartis Pharmaceuticals Corp; 2021. Accessed December 27, 2021. https://www.novartis.us/sites/www.novartis.us/files/cosentyx.pdf