Novartis Announces Positive Phase III JUNIPERA Trial Results for Cosentyx in Pediatric Patients with Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis

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Recently, Novartis announced new analysis data from the Phase 3 JUNIPERA study, confirming the treatment response of the anti-inflammatory drug Cosentyx (brand name: secukinumab) in pediatric and adolescent patients with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA). The safety profile of Cosentyx in these conditions is consistent with its safety profile in adult patients with plaque psoriasis, psoriatic arthritis, radiographic negative axial spondyloarthritis, and ankylosing spondylitis. ERA and JPsA are two major subtypes of juvenile idiopathic arthritis (JIA). Globally, approximately 2 million children have been diagnosed with JIA.

JUNIPERA is a 2-year, three-part, double-blind, placebo-controlled, randomized withdrawal Phase III clinical study that enrolled 86 pediatric and adolescent patients aged 2 to 17 years who were diagnosed with JPsA or ERA according to the classification criteria of the International League of Associations for Rheumatology (active ERA patients, n=52, mean age: 13.7 years; active JPsA patients, n=34, mean age: 12.2 years).

During the first treatment period of the study, all patients received open-label treatment with Cosentyx 75mg/150mg (prefilled syringe, 75mg dose for patients weighing <50kg and 150mg dose for patients weighing ≥50kg) until week 12. Patients who achieved at least a JIA ACR 30 response during this treatment period subsequently entered the second treatment period of the study. In the second treatment period, patients were divided into two groups, receiving either Cosentyx 75mg/150mg (depending on body weight) or placebo, and their treatment responses were observed until week 104.

The primary endpoint of the study was the time to disease flare during Treatment Period 2 (Week 12 to Week 104). Secondary endpoints during Treatment Period 1 (Week 0 to Week 12) included assessments of JIA ACR 30/50/70/90/100 responses and each JIA ACR core component, changes in Juvenile Arthritis Disease Activity Score (JADAS 27) relative to baseline, as well as total enthesitis and dactylitis counts.

Two-year results from the study indicate that patients treated with Cosentyx experienced a significant delay in disease flare. The risk of disease flare was reduced by 72% in the Cosentyx group compared to the placebo group (p<0.001). In the first week, over 30% of patients in the Cosentyx group showed symptom improvement (achieving JIA ACR30 response), and nearly 90% of patients reached JIA ACR30 response by the end of the first treatment period (12 weeks). Additionally, by week 12, nearly 35% of patients (N=86) achieved JIA ACR inactive disease status. Improvement in disease activity, based on the JADAS 27 average score, was observed as early as the first week, reaching low disease activity from week 12 to week 104. The safety profile in this pediatric population was consistent with the known safety profile of Cosentyx.

If left untreated, ERA and JPsA will significantly negatively impact the quality of life of pediatric patients and may lead to deformities and long-term disabilities. The above research findings confirm that Cosentyx is highly effective in treating ERA and JPsA in pediatric patients. Currently, treatment options that can help improve arthritis, dactylitis, and enthesitis in this population are very limited.

Novartis has submitted regulatory applications for Cosentyx in the treatment of ERA and JPsA in Europe and the United States, with review results expected within the next few months. Currently, the U.S. FDA is conducting a priority review of these two indications. If approved, Cosentyx will become the first biologic in the U.S. to treat pediatric patients with ERA.

The development of pediatric indications is an important part of the Cosentyx clinical development program. In July 2020, Cosentyx received approval in the EU as a first-line systemic treatment for pediatric psoriasis, and has recently also been approved in the United States and China. In Japan, Cosentyx has also been approved for the treatment of psoriatic arthritis and psoriasis patients aged 6 years and above.

Reference Source: Novartis Presents Positive Phase III Results for Cosentyx® in Children with Active Enthesitis-Related Arthritis (ERA) and Juvenile Psoriatic Arthritis (JPsA) at ACR 2021