- Phase III PREVENT study met 52-week primary endpoint of ASAS40, showing a sustained response in patients with non-radiographic axial spondyloarthritis (nr-axSpA)
- Novartis plans FDA submission for nr-axSpA, having submitted to EMA previously. This would be the fourth indication for Cosentyx ,
- PREVENT underlines Cosentyx leadership and is a step forward in providing patients with a treatment that addresses the complete axSpA disease spectrum
- There are approximately 1.7 million patients with nr-axSpA in the US and EU
Basel, October 02, 2019 - Novartis, a leader in rheumatology and immuno-dermatology, today announced additional positive data from the PREVENT trial, evaluating the efficacy and safety of Cosentyx (secukinumab) in patients with non-radiographic axial spondyloarthritis (nr-axSpA). The ongoing Phase III trial met its primary endpoint of ASAS40 at Week 52, showing a significant and clinically meaningful reduction in disease activity for patients treated with Cosentyx versus placebo. The trial demonstrated a sustained response and a safety profile consistent with previous clinical trials. No new safety signals were detected ,[5-10].
Positive 16-week PREVENT data were announced mid-September and submitted to EMA for approval in nr-axSpA. These data add to the five-years of clinical data supporting the long-term efficacy and safety of Cosentyx across ankylosing spondylitis, psoriatic arthritis and psoriasis[5-10].
"Non-radiographic axial spondyloarthritis is a chronic debilitating disease, which left untreated can have a significant impact on patients’ quality of life," said Atul Deodhar, MD, professor of medicine and medical director of Rheumatology Clinics at Oregon Health & Science University, and an investigator in the secukinumab clinical trial program. "These positive results indicate a potential new treatment option to help patients experience relief from the signs and symptoms of their disease."
"These data are encouraging for people living with nr-axSpA, where there are only limited treatment options available," said John Tsai, M.D., Head of Global Drug Development and Chief Medical Officer for Novartis. "It’s a great example of how we’re working to reimagine medicine to help patients realize early relief from this disease."
Detailed data is planned to be presented at a future scientific congress.
Axial spondyloarthritis (axSpA) is a spectrum of long-term inflammatory disease characterized by chronic inflammatory back pain. The axSpA disease spectrum includes ankylosing spondylitis (AS), in which joint damage is generally visible on x-ray, and non-radiographic axial spondyloarthritis (nr-axSpA), in which joint damage is not visible on x-ray , . Both parts of the disease spectrum have a similar symptom burden, including nocturnal pain, fatigue, morning stiffness and functional disability. If left untreated, axSpA could impair activity, lead to lost work time and have a significant impact on quality of life.
PREVENT is an ongoing two-year randomized, double-blind, placebo-controlled Phase III study (with a two-year extension phase) to investigate the efficacy and safety of Cosentyx, in patients with active nr-axSpA. The study enrolled 555 male and female adult patients with active nr-axSpA (with onset before 45 years of age, spinal pain rated as