Treatment with Novartis’ Cosentyx (secukinumab) significantly reduced disease activity compared to placebo in patients with non-radiographic axial spondyloarthritis (nr-axSpA), according to new data from the Phase 3 PREVENT trial.
The trial achieved its primary endpoint (goal) of Assessment of Spondyloarthritis International Society response criteria (ASAS40) — defined as an improvement of at least 40% and an increase of at least 10 units (on a scale of 0 to 100) in at least three of four main ASAS domains — at one year (52 weeks) of treatment.
The company announced earlier that Cosentyx achieved its 16-week primary endpoint as well as all secondary endpoints. The treatment’s favorable safety profile was similar to that seen in previous clinical studies.
Novartis now plans to request approval of Cosentyx for nr-axSpA to the U.S. Food and Drug Administration (FDA). The company has already submitted a similar request for approval to the European Medicines Agency.
Axial spondyloarthritis (axSpA) is a type of arthritis that mainly affects the joints of the spine, causing chronic pain and lifelong physical disability. The disease can be categorized into ankylosing spondylitis (AS), when joint damage is visible through imaging techniques called radiographs (commonly called X-rays), or non-radiographic axial spondyloarthritis (nr-axSpA), when joint damage is not visible on plain-film radiographs.
Cosentyx is a human monoclonal antibody that inhibits a pro-inflammatory cytokine (signaling molecule) called interleukin-17A, preventing exacerbated inflammation and immune reactions in chronic inflammatory diseases.
“Non-radiographic axial spondyloarthritis is a chronic debilitating disease, which left untreated can have a significant impact on patients’ quality of life,” Atul Deodhar, MD, an investigator in the Cosentyx clinical trial program and a professor at Oregon Health & Science University, said in a press release.
“These positive results indicate a potential new treatment option to help patients experience relief from the signs and symptoms of their disease,” he added.
The PREVENT study (NCT02696031) is an international, 176-center trial evaluating the effectiveness and safety of Cosentyx compared to a placebo in patients with active nr-axSpA.
A total of 555 adults with active nr-axSpA undergoing treatment with at least two non-steroidal anti-inflammatory drugs (NSAIDs) up to four weeks before the study start were enrolled. Patients also could have been previously treated with an anti-TNF (tumor necrosis factor) therapy, but had had an inadequate response to it. Most of those enrolled (90%) were naive to biologic treatments.
Patients were randomized to either Cosentyx injected subcutaneously (under the skin) as a 150 mg monthly dose, with or without an induction phase (150 mg administered weekly for four weeks), or to a placebo.
The trial’s primary objective was to determine the proportion of patients who met ASAS40 at weeks 16 and 52, as a measure of efficacy.
Additional (secondary) endpoints included improvements in disease activity as measured by the AS Disease Activity Score (ASDAS)-CRP and the Bath AS Disease Activity Index (BASDAI) SCORES.
These new results will be presented in future medical meetings.
“These data are encouraging for people living with nr-axSpA, where there are only limited treatment options available,” said John Tsai, MD, head of global drug development and chief medical officer of Novartis. “It’s a great example of how we’re working to reimagine medicine to help patients realize early relief from this disease.”