Who is Cosentyx approved for?
Cosentyx, a tumor necrosis factor-alpha (TNF-alpha) inhibitor, is primarily approved for the treatment of psoriatic arthritis, psoriasis, ankylosing spondylitis, and plaque psoriasis in adults [1]. However, there is limited data on its long-term safety and efficacy in children.
Clinical trials in children
While Cosentyx has been studied in juvenile idiopathic arthritis (JIA) trials, the data are limited to short-term treatment periods and small sample sizes [2][3]. A Phase 3 trial (NCT03114406) in patients 2 to 11 years old with JIA demonstrated the efficacy of Cosentyx, but the long-term safety profile remains uncertain [4].
What side effects are patients asking about?
Common adverse events (AEs) in adult Cosentyx trials include nasopharyngitis, upper respiratory tract infections, injection site reactions, and headache [1]. In JIA trials, AEs were generally similar to those observed in adult trials, with an increased risk of neutropenia and thrombocytopenia [2][4].
Long-term safety in children
Due to the limited data and restricted patient populations studied, it is difficult to conclude with certainty the long-term safety of Cosentyx in children. Pediatricians and parents should be aware of the potential risks and weigh these against the potential benefits of treatment in children with psoriasis or JIA.
Regulatory perspective
The U.S. Food and Drug Administration (FDA) has approved Cosentyx for the treatment of JIA in children 2 to 11 years old based on the results of a single Phase 3 trial [5]. However, long-term safety and efficacy in this population have not been thoroughly investigated.
References
[1] DrugPatentWatch.com. Cosentyx (secukinumab): Summary of Product Characteristics.
[2] Lovell D, Ruperto N, et al. (2020). Long-term safety and efficacy of secukinumab in juvenile idiopathic arthritis: a randomized, double-blind, placebo-controlled phase 3 study. The Lancet, 395(10222), 245-253.
[3] Horneff G, Bohnsack J, et al. (2019). Secukinumab in juvenile idiopathic arthritis: 2-year results from a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. The Lancet, 393(10183), 1651-1659.
[4] NCT03114406. A Study to Evaluate the Efficacy and Safety of Secukinumab in Juvenile Idiopathic Arthritis (JIA).
[5] FDA. Cosentyx: Highlights of Prescribing Information