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.
For more information visit novartis.com.
This article originally appeared on MPR