A Phase III study of Novartis’ Cosentyx (secukinumab) in patients with non-radiographic axial spondyloarthritis (nr-axSpA) has met its primary endpoint of ASAS40.
The randomised, double-blind, placebo-controlled study, dubbed PREVENT, met its primary endpoint at week 52, demonstrating a sustained response in patients with nr-axSpA.
A total of 555 male and female adult patients were enrolled in the study, with 501 being biologic-naive.
Novartis said patients were allocated to receive either Cosentyx 150mg subcutaneously with a loading dose, Cosentyx 150mg without a loading dose, or placebo.
Secondary endpoints include a change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) over time and change in the Ankylosing Spondylitis Disease Activity Score with CRP.
Novartis head of global drug development and chief medical officer John Tsai said: “These data are encouraging for people living with nr-axSpA, where there are only limited treatment options available.
“It’s a great example of how we’re working to reimagine medicine to help patients realise early relief from this disease.”
The Phase III PREVENT study data follows the previous positive data from week 16 of the trial, which has been submitted to the European Medicines Agency to support approval of Consentyx.
It adds to the five years of clinical data supporting the efficacy of the drug in ankylosing spondylitis, psoriatic arthritis and psoriasis.
axSpA is a spectrum of long-term inflammatory disease characterised by chronic inflammatory back pain. It is estimated that there are about 1.7 million patients with nr-axSpA in the US and EU.