Novartis Announces Positive Phase 3 Results for Cosentyx in Non-Radiographic Axial Spondyloarthritis, Paving Way for New Indication

Today, Novartis announced that Cosentyx (secukinumab), the world’s first approved fully human anti-IL-17A monoclonal antibody, met the primary endpoint and all secondary endpoints in the Phase 3 PREVENT clinical trial for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA). Novartis expects to submit a regulatory application to the U.S. Food and Drug Administration (FDA) later this year. If approved, this would mark the fourth indication for Cosentyx. Previously, Novartis had already submitted an application for this indication to the European Medicines Agency (EMA).

Axial Spondyloarthritis (axSpA) is a form of spondyloarthritis that affects the pelvic joints and spine, manifesting as chronic inflammatory back pain, spinal stiffness, and impaired skeletal function and mobility. In its most severe cases, inflammation can lead to new bone formation, causing spinal segments to fuse in a fixed, immobile position. Based on whether radiographic damage to the sacroiliac joints is detectable by X-ray, axSpA is classified into two categories: non-radiographic axial spondyloarthritis (nr-axSpA) and radiographic axial spondyloarthritis (r-axSpA). nr-axSpA is often difficult to diagnose, resulting in delayed diagnosis and challenges in receiving appropriate treatment for many patients.

Cosentyx is the first fully human biologic agent that directly inhibits IL-17A. IL-17A (interleukin-17A) is a core pathogenic factor involved in inflammation and disease progression in psoriatic arthritis (PsA), ankylosing spondylitis (AS), and psoriasis, playing a key role in their pathogenesis. Cosentyx specifically binds to IL-17A from any source without interfering with the normal function of other cytokines. Due to its precise targeting and the enhanced safety profile associated with fully human antibodies, this drug demonstrates rapid and sustained efficacy and safety in the treatment of inflammatory diseases. Currently, Cosentyx has been approved for the treatment of PsA, AS, and psoriasis, and is being evaluated in clinical trials for other inflammatory conditions.

A total of 555 adult patients with non-radiographic axial spondyloarthritis (nr-axSpA) participated in this 2-year, randomized, double-blind, placebo-controlled Phase 3 clinical study. The study aimed to evaluate the efficacy and safety of Cosentyx in the treatment of patients with nr-axSpA. Trial results demonstrated that, compared with placebo, patients treated with Cosentyx experienced a statistically significant and clinically meaningful reduction in disease activity. At 16 weeks, the proportion of patients achieving Assessment of SpondyloArthritis international Society 40% improvement criteria (ASAS40) was significantly higher than that in the control group, thereby meeting the primary endpoint of the trial. Cosentyx also met all secondary endpoints. ASAS40 represents a 40% improvement in signs and symptoms of the disease, such as pain, inflammation, and function. Furthermore, Cosentyx exhibited a safety profile consistent with previous trials. Detailed data from this trial will be presented at future medical conferences.

“These positive study results for Cosentyx build upon our extensive long-term research experience in axSpA. This also marks another step forward in our commitment to improving outcomes for patients with axSpA,” said Dr. John Tsai, Global Head of Drug Development and Chief Medical Officer at Novartis. “If approved, this would be the fourth indicated indication for Cosentyx.”

References:

[1] Novartis Cosentyx® positive 16-week PREVENT results advance potential new indication for patients with axial spondyloarthritis，Retrieved September 17, 2019, from https://www.novartis.com/news/media-releases/novartis-cosentyx-positive-16-week-prevent-results-advance-potential-new-indication-patients-axial-spondyloarthritis

[2] Novaritis Official Website，Retrieved September 16, 2019, from https://www.novartis.com/our-science/novartis-global-pipeline?search_api_views_fulltext=Cosentyx&field_pipeline_filing_date=All

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