Novartis presents positive Phase III results from JUNIPERA study supporting Cosentyx as a potential treatment in a JIA population at EULAR 2021 - Seite 2

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.

“JPsA and ERA are associated with high levels of pain and functional disability, which can impact children as young as two years of age. These new data in pediatric patients are an example of our continued commitment to reimagine the future of rheumatology for those with inflammatory rheumatic diseases,” said Todd Fox, Global Head of Medical Affairs Immunology, Hepatology and Dermatology at Novartis.

Cosentyx is the first and only fully human biologic that directly inhibits interleukin-17A (IL-17A), a cornerstone cytokine involved in the inflammation and development of psoriatic arthritis (PsA), psoriasis and axial spondyloarthritis (axSpA).

Regulatory submissions in Europe and the US are anticipated in the coming weeks. In August 2020, Cosentyx received EU approval as a first-line systemic treatment for pediatric psoriasis and recently received US approval for the same indication.

Plain Language Media Summaries for JUNIPERA and other key abstracts presented at EULAR 2021 are available from the Novartis website: https://www.novartis.com/our-focus/immunology-dermatology/abstract-sum ...

About the JUNIPERA study¹⁰
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.