A drug that can reduce the risk of flare and disease activity in children with enthesitis-related arthritis (ERA) and psoriatic arthritis (PsA) has been approved based on data from a clinical trial.
The JUNIPERA trial, showing that Cosentyx (secukinumab) reduced the risk of flare and disease activity compared to placebo over two years in pediatric patients with ERA and PsA.
Novartis, which manufactures the drug, said that safety in these pediatric populations was consistent with the known safety profile across approved adult and pediatric indications.
Since its initial approval in 2015, Cosentyx has a proven sustained efficacy profile across several systemic inflammatory conditions and has been used to treat more than 700,000 patients worldwide.
The European Commission (EC) says that Cosentyx can be used alone or in combination with methotrexate, in the juvenile idiopathic arthritis (JIA) categories ERA and juvenile PsA in patients six years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.
Ivan Foeldvari, managing director at the Center for Pediatric Rheumatology, Germany, said: “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.”
ERA and Juvenile PsA are two forms of juvenile idiopathic arthritis and are progressive, debilitating autoimmune diseases. ERA causes joint swelling and pain where tendons and ligaments attach to bone and may bring on 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.
Todd Fox, global head of medical affairs immunology at Novartis said: “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. 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 phase 3 JUNIPERA trial was a 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.
Novartis is working closely with regulatory agencies to ensure that eligible European patients can start benefitting from Cosentyx as quickly as possible. In July 2020, Cosentyx received European Medicines Agency approval as a first-line systemic treatment for pediatric psoriasis in patients aged six–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.
The drug is the first and only fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation of psoriatic arthritis (PsA), moderate to severe plaque psoriasis, ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).
Novartis said Cosentyx is a proven medicine and has been studied clinically for more than 14 years.