CHMP recommends Cosentyx in the juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in patients 6 years and older.- Novartis
Novartis announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for 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 positive CHMP opinion is based on data from the Phase III JUNIPERA study, a 2-year, three-part, double-blind, placebo-controlled, randomized withdrawal trial showing significantly longer time to flare in Cosentyx vs placebo (P<.001) in pediatric era and jpsa patients safety in this pediatric population was consistent with the known safety profile of cosentyx across approved adult and pediatric indications.></.001)>
About the JUNIPERA trial :The positive CHMP opinion is based on data from the Phase III JUNIPERA study, a 2-year, three-part, double-blind, placebo-controlled, randomized withdrawal trial that enrolled 86 children and adolescents aged 2–18 years old with a confirmed diagnosis of ERA or JPsA according to a modified International League of Associations for Rheumatology classification criteria1.The primary endpoint of the study was time to flare in the treatment period 2 (Week 12 to Week 104).
The study met its primary endpoint and demonstrated a statistically significant longer time to disease flare in treatment period 2 for ERA and JPsA with secukinumab versus placebo. The risk of flare was reduced by 72% for patients on secukinumab compared with patients on placebo in treatment period 2 (Hazard ratio=0.28, 95% CI: 0.13 to 0.63, p<0.001). a total of 21 patients in the placebo group experienced a flare event (11 jpsa and 10 era) compared with 10 patients in the secukinumab group (4 jpsa and 6 era) during the placebo-controlled treatment period 2 of the study. safety in this pediatric population was consistent with the known safety profile of cosentyx for the treatment of adult and pediatric plaque psoriasis, psa and axial spondyloarthritis.></0.001).>
ERA and JPsA 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, they can lead to high levels of pain and disability.
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