The approvals were based on results from the JUNIPERA trial, which showed secukinumab reduced the risk of flare and disease activity when compared with placebo over 2 years in pediatric patients with ERA and JPsA.
Novartis announced that the European Commission (EC) approved secukinumab, either alone or in combination with methotrexate, in juvenile idiopathic arthritis (JIA) enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in pediatric patients aged 6 years and older who had inadequate response or were intolerant to conventional therapy.
The approvals were based on results from the JUNIPERA trial, which showed secukinumab reduced the risk of flare and disease activity when compared with placebo over 2 years in pediatric patients with ERA and JPsA. Additionally, safety was consistent with known safety profiles across both adult and pediatric indications.
Since its initial approval in 2014, secukinumab, the first and only fully human biologic that inhibits interleukin-17A (IL-17A), has treated more than 700,000 patients internationally with sustained efficacy across multiple inflammatory conditions.
“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,” Todd Fox, Global Head of Medical Affairs Immunology at Novartis, stated. “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 III, 2-year, 3-part, double-blind, placebo-controlled, randomized withdrawal JUNIPERA trial showed that pediatric patients with ERA and JPsA receiving secukinumab had a significantly longer time to flare when compared with placebo. The study included 86 children and adolescents (aged 2 to 18 years) diagnosed according to the modified International League of Associations for Rheumatology classification criteria. The primary endpoint was time to flare in the treatment period 2 (week 12 to week 104). Risk of flare was reduced by 72% in patients receiving secukinumab during treatment period 2 (hazard ratio=0.28, 95% confidence interval: 0.13 to 0.63; P<0.001). In total, 10 patients in the secukinumab cohort experienced a flare compared with 21 patients in the placebo cohort during the placebo-controlled treatment period 2.
“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,” Ivan Foeldvari, M.D., Hamburg Centre for Pediatric Rheumatology, Germany, stated.