- Phase III JUNIPERA study met its primary endpoint, with Cosentyx (secukinumab) showing significantly longer time to flare (longer time to worsening of symptoms1) vs. placebo (P<.001) in pediatric patients with two subtypes of juvenile idiopathic arthritis (JIA)2
- JIA has limited treatment options and affects approximately 2 million children worldwide3,4. Subtypes juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA) are progressive, debilitating diseases associated with high levels of pain and functional disability, affecting children as young as two years old5
- Data follow recent US and EU approval of Cosentyx as a first-line systemic treatment for pediatric psoriasis, reinforcing the commitment of Novartis to the pediatric community
- Cosentyx has approvals across four indications, and is supported by long-term five-year sustained efficacy and safety data across psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with more than 400,000 patients treated worldwide since launch6-9
Basel, June 2, 2021 - Novartis, a leader in rheumatology and immuno-dermatology, today announced 2-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)2. 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) 2.
"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.
"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-summaries-eular
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