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Novartis: Phase III PREVENT Trial Met Primary Endpoint Of ASAS40 At Week 16

Swiss drug major Novartis AG (NVS) announced detailed results from the Phase III PREVENT trial that evaluates the efficacy and safety of Cosentyx, or secukinumab, in patients with non-radiographic axial spondyloarthritis or nr-axSpA.

According to Novartis, the ongoing trial met its primary endpoint of ASAS40 at Week 16, with 42.2 percent of nr-axSpA patients treated with Cosentyx 150 mg showing a significant and clinically meaningful reduction in disease activity compared to placebo.

ASAS40 is achieved when there is a measure of an improvement of at least 40 percent and an improvement of at least 10 units on a 0 to 100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation.

The trial also demonstrated statistically significant improvements in secondary endpoints, including pain, mobility and health-related quality of life.

The trial showed a sustained response and a safety profile consistent with previous clinical trials and no new safety signals were detected.

"The PREVENT study showed clinically significant outcomes as early as week three, and these were maintained up to one year for patients treated with Cosentyx. Non-radiographic axial spondyloarthritis can have a debilitating symptom burden, and if approved, this would be a welcome addition to the limited treatment options currently available to treat this condition," said Atul Deodhar, professor of medicine and medical director of Rheumatology Clinics at Oregon Health & Science University, USA, and lead author for the trial.

Axial spondyloarthritis or axSpA is a spectrum of long-term inflammatory disease characterized by chronic inflammatory back pain.

The axSpA disease spectrum includes ankylosing spondylitis or AS, in which joint damage is visible on x-ray, and non-radiographic axial spondyloarthritis or nr-axSpA, in which joint damage is not visible on x-ray.

Novartis recently said it has submitted to the EMA and plans to submit to the FDA for approval in nr-axSpA. It would be the fourth indication for Cosentyx, which is backed by five-year sustained efficacy and safety data across AS, psoriasis and psoriatic arthritis.

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