Novartis PREVENT data show Cosentyx helps patients realize early and lasting relief in axial spondyloarthritis

• Phase III PREVENT data show Cosentyx 150 mg provided significant and sustained improvement in signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) up to Week 52¹
   
• nr-axSpA is the fourth EU indication for Cosentyx, providing patients in Europe with a first-in-class treatment that addresses the axial spondyloarthritis (axSpA) disease spectrum
   
• There are approximately 1.7 million patients with nr-axSpA in the top five EU countries and US²
   
• PREVENT is the largest ever study of a biologic in patients with nr-axSpA; data reinforce Cosentyx leadership in rheumatology and immuno-dermatology

Basel, June 4, 2020 — Novartis, a leader in rheumatology and immuno-dermatology, today announced the full 52-week results from the Phase III PREVENT trial, which reinforce the substantial and sustained benefits of Cosentyx (secukinumab) across the axial spondyloarthritis (axSpA) spectrum.

The study found patients treated with Cosentyx 150 mg showed significant and sustained improvements in signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) at 52 weeks. nr-axSpA is a painful and debilitating condition affecting 1.7 million people in the top five EU countries and the US². However, because nr-axSpA is underdiagnosed, with an average delay in diagnosis of more than seven years, that number may be higher³.

“Axial spondyloarthritis can have a serious impact on a patient’s quality of life and ability to carry out everyday tasks. PREVENT demonstrated the efficacy and safety of secukinumab in non-radiographic axial spondyloarthritis, showing early and sustained relief from the signs and symptoms of this often painful disease,” said Jürgen Braun, MD, Professor of Rheumatology at Ruhr-University Bochum, Germany, and an investigator in the secukinumab clinical trial program.

The PREVENT trial met its primary endpoint of 40% improvement in the Assessment of Spondyloarthritis International Society (ASAS40) in biologic treatment-naïve patients at Week 16 and Week 52 versus placebo (41.5% vs 29.2%: P<0.05 and 35.4% vs 19.9%: P<0.05), respectively when a loading dose was used. Secondary endpoints indicating improvements in pain, mobility and health-related quality of life were also met in the trial up to Week 52. The trial demonstrated a safety profile consistent with previous clinical trials with no new safety signals reported¹. The PREVENT data are being presented at the Annual European Congress of Rheumatology (EULAR) e-congress 2020.