Results from the ongoing PREVENT phase 3 trial of secukinumab (Cosentyx; Novartis), an interleukin-17A antagonist, found that the treatment met its 52-week primary endpoint of Assessment of SpondyloArthritis International Society criteria 40 (ASA40) response in patients with active nonradiographic axial spondyloarthritis (nr-axSpA).
The trial enrolled 555 nr-axSpA patients who were randomized to receive either secukinumab 150mg subcutaneously monthly with a loading dose (secukinumab 150mg weekly for 4 weeks), secukinumab 150mg SC monthly with no loading dose, or placebo.
Results showed that at Week 52, secukinumab was associated with a significant and clinically meaningful reduction in disease activity compared with placebo, as assessed by ASAS40 response (defined as a measure of improvement of ≥40% and ≥2 units on a scale of 10 in at least 3 of the 4 ASAS main domains and no worsening at all in the remaining domain). According to the Company, full data is expected to be presented at a future scientific congress.
“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 CMO at Novartis. The Company plans to submit a supplemental New Drug Application (sNDA) for secukinumab in nr-axSpA with the Food and Drug Administration.
Secukinumab (Cosentyx), an interleukin-17A antagonist, is currently approved for the treatment of active psoriatic arthritis, ankylosing spondylitis, as well as for moderate to severe plaque psoriasis.
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