Novartis has reported that the ongoing Phase III PREVENT clinical trial of Cosentyx (secukinumab) has met its primary endpoint in non-radiographic axial spondyloarthritis (nr-axSpA) patients.
PREVENT is a randomised, double-blind, placebo-controlled trial evaluating the safety and efficacy of the drug in 555 adult patients.
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The trial enrolled patients on at least two different non-steroidal anti-inflammatory drugs (NSAIDs) up to four weeks before the study was initiated.
The primary endpoints of the trial are the proportion of patients experiencing an ASAS40 response with 150mg Cosentyx at weeks 16 and 52.
Data showed that the endpoint at week 16 was met, with 42.2% of patients in the Cosentyx group achieving a significant and clinically meaningful decrease in disease activity compared to 29.2% on placebo.
Investigators also reported statistically significant improvements in secondary endpoints, including pain, mobility and health-related quality of life.
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By GlobalDataThe safety profile of the drug was consistent with previous studies, without any new safety signals.
axSpA is an inflammatory disorder that leads to chronic back pain and could impair activity.
Novartis Immunology, Hepatology & Dermatology global development unit head Eric Hughes said: “These data strengthen the evidence for Cosentyx as a treatment option that addresses the complete axSpA disease spectrum.
“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.”
The company filed an application with the European Medicines Agency (EMA) for the approval of Cosentyx to treat nr-axSpA. Novartis also intends to seek US Food and Drug Administration (FDA) approval.
If approved, nr-axSpA would be the fourth indication, expanding the drug’s use in ankylosing spondylitis (AS), psoriasis and psoriatic arthritis treatment.
