A phase 3 trial evaluating the efficacy and safety of secukinumab in patients with non-radiographic axial spondyloarthritis (nr-axSpA) met its 16-week primary end point, according to Novartis.
The PREVENT trial is an ongoing 2-year placebo-controlled study that enrolled patients with active nr-axSpA who had been on at least 2 different nonsteroidal anti-inflammatory drugs with an inadequate response (N=555). Patients were randomized to receive secukinumab 150mg subcutaneously (SC) monthly with a loading dose (secukinumab 150mg weekly for 4 weeks), secukinumab 150mg SC monthly with no loading dose, or placebo.
The primary end point of the study was the proportion of patients achieving ASAS40, an Assessment of SpondyloArthritis International Society criteria response defined as an 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 at weeks 16 and 52.
Results showed that at week 16, treatment with secukinumab led to a significant and clinically meaningful reduction in disease activity, compared with placebo; 52-week data to support FDA submission for this indication is expected later this year, according to the Company. With regard to safety, a favorable profile was observed and consistent with previous clinical trials of secukinumab.
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.