The UK Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Novartis’ Cosentyx (secukinumab) in two types of juvenile idiopathic arthritis (JIA), enthesitis-related arthritis (ERA), and juvenile psoriatic arthritis (JPsA).
The drug is approved alone or in combination with methotrexate (MTX) in patients six years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.
JIA is the most common type of arthritis in under 16s, affecting about one in 1,000, with approximately 1,500 diagnosed in the UK every year. ERA and JPsA are forms of JIA and are progressive, debilitating autoimmune diseases, each accounting for up to 11% of all JIA cases.
If properly managed, it’s possible for patients to live with inactive disease and prevent the progression of rheumatoid arthritis, including hand, limb and spine deformities.
The approval is based on results from the Phase III JUNIPERA trial, which showed significantly longer time to flare for both JPsA and ERA patients who were treated with secukinumab compared with placebo. The risk of flare was reduced by 72% for patients on secukinumab for two years.
“If left untreated, both ERA and JPsA can lead to high levels of pain and long-term disability. Evidence shows secukinumab reduces flare risk and joint symptoms in young people affected by JPsA and ERA for a sustained period up to two years. This authorisation provides us with an alternative targeted therapy, offering patients the potential for a monthly dosing option,” said Professor Athimalaipet Ramanan, Consultant Paediatric Rheumatologist at University Hospitals Bristol and Weston NHS Foundation Trust (UHBW).
