The US Food and Drug Administration (FDA) has approved secukinumab (Cosentyx, Novartis) for the treatment of active enthesitis-related arthritis (ERA) in children and adolescents age 4 years and older. The FDA also extended the psoriatic arthritis (PsA) indication of secukinumab to include children and adolescents age 2 years and older, according to a December 22 press release.
Secukinumab is the only biologic treatment approved for children and adolescents for both ERA and PsA in the US.
“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, Cincinnati, Ohio, in the press release. She noted, “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.”
Secukinumab is the first and only fully human biologic that directly inhibits interleukin-17A (IL-17A), a cytokine involved in the inflammation of PsA, moderate to severe plaque psoriasis, ankylosing spondylitis, and nonradiographic axial spondyloarthritis, according to Novartis. The drug was approved as a first-line systemic treatment for pediatric psoriasis earlier this year. The drug is administered according to body weight as a subcutaneous injection by a pre-filled syringe or pen every 4 weeks after initial loading doses
“The symptoms of PsA and ERA can be debilitating for children and adolescents living with these chronic conditions, impacting their daily lives,” said Tiffany Westrich-Robertson, CEO, International Foundation for Autoimmune & Autoinflammatory Arthritis (AiArthritis). “It is encouraging to see an additional treatment option for these underserved patient populations.”
The FDA approval was based on data from the phase 3 JUNIPERA study, a 2-year, three-part, double-blind, placebo-controlled, randomized-withdrawal trial that enrolled 86 children and adolescents aged 2-17 years with a confirmed diagnosis of ERA or JPsA. The study, as previously reported by Medscape Medical News, demonstrated that patients with active JPsA (n = 34; mean age: 12.2) treated with secukinumab had a significantly longer time to flare, showing an 85% reduction in the risk of flare (P < .001) vs placebo.
The study also demonstrated that patients with active ERA (n = 52; mean age: 13.7) treated with secukinumab had a longer time to flare, showing a 53% reduction in the risk of flare vs placebo.
Adverse Effects and Contraindications
The full prescribing information for secukinumab includes specific warnings and areas of concern. The drug should not be administered to individuals with known hypersensitivity to secukinumab. The drug may lower the ability of the immune system to fight infections and may increase risk of infections, sometimes serious, and a test for tuberculosis infection should be given before administration.
The use of live vaccines in patients receiving secukinumab should be avoided.
The most common adverse effects include cold symptoms, diarrhea, and upper respiratory infections. New cases of inflammatory bowel disease or flare‐ups can occur with secukinumab and can sometimes be serious.