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Novartis presents positive phase III results from JUNIPERA study supporting Cosentyx as a potential treatment in a JIA population at EULAR 2021.-

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Published:3rd Jun 2021
Novartis, announced two-year positive results from the Phase III JUNIPERA study, demonstrating that Cosentyx (secukinumab) significantly delayed time to flare vs placebo (P<.001) in pediatric patients with juvenile psoriatic arthritis (jpsa) and enthesitis-related arthritis (era) – two subtypes of juvenile idiopathic arthritis (jia). the data will be presented as a late-breaker at the eular 2021 annual european congress of rheumatology (abstract #lb0004; oral presentation: saturday, june 5, 8:10 am cest) .>

 | “both jpsa and era are progressive, chronic, debilitating diseases with limited treatment options. jia can impact the daily lives of children and teenagers, with over 30% of children with jia finding it difficult to attend school due to their condition, and many children still having active disease as adults,” said dr. hermine brunner, cincinnati children's hospital medical center and lead investigator of the junipera study. “the junipera data are encouraging and pave the way for an effective treatment option that delays the worsening of symptoms leading to improvement in quality of life for these children.” the junipera study also demonstrated sustained efficacy for cosentyx with more patients achieving and maintaining the jia american college of rheumatology (acr) 30 and jia acr 70 responses from week 12 to week 104 vs placebo. cosentyx demonstrated a favorable safety profile with no new safety signals reported in pediatric patients (age 2 to 17 years) with two years of treatment. about the junipera study :junipera is a two-year, three-part, double-blind, placebo-controlled, randomized-withdrawal, phase iii study investigating the efficacy and safety of secukinumab in the juvenile idiopathic arthritis (jia) subtypes of juvenile psoriatic arthritis (jpsa) and enthesitis-related arthritis (era). the junipera study enrolled 86 children and adolescents aged 2 to 17 years with a confirmed diagnosis of jpsa or era according to the international league of associations for rheumatology classification criteria. patients were given open-label secukinumab 75 mg 150 mg (prefilled syringe at doses of 75 mg in patients><50 kg and 150 mg in patients ?50 kg) up until week 12. in this treatment period 1, patients achieving at least jia acr 30 response then progressed onto treatment period 2. in treatment period 2, patients were allocated to one of two arms: secukinumab 75 mg 150 mg (depending on bodyweight) or placebo and responses observed up until week 104. the primary endpoint of the study was time to flare in the treatment period 2 (week 12 to week 104). secondary endpoints in treatment period 1 (up to week 12) included evaluation of jia acr 30 50 70 90 100 responses and each jia acr core component, change from baseline of the juvenile arthritis disease activity score (jadas), and total enthesitis and dactylitis count. additional secondary endpoints during treatment period 2 from week 12 to week 104 included: effect of withdrawing secukinumab treatment with respect to jia acr 30 50 70 90 100 response and inactive disease; secukinumab serum concentration; safety tolerability and immunogenicity of secukinumab. an extension study of secukinumab to evaluate the long-term efficacy, safety and tolerability up to four years in patients with jpsa and era is currently ongoing. see- "efficacy and safety of secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: primary results from a randomised, double-blind, placebo-controlled, treatment withdrawal, phase iii study (junipera)". presented as a late-breaking abstract at eular 2021. abstract lb0004.></50></.001)>

Condition: Juvenile Idiopathic Arthritis
Type: drug

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