Novartis has announced detailed results from its Phase III PREVENT trial, evaluating the efficacy and safety of Cosentyx (secukinumab) in patients with non-radiographic axial spondyloarthritis (nr-axSpA).
The company revealed that the ongoing trial met its primary endpoint – defined as ASAS40 – at week 16, with 42.2% of nr-axSpA patients treated with 150mg of Cosentyx showing a significant and clinically meaningful reduction in disease activity, compared to placebo.
In addition to the primary endpoint, secondary endpoints of pain, mobility and health-related quality of life were also met, and the trial showed a sustained response and a safety profile consistent with previous clinical trials.
The trial is the largest ever study of a biologic in patients with nr-axSpA, with 555 patients enrolled in the study, 501 (90.3%) who were biologic naïve.
The data “strengthen the evidence for Cosentyx as a treatment option that addresses the complete axSpA disease spectrum,” said Eric Hughes, global development unit head, Immunology, Hepatology & Dermatology, Novartis.
He continued, “As the largest ever study of its kind in nr-axSpA, PREVENT is an example of how we’re working to reimagine medicine for improved patient outcomes.”
Novartis has also submitted to the European Medicines Agency (EMA) for approval in nr-axSpA, which would be the fourth indication for Cosentyx, and the full data add to 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.
AxSpA is a spectrum of long-term inflammatory disease characterised by chronic inflammatory back pain, including 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.