If FDA approved for children, secukinumab (Cosentyx) will be the first biologic treatment for children in the US living with enthesitis-related arthritis.
Results from the phase III JUNIPERA study showed that in children and adolescents with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA), secukinumab efficacy had a significantly longer time to flare with consistent improvement of symptoms up to week 104 compared with a placebo, Novartis announced in a news release.
The 2-year JUNIPERA study evaluated efficacy and safety of secukinumab in patients with active ERA and JPsA using a randomized, double-blind, placebo-controlled flare prevention design from week 12 to week 104.
Secukinumab, marketed as Cosentyx, was used to treat patients with these 2 conditions that are categories of juvenile idiopathic arthritis (JIA). ERA is a pediatric correlate of axial spondyloarthritis (axSpA) and JPsA is a pediatric correlate of adult psoriatic arthritis (PsA).
“If left untreated, ERA and JPsA can have a substantial negative impact on quality of life and may lead to deformities and long-term disability for children and adolescents who live with these conditions,” said Hermine Brunner, MD, MSc, MBA, lead investigator of the JUNIPERA study. “It is promising that the JUNIPERA study shows that secukinumab demonstrated marked responses in patients with ERA and JPsA, a population that currently has limited treatment options available to help improve joint inflammation, dactylitis and enthesitis.”
According to the news release, secukinumab has shown efficacy and safety in adult patients with PsA, non-radiographic axSpA, and ankylosing spondylitis. The goal of the JUNIPERA study was to evaluate the efficacy and safety of the drug.
“The safety profile was consistent with that of Cosentyx in adults with plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis,” the news release said.
The study included 52 children and adolescents between ages 2 and 17 with active ERA (mean age 13.7) and 34 with active JPsA (mean age 12.2). The results showed that patients treated with secukinumab had a significantly longer time to flare, with a 72% reduced risk (P < .001) compared with placebo.
In the first week, more than 30% of patients showed improvement with secukinumab, with the improvement meeting criteria for JIA American College of Rheumatology (ACR) 30 (exhibiting ≤30% improvement in the ACR JIA response criteria) At 12 weeks—the end of the first treatment period—nearly 90% of patients achieved JIA ACR 30 and nearly 35% (86) achieved JIA ACR inactive disease status.
“Improvements in disease activity, as measured by the mean juvenile arthritis disease activity score (JADAS 27), were observed at Week 1, reaching low disease activity from Week 12 through Week 104,” the release said.
Novartis has submitted secukinumab for FDA and European Medicines Agency (EMA) approval for ERA and JPsA. The agencies are expected to make a decision in the coming months. If approved, secukinumab will be the first biologic treatment for children in the United States living with ERA.