Novartis Cosentyx positive 16-week PREVENT results advance potential new indication for patients with axial spondyloarthritis

  • Phase III PREVENT study met 16-week primary endpoint of ASAS40 in patients with active non-radiographic axial spondyloarthritis (nr-axSpA). All secondary endpoints were also met
  • Novartis has submitted to EMA for approval in nr-axSpA, which would be the fourth indication for Cosentyx. 52-week data from the PREVENT study, to support FDA submission, are expected later in the year
  • There are approximately 1.7 million patients with nr-axSpA in the EU and US. nr-axSpA forms part of the axial spondyloarthritis (axSpA) spectrum and is characterized by chronic inflammatory back pain and symptoms such as nocturnal pain, morning stiffness and impaired quality of life [4,5]
  • The PREVENT study underlines Cosentyx leadership and is a step forward in providing patients with a treatment that addresses the complete axSpA disease spectrum

Basel, September 17, 2019 - Novartis, a leader reimagining rheumatology and immuno-dermatology, today announced positive new data from the PREVENT trial evaluating the efficacy and safety of Cosentyx (secukinumab) in patients with nr-axSpA (non-radiographic axial spondyloarthritis). The ongoing Phase III trial met its primary endpoint of ASAS40 at Week 16, showing a significant and clinically meaningful reduction in disease activity for patients treated with Cosentyx versus placebo. The trial demonstrated a favorable safety profile consistent with previous clinical trials [1,6,7,8].

"These study results for Cosentyx build on our long-standing experience in ankylosing spondylitis and are a step toward a new treatment option that could allow patients to realize relief much earlier in axial spondyloarthritis," said John Tsai, M.D., Head of Global Drug Development and Chief Medical Officer for Novartis. "If approved, this would be the fourth indication for Cosentyx."

Detailed data is planned to be presented at a future scientific congress. These data add to the existing evidence supporting Cosentyx as a rapid and long-lasting comprehensive treatment, backed by evidence from over 100 studies, across axial spondyloarthritis, psoriatic arthritis and psoriatic disease, with over 250,000 patients treated worldwide [9,10].

About axSpA
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 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