The European Commission (EC) has approved Novartis’ Cosentyx (secukinumab), used alone or in combination with methotrexate, in the juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.
“The approval of Cosentyx is very positive news for children affected by JPsA and ERA across Europe. We are now able to offer a new therapeutic target, which was not on the market for this disease in children and also offers a lower frequency of administration. Cosentyx adds to the body of other approved treatments that may provide children and adolescent patients, with the opportunity to participate in all daily activities, and even sports,” said Ivan Foeldvari, M.D., Hamburg Centre for Pediatric Rheumatology, Germany.
ERA and JPsA are two forms of juvenile idiopathic arthritis (JIA) and are progressive, debilitating autoimmune diseases. ERA is characterized by joint swelling and pain where tendons and ligaments attach to bone and may present with lower back pain or tenderness at the palpation of the hips. JPsA is characterized by joint swelling and skin psoriasis and may present with nail changes, inflammation of fingers and/or toes or psoriatic skin changes in a first-degree relative. If left untreated, these diseases can lead to high levels of pain and disability.
“Cosentyx could now provide a treatment option for eligible patients who continue to struggle with the painful symptoms which negatively impact their quality of life, such as inflammation of the joints, swollen fingers and toes,” said Todd Fox, global head of Medical Affairs Immunology at Novartis. “This approval represents an important step in our ambition to expand Cosentyx to 10 indications for children and adults living with rheumatic and dermatologic diseases.”
The approval is based on data from the Phase III JUNIPERA trial, a 2-year, three-part, double-blind, placebo-controlled, randomized withdrawal trial showing significantly longer time to flare in Cosentyx versus placebo in pediatric patients with ERA and JPsA. Safety in this pediatric population was consistent with the known safety profile of Cosentyx across approved adult and pediatric indications.
In July 2020, Cosentyx received European Medicines Agency approval as a first-line systemic treatment for pediatric psoriasis in patients aged 6–18 years old and recently received approval in the US and China. In 2021, Cosentyx was also approved in Japan for pediatric psoriasis. Cosentyx was also approved in the US in December 2021 and earlier this year in Brazil to treat ERA in patients 4 years or older and JPsA in patients aged 2 years and older.
